Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.

Device Description

Shenzhen Med-link Pulse Oximeter Probes are electro-optical probes which function without skin penetration, electrical contact, or heat transfer. The probes use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads. These SpO2 probes not made with natural rubber latex.

AI/ML Overview

The Shenzhen Med-Link Pulse Oximeter Probe, model S0136J-L, was tested to ensure its performance and safety, primarily focusing on SpO2 accuracy and pulse rate accuracy.

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 9919:2005)	Reported Device Performance (Shenzhen Med-Link S0136J-L)
SpO2 Accuracy (70-100%):	SpO2 Accuracy (70-100%):
70-100%: ±2% (Predicate device standard)	70-100%: ±3%
70-80%: ±2%	70-80%: ±3%
80-90%: ±2%	80-90%: ±2%
90-100%: ±2%	90-100%: ±2%
Pulse Rate Accuracy (20-250 bpm):	20 to 250 bpm ±3 digits
20 to 250 bpm ±3 digits
Excessive Temperature:
Does not exceed 41°C at probe-tissue interface at 35°C ambient temperature	Does not exceed 41°C at probe-tissue interface at 35°C ambient temperature

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "clinical testing to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." However, it does not specify the exact sample size of subjects used for this clinical test set.

The data provenance is prospective, as indicated by the description of the clinical study, which involved "all testing performed under an institutionally approved protocol with subject informed consent." The country of origin of the data is not explicitly stated, but it can be inferred to be from the location where the clinical study was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth for SpO2 accuracy was determined by "arterial oxygen saturation as determined by co-oximetry." This implies instrumental measurement as the "ground truth" rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set, as the ground truth was established by co-oximetry, which is an objective measurement rather than a subjective interpretation requiring adjudication among experts.

5. 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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a pulse oximeter probe, not an AI-assisted diagnostic tool that requires human interpretation of images or data. Therefore, the concept of human reader improvement with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was conducted for the device. The clinical study evaluated the performance of the Shenzhen Med-link Probe itself in determining SpO2 accuracy under controlled hypoxia, compared to co-oximetry as the reference standard. This is a direct measure of the device's algorithmic performance.

7. The Type of Ground Truth Used:

The ground truth for SpO2 accuracy was arterial oxygen saturation as determined by co-oximetry. This is an objective, instrumental measurement of the true physiological value.

8. The Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. For a medical device like a pulse oximeter, the "training" typically refers to the development and calibration of the internal algorithms based on physiological principles and empirical data, rather than a distinct machine learning training set in the conventional sense. The "clinical testing" described serves as the validation or test set against which the device's performance is measured.

9. How the Ground Truth for the Training Set Was Established:

As no distinct training set for an AI/ML algorithm is described in the context of this traditional medical device, the concept of establishing ground truth for a training set in that manner is not applicable. The device's internal algorithms would have been developed based on established physiological models of light absorption by oxygenated and deoxygenated hemoglobin, and calibrated using data that correlates pulse oximetry readings with gold standard co-oximetry measurements during the device's development process. Details of this development process are not provided in the summary.

Summary

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Premarket Notification 510(K) Summary

The assigned 510(k) number is:	K113727 (applicant leave blank)
Submission Date:	December 6, 2012
Submitter:	Shenzhen Med-link Electronics Tech Co., Ltd.Building 2, HuaFu Ind. Park, Hua Wang Road,LongHua, BaoAn, District 518109 Shenzhen City,P.R.China
Submitter Contact:	Eric ZhanRegulatory Affairs SpecialistPhone Number: 011 86 (755) 61568827Fax Number: 011 86 (755) 61120755E-mail Address: User22@med-linket.com
Device Name/Model:	Shenzhen Med-Link Pulse Oximeter ProbeModel S0136J-L
Common Name:	Pulse Oximeter Probe
Classification Name:	Oximeter
Regulation:	21 CFR §870.2700
Product Code:	DQA
Intended Use:	Shenzhen Med-link disposable probe, model S0136J-L,is indicated for single patient use when continuous,non-invasive arterial oxygen saturation and pulse ratemonitoring are required for adult patients or pediatricpatients weighing more than 30 kg. The S0136J-L iscontraindicated for use with patients during motioncondition.
Predicate Device	Reprocessed Nellcor TM D-25 Oximetry Sensor.K Number: K072194Manufacturer: ReNu Medical, Inc.
Instrumentcompatibility	Instrument Compatibility: Nellcor N595
Shenzhen Med-linkDevice Description:	Shenzhen Med-link Pulse Oximeter Probes areelectro-optical probes which function without skinpenetration, electrical contact, or heat transfer. Theprobes use optical means to determine the lightabsorption of functional arterial hemoglobin by being

MAR 2 1 2013

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connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads. These SpO2 probes not made with natural rubber latex.

Patient contact with materials used in Med-Link Probes

were tested in accordance with ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests

cytotoxicity

and

ISO

vitro

Performance Testing: Biocompatibility Testing

for

Electrical Safety

Electromagnetic Compatibility Testing

Pulse Rate Accuracy

Bench testing

10993-10:2002/Amd1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment I. Test results indicated that the patient contact material were non-toxic, non-sensitizing and non-irritating. Med-Link Probes were tested in accordance with applicable clause of IEC 60601-1:1988; Am1:1991;

A2:1995, Medical electrical equipment-Part 1: General requirements for safety and ISO 9919:2005, Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

Test results indicated that the Probes comply with the applicable clauses of the Standards.

Med-Link Probes were tested in accordance with applicable clause of 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.

Test results indicated that the Probes comply with the applicable clauses of the Standards.

