INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

K060413 · Intact Medical Corporation · KNW · Apr 27, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060413
• Device Name: INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
• Applicant: Intact Medical Corporation
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The intact™ BLES 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™ BLES 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

The intact™ Breast Lesion Excision System (BLES) is an electrosurgical device used to obtain breast tissue samples for histologic examination. It functions by excising palpable or imaged breast abnormalities. The system is operated by clinicians in a clinical setting. By providing tissue samples, the device facilitates the diagnosis of breast abnormalities. If the excised tissue is found to be non-benign, the clinician must use standard surgical procedures to ensure complete removal of the lesion and clear margins. The device aids in the standard of care by enabling both diagnostic sampling and the partial or complete removal of lesions.

Clinical Evidence

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

Technological Characteristics

Electrosurgical cutting and coagulation device. Operates as an electrosurgical generator with biopsy instrumentation. Designed for breast tissue excision.

Indications for Use

Indicated for patients with palpable or imaged breast abnormalities requiring diagnostic tissue sampling or partial/complete excision for histologic examination. Applicable to benign lesions (e.g., fibroadenoma, fibrocystic lesions). Not intended to ensure complete removal of malignant histologic abnormalities; requires standard surgical follow-up for margin assessment if non-benign.

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 (K003190, K021577, K020031, K042170, K050737, K052246)
• Ethicon Endo-Surgery Mammotome (K003297)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Intact Medical Corporation's intact "M Breast Lesion Excision System (BLES)

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

David Jacobs VP. Engineering Intact Medical Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: [phone] Facsimile: [phone]

7 233

Date Prepared: February 14, 2005

## Name of Device and Name/Address of Sponsor

| Common or Usual Name: | Electrosurgical Generator |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Trade or Proprietary Name: | intact™ Breast Lesion Excision System (BLES) |
| Classification Name: | Electrosurgical Cutting & Coagulation Device &<br>Accessories (21 C.F.R. § 878.4400)<br>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 Corporation's intact™ BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297).

## Intended Use

The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The intact™ BLES is intended to provide breast tissue for histologic examination with partial

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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™ BLES may also be used to partially remove such palpable lesions. Whenever treast 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 examind for completeness of removal using standard surgical procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 2 7 2006

Intact Medical Corporation c/o Mr. David Jacobs VP, Engineering One Apple Hill. Suite-316 Natick, Massachusetts 01760

Re: K060413

Trade/Device Name: intact™ Breast Lesion Excision System (BLES) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 7, 2006 Received: April 11, 2006

Dear Mr. Jacobs:

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

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Page 2 - Mr. David Jacobs

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 [phone]. 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/dsma/dsmamain.html

Sincerely yours,

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

510(k) Number (if known):

Device Name: intact™ Breast Lesion Excision System (BLES)

Indications For Use:

The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The intact™ BLES 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™ BLES 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 AND/OR (Part 21 CFR 801 Subpart D)

R Over-The-Co
(21 CFR 807 Sub

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

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KOGO413