(90 days)
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.
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.
The provided text is a 510(k) summary for the Mammotome® Biopsy System, which is a device used for diagnostic sampling of breast tissue. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern AI/software as a medical device (SaMD) submission would.
The document states: "Performance Data: Clinical data from published literature is provided that supports the clarification in the indication for use." However, it does not detail what that clinical data is, what specific metrics were measured, or what thresholds were considered acceptable.
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.
Here is what can be inferred or explicitly stated from the given document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of device performance against such criteria. The FDA's substantial equivalence determination for this device, a biopsy system rather than an AI diagnostic tool, is based on its similarity to a predicate device and its intended use for tissue sampling, not on specific performance metrics like those for an AI algorithm.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Clinical data from published literature" but does not specify the sample size, data provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. This information is not present. The "ground truth" for a biopsy system is typically the pathological examination of the tissue sample itself, rather than expert consensus on imaging.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a medical device (biopsy system), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device (biopsy system), not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on the device's function, the "ground truth" for determining the diagnostic accuracy of the tissue samples obtained would be pathology (histologic examination). The document states: "The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination..." and "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."
8. The sample size for the training set
- Not applicable for an AI training set. This is a hardware biopsy system, not an AI algorithm. If "training set" refers to data used to develop or refine the physical device, that information is not provided.
9. How the ground truth for the training set was established
- Not applicable for an AI training set. This is a hardware biopsy system.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (Mammotome® Biopsy System) from 1999. The regulatory requirements and the type of information presented are very different from what would be expected for an AI/SaMD product today. The document focuses on demonstrating substantial equivalence to a predicate device and clarifying its intended use for diagnostic tissue sampling, with "clinical data from published literature" supporting the indication for use, rather than detailed performance metrics of a diagnostic algorithm.
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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.
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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
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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)
§ 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.