INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL

K081057 · Intact Medical Corporation · KNW · Jun 17, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K081057
• Device Name: INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
• Applicant: Intact Medical Corporation
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The Intact Excision XL is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Story

Intact Excision XL is an electrosurgical generator and biopsy instrument; used for diagnostic sampling of breast abnormalities. Device provides tissue for histologic examination via partial or complete removal of imaged or palpable lesions. Operated by clinicians in a surgical or clinical setting. System utilizes electrosurgical energy to excise tissue samples. Output is a tissue specimen for pathology; clinical decision-making relies on subsequent histologic evaluation of margins to ensure completeness of removal, particularly if malignancy is suspected. Benefits include ability to obtain diagnostic tissue samples for standard-of-care evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Electrosurgical generator and biopsy instrument. Utilizes electrosurgical energy for tissue cutting and coagulation. Classified as Class II (21 CFR 878.4400 and 21 CFR 876.1075).

Indications for Use

Indicated for patients with breast abnormalities (imaged or palpable) requiring tissue sampling for histologic examination. Includes partial or complete removal of imaged abnormalities and partial removal of palpable benign lesions (e.g., fibroadenoma, fibrocystic lesions).

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

• Intact BLES and Intact® Advance (formerly enbloc Biopsy) System (K060413)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

K081057

Intact Medical Corporation's Intact® Excision XL

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Doug Macarthur Senior Director of Engineering Intact Medical Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: [phone] Facsimile: [phone]

Date Prepared: April 11, 2008

### Name of Device and Name/Address of Sponsor

Common or Usual Name:

Electrosurgical Generator

Intact® Excision XL

Trade or Proprietary Name:

Classification Name:

Electrosurgical Cutting & Coagulation Device & Accessories (21 C.F.R. § 878.4400) Biopsy Instrument (21 C.F.R. § 876.1075)

Intact Medical Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: [phone] Facsimile: [phone]

## Predicate Devices

Intact Medical (formerly Neothermia) Corp.'s Intact BLES and Intact® Advance (formerly enbloc Biopsy) System (K060413).

#### Intended Use

The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The Intact Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

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The Intact Excision XL is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ system may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 7 2008

Intact Medical Corporation % Mr. Doug Macarthur Senior Director of Engineering One Apple Hill, Suite 316 Natick, Massachusetts 01760

Re: K081057

Trade/Device Name; Intact® Excision XL Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 11, 2008 Received: April 14, 2008

Dear Mr. Macarthur:

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 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.

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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Page 2 - Mr. Doug Macarthur

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark W. Miller

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

K081057 510(k) Number (if known):

Device Name: Intact® Excision XL

Indications For Use:

The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The Intact Excision XL is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign. it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Neil R. d. for man
Clerk

Division of General, Restorative, and Neurological Devices

510(k) Number K081057