(169 days)
Not Found
No
The summary describes standard signal processing and data display for a pulse oximeter, with no mention of AI or ML techniques.
No.
The device is a diagnostic tool that monitors oxygen saturation and pulse rate; it does not provide treatment.
Yes
The device is described as a "functional arterial oxygen saturation and pulse rate monitor" that provides "information to the medical and nursing staff about the physiological condition of the patient," which are functions of a diagnostic device. It also states that the device "reduce the need for arterial puncture and bloodgas analysis," implying it assists in diagnosis.
No
The device description explicitly states it is a "Handheld Pulse Oximeter with Sensor Accessories" and mentions operating on battery power and using reusable SpO2 sensors. This indicates the device includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Solaris NT1 and NT1A Handheld Pulse Oximeters are described as non-invasive devices that measure functional arterial oxygen saturation and pulse rate. They do this by placing a sensor on the patient's body (likely a finger or earlobe) and using light to determine these values. This is a non-invasive measurement performed on the patient, not on a specimen taken from the patient.
- Intended Use: The intended use is to monitor physiological parameters directly from the patient, not to analyze biological samples.
Therefore, based on the provided information, the Solaris NT1 and NT1A Handheld Pulse Oximeters are not IVD devices. They are considered medical devices used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
Product codes (comma separated list FDA assigned to the subject device)
DOA
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.
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
medical and nursing staff, hospital clinical areas, clinics
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. 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. Performance testing for the NT1A device was conducted to show that the accuracy and measurement range of the device is not affected by the device re-design. Performance testing documentation was included in the submission under "NT1A Sp02 Oximeter Testing Reports".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 2 2010
Exhibit #1
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 510(k) number is:_097956
1. Submitter's Identification:
Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd. Great Neck, N.Y. 11021
Date Summary Prepared: September 22, 2009
Sponsor Company Name/Address/Contact Person 2.
Solaris Medical Technology, Inc. 400 Oyster Point Blvd., Ste. 534 South San Francisco, CA 94080 Tel: (650) 588-3980 Fax: (650) 588-3988
Rachel Cheng Contact: Position: Director, Requlatory Affairs
3. Manufacturing Facility Name and Address
Newtech, Inc. R1-B1, Hi-Tech Industrial Park Nanshan District, Shenzhen Guangdong 518057 P.R. China
4. Name of the Device:
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:
K073249. SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories, Solaris Medical Technology, Inc.
7. 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.
8. Intended Use:
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a noninvasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a noninvasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
2
ഗ് Comparison to Predicate Devices:
The modified SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories have the same "Indications for Use Statement" and are similar in design to our original 510(k) cleared device predicates.
Based on new market requirements for NT1 and NT1A Handheld Pulse Oximeters, we are adding USB hub, test data storage and output and external storage functions, making operation and data processing more convenient and allowing implementation of external database processing and third-party analysis.
Modifications made to the original device design (NT1 and NT1A) do not affect any change in structure and appearance. Design improvements on the hardware circuit and software has been made by adding USB hub, data storage and data output functions.
10. Testing
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. 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. Performance testing for the NT1A device was conducted to show that the accuracy and measurement range of the device is not affected by the device re-design. Performance testing documentation was included in the submission under "NT1A Sp02 Oximeter Testing Reports".
11. Conclusions:
The conclusions drawn from 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wave-like lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Solaris Medical Technology, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
MAR 1 2 2010
Re: K092950
Trade/Device Name: SOLARIS NT1 Handheld Pulse Oximeter with Sensor Accessories, SOLARIS NT1A Handheld Pulse Oximeter with Sensor Accessories Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: March 4, 2010 Received: March 5, 2010
Dear Ms. Goldstein-Falk:
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 Federal Register.
4
Page 2- Ms. Goldstein-Falk
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
5
Exhibit C
Indications for Use
Page _ 1 of of ______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: SOLARIS NT1 Handheld Pulse Oximeter with Sensor Accessories
Indications For Use:
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
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)
L Schult
(Division Sign-Off) (Division Sign-Off) ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— ofection Control, Dental Devices
510(k) Number: K092750
6
Exhibit C
Indications for Use
Page __ 2 of of 2
510(k) Number (if known):
SOLARIS NT1A Handheld Pulse Oximeter with Device Name: Sensor Accessories
Indications For Use:
The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
Prescription Use X (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)
L- Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital .. Ifection Control, Dental Devices
510(k) Number: K092950