(90 days)
K/DEN: not found
Not Found
No
The summary describes a mechanical biopsy system and does not mention any AI/ML components or functions.
No
The device is described as being for "diagnostic sampling" and for providing "breast tissue samples for diagnostic sampling." It is used to get tissue for "histologic examination" which is a diagnostic process. The description explicitly states that "the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy" and that for non-benign cases, "it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures," indicating that the device itself is not therapeutic but rather a diagnostic tool for tissue collection.
Yes
Explanation: The device is explicitly stated to be intended for "diagnostic sampling of breast tissue" and to "provide breast tissue samples for diagnostic sampling of breast abnormalities." The tissue collected is for "histologic examination," which is a diagnostic process.
No
The device description clearly outlines a system that includes physical components (needle, probe, tubing, clamps) used for excising tissue, which are hardware. It also mentions using imaging guidance, implying interaction with imaging hardware. This is not a software-only device.
Based on the provided information, the Mammotome® Biopsy System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens outside the body. They analyze samples like blood, urine, or tissue to provide information about a person's health.
- The Mammotome Biopsy System is a device used during a medical procedure (biopsy) to collect tissue samples. It is a surgical/procedural device, not a device that performs the diagnostic analysis itself.
- The collected tissue samples are then sent to a laboratory for histologic examination. This examination, which is performed in vitro (outside the body), is where the actual diagnostic analysis of the tissue takes place.
The Mammotome Biopsy System is a tool that facilitates the collection of the sample that will later be used in an IVD process (histologic examination).
N/A
Intended Use / Indications for Use
The Mammotome® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.
The Mammotome Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes
KNW
Device Description
The Mammotome Biopsy System may use imaging guidance such as ultrasound, X-ray, and Computed Tomography (CT) to excise a diagnostic sample for diagnosis. The Mammotome® Biopsy System allows the operator to sample breast tissue that has been identified as suspicious. Multiples samples, if necessary, can be taken without removing the needle. When imaging guidance is used, the operator may label or code the tissue as it is collected to correspond with the imaging display. Fluids can be delivered through the Mammotome® probe for the management of selected patient/procedure requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, X-ray, and Computed Tomography (CT)
Anatomical Site
breast tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data from published literature is provided that supports the clarification in the indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mammotome® Biopsy System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
NOV 1 8 1999
Mammotome® Biopsy System
510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Tamima Itani, Ph.D., RAC Director, Regulatory Affairs
Date Prepared:
November 18, 1999
Name of Device
Trade Name: Mammotome® Biopsy System Classification Name: Biopsy Needle
Predicate Devices:
Mammotome® Biopsy System Powered Suction Pump Tubing Clamp and Tubing Accessory Arm Clamp
Intended Use
The Mammotome® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.
Indication for Use
The Mammotome Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Contraindication:
The Mammotome® Biopsy System is for diagnostic use only and is not indicated for therapeutic use.
1
Device Description
The Mammotome Biopsy System may use imaging guidance such as ultrasound, X-ray, and Computed Tomography (CT) to excise a diagnostic sample for diagnosis. The Mammotome® Biopsy System allows the operator to sample breast tissue that has been identified as suspicious. Multiples samples, if necessary, can be taken without removing the needle. When imaging guidance is used, the operator may label or code the tissue as it is collected to correspond with the imaging display. Fluids can be delivered through the Mammotome® probe for the management of selected patient/procedure requirements.
Technological Characteristics
The technological characteristics are identical to those of the predicate device.
Performance Data
Clinical data from published literature is provided that supports the clarification in the indication for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1999
Tamima Itani, Ph.D., RAC Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
K992813 Re:
Trade Name: Mammotome® Biopsy System Regulatory Class: II Product Code: KNW Dated: August 19, 1999 Received: August 20, 1999
Dear Dr. Itani:
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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Page 2 - Tamima Itani, Ph.D., RAC
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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K992813
Device Name: Mammotome® Biopsy System
Indications for Use:
The Mammotome® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a bistologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benigo, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Acelbs
General Restorative De
Prescription Use
(Per 21 CFR 801.109)