(21 days)
Not Found
Not Found
No
The 510(k) summary describes a physical marker for breast tissue and contains no mention of AI, ML, image processing, or any other computational analysis of data.
No
The device is used to mark breast tissue for imaging prior to or during a biopsy, which is a diagnostic procedure, not a therapeutic one.
No
The device is used to mark breast tissue for biopsy, which is an interventional procedure, not a diagnostic one. It aids in localization rather than providing a diagnosis.
No
The intended use describes a device that "mark[s] breast tissue prior to or during a breast biopsy procedure," which strongly implies a physical marker or implantable device, not software. The lack of a device description prevents definitive confirmation, but the function described is inherently hardware-based.
Based on the provided information, the Gel Mark IV is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure." This describes a device used in vivo (within the body) to aid in a medical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML (Not Found): These are often associated with IVDs that analyze images or data for diagnostic purposes. Their absence further supports it not being an IVD.
- Input Imaging Modality: Radiography and sonography are imaging techniques used on the patient, not on a sample.
- Anatomical Site: Breast tissue is the target in vivo.
IVDs are typically used to examine samples like blood, urine, tissue biopsies (after removal from the body), etc., to provide information about a patient's health status. The Gel Mark IV's function is to physically mark tissue within the body for guidance during a procedure.
N/A
Intended Use / Indications for Use
The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.
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
breast tissue
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 (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.
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national scope.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viego, California 92656
Re: K040706
Trade/Device Name: Gel Mark IV Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: March 17, 2004 Received: March 18, 2004
Dear Ms. Boucly:
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 adviscd 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Amy Boucly
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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Milliman
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
2
Indications for Use
510(k) Number (if known): K040706
Device Name: Gel Mark IV Tissue Marker
Indications For Use:
The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER, PAGE IF NEEDED)
Concurrence of CDRH, Office of Dévice Evaluation (ODE)
K04070
b. Mark A. Mellema
Division of General, Restorative, and Neurological Devices
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510(k) Number