The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused.

Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.

Device Description

The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.

AI/ML Overview

The provided text describes the Unimed Medical Supplies Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) and its acceptance criteria as well as the study that proves it meets those criteria.

Acceptance Criteria and Device Performance

The device's performance is compared against the ISO 80601-2-61 standard for pulse oximeters. The acceptance criteria and reported device performance are presented in the table below:

Table 1: Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (per ISO 80601-2-61)	Reported Device Performance (All Models unless specified)
Measurement Accuracy (SpO2)
SpO2, No Motion	70 – 100%, 2% ARMS, adults/pediatrics	70 – 100%, 2% ARMS, adults/pediatrics
SpO2, Motion	70 – 100%, 3% ARMS, adults/pediatrics	70 – 100%, 3% ARMS, adults/pediatrics
SpO2, Low Perfusion	70 – 100%, 2% ARMS, adults/pediatrics	70 – 100%, 2% ARMS, adults/pediatrics (for UC-200/UC-100)
Measurement Accuracy (Pulse Rate)
Pulse Rate, No Motion	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics
Pulse Rate, Motion	25 – 250 BPM, 4 BPM ARMS, adults/pediatrics	25 – 250 BPM, 4 BPM ARMS, adults/pediatrics
Pulse Rate, Low Perfusion	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics (for UC-200/UC-100)
Display Range
Oxygen Saturation (SpO2)	0-100%	0-100%
Pulse Rate (PR)	25-250 beats per minute (BPM)	25-250 beats per minute (BPM)
Perfusion Index (PI)	0.02-20%	0.02-20%
Display Resolution
SpO2	1%	1%
PR	1 BPM	1 BPM
Other Compliance Standards
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10	ISO 10993-1, ISO 10993-5, ISO 10993-10
Electrical Safety	IEC 60601-1, IEC 60601-1-11	IEC 60601-1, IEC 60601-1-11
EMC	IEC 60601-1-2	IEC 60601-1-2
Photobiological Safety	IEC 62471	IEC 62471
Usability	IEC 60601-1-6, IEC 62366-1	IEC 60601-1-6, IEC 62366-1
Symbols	EN ISO 15223-1	EN ISO 15223-1

Study Proving Acceptance Criteria is Met

The document states that the subject devices (Unimed Pulse Oximeters) are identical to the predicate device (Nariq Bio-Medical Pulse Oximeter, K211632). Therefore, the studies conducted for the predicate device are used to demonstrate the substantial equivalence and compliance of the subject device.

Here's the breakdown of the study details based on the provided text:

1. Sample sized used for the test set and the data provenance:
- The document does not explicitly state the sample size for the test set of the predicate device.
- The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin specified in detail for the clinical data. It generally refers to clinical testing that aligns with ISO 80601-2-61:2017.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The general reference is to compliance with ISO standards, which implies the ground truth methodology as defined in those standards for pulse oximetry accuracy.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. The text indicates that the predicate devices have undergone clinical testing that meets relevant consensus standards (ISO 80601-2-61:2017), which would dictate the clinical study design and ground truth establishment methods for SpO2 accuracy.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable to this device. The device is a pulse oximeter for measuring SpO2 and pulse rate, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance metrics provided (SpO2 and PR accuracy) are inherent to the device's measurement algorithms and sensors. Therefore, the bench and clinical testing of the predicate device assesses the standalone performance of the oximetry technology. No human-in-the-loop component is mentioned for these accuracy measurements.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For SpO2 accuracy claims, the ground truth would typically be established through controlled desaturation studies against a co-oximeter (which provides gold standard arterial blood gas measurements). This is implied by the adherence to ISO 80601-2-61, which outlines these requirements.
7. The sample size for the training set:
- This information is not applicable as the device is not described as an AI/ML product developed with a training set in the conventional sense. Its performance is based on established optical measurement principles.
8. How the ground truth for the training set was established:
- This information is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2022

Unimed Medical Supplies, Inc. Hui Zhang General Manager Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan Shenzhen, Guangdong 518108 China

Re: K222213

Trade/Device Name: Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 10, 2022 Received: November 10, 2022

Dear Hui Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222213

Device Name Pulse Oximeter

Indications for Use (Describe)

Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" above the word "Unimed" in gray letters. To the right of the word "Unimed" is a red oval with a white design inside.

510(k) Summary

In accordance with 21 CFR 807.92 the 510(k) Summary for the Unimed pulse oximeters are provided below.

1. SUBMITTER

Applicant:	Unimed Medical Supplies, Inc.Bld #8,Nangang 3rd Industrial Park, Tangtou, Shiyan, BaoanShenzhen Guangdong, CHINA 518108Tel: +86 755 2669 5165
Contact:	Contact Person: HuiZhangTitle: General ManagerPhone: +86 15013808983Tel: +86 755 2669 5165E-mail: FrankZhang@unimed.cn

Date Prepared: June 24, 2022

2. DEVICE

510(k) Number: K222213

Device Trade Name: Oximeter (including UC-200, UC-201, Pulse UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Classification Name: 21 CFR 870.2700, Oximeter
Regulatory Class: Class II
Product Code, Panel: DQA, Anesthesiology
Reason for Submission: New Application. No prior submission associated with the current submission.
Predicate Device: Nariq Bio-Medical Pulse Oximeter, K211632

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "UNIMED" in a larger, gray font. Below "UNIMED" is the text "medical supplies" also in gray. To the right of the text is a red circle containing a white stylized "UM".

