When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring.

Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg.

Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.

Prescription device.

Device Description

Solaris Compatible Reusable and Disposable SpO2 Sensors (Solaris Sensors) are compatible sensors for use with major types of patient monitors and oximeter devices as listed above.

Solaris Sensors employ non-invasive electro-optical means to determine the light absorption of functional arterial hemoglobin. 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 the sensor housing.

Four types of sensor housings are described in this submission:

Reusable soft finger sensor comprised of an integrated silicone rubber tube.
Reusable finger clip sensor with rigid halves and silicone pads
Disposable soft-digit sensor with flexible silicone housing
Disposable adhesive sensors constructed of a medical tape laminate

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, Nonin, HP/Philips, BCI).

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the acceptance criterion for the Solaris SpO2 sensors is "stated accuracy claims over the 70% - 100% range." The reported device performance is that the "Clinical test results indicated that the sensors meet the stated accuracy claims over the 70% - 100% range."

Acceptance Criteria	Reported Device Performance
Sensors meet stated accuracy claims over the 70% - 100% range	Clinical test results indicated that the sensors meet the stated accuracy claims over the 70% - 100% range.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify an exact numerical sample size for the clinical test set. It only mentions "clinical testing... with subject informed consent."
Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. It was performed "under an institutionally approved protocol."

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

The document describes the ground truth as "arterial oxygen saturation as determined by co-oximetry." It does not mention the involvement of human experts for establishing this ground truth, as co-oximetry is a laboratory measurement.

4. Adjudication Method for the Test Set:

Not applicable as the ground truth was established by co-oximetry, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This is not applicable. The device is a physical SpO2 sensor, not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The clinical testing assessed the "performance and accuracy of the Solaris Reusable and Disposable sensors" (algorithm/device only) against co-oximetry. There's no mention of a human-in-the-loop component in this specific accuracy study.

7. The Type of Ground Truth Used:

Co-oximetry: The ground truth for the clinical study was "arterial oxygen saturation as determined by co-oximetry."

8. The Sample Size for the Training Set:

The document does not describe a "training set" as this is not an AI/machine learning device that typically requires a separate training phase. The clinical testing was for validation.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI/machine learning model. The clinical validation directly compared the sensor's readings to co-oximetry.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Solaris Medical Technology, Inc. The logo features a stylized graphic element resembling a waveform or mountain range to the left of the word "SOLARIS", which is written in a bold, sans-serif font. A thin line underlines the word "SOLARIS". Below the line is the text "Solaris Medical Technology, Inc." in a smaller, serif font.

OCT 7 2010
12100027

Page 1 of 4

510(k) Summary of Safety and Effectiveness

(a)

Date of Preparation:		October 7, 2010
(1)	Submitted by:		Solaris Medical Technology, Inc. (China)6/F Building 9, 30th District, Keji Road,Science Park, Nanshan District Shenzhen,Guangdong, 518057 CHINA
	Submitter Contact:		Rachel ChengVice President, Business DevelopmentSolaris Medical Technology Inc. (USA)Phone: +1 (650) 588-3980Fax: +1 (650) 588-3988rcheng@solarismedtech.com
(2)	Trade Name:		Solaris Medical Technology, Inc. Reusable & DisposableSpO2 Sensors
	Common Name:		Pulse Oximeter Sensor
	Classification Name:		Oximeter
	Classification Regulation:		21 CFR §870.2700
	Product Code:		DQA
	Class:		Class II
(3)	Predicate Device(s):		Substantial Equivalence to:
	K Number	Model	Manufacturer
	K993637*	Device Name MODEL 2500APalmsat Pulse Oximeter (with model8000AA Finger Clip Sensor, 7000A,7000P, 7000I Flexi-Form IIDisposable sensors specified)	Nellcor Puritan Bennett, Inc.

6/F Building 9, 30" District, Keji Road, Science Park, Nanshan District, Shenzhen Guangdong, 518057 CHINA
Tel: +86 755 26525478 Fax: +86 755 26525386 www.szsolaris.com

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Image /page/1/Picture/0 description: The image shows the logo for Solaris Medical Technology, Inc. The logo features a stylized waveform graphic to the left of the word "SOLARIS" in bold, capitalized letters. Below the waveform and the word "SOLARIS" is the text "Solaris Medical Technology, Inc." in a smaller font size.

