AUTO SUTURE ABBI SYSTEM

K983296 · United States Surgical, A Division of Tyco Healthc · KNW · Jun 4, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983296
• Device Name: AUTO SUTURE ABBI SYSTEM
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jun 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mammographic abnormality that is suspicious for malignant disease (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a mammographic abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal. The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.

Device Story

System uses stereotactic mammography to target non-palpable breast abnormalities; utilizes disposable biopsy device with circular scalpel and electrocautery snare to excise tissue samples. Used in clinical settings by physicians; device diameter (5-20mm) matched to lesion size. Provides tissue for histologic examination; aids in diagnosis of malignant disease. Benefits include ability to perform partial or complete removal of imaged abnormality for diagnostic purposes.

Clinical Evidence

Prospective, multi-centered, non-randomized study of 106 patients. Primary endpoint: 100% success rate for histological diagnosis (80.2% benign, 19.8% malignant). Secondary endpoint: 100% success in removing radiographically marked abnormalities; 96.2% complete removal verified by specimen and post-operative mammography.

Technological Characteristics

Disposable biopsy device; circular scalpel and electrocautery snare; diameters 5, 10, 15, 20mm. Materials compliant with ISO 10993-1.

Indications for Use

Indicated for patients requiring diagnostic sampling of mammographically suspicious breast abnormalities (typically BIRADS 4 or 5) that have been stereotactically localized via needle wire. Not contraindicated by age/gender, though intended for breast tissue biopsy.

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

• Auto Suture ABBI System (K963825)

Submission Summary (Full Text)

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# Auto Suture* ABBI* System

K983296

SE 6-4-99

#### 510(k)_Summary of Safety and Effectiveness IX.

United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856

Christopher A. Graham CONTACT PERSON:

June 4, 1999 DATE PREPARED:

CI.ASSIFICATION NAME: Instrument, Biopsy

Instrument, Biopsy COMMON NAME:

Auto Suture* ABBI+ System PROPRIETARY NAME:

Auto Suture* ABBI* System (K963825). PREDICATE DEVICES:

The Auto Suture* ABBI* System uses stereotactic DEVICE DESCRIPTION: mammography to target non-palpable breast abnormalitics for biopsy. The system includes a disposable biopsy device, which uses a circular scalpel and elcctrocautcry snare to excise a diagnostic sample for diagnosis.

To be used when stereotactically localized, large diameter, INTENDED USE: breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mainmographic abnormality that is suspicious for malignant disease (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

> The extent of a histologic abnormality cannot be appearance. mammographic determined from its Therefore, the extent of removal of a mammographic abnormality docs not predict the extent of removal of a histologic abnormality, c.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal.

> The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.

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## Auto Suture* ABBI* System

#### MATERIALS: All component materials of the Auto Suture* ABBI* System are comprised of materials which are in accordance with ISO Standard # 10993-1.

CLINICAL SUMMARY: In a multi-centered, non-randomized, prospective study, 106 patients under went breast biopsy procedures using the Auto Suture* ABBI* System to evaluate the device for use in the removal of mammographic abnormalities. The Auto Suture* ABBI* System was evaluated on the following endpoints:

- Primary endpoint: 106 of the 106 (100%) complete . procedures were successful for a histological diagnosis. 85 patients (80.2%) had benign lesions and 21 patients (19.8%) had malignant lesions. Of the 21 patients with malignant lesions, 7 (33.3%) had negative margins, 11 (52.4%) had positive margins, and 3 (14.3%) were undetermined. Consistent with the standard of care for excisional biopsies, all patients with malignancies were treated with a therapoutic modality after the diagnostic ABBI* procedure.
- Secondary endpoint: 106 of the 106 (100%) . procedures were successful, in terms of removing a mammographically visible abnormality that had been radiographically marked for the purpose of diagnosis. 102 of the 106 (96.2%) procedures were completely removed, as verified by the presence of the Icsion in the specimen radiograph and by its absence in the patient's post-operative mammogram of the biopsy site.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes and a flowing tail.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re: K983296 Trade Name: Auto Suture ABBI System Regulatory Class: II Product Code: KNW Dated: May 10, 1999 Received: May 12, 1999

Dear Mr. Graham:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 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 device 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.

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### Page 2 - Mr. Christopher A. Graham

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 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 device, 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,

tocottefa

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

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IV. Indications For Use:

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510(k) Number (if known):

Name: Auto Suture* ABBI* System

Indications For-Use:

To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mammographic abnormality that is suspicious for malignant diseasc (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a mammographic abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal.

The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use: OR Over-The-Counter Use:
(Per 21 CFR §801.109)

(Division Sign-Off)
Division of General Restorative Devices K983296
510(k) Number

510(k) K983296
Additional Information
May 20, 1999

United States Surgical
* Trademark of United States Surgical
** Trademark name not yet determined

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