SHENZHEN MED-LINK PULSE OXIMETER PROBE

K113727 · Shenzhen Med-Link Electronics Tech Co., Ltd. · DQA · Mar 21, 2013 · Cardiovascular

Device Facts

• Record ID: K113727
• Device Name: SHENZHEN MED-LINK PULSE OXIMETER PROBE
• Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 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 Story

Electro-optical pulse oximeter probe; connects patient to compatible monitor (e.g., Nellcor N595). Uses two LEDs (660 nm, 905 nm) and one photodetector to measure light absorption of arterial hemoglobin; determines SpO2 and pulse rate. Single-patient use; non-invasive; no skin penetration or electrical contact. Used in clinical settings; operated by healthcare professionals. Output displayed on host monitor to assist clinical decision-making regarding patient oxygenation status. Benefits include continuous, non-invasive monitoring of vital signs.

Clinical Evidence

Clinical study conducted under controlled hypoxia to validate SpO2 accuracy against co-oximetry reference. Testing performed per ISO 9919:2005, ISO 14155-1:2003, and ISO 14155-2. Bench testing included biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), pulse rate accuracy, and environmental stress testing (vibration, shock, temperature, drop). Results confirmed compliance with standards and published accuracy specifications.

Technological Characteristics

Electro-optical probe; silicon rubber pads; two LEDs (660 nm, 905 nm) and one photodetector. Non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 9919:2005. Biocompatibility per ISO 10993-5 and ISO 10993-10. Cable length 0.9m.

Indications for Use

Indicated for single patient use for continuous, non-invasive arterial oxygen saturation and pulse rate monitoring in adult and pediatric patients weighing >30 kg. Contraindicated for use during patient motion.

Regulatory Classification

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.

Predicate Devices

• Reprocessed Nellcor TM D-25 Oximetry Sensor (K072194)

Submission Summary (Full Text)

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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.<br>Building 2, HuaFu Ind. Park, Hua Wang Road,<br>LongHua, BaoAn, District 518109 Shenzhen City,<br>P.R.China |
| Submitter Contact: | Eric Zhan<br>Regulatory Affairs Specialist<br>Phone Number: 011 86 (755) 61568827<br>Fax Number: 011 86 (755) 61120755<br>E-mail Address: [e-mail] |
| Device Name/Model: | Shenzhen Med-Link Pulse Oximeter Probe<br>Model 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,<br>is indicated for single patient use when continuous,<br>non-invasive arterial oxygen saturation and pulse rate<br>monitoring are required for adult patients or pediatric<br>patients weighing more than 30 kg. The S0136J-L is<br>contraindicated for use with patients during motion<br>condition. |
| Predicate Device | Reprocessed Nellcor ^TM D-25 Oximetry Sensor.<br>K Number: K072194<br>Manufacturer: ReNu Medical, Inc. |
| Instrument<br>compatibility | Instrument Compatibility: Nellcor N595 |
| Shenzhen Med-link<br>Device Description: | Shenzhen Med-link Pulse Oximeter Probes are<br>electro-optical probes which function without skin<br>penetration, electrical contact, or heat transfer. The<br>probes use optical means to determine the light<br>absorption 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

in

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

| Comparison<br>Item | ReNu Medical Reprocessed<br>NellcorTM D-25 Oximetry<br>Sensor (K072194) | Shenzhen Med-Link<br>Disposable SpO2 Probe, Model<br>S0136J-L |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | D-25 continuous non-invasive<br>arterial oxygen saturation and<br>pulse rate monitoring of<br>patients >30kg, disposable. | Shenzhen Med-link disposable<br>probe, model S0136J-L, is<br>indicated for single patient use<br>when continuous, non-invasive<br>arterial oxygen saturation and<br>pulse rate monitoring are required<br>for adult patients or pediatric<br>patients weighing more than 30<br>kg. The S0136J-L is<br>contraindicated for use with<br>patients during motion condition. |
| Measurement<br>Method | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption |
| Light Emitting<br>Diodes (LEDs)<br>wavelengths | RED: 660 nm, nominal;<br>IRED:905 nm, nominal; | RED: 660 nm, nominal;<br>IRED:905 nm, nominal; |
| Signal Detection<br>Method | Photodetector | Photodetector |
| SpO2 Range | 1% to 100% SpO2 | 70% to 100% SpO2 |
| SpO2 Accuracy<br>(70 - 100%)<br>Without Motion | 70-100%: ±2%<br>70-80%:±2%<br>80-90%:±2%<br>90-100%:±2% | 70-100%: ±3%<br>70-80%:±3%<br>80-90%:±2%<br>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,<br>Aml:1991, Am2:1995<br>● IEC 60601-1-2:2001<br>● ISO 9919:2005<br>● ISO 10993-1:2003,<br>● ISO 10993-5:1999 and<br>ISO 10993-10:2006 | ● IEC 60601-1:1988,<br>Aml:1991, Am2:1995<br>● IEC 60601-1-2:2007<br>● ISO 9919:2005<br>● ISO 10993-1:2003,<br>● ISO 10993-5:1999 and ISO<br>10993-10:2006 |
| Environment<br>Conditions | Storage and Transport (In<br>shipping container)<br>● Temperature:<br>-20 °C to 70 °C<br>● Atmospheric Pressure:<br>50 kPa to 106kPa<br>● Operating Temperature:<br>5 °C to 40 °C<br>● Atmospheric Pressure:<br>50 kPa to 106kPa<br>Relative Humidity:<br>15% to 95% non-condensing | Storage and Transport(In shipping<br>container)<br>● Temperature: -10°C to 40°C<br>● Atmospheric Pressure:<br>86kPa to 106kPa<br>● Operating Temperature:<br>-10°C to 40°C<br>● Atmospheric Pressure:<br>86kPa to106kPa<br>Relative Humidity:<br>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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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 [phone] or [phone] or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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:

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.

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)

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510{k) Number:

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