PERCUTANEOUS BREAST BIOPSY (PBB)

K972328 · Urothealth System, Inc. · KNW · Jul 7, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K972328
• Device Name: PERCUTANEOUS BREAST BIOPSY (PBB)
• Applicant: Urothealth System, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.

Device Story

Disposable breast biopsy device used to obtain localized tissue samples. Device operates by obturating to a lesion while leaving intervening tissue intact. Used with stereotactic mammographic imaging systems via reusable instrument accessories (holder, stop) mounted on a stereotactic table. Available in versions with or without monopolar electrosurgery capability; electrosurgical versions connect to standard generators via 4mm plug. Operated by clinicians in a clinical setting. Provides tissue samples for diagnostic evaluation; not for therapeutic use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material biocompatibility evaluation (ISO-10993), and compliance with electrical safety standards (ANSI/AAMI ES1-1993, HF18-1993) and sterilization validation (ANSI/AAMI/ISO 11135-1994).

Technological Characteristics

Materials: surgical stainless steel, thermoplastics. Energy: optional monopolar electrosurgery (4mm plug). Connectivity: mechanical mounting to stereotactic tables. Sterilization: ethylene oxide (ISO 11135). Biocompatibility: ISO-10993 (cytotoxicity, sensitization, irritation). Standards: ANSI/AAMI ES1-1993, ANSI/AAMI HF18-1993.

Indications for Use

Indicated for patients requiring localized breast tissue biopsies for diagnostic purposes. Used in conjunction with stereotactic mammographic imaging systems.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• USSC breast biopsy devices
• C.R. Bard breast biopsy devices
• Biopsys Medical breast biopsy devices
• C.R. Bard Magnum device

Reference Devices

• USSC ABBI device

Submission Summary (Full Text)

{0}------------------------------------------------

.. ...

g72328

### Appendix II

### Summary of Safety and Effectiveness

The PBB, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These similar devices are marketed by United States Surgical Corporation (USSC), C.R. Bard, and Biopsys Medical.

PBB, USSC, C.R. Bard and Biopsys devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are all used with stereotactic mammographic imaging systems.

The PBB device is like the C.R. Bard and Biopsys devices in that they all remove a localized biopsy. These devices obturate up to the lesion, leaving intact the tissue in route to the target area.

The PBB Instrument Accessories (Instrument Holder, and Stop) are similar to the instrument holding devices marketed by USSC, Biopsys, and C.R. Bard Magnum devices in that they are all reusable devices. All of these devices are used to mount their biopsy instrument on stereotactic tables.

The PBB and similar devices on the market have components that are of similar materials that are well known and extensively used by device manufacturers. Materials which have patient contact consist of surgical stainless steel and thermoplastics. Biocompatibility testing will be conducted on sterile component samples, according to ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The testing will include, but is not limited to Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. This device is categorized as Body Contact - Tissue/Bone/Dentin Communicating for a limited duration (≤ 24 hours).

The PBB device is available with and without electrosurgery capability. The PBB device with electrosurgery capability and the USSC ABBI device both have monopolar electrosurgical capability. Both are equipped with a 4mm male plug to allow their use with standard monopolar electrosurgical generators. The PBB device with Electrosurgery capability complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and Association for the Advancement of Medical Instrumentation, ANSVAAMI ES1-1993 Safe current limits for electromedical apparatus and ANSVAAMI HF18-1993 Electrosurgical devices.

The method of sterilization and the method used to validate the sterilization process are in compliance with the ANSVAAMI/ISO 11135-1994 Medical Devices - Validation and routine control of ethylene oxide sterilization.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 JUL

Ms. Julie Powell Quality Assurance and Regulatory Affairs Director Imaging Surgical Division of Imaging Medical Technologies 8850 M89 Box 351 Richland, Michigan 49083-03513

Re: K972328

Trade Name: Percutaneous Breast Biopsy (PBB) and Percutaneous Breast Biopsy (PBB) Instrument Accessories Regulatory Class: II Product Code: KNW Dated: April 1, 1998 Received: April 2, 1998

Dear Ms. Powell:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

{2}------------------------------------------------

Page 2 - Ms. Julie Powell

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Celia M. White, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# 510(k) Number (if known):

### Percutaneous Breast Biopsy (PBB) and Percutaneous Breast Biopsy Device Name: (PBB) Instrument Accessories

## Indications for Use:

Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div>(Division Sign-Off)</div> |
|-----------------------------------------|--------------------------------|
| Division of General Restorative Devices | K972328 |
| 510(k) Number | |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;">X</div> | OR | Over-The-Counter Use _________ |
|------------------------------------------|------------------------------------------|----|--------------------------------|
|------------------------------------------|------------------------------------------|----|--------------------------------|

(Optional Format 1-2-96)