FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

K061651 · Apple Medical Corp. · HGI · Oct 20, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061651
• Device Name: FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
• Applicant: Apple Medical Corp.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias. The intended use is the same.

Device Story

Fischer Cone Biopsy Excisor is a surgical instrument used for Large Loop Excision of the Transformation Zone (LLETZ). Device facilitates excision of cervical tissue for diagnosis and treatment of cervical intraepithelial neoplasia (CIN) and dysplasias. Operated by physicians in clinical settings; device functions as an accessory to electrosurgical units to excise tissue via electrical current. Provides clinicians with a method to remove targeted cervical tissue, aiding in the management of cervical pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gynecologic electrocautery accessory; manual surgical instrument form factor; intended for use with electrosurgical generators. Materials and sterilization methods not specified in provided text.

Indications for Use

Indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in patients requiring diagnosis and treatment of cervical intraepithelial neoplasias (CIN) and dysplasias.

Regulatory Classification

Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## OCT 2 0 2006

Mr. John C. Pulford Director of Operations Apple Medical Corporation 28 Lord Road, Unit 135 MARLBOROUGH MA 01752

Re: K061651

Trade/Device Name: Fischer Cone Biopsy Excisor, Models 900-150, -151, -152, -154, -155, -157 and -158 . . Regulation Number: 21 CFR §884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: HGI Dated: September 11, 2006 Received: September 18, 2006

Dear Mr. Pulford:

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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oting Sublic

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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. Your must comply with all the Act's requirements, including, but not limited to: registration and liasting (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 ed act 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 logal/v marketed predicate device results in a classification for your device and thus, percoits 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 innler the Act from the Division of Small Manufacturers, International and Consumer Assistance and its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/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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## Page

510(k) Number (if known):

Device Name: _Fischer Cone Biopsy Excisor

Indications for Use:

## INDICATIONS FOR USE:

The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

The intended use is the same.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Part 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)

Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K061651