(65 days)
Not Found
Not Found
No
The provided text does not contain any mentions of AI, ML, deep learning, or related concepts. The device description and performance study sections are also missing, which would typically contain information about AI/ML if present.
No
The device is described as being used to "mark an open or ... mark the location of the biopsy site," which indicates a marking or localization function rather than a therapeutic one (treatment or cure of disease).
No
The device is described as being used to "mark the location of the biopsy site," which is an interventional or procedural function, not a diagnostic one. It doesn't interpret or analyze medical data to identify a disease or condition.
Unknown
The provided text is a 510(k) summary template with many sections marked "Not Found". Without a "Device Description" or any mention of hardware components, it is impossible to determine if the device is software-only. The "Intended Use" only describes the function, not the form factor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "mark the location of the biopsy site." This is a physical action performed on or within the body to indicate a location.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description doesn't mention any analysis of biological samples.
- Anatomical Site: The device is used at the "biopsy site," which is a location on or within the patient's body.
The device appears to be a marker used during or after a biopsy procedure, which is a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.
Product codes
NEU
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, symbolizing health, services, and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
DEC 1 9 2002
Food and Drug Administration 200 Corporate Boulevard ckville MD 20850
Mr. Joseph L. Mark Vice President Promex, Inc. 3049 Hudson Street Franklin, Indiana 46131
Re: K023450
Trade/Device Name: Biopsy Site Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: October 9, 2002 Received: October 15, 2002
Dear Mr. Mark :
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 such 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);
1
Page 2 - Mr. Joseph L. Mark
labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
(or Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name:___Tissue Site Marker
Indications For Use:
These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
: Vision 3191-011 Olvision of General, Restorative id Neurological Devices
(Optional Format 1-2-96)