(69 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a biopsy site marker and its deployment system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used for radiographic marking of sites in soft tissue, specifically for locating biopsy cavities after a breast biopsy. It does not provide any treatment or therapy for a disease or condition.
No
Explanation: The device is used for marking sites in soft tissue for future reference and localization, not for diagnosing a condition. It provides a physical marker, not diagnostic information about the presence or absence of a disease.
No
The device description clearly outlines physical components including a marker, bioabsorbable material, and a deployment device with a cannula, handle, push rod, spring, and plunger. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "permanent radiographic marking of sites in soft tissue." This is a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical marker and a deployment system used to place the marker within the patient's tissue. It is used in conjunction with a biopsy device, which is also an interventional tool.
- Mechanism of Action: The device's function is to physically mark a location within the body for future imaging and potential intervention. It does not analyze biological samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic results based on laboratory testing.
In Vitro Diagnostic (IVD) devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 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 Biopsy Site Markers provide the user with the ability to mark the location of the cavity where a breast biopsy was performed. Radiographic marking allows physicians to locate biopsy cavities should a follow-up lumpectomy or re-biopsy be necessary.
The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, permanent biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and a deployment device.
The deployment device consists of a rigid cannula, handle, rigid push rod, spring, and plunger. The marker is located at the distal end of the deployment device. The marker is used in conjunction with a biopsy device. The biopsy devices available for use with the SecurMark markers are offered in different needle gauge sizes and lengths. In order to be compatible with their respective biopsy devices, the biopsy site marker deployment devices may be available in multiple size offerings.
The hand-held deployment device is utilized for both introducing the marker into the breast and depositing the marker into the biopsy cavity. The deployment device is manually operated and has limited contact with the patient. After the physician has appropriately positioned the deployment device, the physician manually depresses the plunger of the deployment device to deposit the marker in the intended location.
The permanent marking components of the SecurMark Biopsy Site Markers are available in different geometric shapes. In the event that two or more biopsy sites need to be marked, the user has the option to use a different shape of marker in each biopsy location. Each marker shape can be discerned under stereotactic (x-ray) imaging.
The permanent markers are classified as magnetic resonance (MRI) conditional at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement/dislodgement or heating.
The SecurMark Biopsy Site Markers should be used only by physicians trained in open or percutaneous biopsy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, x-ray, magnetic resonance, direct visualization, and others.
Anatomical Site
soft tissue (breast)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained in open or percutaneous biopsy procedures
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)
Design Control Activities:
- X-ray testing: New marker shapes must be discernable from other new marker shapes and current Hologic SecurMark marker shapes. Results: Met acceptance criteria.
- Simulated use: Deployment device must accommodate marker and deploy marker as intended. Results: Met acceptance criteria.
- Tolerance analysis: Biopsy Site Marker must be able to be inserted into an introducer (coaxial) with specific minimum and maximum dimensions. Results: Minimum introducer (coaxial) cannula inner diameter dimension established. Maximum introducer (coaxial) cannula length established.
- Simulated use: Biopsy site marker deployment device must be geometrically compatible with introducers (coaxial) that meet the length and diameter criteria set by the Tolerance Analysis. Results: Hologic biopsy devices tested with multiple introducer (coaxial) devices. Biopsy Site Markers met acceptance criteria.
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
SECTION 3 -- 510(k) SUMMARY
DATE PREPARED: September 17, 2010
OWNER/OPERATOR:
| Firm: | Hologic, Inc. |
|---|---|
| Address: | 6100 Technology Center Drive |
| Indianapolis, IN 46278 | |
| Phone #: | 317-344-7500 |
| Fax #: | 317-344-7697 |
| Registration #: | 3003862400 |
CONTACT:
Primary Contact from September 20-October 1
Heidi Strunk Director, Quality and Regulatory Affairs Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN 46278 Phone: 317-344-7630 E-mail: heidi.strunk@hologic.com
Primary Contact after October 1
Alyssa M. Lobo Senior Quality and Regulatory Consultant (a full-time employee of Hologic, Inc.) Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN 46278 Phone: 317-344-7532 E-mail: alyssa.lobo@hologic.com
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 |
1
Image /page/1/Picture/0 description: The image shows the word "HOLOGIC" in bold, black letters. Underneath the word "HOLOGIC" is a horizontal line. Below the line, the words "CLARITY Of VISION" are written in a smaller font size. The text is centered.
PREDICATE DEVICES:
510(k) Number K062528
Device Name Tissue Site Marking System
Device Manufacturer Hologic, Inc. (formerly Suros Surgical Systems, Inc.)
