(208 days)
Not Found
No
The device description and performance studies focus on the electro-optical nature of the sensor and standard electrical and biocompatibility testing. There is no mention of AI, ML, or any data processing beyond basic signal detection and calculation of SpO2 and pulse rate.
No
The device is indicated for monitoring vital signs (SpO2 and pulse rate), not for providing treatment or therapy.
Yes
The device is indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device as it provides information for diagnosis or monitoring illnesses.
No
The device description explicitly states it is an "electro-optical sensor" containing "two light emitting diodes (LED)" and "one photodiode," which are physical hardware components. The performance studies also include testing related to hardware aspects like cleaning, biocompatibility, electrical safety, and electromagnetic compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The Solaris SpO2 sensor is a non-invasive device that measures arterial oxygen saturation and pulse rate by being placed on the patient's finger. It uses optical means to analyze light absorption within the living body.
- Lack of Sample Analysis: The device does not collect or analyze any biological samples from the patient.
Therefore, the Solaris SpO2 sensor falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DOA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Patients weighing more than 40 kg.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. Test results indicated that the cleaning instructions do not damage sensor labeling or degrade the material.
Biocompatibility Testing: Patient contact materials used in Solaris Sensors were tested in accordance with ISO 10993-1: 2003, Biological evaluation of medical 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 Testing: Solaris Sensors were tested in accordance with IEC 60601-1:1988: 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.
Electromagnetic Compatibility Testing: Solaris Sensors were tested in accordance with IEC 60601-1-2:2001, Medical electrical equipment - Part 1-2: General requirements for 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.
Key results: Test results indicated that the sensors meet the published specifications for accuracy over the 70 % - 100 % SpO2 range.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 101 | |
| San Francisco, CA 94121 USA | |
| Submitter Contact: | Rachel Cheng, Director, Regulatory Affairs |
| 415 221 2350 | |
| 415 221 2360 (fax) | |
| rcheng@solarismedtech.com | |
| Manufacturing Site: | Solaris Medical Technology, Inc. |
| 6/F Building 9, 30th District, Keji Road | |
| Science Park, Nanshan District | |
| Shenzhen, Guangdong, 518057 CHINA | |
| Official Contact: | Thomas Kroenke |
| Principal Consultant | |
| Speed To Market, Inc. | |
| 2355 East Flamingo Road, Suite 201 G | |
| Las Vegas, NV 89119 USA | |
| tkroenke@speedtomarket.net | |
| 303 956 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 |
| Classification | |
| Regulation: | 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
ﺒﻪ .
ج Page 1 of 3
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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.
| Substantially
Equivalent Devices: | Solaris Model | Predicate 510(k)
Number | Predicate
Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------|
| | S100A-090103 SpO2
Finger Sensor | K993637* | Nellcor DS-100A SpO2
Sensor, 0.9 m cable |
| | S100A-300103 SpO2
Finger Sensor | K993637* | Nellcor DS-100A SpO2
Sensor, 3.0 m cable |
| | S200A-090101 SpO2
Finger Sensor | K030407* | BCI 3044 SpO2 Sensor,
0.9 m cable |
| | S200A-300101 SpO2
Finger Sensor | K030407* | BCI 3044 SpO2 Sensor,
3.0 m cable |
| | S300A-300046 SpO2
Finger Sensor | K962127* | Datex-Ohmeda OXY-
F4-H SpO2 Sensor, 3.0
m cable |
| | * Please note these 510(k) numbers represent monitors containing a pulse oximetry
module in which the predicate sensors were included as accessories. | | |
| Device Description: | 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. | | |
| Intended Use: | Solaris Sensors are indicated for use in continuous, non-invasive
monitoring of arterial oxygen saturation and pulse rate for patients
weighing more than 40 kg. | | |
| Technology
Comparison: | 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 reusable sensors that are the subject of this submission as well as the predicate devices. | | |
:
2
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.
3
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.
4
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
5
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