Page 2 of 4

K Number	Model	Manufacturer
K050056*	Device Name MODEL 2500APalmsat Pulse Oximeter (with model8000AA Finger Clip Sensor, 7000A,7000P, 70001 Flexi-Form IIDisposable sensors specified)	Nonin Medical, Inc.
K000822*	Philips/Agilent componentmonitoring system, Agilent 24/26(with model M1191A ReusableSpO2 Sensor specified as accessory)	Agilent Technologies, GmbH(formerly HP)
K042306	Philips M1131A SpO2 DisposableSpO2 Sensor	Philips MedizinsystemeBoeblingen GmbH (formerly HP)
K083705*	BCI WW1020 SPECTRO2 PulseOximeter (with model 3044 ReusableFinger Clip Sensor and model 1300Disposable Finger Sensor, Adultspecified as accessories)	Smiths Medical PM, Inc. (formerlySIMS BCI)

Please note these 510(k) numbers represent monitors containing a pulse oximeter in which the predicate sensors were included as accessories.

Reason for Submission: New Device(s)

Device Description: (4)

Solaris Compatible Reusable and Disposable SpO2 Sensors (Solaris Sensors) are compatible sensors for use with major types of patient monitors and oximeter devices as listed above.

Four types of sensor housings are described in this submission:

Reusable soft finger sensor comprised of an integrated silicone rubber 트 tube.
Reusable finger clip sensor with rigid halves and silicone pads 트
Disposable soft-digit sensor with flexible silicone housing I
Disposable adhesive sensors constructed of a medical tape laminate E

6/F Building 9, 30" District, Keji Road, Science Park, Nanshan District, Shenzhen Guangdong, 518057 CHINA Tel: +86 755 26525478 Fax: +86 755 26525386 www.szsolaris.com

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Image /page/2/Picture/0 description: The image shows the logo for Solaris Medical Technology, Inc. The logo features a stylized mountain range graphic connected to the word "SOLARIS" in bold, capitalized letters. Below the logo is the text "Solaris Medical Technology, Inc." in a smaller font size.

Page 3 of 4

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, Nonin, HP/Philips, BCI).

Intended use: (2)

Prescription device.

Technology Comparison: (6)

Solaris Sensors 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.

This method is characteristic of all sensors that are the subject of this submission as well as the predicate devices.

Non-Clinical Performance Tests: (1) (b)

Cleaning Instruction Testing

Solaris Sensors were tested in accordance with internal protocols to ensure that the cleaning instructions do not damage sensor labeling or degrade the material.

6/F Building 9, 30" District, Keji Road, Science Park, Nanshan District, Shenzhen Guangdong, 518057 CHINA lsthol, Roj. Roud, Coac. +86 755 26525386 www.szsolaris.com

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Image /page/3/Picture/0 description: The image shows the logo for Solaris Medical Technology, Inc. The logo features a stylized graphic element resembling a mountain range or a waveform, with the word "SOLARIS" in bold, sans-serif font to the right of the graphic. A thin line underlines the word "SOLARIS". Below the logo is the text "Solaris Medical Technology, Inc." in a smaller font size.

Page 4 of 4

Biocompatibility

Sensor patient contact materials meet applicable standards for biocompatibility.

Electrical Safety and EMC Testing

The sensors were tested in accordance with current applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. Test results indicated that the sensors comply with the stated clauses.

Pulse Rate Accuracy Testing

The sensors were tested for pulse rate accuracy with a listed SpO2 simulator with predicate device monitors. The sensors met their specified pulse accuracy.

(2) Clinical Testing:
Solaris Sensors were clinically tested to validate the performance and accuracy of the Solaris Reusable and Disposable sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approved protocol with subject informed consent.

Clinical test results indicated that the sensors meet the stated accuracy claims over the 70 % - 100 % range.

Conclusions: (3)

Based upon device evaluations, predicate comparisons, and performance testing results, Solaris Reusable and Disposable SpO2 Sensors are substantially equivalent to the predicate devices.

6/F Building 9, 30" District, Keji Road, Science Park, Nanshan District, Shenzhen Guangdong, 518057 CHINA Tel: +86 755 26525478 Fax: +86 755 26525386 www.szsolaris.com

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Rachel Cheng Vice President, Business Development Solaris Medical Technology, Incorporated 400 Oyster Point Boulevard, Suite 534 South San Francisco, California 94080

OCT 7 2010

Re: K100077

Trade/Device Name: Solaris Reusable & Disposable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Accessory to Pulse Oximeter Regulatory Class: II Product Code: DQA Dated: October 2, 2010 Received: October 4, 2010

Dear Ms. Cheng:

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 Eederal Register.

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Page 2- Ms. Cheng

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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Solaris Medical Technology, Inc. Reusable & Disposable SpO2 Sensors Device Name:

Indications for use:

Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multipatient use SpO₂ Finger Sensors, and disposable si ngle patient use SpO₂ Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg.

Solaris Medical Technology, Inc. disposable single patient use SpO₂ Adhesive Sensors are for use with adult patients weighing greater than 4 0kg, pediatric patients weighing 10 – 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

× Prescription Use (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 ANO THER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuttertins

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

510(k) Number: K100007 Page 1 of

C-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).