(28 days)
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
The SecurMark Biopsy Site Marking System is intended for use with the manual method of deployment. It can be visualized under various imaging modalities such as ultrasound, x-ray, magnetic resonance, direct visualization, and others. This system is intended for single patient use only.
The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and deployment device.
The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the deployment device.
The provided text is a 510(k) summary for the SecurMark Biopsy Site Marking System. It details the device, its indications for use, and a comparison to predicate devices. However, explicit acceptance criteria and a description of a study proving the device meets these criteria are not detailed in the provided text.
The section titled "Non-Clinical Evaluation" generally states that tests were performed and that "The devices met or exceeded the acceptance criteria for all evaluations." but it does not specify what those acceptance criteria were, what the reported device performance was against those criteria, or the methodology of the study.
Therefore, I cannot populate most of the requested table and information as it is not present in the provided text.
Here is what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met or exceeded criteria for all evaluations (simulation, shelf life, tensile testing, functionality at specified temperatures, MRI compatibility and artifacts, X-ray distinctive visualization, calcification distinguishability, sterilization, biocompatibility, tolerance analyses, and viscosity and moisture). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (likely from the manufacturer's internal testing, no country of origin is mentioned, retrospectivity/prospectivity not mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The evaluation appears to be non-clinical (device performance tests) rather than reader studies involving human observers and ground truth from experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the evaluations are non-clinical device performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC or comparative effectiveness study is described. The device is a physical marker system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as the device is a physical marker system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the human sense. For the non-clinical tests, the "ground truth" would be engineering and material science standards/specifications.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
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SECTION 3 - 510(k) SUMMARY
DATE PREPARED: DATE REVISED:
ﮨﮯ
ﻣﯿ
August 27, 2010 (original submission) October 8, 2010
OWNER/OPERATOR:
| Firm: | Hologic, Inc. | Contact Name: Alyssa M. Lobo |
|---|---|---|
| Address: | 6100 Technology Center DriveIndianapolis, IN 46278 | Title: Senior Quality and Regulatory Consultant |
| (a full-time employee of Hologic, Inc.) | ||
| Phone Number: | 317-344-7500 | Phone Number: 317-344-7532 |
| Fax Number: | 317-344-7697 | E-mail: alyssa.lobo@hologic.com |
| Registration Number: | 3003862400 |
DEVICE NAME:
| Classification Name: | Marker, Implantable Radiographic |
|---|---|
| Common/Usual Name: | Tissue Site Marking System |
| Proprietary Name: | SecurMark Biopsy Site Marking System |
| Device Class: | Class II |
| Description: | Implantable Clip |
| Number: | NEU |
| 21 CFR Ref: | 878.4300 |
| Performance Standard: | None established |
PREDICATE DEVICES:
| 510(k) Number | Device Name | Device Manufacturer | Location |
|---|---|---|---|
| K072913 | SecurMark Biopsy SiteIdentification System | Hologic, Inc.(formerly Suros Surgical Systems, Inc.) | Indianapolis, IN |
| K062528 | Tissue Site MarkingSystem | Hologic, Inc.(formerly Suros Surgical Systems, Inc.) | Indianapolis, IN |
Description of the Device
The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and deployment device.
The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the deployment device.
Indications for Use and Intended Use
Indications for Use
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
Intended Use
The SecurMark Biopsy Site Marking System is intended for use with the manual method of deployment. It can be visualized under various imaging modalities such as ultrasound, x-ray, magnetic resonance, direct visualization, and others. This system is intended for single patient use only.
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Comparison of 510(k) Cleared Tissue Site Marking Systems
The SecurMark Biopsy Site Marker that is the subject of this submission is comprised of two 510(k) cleared devices. The first is an implantable component, covered by K062528, held by Hologic, Inc. which is composed of a bioabsorbable component and a permanent marking component (316 stainless steel or titanium). The second is a deployment device, covered by K072913, held by Hologic, Inc. The subject of this 510(k) is similar to the predicate devices in the following areas: Indications for Use, Intended Use, Scientific Technology, biocompatibility, sterilization (dose, method, and SAL), marker materials, deployment device materials, packaging materials, deployment device manufacturing site, deployment device manufacturing methods, deployment device dimensions, marker dimensions, shelf life, and deployment method. The product is also supplied sterile for single patient use, like the predicate devices.
The subject of this 510(k) is different from the device cleared in K072913 in that the permanent marker material in that 510(k) was listed only as titanium. The subject of this 510(k) is different from the device cleared in K062528 in that the deployment device is constructed from different materials. The shapes of the permanent marking components in this submission are different from the shapes of the marking components that were cleared in both K072913 and K062528. All other aspects of the subject of this 510(k) submission are the legally marketed devices.
Non-Clinical Evaluation
The devices that are the subject of this submission have been evaluated through a number of test, or prior test results for predicate devices apply to the devices that are subject of this submission. Testing, evaluations, and/or analyses have been performed for: simulation, shelf life, tensile testing, functionality at specified temperatures, MRI compatibility and artifacts, X-ray distinctive visualization, calcification distinguishability, sterilization, biocompatibility, tolerance analyses, and viscosity and moisture.
The devices met or exceeded the acceptance criteria for all evaluations.
Conclusion
Based on the information presented in this Special 510(k) submission, the SecurMark Biopsy Site Marking System is substantially equivalent to the presently marketed Hologic, Inc. Tissue Site Marking System (K062528) and the SecurMark Biopsy Site Identification System (K072913).
No new safety or efficacy questions are raised with the SecurMark Biopsy Site Marking System that is the subject of this submission.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hologic, Inc. % Ms. Alyssa M. Lobo Senior Quality and Regulatory Consultant 6100 Technology Center Drive Indianapolis, Indiana 46278
OCT O & 2010
Re: K102608
Trade/Device Name: SecurMark Biopsy Site Marking System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: August 27, 2010 Received: September 13, 2010
Dear Ms. Lobo:
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
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Page 2 - Ms. Alyssa M. Lobo
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102608
Device Name: SecurMark Biopsy Site Marking System
Indications For Use: The SecurMark Biopsy Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
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 Device Evaluation (ODE)
Daniel Kroeber for MXM
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102608
Page 1 of
§ 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.