(90 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No.
A pulse oximeter is a monitoring device that measures physiological parameters (SpO2 and pulse rate) rather than providing a therapeutic treatment or intervention.
No
The pulse oximeter monitors oxygen saturation and pulse rate, which are measurements of physiological parameters. It does not provide a diagnosis of a disease or condition.
No
The device description explicitly states it is a "Fingertip Pulse Oximeter" and describes putting a fingertip "into the sensor of the device," indicating a physical hardware component is involved in the measurement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
- Pulse Oximeter Function: A pulse oximeter is a non-invasive device that measures oxygen saturation and pulse rate by shining light through the skin (specifically, the fingertip) and analyzing the light absorption. This is a measurement taken on the body, not on a sample taken from the body.
The description clearly states it's a "non-invasive device" and measures parameters "through finger". This aligns with the definition of a medical device that performs measurements in vivo (within the living body), not in vitro.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
adult patients
Intended User / Care Setting
home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.)
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
Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Pm-60 Pulse Oximeter K072581
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
510(k) Summary KOQ67) Section 3
As required by 807.97
The assigned 510(k) Number is
Sponsor
Contec Medical Systems Co., Ltd No. 24, West Huanghe Road Qinhuangdao, Hebei, 066000, China
Mr. Li Xueyong, Quality Manager Tel:+86-335-8015490 Fax: +86-335-8015505 Email: lxyong1011@163.com
Submission Correspondent Ms. Diana Hong / Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd Sute 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: 760-466-5084 Email: diana.hong@mid-link.net
JUN 11 2009
Proposed Product | |
---|---|
Trade Name | Pulse Oximeter |
Model | CMS-50E |
Product Code: | DQA |
Regulation Number: | 21 CFR 870.2700 |
Device Class: | Class II |
Submission Purpose: | New Device |
Predicate Device: | Pm-60 Pulse Oximeter |
K072581 | |
Device Description | The Fingertip Pulse Oximeter is tiny, and with low power |
consumption, convenient to use and carry. You just need to | |
put the fingertip into the sensor of the device, the SpO2 value | |
will appear on the screen immediately. | |
Test Conclusion | Laboratory testing was conducted to validate and verify that |
the proposed devices met all design specifications, including |
3-1
1
SE Determination
Use/Indication for Use
Intended
proposed device, Fingertip Pulse Oximeter, The is substantially equivalent (SE) to the predicate device Pm-60 Pulse Oximeter (K072581).
electrical safety, EMC, specifications.
CMS50E
The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
JUN 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Contec Medical System Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion, No 19, Lane 999, Zhong Shan, Shanghai CHINA 200030
Re: K090671
Trade/Device Name: CMS50E Fingertip Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 13. 2009 Received: March 13, 2009
Dear Ms. Hong:
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 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.
3
Page 2 - Ms. Hong
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Gunner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510(k) Number (if known):
Device Name: _CMS50E Fingertip Pulse Oximeter
Indications for Use:
The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.
Prescription Use __ (Part 21 CFR 801 Subpart D)
.
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultr
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: k O