DEVICE DESCRIPTION 3.

The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.

The function difference of models is listed as follows:

Function Difference of Models

Abbreviation description:

A sup: support function
A opt: optional function
n/a: disable/not support function

Function	UC-200	UC-201	UC-202	UC-203	UC-204	UC-100	UC-101	UC-102	UC-103	UC-104
Display Type	OLED	OLED	OLED	OLED	OLED	LED	LED	LED	LED	LED
Key Function	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Automatic Shut-Down	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Low Power Tip	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Low Power Shut-Down	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Display Light Intensity	opt	opt	opt	opt	opt	opt	opt	opt	opt	opt
Direction Rotation	opt	opt	opt	opt	opt	n/a	n/a	n/a	n/a	n/a
SpO2 Parameter	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Pulse Parameter	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Perfusion Parameter	opt	opt	opt	opt	opt	opt	opt	opt	opt	opt
Bargraph	sup	sup	sup	sup	sup	sup	sup	sup	sup	sup
Plethysmogram	sup	sup	sup	sup	sup	n/a	n/a	n/a	n/a	n/a
Battery Display	sup	sup	sup	sup	sup	n/a	n/a	n/a	n/a	n/a
User Menu Setup	opt	opt	opt	opt	opt	n/a	n/a	n/a	n/a	n/a
Trend Graph	opt	opt	opt	opt	opt	n/a	n/a	n/a	n/a	n/a

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "UNIMED" in a larger, gray font. Below "UNIMED" is the text "medical supplies" in a smaller, gray font. To the right of the text is a red circle with a white, stylized "UM" inside.

INTENDED USE/INDICATIONS FOR USE 4.

The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

Pulse Oximeter is intended for hospital-type facilities, home environments.

SUBSTANTIAL EQUIVALENCE 5.

Device Specification

Feature	Specification	Models
Display
Display Range	Oxygen Saturation (SpO2): 0-100%	All models
	Pulse Rate (PR): 25-250 beats per minute (BPM)	All models
	Perfusion Index (PI): 0.02-20%	All models
Display Waveform	Plethysmogram	UC-200/ UC-201/ UC-202/UC-203/UC-204
	Bargraph	All models
Display Resolution	SpO2: 1%	All models
	PR: 1 BPM
Measurement Accuracy in Accordance with ISO80601-2-61
SpO2, No Motion	70 – 100%, 2%, ARMS, adults/pediatrics	All models
SpO2, Motion	70 – 100%, 3% ARMS, adults/pediatrics	All models
SpO2, Low Perfusion	70 – 100%, 2%, ARMS, adults/pediatrics	UC-200/ UC-100
Pulse Rate, No Motion	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics	All models
Pulse Rate, Motion	25 – 250 BPM, 4 BPM ARMS, adults/pediatrics	All models
Pulse Rate, Low Perfusion	25 – 250 BPM, 2 BPM ARMS, adults/pediatrics	UC-200/ UC-100
Power
Internal battery	Alkaline “AAA” batteries	All models

The pulse oximeter specifications are as follows:

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a logo for Unimed medical supplies, a brand of Xinwell. The word "Unimed" is in large, gray, sans-serif font. Below it, the words "medical supplies" are in a smaller, lighter font. To the right of the word "Unimed" is a red oval with a white, stylized "um" inside.

Mechanical
Enclosure Material	Plastic	All models
Dimensions/Weight	62mm × 35mm × 31mm	All models
Weight	Less than 75g (contain battery)	All models
Environmental
Operating Temperature	0°C to +40°C, ambient humidity	All models
Storage Temperature	-20°C to +60°C, ambient humidity	All models
Operating/Storage Humidity	15% to 95%, non-condensing	All models
Atmospheric Pressure	79.5kPa~107.4kPa	All models
Mode of Operation
Mode of Operation	Spot Check	All models

In conclusion, the minor differences of the models do not change the fundamental intended use of the pulse oximeter.

Technological Comparison

The table below compares the key technological feature of the subject devices to the predicate device (the Narig Bio-Medical's Pulse Oximeter, K211632).

