(268 days)
None
No
The device description and performance studies focus on standard electro-optical sensing technology and clinical validation against co-oximetry, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a sensor intended for monitoring physiological parameters (SpO2 and pulse rate), not for treating a disease or condition.
Yes
Explanation: The device is intended for "continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring," which are measurements used to assess a patient's physiological state and can indicate medical conditions, thereby classifying it as a diagnostic device.
No
The device description explicitly details hardware components (LEDs, photodiode, sensor housing) and the testing section includes hardware-specific tests (cleaning, biocompatibility, electrical safety, EMC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring." This involves measuring physiological parameters directly from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device uses "non-invasive electro-optical means to determine the light absorption of functional arterial hemoglobin." This is a physical measurement technique applied externally to the patient.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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
- 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Non-invasive electro-optical means
Anatomical Site
Not Found
Indicated Patient Age Range
adult/pediatric patients weighing greater than 40kg.
adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Tests:
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993637, K050056, K000822, K042306, K083705
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
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 Cheng | |||
| Vice President, Business Development | ||||
| Solaris Medical Technology Inc. (USA) | ||||
| Phone: +1 (650) 588-3980 | ||||
| Fax: +1 (650) 588-3988 | ||||
| rcheng@solarismedtech.com | ||||
| (2) | Trade Name: | Solaris Medical Technology, Inc. Reusable & Disposable | ||
| SpO2 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 2500A | |||
| Palmsat Pulse Oximeter (with model | ||||
| 8000AA Finger Clip Sensor, 7000A, | ||||
| 7000P, 7000I Flexi-Form II | ||||
| Disposable sensors specified) | Nellcor Puritan Bennett, Inc. |
1
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
1
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 2500A | |
| Palmsat Pulse Oximeter (with model | ||
| 8000AA Finger Clip Sensor, 7000A, | ||
| 7000P, 70001 Flexi-Form II | ||
| Disposable sensors specified) | Nonin Medical, Inc. | |
| K000822* | Philips/Agilent component | |
| monitoring system, Agilent 24/26 | ||
| (with model M1191A Reusable | ||
| SpO2 Sensor specified as accessory) | Agilent Technologies, GmbH | |
| (formerly HP) | ||
| K042306 | Philips M1131A SpO2 Disposable | |
| SpO2 Sensor | Philips Medizinsysteme | |
| Boeblingen GmbH (formerly HP) | ||
| K083705* | BCI WW1020 SPECTRO2 Pulse | |
| Oximeter (with model 3044 Reusable | ||
| Finger Clip Sensor and model 1300 | ||
| Disposable Finger Sensor, Adult | ||
| specified as accessories) | Smiths Medical PM, Inc. (formerly | |
| SIMS 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.
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 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
2
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
2
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)
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.
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
3
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
4
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.
5
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
6
Indications for Use
510(k) Number (if known):
Solaris Medical Technology, Inc. Reusable & Disposable SpO2 Sensors Device Name:
Indications for use:
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 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
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