Med-Link Probes were tested in accordance with ISO 9919:2005, Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use to ensure that the probes meet pulse rate accuracy specifications.

Test results indicated that the probes meet the published specifications for pulse rate accuracy over the specified range.

Shenzhen Med-link probe have been conducted the bench testing for the subject device in accordance with FDA Guidance Document for Pulse Oximeters. The

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bench testing include broad band random vibration, ambient temperature testing, in vitro testing for pulse rate accuracy, shock testing, sinusoidal vibration testing , in vitro testing for SpO2 accuracy under low perfusion conditions, in vitro testing for pulse rate accuracy under low perfusion conditions and drop testing. The test results indicated that the bench testing has not produced new issue to affect the safety and effectiveness of the device of S0136J-L.

Excessive Temperature

Shenzhen Med-link Probes were tested in accordance with ISO 9919:2005, Medical electrical equipment --Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use to ensure that the probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35℃.

Test results indicated that the probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35°C.

Shenzhen Med-link Probes were clinically tested to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approval protocol with subject informed consent. Med-link Probes clinical study in accordance with ISO 9919:2005, Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use, ISO 14155-1:2003, Clinical investigation of medical devices for human subjects -Part 1 : General requirements and ISO 14155-2, Clinical investigation of medical devices for human subjects -Part 2: Clinical investigation plans.

Med-Link SpO2 probe employ the same technological characteristics as the predicate devices to determine arterial oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of LEDs, and the time varying absorbance of the tissue is measured by a photodetector.

The comparison of the technological characteristics between the subject device and the predicate device in following table.

Clinical

Technology Comparison:

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Table-1 Comparison of the technological characteristics between the subject device and the predicate device

ComparisonItem	ReNu Medical ReprocessedNellcorTM D-25 OximetrySensor (K072194)	Shenzhen Med-LinkDisposable SpO2 Probe, ModelS0136J-L
Intended use	D-25 continuous non-invasivearterial oxygen saturation andpulse rate monitoring ofpatients >30kg, disposable.	Shenzhen Med-link disposableprobe, model S0136J-L, isindicated for single patient usewhen continuous, non-invasivearterial oxygen saturation andpulse rate monitoring are requiredfor adult patients or pediatricpatients weighing more than 30kg. The S0136J-L iscontraindicated for use withpatients during motion condition.
MeasurementMethod	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption
Light EmittingDiodes (LEDs)wavelengths	RED: 660 nm, nominal;IRED:905 nm, nominal;	RED: 660 nm, nominal;IRED:905 nm, nominal;
Signal DetectionMethod	Photodetector	Photodetector
SpO2 Range	1% to 100% SpO2	70% to 100% SpO2
SpO2 Accuracy(70 - 100%)Without Motion	70-100%: ±2%70-80%:±2%80-90%:±2%90-100%:±2%	70-100%: ±3%70-80%:±3%80-90%:±2%90-100%:±2%
Pulse Rate Range	20 to 250 bpm	20 to 250 bpm
Pulse Rate Accuracy	20 to 250 bpm±3digits	20 to 250 bpm±3digits
Shipped sterile	Yes	No
Compliance	● IEC 60601-1:1988,Aml:1991, Am2:1995● IEC 60601-1-2:2001● ISO 9919:2005● ISO 10993-1:2003,● ISO 10993-5:1999 andISO 10993-10:2006	● IEC 60601-1:1988,Aml:1991, Am2:1995● IEC 60601-1-2:2007● ISO 9919:2005● ISO 10993-1:2003,● ISO 10993-5:1999 and ISO10993-10:2006
EnvironmentConditions	Storage and Transport (Inshipping container)● Temperature:-20 °C to 70 °C● Atmospheric Pressure:50 kPa to 106kPa● Operating Temperature:5 °C to 40 °C● Atmospheric Pressure:50 kPa to 106kPaRelative Humidity:15% to 95% non-condensing	Storage and Transport(In shippingcontainer)● Temperature: -10°C to 40°C● Atmospheric Pressure:86kPa to 106kPa● Operating Temperature:-10°C to 40°C● Atmospheric Pressure:86kPa to106kPaRelative Humidity:0~80% non-condensing
Cable Length	0.45m	0.9m

Conclusion

・

Based upon a comparison of devices and performance testing results, Shenzhen Med-link Probes are substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circular border of the seal. The emblem is black, and the text is also black.

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

March 21, 2013

Shenzhen Med-Link Electronics Tech Company, Limited C/O Ms. Rhonda Alexander, M.S., M.P.A. Senior Regulatory Specialist Registrar Corporation 144 Research Drive HAMPTON VA 23666

Re: KI13727

Trade/Device Name: Shenzhen Med-Link Pulse Oximeter Probe Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: March 12, 2013 Received: March 14, 2013

Dear Ms. Alexander:

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,

ff 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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Act from 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/Industry/default.htm.

Sincerely yours.

Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. To the right of the name is the word "for" in a smaller, plain font. Behind the name is a stylized graphic, possibly a logo or design element, that adds a visual backdrop to the text.

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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Indications for Use

510(k) Number (if known):

K 11 3727

Device Name:

Shenzhen Med-Link Pulse Oximeter Probe

Indications of Use:

Prescription Use _ J AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subparts D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1

ed by Bahram Par ninian Bahram US. Go promont northits le. co-Rahram Parvinian 0300.100.1.1=1300404336 2013.03.18 13:36:12 -04'00

for Lester Schultheis

(Division Sign-Off) (Givision of Anestheslology, General Hospital Infection Control, Dental Devices

. -

510{k) Number:

Page I of I

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).