(249 days)
K# 001688
No
The summary describes standard signal processing and data display for a pulse oximeter, with no mention of AI, ML, or related concepts. The performance studies focus on equivalence to a predicate device and compliance with standards, not on AI/ML model validation.
No.
This device is a diagnostic tool that measures pulse rate and oxygen saturation, providing information about a patient's physiological condition. It does not provide therapy or treatment.
Yes
Explanation: The device measures pulse rate and oxygen saturation to provide information about the physiological condition of a patient, which is used by medical staff for diagnostic purposes.
No
The device description explicitly lists hardware components such as boards, a keypad, and a battery, indicating it is a physical device with integrated software, not a software-only medical device.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Solaris NT1 and NT1A Handheld Pulse Oximeters are described as non-invasive devices that measure oxygen saturation and pulse rate directly from the patient's body (specifically, likely from a finger or toe). They do not analyze samples taken from the body.
- Intended Use: The intended use is to monitor physiological conditions (oxygenation and pulse rate) in patients, not to analyze biological samples.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SOLARIS NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive, spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.
Product codes
DQA
Device Description
The subject SOLARIS NT1 and NT1A Handheld Pulse Oximeters measure pulse rate and oxygen saturation. The signals are converted into digital data and processed; the pulse oximeter examines the data and displays the data. The subject pulse oximeters also provide operating control for the user. The pulse oximeters are intended for use in spot checking; the NT1A model is intended to both spot check and perform continuous monitoring. The pulse oximeters can be used in hospital clinical areas such as general wards to provide additional information to the medical and nursing staff about the physiological condition of the patient. The subject devices are intended to be used under supervision by clinical personnel. The intended location of use is clinics.
The subject pulse oximeters provide a rapid indication of a patient's level of oxygenation which reflects the effective ventilation. The NT1A Pulse Oximeter with alarm allows continuous and instantaneous monitoring of SpO2 and both the NT1 and NT1A Pulse Oximeters reduce the need for arterial puncture and bloodgas analysis.
The subject pulse oximeters are composed of two boards, a main control board and a physiological singal processing board. The main control board is composed of a LED display and its control and driver, data memory, audio circuit, UART communication interface, and DC/DC circuits. The physiological processing board is composed of a SpO2 sensor control and IR/RED LEDs driver, data collection, signal processing algorithm execution, UART communication interface and DC/DC circuits.
The oximeter is housed in a single package. The main components of the assembly are listed as following
- Main Board .
- SpO2 Module .
- Key Pad .
- Batterv ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients.
Intended User / Care Setting
used under supervision by clinical personnel. The intended location of use is clinics. hospital clinical areas such as general wards to provide additional information to the medical and nursing staff
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)
Laboratory testing was conducted to validate and verify that the SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories met all design specifications and were substantially equivalent to the predicate device, Datex-Ohmeda TuffSat 3000 Pulse Oximeter. SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories have also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-2, IEC60601-1-4, EN865, EN475, and ISO14971.
The conclusions drawn from clinical and laboratory testing of the SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device, the Datex-Ohmeda TufSet 3000 Pulse Oximeter, K001688.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K# 001688, Datex-Ohmeda TuffSat 3000 Pulse Oximeter
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
Exhibit #1 4073249
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Alan P. Schwartz mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, N.Y. 11021
Date Summary Prepared: July 17, 2008
Sponsor Company Name/Address/Contact Person 2.
Solaris Medical Technology, Inc. 400 Oyster Point Blvd., Ste. 534 South San Francisco, CA 94080 Tel: (415) 221-4350 Fax: (415) 221-4360
Rachel Cheng Contact: Director, Regulatory Affairs Position:
Manufacturing Facility Name and Address 3.
Newtech, Inc. R1-B1, Hi-Tech Industrial Park Nanshan District, Shenzhen Guanadong 518057 P.R. China
Name of the Device: 4.
SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories
1
5. Common or Usual Name:
Oximeter. Pulse 74 DQA. 21 CFR Part 870.2700
6. Predicate Device Information:
K# 001688, Datex-Ohmeda TuffSat 3000 Pulse Oximeter, Datex-Ohmeda Inc.
7. Device Description:
Purpose and Function of Device:
The subject SOLARIS NT1 and NT1A Handheld Pulse Oximeters measure pulse rate and oxygen saturation. The signals are converted into digital data and processed; the pulse oximeter examines the data and displays the data. The subject pulse oximeters also provide operating control for the user. The pulse oximeters are intended for use in spot checking; the NT1A model is intended to both spot check and perform continuous monitoring. The pulse oximeters can be used in hospital clinical areas such as general wards to provide additional information to the medical and nursing staff about the physiological condition of the patient. The subject devices are intended to be used under supervision by clinical personnel. The intended location of use is clinics.
The subject pulse oximeters provide a rapid indication of a patient's level of oxygenation which reflects the effective ventilation. The NT1A Pulse Oximeter with alarm allows continuous and instantaneous monitoring of SpO2 and both the NT1 and NT1A Pulse Oximeters reduce the need for arterial puncture and bloodgas analysis.
The subject pulse oximeters are composed of two boards, a main control board and a physiological singal processing board. The main control board is composed of a LED display and its control and driver, data memory, audio circuit, UART communication interface, and DC/DC circuits. The physiological processing board is composed of a SpO2 sensor control and IR/RED LEDs driver, data collection, signal processing algorithm execution, UART communication interface and DC/DC circuits.
The oximeter is housed in a single package. The main components of the assembly are listed as following
- Main Board .
- SpO2 Module .
2
- Key Pad .
- Batterv ●
8. Intended Use:
The SOLARIS NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive, spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.
Comparison to Predicate Devices: 9.
The basic intended use of the subject devices and Datex-Obmeda TuffSat 3000 Pulse Oximeter are the same:
- I. Both the NT1 Pulse Oximeter and Datex-Ohmeda TuffSat 3000 Pulse Oximeter are non-invasive, spot-checking monitors. The difference between the NT1 and Datex-Ohmeda devices and the NT1A device is that in addition to being noninvasive spot-checking monitors, the NT1A device performs continuous monitoring.
-
- The patient parameters for both the subject devices and Datex-Ohmeda TuffSat 3000 Pulse Oximeter are the same: oxygen saturation (SpO2), pulse rate (PR) and pulse strength.
-
- The target populations range for both the subject devices and the Datex-Ohmeda Tuffsat 3000 Pulse Oximeter is the same: for pediatrics and adults.
Both the NT1 and NT1A Pulse Oximeters are substantially equivalent to Datex-Ohmeda TuffSat 3000 Pulse Oximeter. The pulse oximeters provide a means for interfacing with a patient and collecting parameter specific physiological signals. Then the signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LED screen.
10. Testing
Laboratory testing was conducted to validate and verify that the SOLARIS NT1
3
and NT1A Handheld Pulse Oximeters with Sensor Accessories met all design specifications and were substantially equivalent to the predicate device, Datex-Ohmeda TuffSat 3000 Pulse Oximeter. SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories have also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-2, IEC60601-1-4, EN865, EN475, and ISO14971.
11. Conclusions:
The conclusions drawn from clinical and laboratory testing of the SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device, the Datex-Ohmeda TufSet 3000 Pulse Oximeter, K001688.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2008
Solaries Medical Technology, Incorporated C/O Mr. Alan P. Schwartz mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K073249
Trade/Device Name: SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 7, 2008 Received: July 9, 2008
Dear Mr. Schwartz:
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.
5
Page 2 - Mr. Schwartz
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
TN Samuels, Rnd, MD for //
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
6
Exhibit B
Indications for Use
1 Page
510(k) Number (if known):
SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Device Name: Sensor Accessories
Indications For Use:
Solaris NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.
Mr. Vml
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K073249 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Prescription Use × (Per 21 CFR 801 Subpart D)
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)