BREAST BOLSTER

K020624 · Beekley Corp. · IZH · Sep 12, 2002 · Radiology

Device Facts

• Record ID: K020624
• Device Name: BREAST BOLSTER
• Applicant: Beekley Corp.
• Product Code: IZH · Radiology
• Decision Date: Sep 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.

Device Story

Breast Bolster is a positioning aid designed for stereotactic breast biopsy procedures; intended for use with thin-breasted patients to facilitate proper breast compression and stabilization during imaging; used in clinical settings by radiologists or breast biopsy specialists; device provides physical support to improve access and imaging quality for patients who might otherwise be difficult to position; benefits include enabling successful biopsy procedures in patients with limited breast tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Positioning bolster/cushion; non-powered; mechanical support device; dimensions and materials not specified in document.

Indications for Use

Indicated for use in thin-breasted patients undergoing stereotactic breast biopsy procedures.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 2 2002

Ms. Maeghan Archambault Breast Biopsy Specialist Beekley Corporation Prestige Lane BRISTOL CT 06010

Re: K020624

Trade/Device Name: Breast Bolster Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: August 5, 2002 Received: August 7, 2002

Dear Ms. Archambault:

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 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 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Grigdon

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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| 510(k) Number (if known): | K020624 |
|---------------------------|----------------|
| Device Name: | Breast Bolster |
| Indications For Use: | |

Page 2 of 2Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2 Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __