← Product Code [KNW](/productcode/KNW) · K973496 # THE AUTO SUTURE* MIBB** SYSTEM (K973496) _United States Surgical, A Division of Tyco Healthc · KNW · Dec 1, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K973496 ## Device Facts - **Applicant:** United States Surgical, A Division of Tyco Healthc - **Product Code:** [KNW](/productcode/KNW.md) - **Decision Date:** Dec 1, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes. ## Device Story The MIBB system is a minimally invasive biopsy device consisting of a biopsy needle probe, a probe driver, and a control module vacuum source. It is designed to pierce, cut, and collect tissue samples during breast biopsy procedures. The device is operated by a clinician to obtain tissue for diagnostic purposes. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics System comprises a biopsy needle probe, probe driver, and vacuum control module. Constructed of biosafe materials compliant with ISO 10993-1 biocompatibility standards. Mechanical/vacuum-assisted tissue collection. ## Regulatory 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 - Mammotome® ([K970565](/device/K970565.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## K973496 Auto Suture* Minimally Invasive Breast Biopsy (MIBB**) System | IX. 510(k) Summary of Safety and Effectiveness | DEC - 1 1997 | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856 | | CONTACT PERSON: | Victor M. Clavelli | | DATE PREPARED: | September 8, 1997 | | CLASSIFICATION NAME: | Biopsy Instrument | | COMMON NAME: | Biopsy Needle | | PROPRIETARY NAME: | Not Yet Determined | | PREDICATE DEVICES: | Mammotome® (K970565) | | DEVICE DESCRIPTION: | The MIBB** system is comprised of a biopsy needle probe,
a probe driver and a control module vacuum source. The
MIBB** system is a minimally invasive biopsy device
designed to pierce, cut and collect tissue during a biopsy
procedure. | | INTENDED USE: | The Auto Suture* MIBB** System has indication in
incisional breast biopsy procedures for diagnostic purposes
only and is not intended for therapeutic purposes. | | MATERIALS: | The AUTO SUTURE* MIBB** system is composed
entirely of biosafe materials which have passed
biocompatibility testing appropriate for their intended
patient contact profile in accordance with ISO 10993-1. | * *Trademark name not yet determined {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - I 1997 Mr. Victor M. Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856 Re: K973496 > Trade Name: Auto Suture Minimally Invasive Breast Biopsy (MIBB) System Regulatory Class: II Product Code: KNW Dated: September 9, 1997 Received: September 15, 1997 Dear Mr. Clavelli: 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 requirements , 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. {2}------------------------------------------------ ## Page 2 - Mr. Victor M. Clavelli 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A cooley ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ਲ Page (revised) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . . . . R402 ## Auto Suturc* Minimally Invasive Breast Biopsy (MIBB**) System IV. Indications For Use: 510(k) Number (if known): AUTO SUTURE* MIBB** System Device Name: Indications For Use: The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes. (Please do not write below this line - continue on another page if needed) Concurrence of CDRII, Office of Device Evaluation (ODE) | Prescription Use: | X | OR Over-The-Counter Use: | | |-----------------------|---|--------------------------|--| | (Per 21 CFR §801.109) | | | | (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | K973476 | |---------------|---------| |---------------|---------| ## UNITED STATES SURCICAL CORPORATION · Trademark of United States Surgical Corporation * * Trademark name not you determined --- **Source:** [https://fda-staging.innolitics.com/device/K973496](https://fda-staging.innolitics.com/device/K973496) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com