The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring.

Model S0044D-S (S0012A) is reusable and for patients weighing more than 40 kg.

The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is contraindicated for use on active patients, or during conditions of motion or low perfusion.

Device Description

Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Med-Linket Sensors) are compatible sensors for use with major brands of patient monitors and oximeter devices.

Med-Linket Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors 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 sensor 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.

AI/ML Overview

Acceptance Criteria and Study for Shenzhen Med-Linket™ Adult SpO2 Finger Sensors

As per the provided 510(k) summary, the Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Model S0044D-S) underwent various performance tests to demonstrate substantial equivalence to predicate devices. The primary focus for demonstrating clinical performance was on pulse rate accuracy and SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Pulse Rate Accuracy	Meets specifications defined in 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 sensors meet the published specifications for pulse rate accuracy over the specified range." (Specific numerical criteria of ISO 9919:2005 not provided in the document for direct comparison, but compliance is stated).
Clinical (SpO2 Accuracy)	Meets published specifications for accuracy over the specified range (as determined by comparison to co-oximetry under controlled hypoxia).	"Test results indicated that the sensors meet the published specifications for accuracy over the specified range." (Specific numerical accuracy criteria not provided, but compliance is stated). This implies that the bias and precision within the specified SpO2 range met pre-defined limits typical for pulse oximeters, such as an Arms (Accuracy Root Mean Square) value below a certain threshold (e.g., 2-3% SpO2).
Biocompatibility	Patient contact materials are non-toxic, non-sensitizing, and non-irritating, in accordance with ISO 10993-1: 2003.	"Test results indicated that the patient contact materials were non-toxic, non-sensitizing and non-irritating."
Electrical Safety	Complies with applicable clauses of IEC 60601-1:1988; Am1: 1991; A2: 1995 and ISO 9919: 2005.	"Test results indicated that the sensors comply with the applicable clauses of the Standards."
Electromagnetic Compatibility	Complies with applicable clauses of IEC 60601-1-2:2001.	"Test results indicated that the sensors comply with the applicable clauses of the Standard."
Cleaning	Cleaning instructions do not damage sensor labeling, degrade materials, and sensors remain functional after cleaning.	"Test results indicated that the cleaning instructions do not damage sensor labeling, degrade materials, and that the sensors remain functional after cleaning."
Excessive Temperature	Sensors do not exceed 41°C at the sensor-tissue interface at an ambient temperature of 35°C, in accordance with ISO 9919: 2005.	"Test results indicated that the sensors do not exceed 41°C at the sensor-tissue interface at an ambient temperature of 35°C."
Environmental	Operative and storage temperatures, and random vibration do not damage sensor functionality (tested in accordance with internal protocols).	"Test results indicated that the operative and storage temperatures, and random vibration do not damage sensor functionality."

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample size (number of subjects/patients) used for the clinical performance testing related to SpO2 accuracy. However, it states that "All testing was performed under an institutionally approved protocol with subject informed consent." This indicates a prospective study involving human subjects. The country of origin for the clinical data is not explicitly stated.

For other performance tests like biocompatibility, electrical safety, etc., the "sample size" would refer to the number of devices or material samples tested, which is not detailed in the summary.

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

Not applicable. The clinical ground truth for oxygen saturation (SpO2) was established using co-oximetry, which is an objective measurement from arterial blood samples, not through expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for clinical SpO2 accuracy was established by co-oximetry, which is an objective measurement and does not require an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a sensor component for a pulse oximeter, which provides direct physiological measurements (SpO2 and pulse rate), rather than an interpretive system requiring human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the performance testing for SpO2 and pulse rate accuracy evaluates the standalone performance of the sensor in conjunction with a patient monitor/oximeter device. The clinical testing conducted under controlled hypoxia directly assesses the sensor's ability to accurately measure physiological parameters without human interpretation in the loop.

7. The Type of Ground Truth Used

For SpO2 accuracy, the ground truth used was arterial oxygen saturation as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood. The study involved "controlled hypoxia," where subjects' oxygen levels were intentionally lowered to create a range of SpO2 values that the device would be challenged to measure accurately.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware sensor, not a machine learning or AI-driven system that requires a "training set" for algorithm development. Its functionality is based on established electro-optical principles for pulse oximetry.

9. How the 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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1083010

JUN 1 0 2009

510(k) Summary

Submission Date:	15 September 2008
Submitter:	Shenzhen Med-Link Electronics Tech Co., Ltd.2F, Building A, Liangheng Ind. Zone,LongHua Town, Baoan DistrictShenzhen, Guangdong 518109 China
Submitter Contact:	Shaorong LinMarketing Manager011 86 (755) 61120085011 86 (755) 61120055link03@med-linket.com
Manufacturing Site:	Shenzhen Med-Link Electronics Tech Co., Ltd.2F, Building A, Liangheng Ind. Zone,LongHua Town, Baoan DistrictShenzhen, Guangdong 518109 China
Official Contact:	Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Trade Name:	Shenzhen Med-Linket™ Adult SpO2 Finger Sensors including
	• Model S0044D-S.
Common Name:	Pulse Oximeter Sensor
Classification Name:	Oximeter
ClassificationRegulation:	21 CFR §870.2700
Product Code:	DQA

