(204 days)
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No
The summary describes a simple connector cable for existing oximeters and contains no mention of AI, ML, or related concepts.
No
The device is a replacement part for connecting oximeter sensors to an oximeter monitor, which serves a diagnostic purpose, not a therapeutic one.
No
The device is described as a replacement part for connecting oximeter sensors to an oximeter monitor. Its function is to facilitate the connection of sensors to a monitoring device, rather than to perform any diagnostic measurements or analyses itself. It serves a utilitarian role in the operation of an oximeter, which is a diagnostic device, but the connector itself is not.
No
The summary describes a device that connects oximeter sensors to an oximeter monitor, implying a hardware component for physical connection and signal transmission. The intended use as a "Replacement for Nellcor Patient Module" further suggests a hardware replacement, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect oximeter sensors to an oximeter monitor. This describes a device that facilitates the measurement of physiological parameters (like blood oxygen saturation) within the body, not a test performed outside the body on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on analysis of biological samples.
This device appears to be an accessory or component for a medical device (an oximeter) that performs measurements on a patient.
N/A
Intended Use / Indications for Use
Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters 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
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey Secunda VP Product Development & Regulatory Affairs Epic Medical Equipment Services, Inc. 4643 Westgrove Drive Dallas, Texas 75248
JUL 16 1997
Re: K965172 Oximeter Pre-AMP Cable Requlatory Class: II (Two) Product Code: 74 DQA Dated: April 16, 1997 Received: April 17, 1997
Dear Mr. Secunda:
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 Existing major regulations affecting your device additional controls. 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 Regulation (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 regulation may result in regulatory 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 regulations.
1
Page 2 - Mr. Jeffrey Secunda
This letter will allow you to begin 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K965172 510(k)
DEVICE NAME: OXIMETER PRE-AMP CABLE
INDICATIONS FOR USE:
Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
eplacement point
Over-the-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Lank madon 7-14-97
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510(k) Number
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K965172