Location Indianapolis, IN
Section 3.1 - Description of the Device
The SecurMark Biopsy Site Markers provide the user with the ability to mark the location of the cavity where a breast biopsy was performed. Radiographic marking allows physicians to locate biopsy cavities should a follow-up lumpectomy or re-biopsy be necessary.
The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, permanent biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and a deployment device.
The deployment device consists of a rigid cannula, handle, rigid push rod, spring, and plunger. The marker is located at the distal end of the deployment device. The marker is used in conjunction with a biopsy device. The biopsy devices available for use with the SecurMark markers are offered in different needle gauge sizes and lengths. In order to be compatible with their respective biopsy devices, the biopsy site marker deployment devices may be available in multiple size offerings.
The hand-held deployment device is utilized for both introducing the marker into the breast and depositing the marker into the biopsy cavity. The deployment device is manually operated and has limited contact with the patient. After the physician has appropriately positioned the deployment device, the physician manually depresses the plunger of the deployment device to deposit the marker in the intended location.
The permanent marking components of the SecurMark Biopsy Site Markers are available in different geometric shapes. In the event that two or more biopsy sites need to be marked, the user has the option to use a different shape of marker in each biopsy location. Each marker shape can be discerned under stereotactic (x-ray) imaging.
The permanent markers are classified as magnetic resonance (MRI) conditional at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement/dislodgement or heating.
The SecurMark Biopsy Site Markers should be used only by physicians trained in open or percutaneous biopsy procedures.
2
Section 3.2 - 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. The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
Section 3.3 - Description of Device Modification
The modifications that are the subject of this 510(k) submission are as follows:
Modification to Permanent Marking Component Shape
The biopsy site markers that were cleared in K062528 specified markers that were cylindrical or "bow tie" shaped. The marking components that are the subject of this submission are shaped in one-hole, two-hole, or three-hole designs. See Section 3.5 for illustrations of the different marker shapes.
Modifications to Instructions for Use (IFU)
The Instructions for Use for the SecurMark Biopsy Site Markers that were cleared in K062528 address use of the biopsy site marker device only with other Hologic devices.
It has come to Hologic's attention that users who place Hologic biopsy site markers under ultrasound guidance sometimes utilize other non-Hologic biopsy devices and accessories, such as an introducer, (also referred to as a coaxial), prior to placement of the markers. Hologic's current IFU does not address the use of the biopsy site markers with any other company's biopsy devices and/or accessories.
In order to further guide users on the safe use of the Hologic biopsy site marker device, the proposed Instructions for Use has been modified to provide information to users regarding the dimensions of other devices that may be compatible with Hologic's biopsy site markers. The proposed new Instructions for Use are provided in Section 4.2.
3
Image /page/3/Picture/0 description: The image shows the word "HOLOGIC" in large, bold, black letters. Below the word "HOLOGIC" is a thin black line. Underneath the line, the words "CLARITY OF VISION" are written in a smaller font, also in black. The text is clear and easy to read.
Section 3.4 – Comparison of 510(k) Cleared Tissue Site Marking Systems
| | SecurMark Biopsy Site Marking System
(this 510(k) application) | Tissue Site Marking System
K062528 (cleared) |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Indicated Use | The Tissue Site Marking System is
indicated for the permanent
radiographic marking of sites in soft
tissue. | IDENTICAL |
| Bioabsorbable Marker
Material | Glycoprene II®
Monofilament
(PLA/PGA) | IDENTICAL |
| Permanent Marker
Material | Titanium (Grade 2) or
316 Stainless Steel | IDENTICAL |
| Supplied Sterile | YES | IDENTICAL |
| Sterilization Method | Gamma Irradiation | IDENTICAL |
| Sterilization Dose | 25kGy-50kGy | IDENTICAL |
| Sterility Assurance
Level (SAL) | 10⁻⁶ | IDENTICAL |
| Single Patient Use | YES | IDENTICAL |
| Deployment Device
Materials | Cannula: Stainless Steel, Titanium, or
similar materials
Handle: Polycarbonate or similar
materials
Spring: Stainless Steel or Beryllium
Copper | IDENTICAL |
| Deployment Device
Manufacturing
Methods | Manufactured by Hologic, Inc. | IDENTICAL |
| Packaging Materials | High Impact Polystyrene (HIPS) Tray and
foil pouch | IDENTICAL |
| Shelf Life | 1 Year | IDENTICAL |
| Method of Marker
Deployment | Manual | IDENTICAL |
| Dimensions | | |
| Deployment Device | Overall Length: 5.934" | IDENTICAL |
| Bioabsorbable Marker | Length: 0.591"
Center Diameter: 0.110"
Closure Diameter: 0.044" | IDENTICAL |
| Permanent Marker Shapes (See Section 3.5 Device Illustrations for images) | | |
| 1st Shape | One-hole | Cylinder |
| 2nd Shape | Two-hole | "Bow tie" |
| 3rd Shape | Three-hole | Item not available |
| | SecurMark Biopsy Site Marking System
(this 510(k) application) | Tissue Site Marking System
K062528 (cleared) |
| Permanent Marker Dimensions | | |
| 1st Shape | Length: 0.100"
Width: 0.037"
Thickness: 0.010" | Length: 0.070"
Diameter: 0.036" |
| 2nd Shape | Length: 0.087"
Width: 0.037"
Thickness: 0.010" | Length: 0.075"
Width: 0.036"
Height: 0.036" |
| 3rd Shape | Length: 0.094"
Width: 0.037"
Thickness: 0.010" | Item not available |
4
Image /page/4/Picture/0 description: The image shows the word "HOLOGIC" in large, bold, black letters. Underneath the word "HOLOGIC" is a horizontal line. Below the line, the words "CLARITY OF VISION" are written in a smaller font size. The text is all black and the background is white.
Section 3.4 – Comparison of 510(k) Cleared Tissue Site Marking Systems, continued
Similarities between device and legally marketed devices
The similarities between the subject of the 510(k) submission and the previously cleared 510(k) device include:
-
- Indications for Use Intended Use
-
- Marker Materials
- Deployment device manufacturing site and methods 7.
-
- Biocompatibility
-
- Sterilization dose and method iz Deployment device materials
Scientific technology
- ರು Shelf Life
-
- Supplied sterile for single patient use
Differences between device and legally marketed devices
Currently, the SecurMark Biopsy Site Identification system that is cleared under K062528 is different from the subject of this 510(k) application only in that:
-
- The permanent marker components from K062528 are available in two shapes: cylinder and "bow tie." The markers that are the subject of this application are available in three shapes that feature one, two, or three openings.
-
- The Instructions for Use for the currently marketed biopsy site markers do not provide users with any language to provide guidance if a customer chooses to use a non-Hologic introducer (co-axial) when placing the biopsy site marker under ultrasound visualization.
The new permanent marker shapes provide users with additional options for marking biopsy site locations. Each new shape is discernable from the other new shapes and from other Hologic marker shapes. The new wording in the IFU will give general guidance to users if they choose not to use a Hologic introducer when placing a Hologic biopsy site marker under ultrasound.
All other aspects of the subject of this 510(k) submission are the legally marketed devices. No changes are made in the intended use or the fundamental scientific principles of the previously cleared devices.
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). No new safety or efficacy questions are raised with the SecurMark Biopsy Site Marking System that is the subject of this submission.
5
Section 3.5 – Device Illustrations
Assembled Deployment Device
Identical to the deployment device cleared in K062528
| Device | Overall Cannula
Length |
|-------------|---------------------------|
| SMark-U-ss1 | 5.934" |
| SMark-U-ss2 | 5.934" |
| SMark-U-ss3 | 5.934" |
Image /page/5/Figure/5 description: The image shows a deployment device labeled K062528. The device consists of a cannula, handle, plunger, spring, and push rod. The plunger is made of Pebax, the push rod is made of stainless steel or titanium, the spring is made of stainless steel or beryllium copper, the handle is made of polycarbonate or similar materials, and the cannula is made of stainless steel, titanium, or similar materials.
The marker is loeded into the distal and of the deployment device during the manufacturing process.
Image /page/5/Picture/7 description: The image is a rectangular shape filled with a dense pattern of black and white pixels. The texture appears rough and grainy, with no discernible objects or figures. The overall impression is one of abstract noise or static, lacking any clear structure or recognizable content.
Marker (Cleared in K062528) Bioabsorbable Component – PLA/PGA (Glycoprene II) Permanent Component - 316 Stainless Steel or Titanium
6
Image /page/6/Picture/0 description: The image shows the word "HOLOGIC" in large, bold, black letters. Below the word "HOLOGIC" is the phrase "CLARITY OF VISION" in smaller, black letters. The phrase is centered below the word "HOLOGIC". The image appears to be a logo or branding for a company or product.