Item	Predicate Devices(K211632)	Subject Devices	Comparison
Display
Display Type	OLED display (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204)LED display (FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)	OLED display (UC-200, UC-201, UC-202, UC-203, UC-204)LED display (UC-100, UC-101, UC-102, UC-103, UC-104)	Different
Display Range	Oxygen Saturation (SpO2): 0-100%Pulse Rate (PR): 25-250 beats per minute (BPM)Perfusion Index (PI): 0.02-20%	Oxygen Saturation (SpO2): 0-100%Pulse Rate (PR): 25-250 beats per minute (BPM)Perfusion Index (PI): 0.02-20%	Same
Display Waveform	Plethysmogram (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204)Bargraph	Plethysmogram (UC-200/ UC-201/ UC-202/UC-203/UC-204)Bargraph	Same
Display Resolution	SpO2: 1%PR: 1 BPM	SpO2: 1%PR: 1 BPM	Same
Measurement Accuracy in Accordance with ISO80601-2-61

SpO2, No Motion	70 - 100%, 2%, ARMS, adults/pediatrics	70 - 100%, 2%, ARMS, adults/pediatrics	Same
SpO2, Motion	70 - 100%, 3% ARMS, adults/pediatrics	70 - 100%, 3% ARMS, adults/pediatrics	Same
SpO2, Low Perfusion	Only for FRO-200 / FRO-100	Only for UC-200 / UC-100	Different
	70 - 100%, 2%, ARMS, adults/pediatrics	70 - 100%, 2%, ARMS, adults/pediatrics
Pulse Rate, No Motion	25 - 250 BPM, 2 BPM ARMS, adults /	25 - 250 BPM, 2 BPM ARMS, adults /	Same
	pediatrics	pediatrics
Pulse Rate, Motion	25 - 250 BPM, 4 BPM ARMS, adults /	25 - 250 BPM, 4 BPM ARMS, adults /	Same
	pediatrics	pediatrics
Pulse Rate, Low Perfusion	Only for FRO-200/ FRO-100	Only for UC-200/ UC-100	Different
	25 - 250 BPM, 2 BPM ARMS, adults /	25 - 250 BPM, 2 BPM ARMS, adults /
	pediatrics	pediatrics
Power
Internal battery	Alkaline "AAA" batteries	Alkaline "AAA" batteries	Same
Mechanical
Enclosure Material	Plastic	Plastic	Same
Dimensions/Weight	62mm × 35mm × 31mm	62mm × 35mm × 31mm	Same
Weight	Less than 75g (contain battery)	Less than 75g (contain battery)	Same
Environmental
Operating Temperature	0°C to +40°C, ambient humidity	0°C to +40°C, ambient humidity	Same
Storage Temperature	-20°C to +60°C, ambient humidity	-20°C to +60°C, ambient humidity	Same
Operating/Storage Humidity	15% to 95%, non-condensing	15% to 95%, non-condensing	Same
Atmospheric Pressure	79.5kPa-107.4kPa	79.5kPa-107.4kPa	Same
Mode of Operation
Mode of Operation	Spot Check	Spot Check	Same
Compliance Standards
Bio-compatibility	ISO 10993-1	ISO 10993-1	Same
	ISO 10993-5	ISO 10993-5
	ISO 10993-10	ISO 10993-10
Electrical Safety	IEC 60601-1	IEC 60601-1	Same
	IEC 60601-1-11	IEC 60601-1-11
EMC	IEC 60601-1-2	IEC 60601-1-2	Same

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "Unimed" in a larger, bold font. To the right of "Unimed" is a red oval shape with a white "U" inside. Below "Unimed" is the text "medical supplies" in a smaller font.

Image /page/7/Picture/1 description: The image shows a red oval with white letters inside. The letters appear to be 'u' and 'm' intertwined. The logo is simple and modern, with a focus on the color red.

As seen in the comparison tables, the subject and predicate devices have same design principle, same design features and performance specifications. In conclusion, the different technological characteristics between the subject and predicate devices will not impact the substantial equivalence.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Unimed medical supplies, a brand of Xinwell. The word "Unimed" is written in a gray sans-serif font, with the words "medical supplies" written in a smaller font below. To the right of the word "Unimed" is a red oval with a white design inside.

PERFORMANCE DATA 6.

The devices and the predicate are identical devices. The predicate devices have been conducted functional and system level test. The functional and system level testing showed that the devices continue to meet specifications and meets relevant consensus standards.

Biocompatibility Testing

The devices and the predicate are identical devices. Testing of the predicate devices have been completed per FDA's "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" guidance document and the requirements of ISO 10993-1:2018.

Software Verification and Validation Testing

The predicate devices were tested for Software verification and validation, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the pulse oximeter was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.

Electromagnetic Compatibility and Electrical Safety

The pulse oximeter was assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and . A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
. IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
. IEC 62471: 2006 Photobiological Safety of Lamps and Lamp Systems.

Bench Testing

The device and the predicate are identical devices. The predicate devices have been conducted functional and system level testing. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "Unimed" in a larger, bolder font. To the right of the text is a red oval containing a white stylized design.

IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment-part 1-6: general . requirements for basic safety and essential performance- collateral standard: usability.
IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to ● medical devices.
. ISO 80601-2-61:2011 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment.
EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, . labelling and information to be supplied. General requirements.

Cleaning Validation

Cleaning and disinfection validation testing of the predicate devices were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The test results meet relevant standards. The device and the predicate are identical devices.

Clinical Data

Clinical testing of the predicate devices have shown that pulse oximeters meet relevant consensus standards.

. ISO 80601-2-61:2017 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

SUBSTANTIAL EQUIVALENCE CONCLUSION 7.

The subject and predicate devices are exactly the same. The pulse oximeter is identical to the cleared version and is not modified. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).