(208 days)
Solaris Medical Technology, Inc. SpO2 sensors are indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.
Solaris Compatible Reusable Adult SpO2 Finger Sensors (Solaris Sensors) are compatible reusable sensors for use with major brands of patient monitors and oximeter devices. Solaris Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. 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 silicon rubber pads.
The provided 510(k) summary for K061931 concerns Solaris Compatible Reusable Adult SpO2 Finger Sensors. According to the document, the device itself is an electro-optical sensor for non-invasive monitoring of arterial oxygen saturation and pulse rate. The study design focuses on establishing substantial equivalence by demonstrating the device meets performance, safety, and accuracy specifications.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Cleaning Instructions Testing: Do not damage sensor labeling or degrade the material after cleaning. Test results indicated that the cleaning instructions do not damage sensor labeling or degrade the material. Biocompatibility Testing (ISO 10993-1:2003): Patient contact materials are non-toxic, non-sensitizing, and non-irritating for skin surface-contact, limited-duration devices. Test results indicated that the patient contact materials were non-toxic, non-sensitizing, and non-irritating. Electrical Safety Testing (IEC 60601-1:1988; Am1:1991; A2:1995, Clauses 3, 5, 6, 48 and 56): Compliance with stated clauses for medical electrical equipment. Test results indicated that the sensors comply with the stated clauses. Electromagnetic Compatibility Testing (IEC 60601-1-2:2001, Clauses 5.1.1, 6.2.1 and 6.3.1): Compliance with stated clauses for electromagnetic compatibility. Test results indicated that the sensors comply with the stated clauses of the Standard. Clinical Testing (Accuracy): Meet published specifications for accuracy over the 70% - 100% SpO2 range, using controlled hypoxia and co-oximetry comparison. Test results indicated that the sensors meet the published specifications for accuracy over the 70% - 100% SpO2 range. (Specific accuracy metric or threshold is not detailed in the summary.) -
Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size (number of subjects) for the clinical testing. It mentions that testing was performed under an "institutionally approved protocol with subject informed consent." The provenance of the data is not specified beyond being generated through "clinical testing." It is implied to be prospective data collected specifically for this submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this type of device and study. Ground truth for SpO2 accuracy is typically established by a recognized reference method like co-oximetry during controlled hypoxia, not by human experts. -
Adjudication method for the test set:
Not applicable. The ground truth (arterial oxygen saturation by co-oximetry) is an objective measurement, not subject to expert adjudication. -
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:
Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic imaging device that involves human readers. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the clinical testing described is a standalone performance assessment of the sensor against a reference standard (co-oximetry) without human interpretation in the loop. The sensor directly outputs SpO2 values. -
The type of ground truth used:
The ground truth for the clinical accuracy testing was "arterial oxygen saturation as determined by co-oximetry" during "controlled hypoxia." This is an objective, gold-standard physiological measurement. -
The sample size for the training set:
Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set in the conventional sense. Its performance is based on its electro-optical design and calibration, which would be validated in testing, not "trained." -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of medical device.
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K061931
Image /page/0/Picture/1 description: The image shows the logo for Solaris Medical Technology, Inc. The logo features a stylized mountain range to the left of the word "SOLARIS" in bold, uppercase letters. Below the logo is the text "Solaris Medical Technology, Inc." in a smaller font.
JAN 3 1 2007
510(k) Summary
| Submission Date: | 23 June 2006 |
|---|---|
| Submitter: | Solaris Medical Technology, Inc.427 26th Avenue, Suite 101San Francisco, CA 94121 USA |
| Submitter Contact: | Rachel Cheng, Director, Regulatory Affairs415 221 2350415 221 2360 (fax)rcheng@solarismedtech.com |
| Manufacturing Site: | Solaris Medical Technology, Inc.6/F Building 9, 30th District, Keji RoadScience Park, Nanshan DistrictShenzhen, Guangdong, 518057 CHINA |
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.2355 East Flamingo Road, Suite 201 GLas Vegas, NV 89119 USAtkroenke@speedtomarket.net303 956 4232 |
| Trade Name: | Solaris Compatible Reusable Adult SpO2 Finger Sensors• Model S100A-090103 SpO2 Finger Sensor• Model S100A-300103 SpO2 Finger Sensor• Model S200A-090101 SpO2 Finger Sensor• Model S200A-300101 SpO2 Finger Sensor• Model S300A-300046 SpO2 Finger Sensor |
| Common Name: | Pulse Oximeter Sensor |
| Classification Name: | Oximeter |
| ClassificationRegulation: | 21 CFR §870.2700 |
| Product Code: | DOA |
427 26th Avenue, Ste. 101, San Francisco, CA 94121 USA Tel: 001-415-221-4350 Fax: 001-415-221-4360() ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( www.solarismedtech.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 "S" that resembles a mountain range. The word "SOLARIS" is written in bold, uppercase letters to the right of the "S", and the company name is written in a smaller font below the logo.
