(226 days)
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No
The summary describes a physical sheath for pulse oximetry probes and contains no mention of AI, ML, or related concepts like image processing or data analysis.
No
The device is described as a "gross contamination barrier" for pulse oximetry finger tip probes, intended to reduce cleaning time and effort, not to treat or diagnose a medical condition.
No
The device is described as a "gross contamination barrier" for pulse oximetry finger tip probes, intended to reduce cleaning time and effort. It explicitly states it should not be used in lieu of sterilizing a reusable probe where sterile is indicated, and its function is to minimize probe exposure to gross contamination. There is no mention of it being used to diagnose conditions or capture physiological information.
No
The device description clearly indicates a physical "Sheath" intended to be used with a physical pulse oximetry probe, acting as a gross contamination barrier. This is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "gross contamination barrier" for pulse oximetry probes. It's designed to reduce cleaning effort and minimize exposure to contamination.
- No mention of in vitro testing: The description does not involve any testing of samples (like blood, urine, tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for a disease.
- Focus on physical barrier: The function is purely as a physical barrier for a medical device used on the body.
IVD devices are specifically designed for testing samples in vitro to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the "clothes pin" style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination.
The COVERox Sheath is supplied non-sterile and is intended for single use only.
Product codes
74 DQA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger tips only
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Guthrie President Ventrex, Inc. 3007 Bunsen Avenue Unit K 93003 Ventura, California
JUL 16 1997
Re: K964821 Coverox Sheath Models Number PS65, PS67, EPS65 and EPS67 Requlatory Class: II (Two) Product Code: 74 DQA Dated: April 14, 1997 Received: April 17, 1997
Dear Mr. Guthrie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Robert Guthrie
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Submission Cover Sheet Supplemental
INDICATIONS FOR USE
The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the "clothes pin" style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination.
The COVERox Sheath is supplied non-sterile and is intended for single use only.
Prescriptim
OTC
Lank Madoo 2-28-97
(Division Sign Off)
Division of Cret Resurairory
and Neurologica Devices
510(k) Number K964821