Section 3.5 - Device Illustrations, continued
Image /page/6/Figure/2 description: The image shows a table comparing the SecurMark Biopsy Site Marking System and the Tissue Site Marking System. The table displays permanent marker images for each system. The SecurMark system has one-hole, two-hole, and three-hole markers, while the Tissue Site Marking System has cylinder and "bow tie" markers. The third shape for the Tissue Site Marking System is listed as "Item not available".
Image /page/6/Figure/3 description: The image shows different shapes of SecurMark Biopsy Site Markers. The shapes are labeled as 1st, 2nd, and 3rd shape. The text indicates that the markers have a bioabsorbable component and are part of a 510(k) submission. The markers are cleared in K062528.
7
Section 3.6 - Stereotactic Images
The stereotactic (x-ray) image below shows the new marker shapes compared to the previously cleared SecurMark Biopsy Site Marker permanent marking components.
Image /page/7/Figure/3 description: The image shows a comparison of different views of four different objects labeled FAB-05149, FAB-05154, FAB-05155, FAB-02643, and FAB-02999. For each object, there is a side view, a top view, and an oblique view. The oblique views are labeled with a description of the shape of the object, such as "One-Hole Marker", "Two-Hole Marker", "Three-Hole Marker", "Cylinder Shaped Marker", and "Bow tie Shaped Marker".
Image from VER-03109
*FAB-05155, the new three-hole marker, has since been modified to form a "J" shape. See images on previous page for illustration.
** Previously cleared under K062528.
8
Image /page/8/Picture/0 description: The image shows the word "HOLOGIC" in large, bold, black letters. Below the word "HOLOGIC" is a horizontal line, and below the line is the phrase "CLARITY OF VISION" in smaller, black letters. The text is simple and clear, with a focus on the brand name.
Section 3.7 - Packaging
Packaging Materials
| Packaging Component | Material |
|---|---|
| Pouch | RFP-048 |
| Tray | White High Impact Polystyrene (HIPS) |
Drawings of the packaging materials are included in the following pages.
After the SecurMark Biopsy Site Markers have been placed into trays and sealed in pouches, they are labeled and placed into boxes. There are ten SecurMark Biopsy Site Markers and one Instructions for Use (IFU) manual packaged in each box. Markers are sold to customers in case quantities; they are not sold individually.
9
9/27/2007 2:16:31 PM
THESE DRAWINGS AND SPECIFICATIONS ARE THE PROPERTY OF SUROS
SURGICAL SYSTEMS, INC. AND SHALL NOT BE REPRODUCED, COPIED, OR USED
FOR THE MANUFACTURE OR SALE OF APPARATUS OR DEVICES WITHOUT PERMISSION.
♦ 6.00±.125
20.00$^{+.250}_{- .125}$
PART AS SUPPLIED BY:
AMCOR
PART SPECIFICATIONS:
♦MATERIAL: RFP-048 = 48 GA PET/1.5LB WLDPE/70GA FOIL(DI)/10LB LDPE/60 GA BIAX NYLON/10 LB LDPE/2MIL PEELABLE (LFM-417)- MOISTURE VAPOR TRANSMISSION RATE (MTVR): .02
- AVERAGE PULL STRENGTH OF EACH SEAL TO BE 1 LB WITH A 0.70 LB MINIMUM.
- SUPPLIER MUST PROVIDE CERTIFICATE OF ANALYSIS FOR SEAL INTEGRITY.
- LOOSE FOREIGN MATTER STANDARDS:
A. MAXIMUM PARTICLE SIZE: 1 mm.
B. MAXIMUM NUMBER OF PARTICLES: 3 PER 20 INCHES.
NOTES:
- SUROS ENGINEERING APPROVAL REQUIRED FOR ALL DIMENSIONAL AND/OR MATERIAL CHANGES.
SUROS PURCHASING TO BE NOTIFIED IN WRITING OF ANY REQUESTED CHANGES. - THIS PART AND/OR DRAWING EXISTS IN AN ELECTRONIC DATABASE
♦PARTS TO BE CLEAN AND FREE OF OIL, GREASE, DEBRIS, AND BURRS♦DENOTES CRITICAL DIMENSION AND/OR SPECIFICATION♦CRITICAL DIMENSIONS AND/OR SPECIFICATIONS REPORT REQUIRED WITH EACH MANUFACTURING LOT- PARTS TO BE SHIPPED/STORED DOUBLE BAGGED IN TALC-FREE POLY BAGS.
