Technical Guideline For Clinical Evaluation Of Pulse Oximeter Equipment

Appendix 4
Technical Guideline for Clinical Evaluation of
Pulse Oximeter Equipment
This guideline is intended to guide registration applicants in
preparing and writing clinical evaluation data for pulse oximeter
equipment (hereinafter referred to as oximeter) and also to provide a
reference for the technical evaluation department to evaluate the
clinical evaluation data for oximeter. This guideline is a general requirement for clinical evaluation
of oximeter. The applicant shall determine whether the content is
applicable according to the specific characteristics of the product. If
not, the reason and corresponding scientific basis shall be explained
in detail, and the content of clinical evaluation data shall be
enriched and refined according to the specific characteristics of the
product. This guideline is a guideline document for applicants and
reviewers. It does not involve administrative matters such as
registration and approval, nor is it enforced as a regulation. If there
are other methods that can meet the requirements of the laws and
regulations, it can also be used, but detailed study and verification

• 2 –
  document shall be provided. This guideline shall be used in
  accordance with relevant laws and regulations. This guideline is formulated under the current laws and
  regulations, standard systems and current levels of awareness. With
  the continuous improvement of laws and regulations and standard
  systems and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in due
  course. I. Scope
  This guideline applies to pulse oximeter equipment, and the
  classification code in the medical device classification catalogue is
  6821.Pulse oximeter equipment uses light signals to interact with
  tissues, and uses pulsed blood flow to cause time-dependent
  changes in tissue optical properties. It is used to non-invasive
  measure pulse oxygen saturation (SpO2) and pulse rate (PR). Pulse oximeter equipment includes pulse oximeter host, blood
  oxygen probe and probe extension cable (if provided), where probe
  extension cable and blood oxygen probe can be combined into a
  single component. The oximeter described in this guideline contains various
• 3 –
  equipment or systems that are expected to measure and monitor
  pulse oxygen saturation. The oximeter can measure pulse oxygen
  saturation in a single or continuous manner, or it can be an
  independent equipment or integrated in a multi-parameter module
  equipment or system. The oximeter can use transmission, reflection, or scattering mode. The transmission, reflection, or scattering mode
  refers to the geometry of the blood oxygen probe, rather than the
  principle of the oximeter or the mechanism of light on hemoglobin. This guideline does not limit the measurement site of the
  oximeter and the intended use environment. For example, the
  measurement site of the oximeter includes but is not limited to
  hands, fingers, feet, forehead, ears, nose and back, etc. The oximeter
  is expected to be used in medical institutions or in homes. II. Basic Requirements
  The manufacturer shall provide the following information for
  the oximeter:
  (I) Summary Information

1. Clinical mechanism, working principle / action mechanism, realization method, for example, measuring principle of functional
   oxygen saturation or oxyhemoglobin, pulse oxygen saturation;
2. Design features and functions;

• 4 –

1. Special specification parameters and performance indicators, for example, whether the continuously measured oximeter includes
   too low pulse oxygen saturation (oxygen saturation is less than
   70%);
2. Measurement methods of oximeter, for example, single
   measurement or continuous measurement;
3. The structural form of the oximeter, for example, an
   independent equipment or integrated in multi-parameter module
   equipment or system;
4. All patient application parts, such as blood oxygen probes, patient cables, extension cables, sensors, bandages, etc. 7. The measurement form of the patient’s application part, for
   example, transmission, reflection or scattering mode, or fiber optic
   technology;
5. The structure and configuration of blood oxygen probe, the
   raw materials of each part, and the raw materials of parts expected
   to contact with human body;
6. The packaging and number of use of the blood oxygen
   probe, for example, sterilized packaging, disposable or reusable. (II) Application Scope and Relevant Information for Clinical Use
   The manufacturer shall clarify the function and intended use of

• 5 –
  the oximeter, the applicable population, the intended use
  environment and the requirements for the operator in the product
  application scope, and provide the following information:

1. The use environment of oximeter, for example, whether it is
   used at home or in medical institutions, in hospitals or out of
   hospitals, and whether it is used in the transport process inside and
   outside hospitals;
2. Alarm function of oximeter;
3. Use methods of the oximeter;
4. The intended use site of the application part of the patient;
5. Taboos for clinical application;
6. Precautions for the use of oximeter, potential safety hazards
   and use restrictions, possible damage or hazards caused by improper
   use;
7. The protective measures for the operator and the user, and
   the emergency and corrective measures that shall be taken when the
   oximeter has an accident during the correct use. (III) Basic Requirements for Clinical Evaluation
   The manufacturer shall provide clinical evaluation documents
   for pulse oximeter equipment, including the following documents:
8. Clinical evaluation report of pulse oximeter equipment;

• 6 –

1. Clinical study report of oxygen saturation accuracy;
2. Verification report of pulse rate accuracy. (IV) Oximeter as a Multi-parameter Module, Integrated
   Equipment or System
   If the equipment or system integrates the oximeter of a supplier
   that has been approved to the market, without substantially
   changing the oximeter and its permission, the manufacturer of the
   equipment or system shall provide the following data:
3. Clinical evaluation data of the equipment or system on
   pulse oxygen saturation;
4. The number of Registration Certificate for Medical Device
   of the approved oximeter;
5. The clinical study evidence of oxygen saturation accuracy
   and the verification report of pulse rate accuracy of the approved
   oximeter;
6. Verification and validation report of pulse oxygen saturation
   function after integration, for example, the evidence whether the
   integration affects the oximeter module measurement and
   calculation of oxygen saturation and pulse rate and so on. (V) Representativeness of Blood Oxygen Probe
   If the blood oxygen probes have the same composition material

• 7 –
  and photoelectric components, and the same structural form, applicable population, fit mode with human body, use site, specification parameters and performance indicators, the blood
  oxygen probes can be regarded as similar. The manufacturer can
  select the representative blood oxygen probe to verify the oxygen
  saturation accuracy. The manufacturer shall submit all the information on the
  composition materials and photoelectric components of blood
  oxygen probe and shall explain the reasons for the selection of the
  representative blood oxygen probe