(43 days)
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No
The device description focuses on mechanical components and manual operation, with no mention of AI/ML features or data processing beyond imaging guidance.
No.
The "Intended Use / Indications for Use" section clearly states that the device is "intended for diagnostic sampling of breast tissue during a biopsy procedure," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure."
No
The device description explicitly details physical hardware components like a disposable needle instrument housing, probes, trocar cannula, and a sliding inner hollow coaxial cutter. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "diagnostic sampling of breast tissue during a biopsy procedure." This describes a procedure performed on the patient to obtain a tissue sample.
- Device Description: The device is a biopsy probe designed to physically extract tissue from the body.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples of biological material (like blood, urine, or tissue) to provide information about a person's health.
The BMI Mammotome is a device used to obtain the sample, not to analyze it in vitro. The analysis of the collected breast tissue sample would likely be performed using IVD methods (e.g., histology, pathology), but the Mammotome itself is a surgical/biopsy device.
N/A
Intended Use / Indications for Use
The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.
Product codes
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Device Description
The Mammotome is comprised of a disposable needle 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound, X-ray, and CT
Anatomical Site
breast
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
APPENDIX V
MAR 28 1997
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 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.
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.