SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg at hospital facilities.

Device Description

The SpO2 Sensors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors. The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Sensors contain finger clip type, soft tip and textile adhesive type. All the sensors will be labeled for compatibility for a specific monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SpO2 Sensor, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	±3% (70-100%)
Pulse Rate Accuracy	±3 (30-250bpm)

Note: The document explicitly states these criteria and performance in the "Comparison to predicate device" section (page 5-6) and confirms that the subject device's accuracy for fingers "meets the requirements of ISO 80601-2-61" (page 6).

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size: 13 human adult volunteers.
Data Provenance: Not explicitly stated, but the study was a "Clinical hypoxia test" performed on "human adult volunteers." This indicates prospective data collection for the purpose of the study. The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth method is specified (co-oximetry), but details about experts establishing this ground truth are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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:

An MRMC study was not performed. This device is an SpO2 sensor (a measurement device), not an AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.

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

A standalone performance study was done in the sense that the device's accuracy was tested directly against an established reference method (co-oximetry) without human interpretation being the primary variable. The device's output (SpO2 and pulse rate) is a direct measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the SpO2 accuracy was "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a recognized reference method for measuring oxygen saturation in arterial blood.

8. The sample size for the training set:

This information is not provided. As this is a sensor (hardware device) and not an AI/software algorithm typically requiring a "training set" in the machine learning sense, such a concept might not apply directly. The document focuses on the sensor's optical principles and signal processing.

9. How the ground truth for the training set was established:

This information is not provided as the concept of a "training set" in the context of machine learning and its associated ground truth establishment is not applicable to this device's description. The device's performance is validated through clinical testing against a reference standard.

Summary

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June 5, 2018

Shenzhen Greatmade Tech limited Mei Mei QA Manager 3th floor, B building, BaiFuli Industrial Zone ShangHengLang, HuaHui Road Shenzhen, CN

Re: K173045

Trade/Device Name: SpO2 Sensor 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 Mei Mei:

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Indications for Use

510(k) Number (if known) K173045

Device Name SpO2 Sensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 6

510(K) Summary

1. Prepared Date: 2018/2/24

2. Submitter Information

Name	Shenzhen Greatmade Tech limited
Address	3th floor , B building , BaiFuli Industrial Zone ,ShangHengLang, HuaHui Road , DaLang Street , LongHua newdistrict , Shenzhen City , GuangDong Province ,China
Tel	86-755-28144774

3. Contact Person

Contact person	Mei
Title	QA manager
Address	3th floor , B building , BaiFuli Industrial Zone ,ShangHengLang, HuaHui Road , DaLang Street ,LongHua new district , Shenzhen City , GuangDongProvince ,China
Tel	0086-755-23463462
Fax	0086-755-29553084
E-mail	Mei_FDA@foxmail.com

4. Proposed Device Information

Trade Name	SpO2 Sensor
Model	AF009, AS009, AF063, AS063, AF024-1, AS024-1, DS024-NB
Common name	Oximeter
Regulatory class	디
Production
requlation	21 CFR §870.2700
Product code	DQA
Panel	Cardiovascular

5. Predicate Device Information

510(K)No.	Trade Name/model	Submitter
K142832	Unimed Disposable And ReusableSpo2 Sensors	Unimed Medical Supplies Inc.

6. Device description

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7. Operation principle& Mechanism of action

The SpO2 Sensors will connect with a compatible patient monitor or a pulse oximeter to continuously, non-invasively monitor the functional arterial oxygen saturation (SpO2) of the patient under stationary state. The SpO2 measurement is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit(Pulse Oximeter). The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of SpO2 measuring unit(Pulse Oximeter). The pleth curve or(and) numeral value of Sp02 will be obtained.

8. Key electrical components description

Spo2 sensor is made up of connector, cable, two specific wavelength LEDs & a photo detector. LED & photo detector are the key electrical components to the subject device. The LED is with wavelength Red: 660-666/Infrared: 880-950m. The minimum breakdown voltage photo detector is 20V and its response time is 50ns.

9. Indications for use

Comparison to predicate device 10.

A comparison of key similarities and differences between the subject devices and the predicate devices (K142832) is provided below

Comparisonitem	Subject Device	Predicate DeviceK142832	Note
Intendeduse&Indicationsfor Use	Spo2 sensors are indicatedfor continuous non-invasivemonitoring of functionaloxygen saturation of arterialhemoglobin (SpO2) andpulse rate(PR) for adult	Unimed Disposable andReusable SPO2 Sensorsare indicated for continuousnon-invasive monitoring offunctional oxygen saturationof arterial hemoglobin	Similar

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K173045

Comparisonitem	Subject Device	Predicate DeviceK142832	Note
patients weighing greaterthan 40kg.	(SpO2) and pulse rate(PR)for adult patients weighinggreater than40kg, pediatricpatients weighing 10 -50 kg,and neonatal patientsweighing no less than 3 Kg.
Measurement Method	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption	Same
LightEmitting	Red: 660-666nm,Ired: 880-950nm	Red: 660-666nm,Ired: 880-950nm	same
SignalDetectionMethod	Photodetector	Photodetector	Same
SPO2Accuracy	±3%(70-100%)	±3%(70-100%)	Same
Pulse RateAccuracy	±3(30-250bpm)	±3(30-250bpm)	Same
Appliedpopulation	Adult(≥40Kg)	Adult(≥30Kg)&Pediatric(10-50Kg)	Similar
Measurement part	Fingers	Fingers or toes	Similar
compatiblemonitor	Nellcor(N395)Ohmeda3800	Nellcor(N395)Ohmeda3700	Similar
Sterility	No	No	Same
Usage	Reusable&disposable	Reusable&disposable	Same
Material	ABS,PVC,TPU,Silicone,3M	ABS,PVC,TPU,Silicone,3M	Same
Cable Length	3.0/1.0 m	3.0/1.1m	Similar
ProximalconnectorDesign	DB9 9pin&Round-head7pin/8p	DB9 9pin&Round-head7pin/8p	Same
DistalconnectorDesign	finger clip , soft tip, textileadhesive	finger clip , soft tip, textileadhesive and spongeadhesive	Similar
Conformancestandard	IEC 60601-1 ,IEC60601-1-2, ISO80601-2-61, ISO10993-5/10	IEC 60601-1 ,IEC60601-1-2, ISO80601-2-61, ISO10993-5/10	Same

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From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method, Sterility, Usage & Conformance standard. There are slightly differences between the subject devices and predicate devices as follows.

Difference clause	Discussion
Intended use&Indications for Use& Appliedpopulation	The subject device is intended use for adultpatients weighing greater than 40Kg. Thepredicate device, which includes 12 models, isintended for adult, pediatric and neonate patients.but both devices are compatible with the samemonitor. This difference does not raise differentquestions of safety and effectiveness.
Measurement part	The subject devices are intended to be used onfingers not toes; the predicate devices will beapplied for fingers and toes. But the spo2 and PRaccuracy of subject device applied for fingersmeets the requirements of ISO 80601-2-61. Thisdifference does not raise different questions ofsafety and effectiveness.
compatible monitor	The subject devices is compatible withNellcor(N395) and Ohmeda3800 monitors. Thepredicate devices is compatible with Nellcor(N395)and Ohmeda3700 monitors. This difference doesnot raise different questions of safety andeffectiveness.
Cable Length	According to the clinical requirements, the subjectdevice's cable length were designed to be 1.0m &3.0m. The predicate device's cable lengths are1.1m & 3.0m. This difference does not raisedifferent questions of safety and effectiveness.Meanwhile the subject device has passed theIEC60601-1, IEC 60601-1-2 and ISO 80601-2-61.
Distal connectorDesign	The spo2 sensor in this submission have 3 types(finger clip , soft tip &3M). The predicate devicehas an additional connector of sponge adhesive.This difference does not raise different questionsof safety and effectiveness. This subject deviceshave passed the IEC 60601-1, IEC 60601-1-2andISO 80601-2-61.

Summary of Biocompatibility test 11.

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According to IFU, the sensor end will contact with patient finger skin. This submission have three types of sensor housings (soft tip, finger clip & Non-woven) and its duration contact time is less than 2 hours.

The Nature of body contact is skin surface. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable tests are:

Cytotoxicity ●
Sensitization
Irritation / Intracutaneous ●

12. Summary of Non-clinical test data

Non clinical tests as follows were conducted to verify that the proposed device met all design specifications to demonstrate Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with requirements of the recognized standards and IFU.

a) Biocompatibility test
b) Testing/ANSI/AAMI/IEC60601-1
c) Testing /ANSI/AAMI/IEC60601-1-2
d) Testing /ISO80601-2-61
e) Cleaning and Disinfection Validation test
Shelf life test f)
q) Performance test for sensors connecting with compatible monitors
h) Pulse rate accuracy test

13. Clinical test data

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in 13 human adult volunteers to validate the accuracy of Spo2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

Substantial Equivalence Statement 14.

Based on the comparison, analysis, and the submitted performance data, Spo2 Sensors are as safe, as effective and performs as well as or better

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than the predicate device and thus can be considered substantially equivalent to the predicate devices.

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).