SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR

K083010 · Shenzhen Med-Link Electronics Tech Co., Ltd. · DQA · Jun 10, 2009 · Cardiovascular

Device Facts

• Record ID: K083010
• Device Name: SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR
• Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The ProFlu™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C. Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture. Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infections with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Story

ProFlu™ Plus is a multiplex Real Time RT-PCR assay for qualitative detection of Influenza A, Influenza B, and RSV nucleic acids. Input consists of nucleic acids isolated from nasopharyngeal swab specimens. The device utilizes the bioMérieux NucliSENS easyMAG system or Roche MagNA Pure LC system for nucleic acid purification, followed by amplification and detection on the Cepheid SmartCycler II Real Time Instrument. The assay provides qualitative results to aid clinicians in differential diagnosis. It is intended for use in clinical laboratory settings by trained personnel. Results are interpreted by healthcare providers to guide patient management, though negative results do not rule out infection and require clinical correlation. The device benefits patients by providing rapid viral identification to inform treatment decisions.

Clinical Evidence

Clinical testing performed under institutionally approved protocol with informed consent. Validated performance and accuracy under controlled hypoxia compared to co-oximetry. Results confirmed sensors meet published accuracy specifications.

Technological Characteristics

Multiplex Real Time RT-PCR assay. Uses bioMérieux NucliSENS easyMAG or Roche MagNA Pure LC for automated nucleic acid extraction. Detection performed on Cepheid SmartCycler II Real Time Instrument. Reagents include specific lysis buffers and magnetic silica for extraction. Connectivity is via the SmartCycler II instrument software (version 1.7b).

Indications for Use

Indicated for symptomatic patients requiring differential diagnosis of Influenza A, Influenza B, and RSV viral infections via nasopharyngeal swab specimens. Prescription use only.

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

• xTAG™ RVP (Respiratory Viral Panel) (k063765)

Submission Summary (Full Text)

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# 1083010

JUN 1 0 2009

### 510(k) Summary

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| Submission Date: | 15 September 2008 |
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| Submitter: | Shenzhen Med-Link Electronics Tech Co., Ltd.<br>2F, Building A, Liangheng Ind. Zone,<br>LongHua Town, Baoan District<br>Shenzhen, Guangdong 518109 China |
| Submitter Contact: | Shaorong Lin<br>Marketing Manager<br>011 86 (755) 61120085<br>011 86 (755) 61120055<br>[e-mail] |
| Manufacturing Site: | Shenzhen Med-Link Electronics Tech Co., Ltd.<br>2F, Building A, Liangheng Ind. Zone,<br>LongHua Town, Baoan District<br>Shenzhen, Guangdong 518109 China |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 |
| Trade Name: | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors including |
| | • Model S0044D-S. |
| Common Name: | Pulse Oximeter Sensor |
| Classification Name: | Oximeter |
| Classification<br>Regulation: | 21 CFR §870.2700 |
| Product Code: | DQA |

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| Substantially<br>Equivalent Devices: | Shenzhen Med-Linket™<br>Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------|
| | Adult Silicone Soft Tip<br>SpO2 Sensor, Model<br>S0044D-S (S0012A) | K910852* | CSI 975AD-3 Adult<br>Reusable Pita SpO2<br>Sensor, 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-Linket<br>Sensors) are compatible sensors for use with major brands of patient<br>monitors and oximeter devices. | | |
| | Med-Linket Sensors are electro-optical sensors which function without<br>skin penetration, electrical contact, or heat transfer. The sensors use<br>optical means to determine the light absorption of functional arterial<br>hemoglobin by being connected between the patient and the patient<br>monitor or oximeter device. The sensor contains three optical<br>components: two light emitting diodes (LED) that serve as light<br>sources and one photodiode that acts as a light detector. The LED and<br>photodiode are contained in silicon rubber pads. | | |
| Intended Use: | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are indicated for<br>use in continuous, non-invasive arterial oxygen saturation and pulse<br>rate monitoring. | | |
| | Model S0044D-S is reusable and for patients weighing more than 40<br>kg. | | |
| | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are<br>contraindicated for use on active patients, or during conditions of<br>motion or low perfusion. | | |
| Technology<br>Comparison: | Med-Linket Sensors employ the same technological characteristics as<br>the predicate devices to determine arterial oxygen saturation: arterially<br>perfused tissue is illuminated sequentially by two wavelengths of<br>LEDs, and the time varying absorbance of the tissue is measured by a<br>photodetector. | | |

