PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

Device Description

The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Predicate Device)	Reported Device Performance (PM601)
SpO2 measurement range	70%-100%	70%-100%
SpO2 accuracy	70%~100%, ±3%	< 3% (from clinical study), ±3% (from comparison)
PR measurement range	Similar (Predicate: 30-235 bpm)	30-199 bpm
PR accuracy	±2 bpm or ±2% MAX	±2 bpm or ±2% MAX

2. Sample Size for the Test Set and Data Provenance

Sample Size: 10 healthy volunteers
Data Provenance: Not explicitly stated, but the study was conducted according to a European standard (ISO9919:2005 Annex EE.2), which might suggest it was conducted outside the US, possibly in China where the manufacturer is located, or by a contract research organization adhering to international standards. The text does not specify if it was retrospective or prospective, but the description of "performed according to Annex EE.2 Procedure for invasive laboratory testing" suggests a prospective study.

3. Number of Experts and Their Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. For a pulse oximeter, "ground truth" for SpO2 accuracy is typically established through direct measurement of arterial blood oxygen saturation (SaO2) via co-oximetry, which is considered the gold standard. The text mentions "invasive laboratory testing," which is consistent with this method.

4. Adjudication Method

Not applicable. The ground truth for pulse oximetry accuracy is established by a co-oximeter directly measuring SaO2, not by expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a directly measuring medical device, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The clinical trial focused solely on the accuracy of the PM601 Finger Pulse Oximeter in measuring SpO2 and pulse rate against a 'gold standard' (implied by "invasive laboratory testing" for SaO2), without human interpretation in the loop.

7. Type of Ground Truth Used

The ground truth used was established through "invasive laboratory testing" according to ISO9919:2005 Annex EE.2. In the context of pulse oximetry, this procedure involves inducing varying levels of hypoxia in volunteers and simultaneously measuring arterial blood oxygen saturation (SaO2) using a co-oximeter (the gold standard) and the device under test.

8. Sample Size for the Training Set

Not applicable. This device is a hardware-based medical instrument that directly measures physiological parameters, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Exhibit #9 510(k) Summary

MAY 2 8 2013

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K123801

Prepared Date: March 01, 2013 1.

Sponsor

Shenzhen Kingyield Technology Co., Ltd Bldg C, Fuhai Industrial Zone, Fuhai Road, Fuyong Town, Baoan, Shenzhen, 518103, China

Establishment Registration Number: 3007420856

Contact Person: Dacheng Gong Position: General Manager Tel: 86 755 27326734 Fax: 86 755 27331856 Email: kingvield@kingyield.com

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

4. Proposed Device Identification

Proposed Device Name: Finger Pulse Oximeter Proposed Device Model: PM601 Device Common Name: Pulse Oximeter Classification Name: Oximeter

Classification: 2 Product Code: DQA

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Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

Indications for Use:

ડ. Predicate Device Identification
510(k) Number: K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd
1. Device Description
  The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen.

Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007), Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 80601-2-61:2011. Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO 9919: 2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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8. Clinical Trial Conclusion

The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO9919:2005 Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use on ten healthy volunteers.

It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 3%.

1. Substantially Equivalent

ITEM	Proposed DeviceFinger Pulse Oximeter PM601	Predicate DeviceMD300C1 Fingertip pulse oximeter(K093757)
Product Code	DQA	Same
Regulation No.	21 CFR 870.2700	Same
Class	2	Same
Intended Use	PM601 Finger pulse oximeter isintended for spot-checking oxygensaturation in blood (SpO2) and pulserate. The pulse oximeter is used onadults at hospital, clinics, and/or home.Not for continuously monitoring.	Similar
SpO2measurementrange	70%-100%	Same
SpO2 accuracy	70%~100%, ±3%	Same
PR measurementrange	30-199 bpm	Similar
PR accuracy	±2 bpm or ±2% MAX	Same
Patient ContactMaterial	Silicone	Same
Electrical Safety	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2	Same

Table 111-1 Substantially Equivalent Comparison

The proposed device has the same classification information, similar intended use, same design principle, similar specifications and same safety performance as the predicate device. The difference in intended use and PR measurement range are discussed in the 510(k) submission documents. it is concluded that these differences will not affect the effectiveness and safety of the proposed device. And the results of bench texts and clinical trial have been conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

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The proposed device, Finger Pulse Oximeter PM601; is determined to be Substantially Equivalent (SE) to the predicate device, MD300C1 Fingertip pulse oximeter (K093757), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2013

Shenzhen Kingyield Technology Company, Limited C/O Ms. Diana Hong General Manager MID-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

Re: K123801

Trade/Device Name: Finger Pulse Oximeter PM601 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 17, 2013 Received: April 29, 2013

Dear Ms. Hong:

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. 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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the ` Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Image /page/5/Picture/7 description: The image shows a signature and contact information. The signature is illegible, but the text next to it reads "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID." The image also contains the phrase "Sincerely yours," and the word "FOR" is at the bottom right.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RTA Response for K123801 - Section II Indications for Use

Section II Indications for Use

510(k) Number: K123801 Device Name: Finger Pulse Oximeter PM601

Indications for Use:

&PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

. •

...

OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Neel J. Patel
2013.05.24 16:13:08 -04'00'

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(Division Sign-Off) ിഴിച്ചിട്ടു of Anesthestology, General Hospital teetion Control, Dental Devices

K123801 510(k) Number:

11-1

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).