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
Indications for 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
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
