(21 days)
Not Found
No
The device description focuses on the physical components and materials of the marker and applicator, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is intended to mark breast tissue for radiographic identification after a biopsy, not to treat a disease or condition. The absorption of body fluids by the pellets for bleeding control is ancillary to its primary purpose of marking.
No
This device is a marker used to identify the location of a biopsy for future radiographic imaging; it does not diagnose a condition.
No
The device description explicitly states it is comprised of a disposable applicator and an implantable marker containing physical components like starch pellets, PLA/PGA pellets, PEG pellets, and a stainless steel wireform. These are hardware components, not 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 "radiographically mark breast tissue during a percutaneous breast biopsy procedure." This is a procedural device used during a medical procedure to aid in imaging and localization.
- Device Description: The device is an implantable marker containing materials for absorption and a wireform for long-term radiographic marking. It is physically placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis on a specimen.
Therefore, the StarchMark® Breast Tissue Marker and StarchMark UltraCor™ Breast Tissue Marker are considered medical devices used in a surgical/interventional procedure, not IVDs.
N/A
Intended Use / Indications for Use
The Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Product codes
NEU
Device Description
StarchMark® Breast Tissue Marker: The StarchMark® Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker. The marker contains six polysaccharide (starch) pellets and one polylactic/polyglycolic acid-based copolymer (PLA/PGA) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PLA/PGA pellet contains a Stainless Steel Ribbon or "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark® Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
StarchMark UltraCor™ Breast Tissue Marker: The StarchMark UltraCor™ Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains four polysaccharide (starch) pellets and one polyethylene glycol (PEG) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PEG pellet contains a Stainless Steel "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark UltraCor™ Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
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
The change to contraindications described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted.
Key Metrics
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
K131654 page 1/3
Page 19 of 76
510(k) Summary 21 CFR 807.92
JUN 2 7 2013
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | SenoRx, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|---------------------------------------------------------------|
| Phone: | 480-638-2954 |
| Fax: | 480-449-2546 |
| Contact: | Sarah McCartney, Regulatory Affairs Associate |
| Date: | June 05, 2013 |
2. Subject Device:
| Device Trade Name: | StarchMark® Breast Tissue Marker
StarchMark UltraCor™ Breast Tissue Marker |
|-----------------------|-------------------------------------------------------------------------------|
| Common or Usual Name: | Tissue Marker |
| Classification: | Class II |
| Classification Name: | Marker, Radiographic, Implantable ( Product Code NEU) |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4300 (Implantable Clip) |
3. Predicate Device:
StarchMark® Breast Tissue Marker (K081085; cleared August 1, 2008)
4. Summary of Change:
A statement regarding allergic reactions was moved from the warnings section to the contraindications section of product labeling. Additional updates to other sections of the IFU are also being implemented through this submission.
1
K131654 Page 2/3
Special 510(k): Device Modification - Change Being Effected StarchMark® Breast Tissue Marker
Page 20 of 76
5. Device Description:
StarchMark® Breast Tissue Marker
The StarchMark® Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker. The marker contains six polysaccharide (starch) pellets and one polylactic/polyglycolic acid-based copolymer (PLA/PGA) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PLA/PGA pellet contains a Stainless Steel Ribbon or "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark® Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
StarchMark UltraCor™ Breast Tissue Marker
The StarchMark UltraCor™ Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains four polysaccharide (starch) pellets and one polyethylene glycol (PEG) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PEG pellet contains a Stainless Steel "V" shaped wireform. The wireform is intended for longterm radiographic marking of the biopsy site. The StarchMark UltraCor™ Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
6. Indications for Use of Device:
The StarchMark® Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
7. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:
- . Intended use
- . Indications for use
- Target population .
- Fundamental scientific technology
Image /page/1/Picture/16 description: The image shows the text "SenoRx, Inc.". The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background.
Image /page/1/Picture/17 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and constructed with thick lines, giving it a blocky appearance. The letters are closely spaced, creating a compact and unified design. The overall style is simple and modern.
2
K13 1654 page 3/3
Special 510(k): Device Modification - Change Being Effected StarchMark® Breast Tissue Marker
- . Operating principle
- . Implant design and materials
- Applicator design and materials .
- . Performance specifications
- Packaging configuration ●
- Sterility assurance and method of sterilization .
There are no changes to the design, materials, performance specifications, packaging or sterilization of the subject device compared to the current legally marketed predicate device. The only modification is to the labeling which is notably different in the following manner:
- Contraindications ●
8. Performance Testing Summary:
The change to contraindications described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted.
9. Conclusion:
The subject StarchMark® Breast Tissue Marker is substantially equivalent to the predicate device.
SenoRx, Inc.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SenoRx, Inc % Ms. Sarah McCartney Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281
June 27, 2013
Re: K131654
Trade/Device Name: StarchMark Breast Tissue Marker; StarchMark Ultracor Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: June 05, 2013 . Received: June 06, 2013
Dear Ms. McCartney:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Sarah McCartney
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | K131654 |
|---|---|
| Device Name: | StarchMark ® Breast Tissue Marker |
| StarchMark UltraCor ™ Breast Tissue Marker | |
| Indications for Use: | The Breast Tissue Marker is intended 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131654