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#### Performance Testing:

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| Biocompatibility<br>Testing | Patient contact materials used in Med-Linket Sensors were tested in<br>accordance with ISO 10993-1: 2003, Biological evaluation of medical<br>devices – Part 1: Evaluation and testing for skin surface-contact.<br>limited-duration devices.<br>Test results indicated that the patient contact materials were non-toxic,<br>non-sensitizing and non-irritating. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | Med-Linket Sensors were tested in accordance with the applicable<br>clauses of IEC 60601-1:1988; Am1: 1991; A2: 1995, Medical electrical<br>equipment - Part 1: General requirements for safety, and ISO 9919:<br>2005. Medical electrical equipment - Particular requirements for the<br>basic safety and essential performance of pulse oximeter equipment for<br>medical use.<br>Test results indicated that the sensors comply with the applicable<br>clauses of the Standards. |
| Electromagnetic<br>Compatibility<br>Testing | Med-Linket Sensors were tested in accordance with the applicable<br>clauses of IEC 60601-1-2:2001, Medical electrical equipment - Part 1-<br>2: General requirements for safety - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests.<br>Test results indicated that the sensors comply with the applicable<br>clauses of the Standard. |
| Pulse Rate Accuracy | Med-Linket Sensors were tested in accordance with ISO 9919: 2005,<br>Medical electrical equipment — Particular requirements for the basic<br>safety and essential performance of pulse oximeter equipment for<br>medical use to ensure that the sensors meet pulse rate accuracy<br>specifications.<br>Test results indicated that the sensors meet the published specifications<br>for pulse rate accuracy over the specified range. |
| Cleaning | Med-Linket Sensors were tested in accordance with internal protocols<br>to ensure that the cleaning instructions do not damage sensor labeling,<br>degrade materials, and that the sensors remain functional after cleaning.<br>Test results indicated that the cleaning instructions do not damage<br>sensor labeling, degrade materials, and that the sensors remain<br>functional after cleaning. |
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| Excessive<br>Temperature | Med-Linket Sensors were tested in accordance with ISO 9919: 2005,<br>Medical electrical equipment — Particular requirements for the basic<br>safety and essential performance of pulse oximeter equipment for<br>medical use to ensure that the sensors do not exceed 41° C at the<br>sensor-tissue interface at an ambient temperature of 35° C. |
| | Test results indicated that the sensors do not exceed 41° C at the sensor-<br>tissue interface at an ambient temperature of 35° С. |
| Environmental | Med-Linket Sensors were tested in accordance with internal protocols<br>to ensure that the operative and storage temperatures, and random<br>vibration do not damage sensor functionality. |
| | Test results indicated that the operative and storage temperatures, and<br>random vibration do not damage sensor functionality. |
| Clinical | Med-Linket Sensors were clinically tested to validate the performance<br>and accuracy of the sensors under controlled hypoxia versus arterial<br>oxygen saturation as determined by co-oximetry. All testing was<br>performed under an institutionally approved protocol with subject<br>informed consent. |
| | Test results indicated that the sensors meet the published specifications<br>for accuracy over the specified range. |
| Conclusion | Based upon a comparison of devices and performance testing results,<br>Med-Linket Sensors are substantially equivalent to the predicate<br>devices. |

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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 [phone] or [phone] 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

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