(87 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® EX Hand Held System is a mechanical breast biopsy device used in incisional breast biopsy of microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal discase, and diffused tissue.
The Mammotome EX Hand Held System consists of three major components, a disposable bladed trocar tipped needle-like probe, a reusable holster, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, footswitch, remote keypad, support arm and cart.
The provided document describes the Mammotome® EX Hand Held System, a breast biopsy device, and its 510(k) Premarket Notification. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria in the context of device accuracy for diagnosis or treatment decision-making.
The document states:
- "Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy." This is a very general statement and does not provide specifics about acceptance criteria or the study design.
- The device is a "modification of the currently marketed Mammotome Hand Held System" with "refinement in design, software and ergonomic enhancements." The submission primarily focuses on establishing substantial equivalence to predicate devices, implying that its performance is expected to be similar to already cleared devices.
Therefore, the following information cannot be fully extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document for diagnostic accuracy.
- Reported Device Performance: The document only generically states "satisfactory performance in breast tissue biopsy." No specific metrics (e.g., sensitivity, specificity, diagnostic yield, pathology correlation rates) are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not detailed in the provided text. The term "preclinical testing" usually refers to bench testing or animal studies, not human clinical trials.
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):
- Not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not detailed in the provided text.
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/mentioned. This device is a biopsy system, not an AI-assisted diagnostic imaging tool. No MRMC study or AI assistance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/mentioned. This is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The intended use is to "provide breast tissue for histologic examination." Therefore, for any study assessing the device's ability to obtain diagnostic tissue, pathology would be the standard ground truth for the tissue obtained. However, the details of such a study are not provided.
8. The sample size for the training set:
- Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable/mentioned.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence for the Mammotome® EX Hand Held System based on its technological characteristics and intended use being similar to predicate devices. It states that "Preclinical testing was performed to ensure the device performs as intended" and "demonstrated satisfactory performance in breast tissue biopsy," but it does not provide the specific details of acceptance criteria or the study design and results typically expected for a detailed performance evaluation in terms of diagnostic accuracy metrics.
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FEB 2 0 2004
510(k) Premarket Notification for Mammotome® EX Hand Held System
K033700
loF2
Mammotome® EX Hand Held 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:
November 24, 2003
Name of Device
Trade Name: Mammotome® EX Hand Held System Classification Name: Biopsy Needle
Predicate Devices:
Mammotome® Hand Held System Mammotome® Hand Held 8 Gauge Probe Mammotome® Biopsy System
Device Description
The Mammotome® EX Hand Held System is a mechanical breast biopsy device used in incisional breast biopsy of microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal discase, and diffused tissue.
The Mammotome EX Hand Held System consists of three major components, a disposable bladed trocar tipped needle-like probe, a reusable holster, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, footswitch, remote keypad, support arm and cart.
Intended Use
The Mammotome EX Hand Held System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome EX Hand Held System is also intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
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Ethicon Endo-Surgery, Inc.
510(k) Premarket Notification for Mammotome® FX Hand Held System
K033700
20F-2
Technological Characteristics
The Mammotome EX Hand Held System is a modification of the currently marketed Mammotome Hand Held System. It represents a refinement in design, software and crgonomic enhancements for ease of use, however, the basic configuration, technology, materials and principles of operation of the proposed and marketed devices are equivalent.
The EX Hand Held biopsy device, used with or without imaging modalities, facilitates the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting 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 bypassed and two mechanical cables are eliminated. Two small motors reside in the holster to power the cutter translation and rotation. These physical changes make the probe/holster easier to handle.
Software modifications allow the Mammotome EX Hand Held System to provide standard and rapid modes of operation for cutter advancement and specimen retrieval. 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
Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three abstract human profiles or a triple-stranded helix, often referred to as the "Human Services Symbol".
Public Health Service
FEB 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Sprinkle, BSN, RN Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K033700
Trade/Device Name: Mammotome® EX Hand Held System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: November 24, 2003 Received: November 25, 2003
Dear Ms. Sprinkle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the l'ederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I cathar all the Act's requirements, including, but not limited to: registration and listing (21 CHR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carol Sprinkle, BSN, RN
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icher will anow you to cogin maing of substantial equivalence of your device to a legally prematics notification. The 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), please If you desire specific acries in 1984 and 1) 594-4659. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milliken
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 Statement
510(k) Number: K 033700
Device Name: Mammotome® EX Hand Held System
Indications for Use:
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 해 examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy System is intended to provide breast tissue for 보 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, c.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.
for
Mark N Millerss
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K033700
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ________
Over-The-Counter-Usc: ________________________________________________________________________________________________________________________________________________________ OR
§ 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.