Reusable SpO2 Sensors, Disposable SpO2 Sensors

K172981 · APK Technology Co., Ltd. · DQA · Jun 8, 2018 · Cardiovascular

Device Facts

• Record ID: K172981
• Device Name: Reusable SpO2 Sensors, Disposable SpO2 Sensors
• Applicant: APK Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

Device Story

SpO2 sensors function as accessories to non-invasive oximeters; measure arterial oxygen saturation and pulse rate. Input: red and infrared light absorption through patient finger; output: electrical signal forwarded to host oximeter. Operation: two LEDs (red/infrared) emit light through tissue; photodiode detects transmitted light; host oximeter amplifies signal and calculates ratio of oxygenated hemoglobin to total hemoglobin. Used in healthcare settings by clinicians for patient monitoring. Benefits: provides non-invasive, real-time physiological data to support clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Clinical hypoxia testing performed on human adult volunteers. Accuracy of the proposed device validated against arterial oxygen saturation (SaO2) measured via co-oximetry. Results support accuracy claims within the specified saturation range.

Technological Characteristics

Surface-contact device (limited contact <24h). Sensing principle: 2-wavelength optical absorption (Red 660nm, IR 940nm). Components: two LEDs and photodiode. Biocompatibility per ISO 10993-5/10. Electrical safety/EMC per IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-61. Non-sterile.

Indications for Use

Indicated for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in adult, pediatric, or infant patients in healthcare settings using compatible non-invasive oximeter equipment.

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

• Caremed Reusable & Disposable SpO2 Sensors (K153184)

Submission Summary (Full Text)

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June 8, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

APK Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K172981

Trade/Device Name: Reusable SpO2 Sensors, Disposable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 26, 2018 Received: April 30, 2018

Dear Diana 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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K172981

Device Name

Reusable SpO2 Sensors, Disposable SpO2 Sensors

Indications for Use (Describe)

The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 20px;"> <span style="border: 1px solid black; padding: 0px 2px;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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## Exhibit #2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172981

- 1. Date of Preparation: 03/26/2018
- 2. Sponsor

### APK Technology Co., Ltd.

6Floor, B2 Building, Industry of Hengfeng, Hezhou, Xixiang, Bao'an Distric, Shenzhen, China

Establishment Registration Number: 3007699081

Contact Person: Caifang Wang Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

- 4. Identification of Proposed Device
Trade Name: Reusable SpO2 Sensors Disposable SpO2 Sensors

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Common Name: Oximeter (Accessory-sensor)

Regulatory Information Classification Name: Oximeter Classification: Class II Product Code: DQA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

Intended Use Statement:

The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

#### Device Description

The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models.

The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).

#### న్. Identification of Predicate Device

510(k) Number: K153184 Device Name: Caremed Reusable & Disposable SpO2 Sensors

- 6. Non-Clinical Test Conclusion

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Non clinical tests were conducted to verify that the proposed device met all design specifications and to demonstrate Substantially Equivalence(SE) to the predicate device. The test include following items

The performance tests performed on proposed devices include following items

- > Pulse and SpO2 Accuracy test
- > Pulse and SpO2 Accuracy test after High and Low Temperature
- > Pulse and SpO2 Accuracy test after Maximum Times Disinfection

Biocompatibility tests were conducted per ISO 10993-1, the test items include

- ▲ Cytotoxicity Test
- > Skin Irritation Test
- > Skin Sensitization Test

Electrical safety and electromagnetic compatibility test were conducted on proposed devices per IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-61.

- 7. Clinical Test Conclusion
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of proposed device versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

- 8. Substantially Equivalent (SE) Comparison

| ITEM | Proposed device | Predicate Device |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K153184 |
| Product Code | DQA | DQA |
| Regulation<br>Number | 21 CFR 880.2910 | 21 CFR 880.2910 |
| Intended Use | The devices are intended for spot<br>checking or continuous monitoring of<br>functional arterial oxygen saturation<br>and pulse rate in non-invasive<br>oximeter equipment. The sensors are<br>reusable or disposable depending on<br>models, and are intended for adult,<br>pediatric or infant, depending on | Caremed Reusable & Disposable<br>SPO2 Sensors are indicated for<br>continuous non-invasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate(PR)<br>for adult patients weighing greater than<br>40 kg and pediatric patients weighing<br>10-50 kg at hospital facilities |

### Table 1 Comparison of Technology Characteristics

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| | models. They shall be used<br>in healthcare settings. | |
|----------------------------|-------------------------------------------------------|---------------------------------------------|
| Principle of<br>Operation | 2-wavelength Relative Optical<br>Absorption | 2-wavelength Relative Optical<br>Absorption |
| Light Emitting | Red: 660nm<br>Ired: 940nm | Red:660-666nm<br>Ired:880-950nm |
| Signal Detection<br>Method | Photodetector | Photodetector |
| SpO2 Range | 70-100% | 70-100% |
| SpO2 Accuracy | $\pm$ 3% @ 70-100% | $\pm$ 3% @ 70-100% |
| PR Range | 30-245 bpm | 30-250 bpm |
| PR Accuracy | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Sterile | No | No |
| Usage | Reusable & Disposable | Reusable & Disposable |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Performance | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 |
| Biocompatibility | | |
| Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 |
| Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
| Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 |

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.