(19 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of a biopsy site marker, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
This device is a marker used to radiographically mark breast tissue during a percutaneous breast biopsy procedure, not to treat a disease or condition.
No.
This device is a marker used to radiographically mark breast tissue during a percutaneous breast biopsy procedure, not to diagnose a condition.
No
The device description clearly outlines physical components like a needle applicator, pellets, a gold marker, and a PEG plug, indicating it is a hardware device.
Based on the provided information, the Gel Mark UltraCor Biopsy Site Marker is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Gel Mark UltraCor is a device that is implanted directly into the breast tissue during a biopsy procedure. It is a marker placed in vivo (within the living body), not a test performed in vitro (in a test tube or outside the body) on a sample.
- The intended use is to radiographically mark breast tissue. This is a procedural aid for imaging, not a diagnostic test performed on a biological sample to determine a disease state or condition.
The device description and intended use clearly indicate it's a medical device used during a procedure to mark a location within the body for future imaging. This falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Product codes
NEU
Device Description
The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposable beveled needle Applicator containing: 2 resorbable polylactic acid/polyglycolic acid pellets. 1 gold marker in the center position. 1 polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks. The Applicator has a beveled 20 cm needle with 1 cm depth marks and a locking plunger. The pellets are deployed from the beveled needle tip into the tissue site.
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)
Preclinical testing had confirmed the radiographic visibility of the gold marker. Gold, as a long-term implant, has an extensive history of use and has been cleared for use in a similar application. The resorbable polyethylene glycol plug has been used previously in SenoRx biopsy site markers to contain pellets in the applicator. The change to a metallic (stainless steel) applicator shaft is similar to the metallic (titanium) of a previous cleared SenoRx device. The reduction in the applicator shaft diameter varies in a manner that has no impact on device safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the word "SENORx" in a bold, sans-serif font. The letters are arranged horizontally, with the "x" slightly smaller and raised compared to the other letters. The text appears to be a logo or brand name.
080698
MAR 3 1 2008
510(K) SUMMARY 7.
| Date prepared | March 10, 2008 |
|---|---|
| Name | SenoRx, Inc. |
| 11 Columbia | |
| Aliso Viejo, CA 92656 | |
| T. 949.362.4800; F. 949.362.0300 | |
| Contact person | Eben Gordon |
| Vice President, RA/QA | |
| SenoRx, Inc. | |
| T. 949.362.4800; F. 949.362.0300 | |
| Device name | Gel Mark UltraCor Biopsy Site Marker |
| Common name | Biopsy site marker |
| Classification name | Implantable Clip |
| Classification regulation | 878.4300 NEU |
| Predicate device | Biopsy Site Marker; K011402; clearance date 7/16/2001; FZP |
| Gel Mark IV Tissue Marker, K040706, clearance date 4/8/2004, NEU | |
| Description | The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposable beveled |
| needle Applicator containing: | |
| 2 resorbable polylactic acid/polyglycolic acid pellets. 1 gold marker in the center position. 1 polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The | |
| pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed | |
| in approximately 12 weeks. | |
| The Applicator has a beveled 20 cm needle with 1 cm depth marks and a locking | |
| plunger. The pellets are deployed from the beveled needle tip into the tissue site. | |
| Indications for use | The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically |
| mark breast tissue during a percutaneous breast biopsy procedure. | |
| Summary of substantial | |
| equivalence | The Gel Mark UltraCor Biopsy Site Marker as the following similarities to the |
| previously cleared predicate devices: | |
| Same indications for use; Same intended treatment site; Same operating principle; and Same basic design. Preclinical testing had confirmed the radiographic visibility of the gold marker. Gold, as | |
| a long-term implant, has an extensive history of use and has been cleared for use in a | |
| similar application. The resorbable polyethylene glycol plug has been used previously | |
| in SenoRx biopsy site markers to contain pellets in the applicator. The change to a | |
| metallic (stainless steel) applicator shaft is similar to the metallic (titanium) of a | |
| previous cleared SenoRx device. The reduction in the applicator shaft diameter varies | |
| in a manner that has no impact on device safety. | |
| In summary, the Gel Mark UltraCor Biopsy Sire Marker as described in this submission | |
| is substantially equivalent to the predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is in a simple sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2008
SenoRx, Inc. % Eben Gordonese VP. Regulatory Affairs & Quality Assurance 11 Columbia Aliso Viejo, California 92656
Re: K080698
Trade/Device Name: Gel Mark UltraCor Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: NEU Dated: March 10, 2008 Received: March 12, 2008
Dear Mr. Mazzarese:
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); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Eben Gordonese
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6. INDICATIONS FOR USE
510(k) Number (if known): 长080698
Device Name: _______ Gel Mark UltraCor Biopsy Site Marker ____________________________________________________________________________________________________________________
Indications for Use:
The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use _______
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mule M. Mllkess Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K08069
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