| SubstantiallyEquivalent Devices: | Solaris Model | Predicate 510(k)Number | PredicateManufacturer / Model |
|---|---|---|---|
| S100A-090103 SpO2Finger Sensor | K993637* | Nellcor DS-100A SpO2Sensor, 0.9 m cable | |
| S100A-300103 SpO2Finger Sensor | K993637* | Nellcor DS-100A SpO2Sensor, 3.0 m cable | |
| S200A-090101 SpO2Finger Sensor | K030407* | BCI 3044 SpO2 Sensor,0.9 m cable | |
| S200A-300101 SpO2Finger Sensor | K030407* | BCI 3044 SpO2 Sensor,3.0 m cable | |
| S300A-300046 SpO2Finger Sensor | K962127* | Datex-Ohmeda OXY-F4-H SpO2 Sensor, 3.0m cable | |
| * Please note these 510(k) numbers represent monitors containing a pulse oximetrymodule in which the predicate sensors were included as accessories. | |||
| Device Description: | Solaris Compatible Reusable Adult SpO2 Finger Sensors (SolarisSensors) are compatible reusable sensors for use with major brands ofpatient monitors and oximeter devices. | ||
| Solaris Sensors are electro-optical sensors which function without skinpenetration, electrical contact, or heat transfer. The sensors use opticalmeans to determine the light absorption of functional arterialhemoglobin by being connected between the patient and the patientmonitor or oximeter device. The sensor contains three opticalcomponents: two light emitting diodes (LED) that serve as lightsources and one photodiode that acts as a light detector. The LED andphotodiode are contained in silicon rubber pads. | |||
| Intended Use: | Solaris Sensors are indicated for use in continuous, non-invasivemonitoring of arterial oxygen saturation and pulse rate for patientsweighing more than 40 kg. | ||
| TechnologyComparison: | Solaris Sensors employ the same technological characteristics as thepredicate devices to determine arterial oxygen saturation: arteriallyperfused tissue is illuminated sequentially by two wavelengths ofLEDs, and the time varying absorbance of the tissue is measured by aphotodetector.This method is characteristic of all reusable sensors that are the subject of this submission as well as the predicate devices. |
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Image /page/2/Picture/0 description: The image contains the logo for Solaris Medical Technology, Inc. The logo features a stylized mountain peak symbol to the left of the word "SOLARIS" in a bold, sans-serif font. Below the word "SOLARIS" is the text "Solaris Medical Technology, Inc." in a smaller font size.
Performance Testing:
Cleaning Instruction Solaris Sensors were tested in accordance with internal protocols to Testing ensure that the cleaning instructions do not damage sensor labeling or degrade the material. Test results indicated that the cleaning instructions do not damage sensor labeling or degrade the material. Biocompatibility Patient contact materials used in Solaris Sensors were tested in accordance with ISO 10993-1: 2003, Biological evaluation of medical Testing devices - Part 1: Evaluation and testing for skin surface-contact, limited-duration devices. Test results indicated that the patient contact materials were non-toxic, non-sensitizing and non-irritating. Electrical Safety Solaris Sensors were tested in accordance with IEC 60601-1:1988: Testing Aml: 1991; A2: 1995, Medical electrical equipment -- Part 1: General requirements for safety, Clauses 3, 5, 6, 48 and 56. Test results indicated that the sensors comply with the stated clauses. Solaris Sensors were tested in accordance with IEC 60601-1-2:2001, Electromagnetic Compatibility Medical electrical equipment - Part 1-2: General requirements for Testing safety - Collateral standard: Electromagnetic compatibility -Requirements and tests, Clauses 5.1.1, 6.2.1 and 6.3.1. Test results indicated that the sensors comply with the stated clauses of the Standard. Clinical Testing Solaris Sensors were clinically tested to validate the performance and accuracy of the 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. Test results indicated that the sensors meet the published specifications for accuracy over the 70 % - 100 % SpO2 range. Conclusion Based upon a comparison of devices and performance testing results, Solaris Sensors are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Solaris Medical Technology, Incorporated C/O Mr. Thomas Kroenke Principal Consultant Speed to Market, Incorporated 2355 East Flamingo Road, Suite 201G Las Vegas, Nevada 89119
JAN 3 1 2007
Re: K061931
Trade/Device Name: Solaris Compatible Reusable Adult SpO2 Finger Sensors Including: Model S100A-090103; Model S100A-300103; Model S200A-090101; Model S200A-300101; and Model S300A-300046
Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 31, 2006 Received: January 3, 2007
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 such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
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): K Solaris Compatible Reusable Adult SpO2 Finger Sensors Device Name: including: Model S100A-090103; . Model S100A-300103; . Model S200A-090101; ● . Model S200A-300101; and Model S300A-300046. � Solaris Medical Technology, Inc. SpO2 sensors are indicated for Indications for Use: use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.
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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chr. Kuhl
KCGVM31
§ 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).