なる

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SubstantiallyEquivalent Devices:	Shenzhen Med-Linket™Model	Predicate510(k) Number	PredicateManufacturer / Model
	Adult Silicone Soft TipSpO2 Sensor, ModelS0044D-S (S0012A)	K910852*	CSI 975AD-3 AdultReusable Pita SpO2Sensor, 3 foot
	* Please note these 510(k) numbers represent monitors containing a pulse oximetry module in which the predicate sensors were included as accessories.
Device Description:	Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Med-LinketSensors) are compatible sensors for use with major brands of patientmonitors and oximeter devices.
	Med-Linket Sensors are electro-optical sensors which function withoutskin penetration, electrical contact, or heat transfer. The sensors useoptical means to determine the light absorption of functional arterialhemoglobin by being connected between the patient and the patientmonitor or oximeter device. The sensor contains three opticalcomponents: two light emitting diodes (LED) that serve as lightsources and one photodiode that acts as a light detector. The LED andphotodiode are contained in silicon rubber pads.
Intended Use:	Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are indicated foruse in continuous, non-invasive arterial oxygen saturation and pulserate monitoring.
	Model S0044D-S is reusable and for patients weighing more than 40kg.
	Shenzhen Med-Linket™ Adult SpO2 Finger Sensors arecontraindicated for use on active patients, or during conditions ofmotion or low perfusion.
TechnologyComparison:	Med-Linket Sensors employ the same technological characteristics asthe predicate devices to determine arterial oxygen saturation: arteriallyperfused tissue is illuminated sequentially by two wavelengths ofLEDs, and the time varying absorbance of the tissue is measured by aphotodetector.

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Performance Testing:

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and the control control of the control of the control of

BiocompatibilityTesting	Patient contact materials used in Med-Linket Sensors were tested inaccordance with ISO 10993-1: 2003, Biological evaluation of medicaldevices – Part 1: Evaluation and testing for skin surface-contact.limited-duration devices.Test results indicated that the patient contact materials were non-toxic,non-sensitizing and non-irritating.
Electrical Safety	Med-Linket Sensors were tested in accordance with the applicableclauses of IEC 60601-1:1988; Am1: 1991; A2: 1995, Medical electricalequipment - Part 1: General requirements for safety, and ISO 9919:2005. Medical electrical equipment - Particular requirements for thebasic safety and essential performance of pulse oximeter equipment formedical use.Test results indicated that the sensors comply with the applicableclauses of the Standards.
ElectromagneticCompatibilityTesting	Med-Linket Sensors were tested in accordance with the applicableclauses of IEC 60601-1-2:2001, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard:Electromagnetic compatibility - Requirements and tests.Test results indicated that the sensors comply with the applicableclauses of the Standard.
Pulse Rate Accuracy	Med-Linket Sensors were tested in accordance with ISO 9919: 2005,Medical electrical equipment — Particular requirements for the basicsafety and essential performance of pulse oximeter equipment formedical use to ensure that the sensors meet pulse rate accuracyspecifications.Test results indicated that the sensors meet the published specificationsfor pulse rate accuracy over the specified range.
Cleaning	Med-Linket Sensors were tested in accordance with internal protocolsto ensure that the cleaning instructions do not damage sensor labeling,degrade materials, and that the sensors remain functional after cleaning.Test results indicated that the cleaning instructions do not damagesensor labeling, degrade materials, and that the sensors remainfunctional after cleaning.

ExcessiveTemperature	Med-Linket Sensors were tested in accordance with ISO 9919: 2005,Medical electrical equipment — Particular requirements for the basicsafety and essential performance of pulse oximeter equipment formedical use to ensure that the sensors do not exceed 41° C at thesensor-tissue interface at an ambient temperature of 35° C.
	Test results indicated that the sensors do not exceed 41° C at the sensor-tissue interface at an ambient temperature of 35° С.
Environmental	Med-Linket Sensors were tested in accordance with internal protocolsto ensure that the operative and storage temperatures, and randomvibration do not damage sensor functionality.
	Test results indicated that the operative and storage temperatures, andrandom vibration do not damage sensor functionality.
Clinical	Med-Linket Sensors were clinically tested to validate the performanceand accuracy of the sensors under controlled hypoxia versus arterialoxygen saturation as determined by co-oximetry. All testing wasperformed under an institutionally approved protocol with subjectinformed consent.
	Test results indicated that the sensors meet the published specificationsfor accuracy over the specified range.
Conclusion	Based upon a comparison of devices and performance testing results,Med-Linket Sensors are substantially equivalent to the predicatedevices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Med-Link Electronics Tech Company, Limited C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated PO Box 3018 Nederland, Colorado 80466

JUN 1 0 2009

Re: K083010

Trade/Device Name: Shenzhen Med-Linket™ Adult SpO2 Finger Sensor, Model S0044D-S Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 12, 2009 Received: May 13, 2009

Dear Mr. Kroenke:

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.

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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Page 2 - Mr. Kroenke

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 go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Runner

Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, 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):

Device Name:

Indications for Use:

K 083DIO

Shenzhen Med-Linket™ Adult SpO2 Finger Sensor, Model S0044D-S.

The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring.

Model S0044D-S (S0012A) is reusable and for patients weighing more than 40 kg.

The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is contraindicated for use on active patients, or during conditions of motion or low perfusion.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

(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)

y. Schutte

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

510(k) Number: k-083010

Page 1 of 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).