HYDROMARK BIOPSY SITE MARKER

K060769 · Biopsy Sciences, LLC · NEU · Jul 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060769
• Device Name: HYDROMARK BIOPSY SITE MARKER
• Applicant: Biopsy Sciences, LLC
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Biopsy Sciences, Inc. HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

Device Story

HydroMark Biopsy Site Marker is an implantable device used to mark biopsy sites in breast tissue. It consists of a titanium coil encased in a hydrogel material (FocalSeal-L). The device is pre-loaded in a delivery system compatible with the J&J Ethicon Mammotome probe. During a percutaneous breast biopsy, the marker is deployed into the biopsy void. Upon contact with fluid, the hydrogel expands to fill the void, providing ultrasound visibility for at least 6 weeks. The hydrogel degrades over time via hydrolysis, while the titanium coil remains to provide permanent visibility under x-ray and MRI. The device is intended to prevent migration and assist clinicians in locating the biopsy site for follow-up procedures.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of delivery system compatibility with the Mammotome probe, and migration studies demonstrating the marker remains at the biopsy site. No clinical data provided.

Technological Characteristics

Implantable biopsy site marker consisting of a titanium coil and a hydrophilic hydrogel (FocalSeal-L). The hydrogel expands upon fluid contact and degrades via hydrolysis. The device is provided sterile and is compatible with the Mammotome biopsy probe delivery system. It provides visibility via ultrasound (temporary) and x-ray/MRI (permanent).

Indications for Use

Indicated for marking tissue during percutaneous breast biopsy procedures.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Biopsy Sciences Bio-Mark Biopsy Site Marker (K023694)
• Biopsy Sciences Bio-Seal Lung Biopsy Site Marker (K041331)
• InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor (K053518)
• J&J MicroMark Biopsy Clip (K970817)

Submission Summary (Full Text)

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Ko60769

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JUL 25 2006

510(K) SUMMARY (21 CFR 807.92)

## HYDROMARK BIOPSY SITE MARKER

Biopsy Sciences, Inc. 510(k) Owner: 3433 East Fort Lowell Road, Suite 103 Tucson AZ 85716 Tel: [phone] Fax: [phone]

- Sharon Rockwell Contact Person: Tel: [phone] E-mail: [e-mail]
March, 2006 Date Prepared:

HydroMark Biopsy Site Marker Trade Name:

Biopsy site marker Common Name:

Classification Name: Implantable staple per 21 CFR 878.4750, FZP

Biopsy Sciences Bio-Mark Biopsy Site Marker, K023694 Predicate Devices: Diopsy Sciences Bio-Seal Lung Biopsy Site Marker, K041331 InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, K053518 J&J MicroMark Biopsy Clip, K970817

The Biopsy Sciences HydroMark Biospy Site Markers are made of Device Description: The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI.

> The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed

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by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.

Intended Use: The Biopsy Sciences, Inc. HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

> The indications are identical to those of the predicate device, the Biopsy Sciences Bio-Mark Biopsy Site Marker.

## Technological Characteristics:

The hydrogel component expands on fluid contact to fill the void created during the biopsy, leaving the HydroMark at the exact location of biopsy. Because the hydrogel is hydrophilic, it is clearly distinct from normal breast structure under ultrasound imaging. The hydrogel material degrades via hydrolysis over time leaving the internal Titanium coil which provides permanent visibility under x-ray and MRI.

Non-Clinical Performance Data:

Non-clinical testing included biocompatibility of the components. validation that delivery system is compatible with the commercially available Mammotome biopsy probe, and evidence that the site marker does not migrate over time. The HydroMark is highly visible under ultrasound imaging, does not migrate, and assures permanent visibility under x-ray and MRI with minimal artifacts. The device performs as intended and has the identical intended use as predicate devices previously cleared under 510(k)s.

- Conclusions: The non-clinical and animal test results demonstrate the HydroMark accurately marks the biopsy site. The testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 25 2006

Ms. Sharon Rockwell Vice-President, Regulatory and Clinical Affairs Biopsv Sciences, LLC 3433 East Fort Lowell Road TUCSON AZ 85718

Re: K060769

Trade/Device Name: HydroMark Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: June 14, 2006 Received: June 19, 2006

Dear Ms. Rockwell:

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 (Premarket Approval), 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.

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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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K060769

Device Name: HydroMark Biopsy Site Marker

Indications for Use:

The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible uneler ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

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)

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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _