Who is the manufacturer of MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

Biopsys Medical, Inc. filed the 510(k) submission for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565).

What is the FDA product code for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)

K970565 · Biopsys Medical, Inc. · KNW · Mar 28, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K970565
Device Name	MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
Applicant	Biopsys Medical, Inc.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Mar 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.

Device Story

Mammotome consists of disposable needle and reusable instrument housing; used for breast tissue biopsy. Probe features outer trocar cannula with distal sampling notch and sliding inner hollow coaxial cutter. Physician-operated; used with imaging guidance (ultrasound, X-ray, CT); can be stereotactically mounted or handheld. Sampling notch thumbwheel allows manual orientation. Device pierces tissue, cuts sample via hollow cutter, and collects/ejects tissue for diagnostic evaluation. Benefits include minimally invasive tissue acquisition for clinical diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Disposable probes constructed of stainless steel. Manual/mechanical piercing and cutting mechanism. Includes trocar cannula with sampling notch and hollow coaxial cutter. Dimensions vary by probe size. No electronic components, software, or energy sources.

Indications for Use

Indicated for diagnostic sampling of breast tissue for biopsy, definitive diagnosis, or confirmation of clinical diagnosis.

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

Biopsys Medical Needle

Related Devices

K992813 — 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT · Ethicon Endo-Surgery, Inc. · Nov 18, 1999
K032847 — EXCISOR BIOPTOME, MODEL 01-0004 · Acueity, Inc. · Sep 26, 2003
K180233 — Eviva Stereotactic Guided Breast Biopsy System · Hologic, Inc. · Apr 10, 2018
K112411 — MAMMOTOME ELITE BIOPSY SYSTEM · Devicor Medical Products, Inc. · Mar 20, 2012
K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM · Devicor Medical Products, Inc. · Nov 15, 2012

Submission Summary (Full Text)

{0} K970565 MAR 28 1997 # APPENDIX V ## Summary of Safety and Effectiveness ## DETERMINATION OF SUBSTANTIAL EQUIVALENCE The BMI Mammotome is substantially equivalent to the Biopsys Medical predicate device. The BMI Mammotome has a substantially equivalent intended use as the predicate device. The BMI Mammotome has technologic characteristics which are substantially equivalent to the Biopsys predicate device. ## COMPANY AND CONTACT PERSON Biopsys Medical, Inc. (BMI) 3 Morgan Irvine, Ca. 92618 Mark A. Cole, Ph.D. 714-460-7800 ## DEVICE NAME BMI Mammotome ## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Biopsys Medical Needle ## DESCRIPTION OF DEVICE The Mammotome is comprised of a disposable needle and reusable instrument housing. The Mammotome probe may be used with imaging guidance (such as ultrasound, X-ray, and CT), and it may be either stereotactically mounted or hand held depending on physician preference and the type of tissue sampled. The disposable Mammotome probes are available in various sizes and lengths. The probe components include an outer trocar cannula and a sliding inner hollow coaxial cutter. The trocar cannula incorporates a distal sampling notch and a proximal notch which forms the tissue retrieval chamber. The sampling notch thumbwheel is used to manually turn and orientate the sampling notch as desired. ## STATEMENT OF INTENDED USE The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure. 510(k) Notification Biopsys Medical, Inc. Feb. 12, 1997 CONFIDENTIAL Page 36 {1} # STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES The predicate device is indicated for use for removal of soft body tissue for a biopsy, definitive diagnosis, or confirmation of a clinical diagnosis. # STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE The BMI Mammotome has technologic characteristics which are substantially equivalent to the predicate device. In general, the disposable probes are made of stainless steel; the probes manually and mechanically pierce the tissue, cut the tissue with a hollow cutter, and collect or eject the tissue from the probe after it is removed from the body. 510(k) Notification Biopsys Medical, Inc. Feb. 12, 1997 CONFIDENTIAL Page 37