DIMENSIONS INCLUDE THICKNESS OF PLATING. ALL EXTERNAL THREADS TO BE CLASS 2A BEFORE PLATING
AND CLASS 2 AFTER PLATING. ALL INTERNAL THREADS TO BE CLASS 2B UNLESS OTHERWISE SPECIFIED.
| Labels | Values |
|---|---|
| NAME: | POUCH, BIRD CAGE FOIL (SHORT) |
| DRAWN BY: | L.FLUKER |
| DESIGNED BY: | B. ZIMMER |
| DATE: | 09-21-07 |
| 01-22-07 | |
| MATERIAL: | SEE PART SPEC |
| PART NO: | PKG-00151 |
| SIZE | B |
| Labels | Values |
|---|---|
| SIGNATURES | |
| ON FILE | |
| REV | 003 |
DO NOT SCALE DRAWING
ALL DIMENSIONS ARE IN INCHES
VARIATIONS ON FINISHED DIMENSIONS
UNLESS OTHERWISE MARKED
| Labels | Values | |
|---|---|---|
| BASIC DIMENSIONS | 2 PLACE DECIMALS | |
| ±.02 | 3 PLACE DECIMALS | |
| ±.005 | ||
| UP TO 6 | ||
| ABOVE 6 TO 24 | ±.03 | ±.010 |
| ABOVE 24 | ±.06 | ±.015 |
| ANGULAR DIMENSIONS | ± 1/2 DEG |
REVISIONS
SEE AGILE FOR REVISION HISTORY
10
Image /page/10/Figure/0 description: This image is a technical drawing of a marker tray, universal short, with dimensions and specifications. The drawing includes multiple views of the tray, along with detailed notes and material information. The overall length of the tray is 10.168 +/- 0.047, and the drawing was created by L. Fluker on 09-21-07. The material used is .030 HIPS 10, and the part number is FAB-03019.
11
Image /page/11/Picture/0 description: The image shows the word "HOLOGIC" in large, bold, black letters. Below the word "HOLOGIC" is the phrase "CLARITY OF VISION" in smaller, black letters. There is a black line separating the word "HOLOGIC" from the phrase "CLARITY OF VISION". The text is centered and the background is white.
Section 3.8 – Design Control Activities Summary
| Modifications from
Predicate Devices | Risk (from
DFMEA) | Verification
/ Validation
Activities | Acceptance Criteria | Results/Justification |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Permanent marker
components are
shaped differently than
those cleared in
K062528 | Product
Performance | X-ray testing | New marker shapes
must be discernable
from other new marker
shapes and current
Hologic SecurMark
marker shapes | Met acceptance
criteria |
| Product
Performance
(deployment of
marker) | Simulated
use | Deployment device
must accommodate
marker and deploy
marker as intended. | Met acceptance
criteria | |
| IFU has been updated
to provide general
guidance for use of the
biopsy site marker with
non-Hologic introducer
(coaxial) devices | Incompatible
geometries | Tolerance
analysis | Biopsy Site Marker
must be able to be
inserted into an
introducer (coaxial) with
specific minimum and
maximum dimensions | Minimum introducer
(coaxial) cannula
inner diameter
dimension
established.
Maximum introducer
(coaxial) cannula
length established. |
| Product
Performance | Simulated
use | Biopsy site marker
deployment device
must be geometrically
compatible with
introducers (coaxial)
that meet the length
and diameter criteria
set by the Tolerance
Analysis | Hologic biopsy
devices tested with
multiple introducer
(coaxial) devices.
Biopsy Site Markers
met acceptance
criteria | |
No new safety or efficacy questions are raised with the SecurMark Biopsy Site Marking System that is the subject of this submission.
12
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle or bird in flight, with its wings spread and feathers suggested by curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird, indicating the department's name and the country it represents. The seal is simple and monochromatic, with a focus on the symbolic representation of the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Hologic, Inc. % Ms. Alyssa M. Lobo Senior Quality and Regulatory Consultant 6100 Technology Center Drive Indianapolis, Indiana 46278
Re: K102768
Trade/Device Name: Biopsy Site Marking System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: `II Product Code: NEU Dated: November 11, 2010 Received: November 23, 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 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
DEC - 2 2010
13
Page 2 - Ms. Alyssa M. Lobo
CIFR 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/CDRH/CDRHOffices/ucm1118001/y praces 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/medicaldevices/resourcesforyou/industry/default.htm.
Sincerely yours;
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
SECTION 2 – STATEMENT OF INDICATIONS FOR USE
Indications for Use
DEC - 2 2010
K102768
510(k) Number (if known):
Biopsy Site Marking System Device Name:
Indications for Use: The 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)
Dand Koncurencor her WKM
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices | Page 1 of 1 |
| 510(k) Number | K102768 |