(35 days)
The Mammotome Biopsy System is indicated to provide 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 Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 MR Biopsy System consists of four major components: a disposable biopsy probe; a disposable, bladed, needle-like introducer; a reusable holster with detachable keypad, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, and control module cart.
The provided text describes the Mammotome® MR Biopsy System and its 510(k) submission but does not contain specific acceptance criteria, performance metrics, or details of a clinical study demonstrating the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Mammotome EX Hand Held System) by highlighting similar technological characteristics and principles of operation, especially concerning its safety in an MR environment.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | MR safety testing demonstrated satisfactory material performance in a 3.0 Tesla magnet environment. |
| Not specified | The basic configuration, technology, and principles of operation are equivalent to the predicate device. |
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely internal testing given the nature of MR safety testing. No mention of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the performance data mentioned relates to MR safety testing, not diagnostic accuracy requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable; MR safety testing does not typically involve adjudication in the way clinical diagnostic study results do.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No, an MRMC study was not described. The device is a biopsy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Mammotome MR Biopsy System is a medical device for tissue sampling, not an algorithm.
7. The type of ground truth used:
- For the described "Performance Data" (MR safety testing), the ground truth would be based on instrument readings and engineering standards to confirm safe operation within a 3.0 Tesla magnet environment. This is not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. This is a hardware device submission, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what is present:
The document primarily focuses on demonstrating the Mammotome® MR Biopsy System's substantial equivalence to a predicate device (Mammotome EX Hand Held System) and its safety in an MR environment. The "Performance Data" section specifically mentions MR safety testing, which verified satisfactory material performance in a 3.0 Tesla magnet. This testing would be based on engineering principles and regulatory guidelines for MR compatibility, not clinical diagnostic performance or AI model validation.
What is missing:
The document does not detail any clinical studies, diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC), or acceptance criteria related to its ability to "provide tissue samples for diagnostic sampling of breast abnormalities." The indications for use are clinical, but the provided "Performance Data" section only addresses MR safety. For a device like this, clinical performance would typically be inferred from the predicate device's established performance and the demonstration of equivalent technological characteristics, rather than a new full-scale clinical trial if substantial equivalence is claimed.
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NOV - 8 2004
K042753 1/2
Mammotome® MR Biopsy System
510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact Carol Sprinkle, BSN, RN Associate, Regulatory Affairs
Date Prepared:
October 1, 2004
Name of Device
Trade Name: Mammotome® MR Biopsy System Classification Name: Biopsy Needle
Predicate Device:
Mammotome EX Hand Held System
Device Description
The Mammotome MR Biopsy System consists of four major components: a disposable biopsy probe; a disposable, bladed, needle-like introducer; a reusable holster with detachable keypad, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, and control module cart.
Indications for Use
The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- 트 The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- 포 The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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
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04275'3 4/2
benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.
Technological Characteristics
The Mammotome MR Biopsy System is a modification of the currently marketed Mammotome EX Hand Held System. It represents a refinement in design to assure safety in a magnetic resonance (MR) environment, however, the basic configuration, technology, and principles of operation of the proposed and marketed devices are equivalent.
The MR biopsy device, used with imaging modalities, facilitates the diagnostic removal of tissue with fluid management through a combination of vacuum and radial crting functions. The proposed and marketed devices contain the same primary components to achieve these functions: a probe, housing/holster, and a control module. The probe needle and cutter, which interface directly with the patient, are similar in both new and marketed devices.
In the proposed device, the control module motors are utilized to power a mechanical cable. A microprocessor provides closed-loop control to reduce dependence of cutter rotation and translation speed on user interaction or tissue variability.
Axial and lateral vacuum can still be controlled independently.
Performance Data
MR safety testing was performed to ensure the device can be used safely in the MR environment. Testing demonstrated satisfactory material performance in a 3.0 Tesla magnet environment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Ms. Carol J. Sprinkle, RN, BSN Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K042753
Trade/Device Name: Mammotome MR Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 1, 2004 Received: October 4, 2004
Dear Ms. Sprinkle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(tr) premainer is substantially equivalent (for the indications felerenced above und nave acterimes ally marketed predicate devices marketed in interstate for use stated in the cholosure) to regars actual date of the Medical Device American Comments, or to commence provision to May 26, 1976, the enaonance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM alle Costliete Act (71ct) that do not request of the general controls provisions of the Act. The You may, therefore, market the dovrees, becales for annual registration, listing of general controls provisions of the Fict lierate soquents misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of Pounts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 issumter of a budevice complies with other requirements of the Act that I DA has made a dolorimation administered by other Federal agencies. You must or ally recetal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the Ace 31equirements, and manufacturing practice requirements as set CITN Fart 807), adoning (21 CFR Part 820); and if applicable, the electronic forum in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carol J. Sprinkle, RN, BSN
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin harketing your as rece as valence of your device to a legally premarket notification. The PDA midning of bassification 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), please If you desire specific advice for your act (240) 276-0115. Also, please note the regulation entitled, provinces and "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Missuranting Uy reference to premail.orginibilities under the Act from the Division of Small other general Information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free humber (800) the local (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: MAMMOTOME MR Biopsy System
Indications For Use:
The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
Ko42753
- The Mammotome Biopsy System is intended to provide breast tissue for histologic 에 examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy System is intended to provide breast tissue for I histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Mriam C. Provost (Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K042753
§ 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.