(84 days)
Not Found
No
The device description and performance studies focus on the physical components and their deployment, with no mention of AI/ML or related concepts like image processing or training/test sets.
No
The device is indicated for permanent radiographic marking of sites in soft tissue, which is a diagnostic or localization function, not a therapeutic one. It does not treat or cure a disease.
No.
The device is described as a "Tissue Site Marking System" intended for "permanent radiographic marking of sites in soft tissue," not for diagnosing conditions or diseases. It is used to mark a site, likely for future reference or intervention, rather than to identify or assess a medical condition.
No
The device description explicitly states it is composed of an implantable component and a deployment device, both of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SeCurMark Tissue Site Marking System is an implantable device used for radiographic marking of sites in soft tissue. It is deployed directly into the body.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device's function is to physically mark a location within the body for imaging purposes.
Therefore, the SeCurMark Tissue Site Marking System falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The SeCurMark family of Tissue Site Marking Systems is composed of two components:
- . an implantable component, composed of a bioabsorbable and permanent component, and
- a deployment device utilized for placement of the implantable component at the site of . interest.
This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, x-ray, magnetic resonance, and direct visualization
Anatomical Site
soft 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)
Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K072913 Page 1/2
Hologic, Inc.
6100 Technology Center Drive, Indianapolis, IN 46278 USA Main: +1.800.650.2169 Fax: +1.317.344.7600
510(k) Summary
Senior Quality & Regulatory Consultant
Hologic, Inc. – Suros Division 6100 Technology Center Drive
Indianapolis, IN 46278 Phone: 317-344-7687
OWNER/OPERATOR:
| Firm: | Hologic, Inc. - Suros Division |
|---|---|
| Address: | 6100 Technology Center Drive |
| Indianapolis, IN 46278 | |
| Phone #: | 317-344-7500 |
| Fax #: | 317-344-7697 |
| Registration #: | 3003862400 |
| CONTACT: | Paula A. Gray |
JAN - 4 2008
DATE: 12/06/2007
DEVICE NAME:
| Classification Name: | Marker, Implantable Radiographic |
|---|---|
| Common/Usual Name: | Tissue Site Marking System |
| Proprietary Name: | SeCurMark Biopsy Site Identification System |
| Device Class: | Class II |
| Description | Implantable Clip |
| Number | NEU |
| 21 CFR Ref. | 878.4300 |
| Performance Standards | No applicable performance standards established |
PREDICATE DEVICES:
| 510(k)-Number | Device Name | Device Manufacturer | Location |
|---|---|---|---|
| K062528 | |||
| IN | Tissue Site Marking | ||
| System | Hologic, Inc. – Suros Division | Indianapolis, | |
| K042296 | BiomarC | Carbon Medical | |
| Technologies, Inc. | St. Paul, MN |
Page 1 of 2
Image /page/0/Picture/13 description: The image shows the word "HOLOGIC" in all caps. The letters are bold and black. The background is white.
Image /page/0/Picture/14 description: The image shows the text "Clarity of Vision" in a simple, sans-serif font. The text is black and appears to be printed on a white background. To the left of the text, there is a partial, abstract graphic, also in black, that adds a visual element to the composition.
1
K072913 Page 2/2
6100 Technology Center Drive, Indianapolis, IN 46278 U Main: +1.800.650.2169 Fax: +1.317.344.7600
DEVICE DESCRIPTION AND CHARACTERISTICS:
The SeCurMark family of Tissue Site Marking Systems is composed of two components:
- . an implantable component, composed of a bioabsorbable and permanent component, and
- a deployment device utilized for placement of the implantable component at the site of . interest.
Hologic, Inc.
This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.
INTENDED USE:
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
SUBSTANTIAL EQUIVALENCE:
Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use.
CONCLUSION:
Based on the information presented in this 510(k) submission, the SeCurMark Biopsy Site Identification System is substantially equivalent to the presently marketed predicate devices. No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System.
Image /page/1/Picture/13 description: The image shows the word "HOLOGIC" in bold, black letters. The letters are evenly spaced and appear to be a sans-serif font. The word is horizontally oriented and fills most of the frame.
Image /page/1/Picture/14 description: The image contains the text "Clarity of Vision" in a bold, sans-serif font. The text is arranged horizontally, with "Clarity of" appearing above "Vision". The overall impression is clean and straightforward, suggesting a focus on clear and distinct visual perception.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
JAN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Suros Surgical Systems, Inc. % Ms. Paula A. Gray Senior Quality & Regulatory Consultant 6100 Technology Center Drive Indianapolis, Indiana 46278
Re: K072913
Trade/Device Name: SeCurMark Biopsy Site Identification System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 6, 2007 Received: December 7, 2007
Dear Ms. Gray:
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
3
Page 2 - Ms. Paula A. Gray
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 Protmarket, 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 vours.
Mark N Milhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072913
Device Name: SeCurMark Biopsy Site Identification System
Indications for Use:
The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
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)
Page 1 of 1
Kimbay H. Bley FOR M.MEIERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K072913 510(k) Number
(Posted November 13, 2003)