(162 days)
None
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML.
No
The device is described as a monitor that provides data (pulse oximetry readings) and does not inherently treat or alleviate a medical condition.
Yes
Explanation: The device is a pulse oximeter, which "offers non-invasive continuous and instantaneous monitoring" and provides "high-level accuracy and a quick measuring response." While the provided text does not explicitly use the word "diagnostic," monitoring and measuring physiological parameters like pulse and blood oxygen saturation is a fundamental step in the diagnostic process to assess a patient's health status and identify potential medical conditions.
No
The device is described as a "Portable Pulse Oximeter MD-600P," which is a hardware device that measures oxygen saturation and pulse rate. The summary does not mention any software-only components or functions.
Based on the provided information, the COMDEK Portable Pulse Oximeter MD-600P is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The description of the COMDEK Portable Pulse Oximeter MD-600P clearly states it offers "non-invasive continuous and instantaneous monitoring". This means it measures physiological parameters directly from the body without requiring a sample to be taken and analyzed externally.
- Pulse oximeters measure oxygen saturation and pulse rate by shining light through the skin. This is a non-invasive method.
Therefore, the COMDEK Portable Pulse Oximeter MD-600P falls under the category of non-invasive medical devices used for monitoring, not IVD devices used for analyzing biological specimens.
N/A
Intended Use / Indications for Use
The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.
Product codes
DQA
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospitals, intra-hospital transport, hospital-type facilities and the home.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 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 seal is a stylized symbol resembling three overlapping human figures or abstract shapes, rendered in a bold, black color.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2009
Y.S. Kuo General Manager Comdek Industrial Corporation 9F-1, No. 3 Yuan Qu Street, Nan Kang Taipei CHINA 11503
Re: K083351
Trade/Device Name: Comdek Portable Pulse Oximeter MD-600P Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 30, 2008 Received: January 29, 2009
Dear Y.S. Kuo:
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.
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.
1
Page 2- Y.S. Kuo
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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. Whan uno en
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K083351
Device Name: COMDEK PORTABLE PULSE OXIMETER MD-600P
Indications for Use: The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) (Division Sign-Off)
Division of Anestheshology MERRESS (Device Evaluation (ODE) Infection Control, Dental Devices
510(k) Number: