(151 days)
The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment. The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.
Not Found
The provided document is a 510(k) premarket notification approval letter for the Oxicare Fingertip Pulse Oximeter, Model DB12. It confirms the substantial equivalence of the device to legally marketed predicate devices.
However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance. This document only confirms the device's substantial equivalence based on prior (unspecified) testing.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not typically for a simple pulse oximeter.
- Information on standalone algorithm performance. A pulse oximeter is a physical sensor, not an algorithm in the sense of AI.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on the regulatory aspects of the device's clearance, such as its classification, regulation number, and general controls provisions of the Act. While it implies that the device has undergone testing to demonstrate its performance for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR)", the details of how that performance was assessed against specific criteria are not included in this FDA letter. Such details would typically be found in the manufacturer's 510(k) submission, which is not fully provided here.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely the header of a document or webpage. The words are all capitalized and evenly spaced.
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
February 28, 2014
DELBio Incorporation C/O Ms. Erica Li Quality Assurance Manager Delta Products Corporation 4405 Cushing Parkway Fremont City, CA 94538
Re: K133090
Trade/Device Name: Oxicare Fingertip Pulse Oximeter, Model DB12 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 28, 2014 Received: January 29, 2014
Dear Ms. Li:
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.
{1}------------------------------------------------
Page 2 - Ms. Erica Li
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/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
Sincerely vours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/1/Picture/7 description: The image shows a signature and some text. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The signature is illegible. The image is in black and white.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Oxicare Fingertip Pulse Oximeter
DELBio Incorporation 510/K) Notification
Indications for Use Form
510(k) Number (if known): K133090
Device Name: Oxicare Fingertip Pulse Oximeter, model DB12
Indications for Use:
The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment.
The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/10 description: The image shows the words "Todd D. Courtney" and "FDA" in a stylized font. Below that is the date and time "2014.02.28 13:00:51.05'00'". The text is black on a white background.
Page 1 of 1
7-1 of 1
§ 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).