← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K970565 # MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565) _Biopsys Medical, Inc. · KNW · Mar 28, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K970565 ## Device Facts - **Applicant:** Biopsys Medical, Inc. - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Mar 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## 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 - Biopsys Medical Needle ## 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} 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 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K970565](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K970565) **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