(132 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 the 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 Biopsy System for Molecular Imaging (MI) consists of four major components: a disposable Biopsy Probe; a disposable Universal Targeting Set; a reusable Holster, and a reusable Control Module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a reusable control module cart, and a reusable interlock box.
The provided text describes a 510(k) premarket notification for the Mammotome Biopsy System for Molecular Imaging. However, it explicitly states that clinical testing was not performed in support of this submission (Section 2, "Clinical testing: Clinical testing was not performed in support of this submission."). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as no such study was conducted for this specific submission.
The submission is based on the device being a modification of an existing, already marketed device (Mammotome MR Biopsy System K042753) for use in a Molecular Imaging environment. The manufacturer claims substantial equivalence based on the intended use, technical characteristics, and performance characteristics remaining equivalent, with risk mitigation for the new environment.
Because no clinical study was performed or is referenced in this document, the following requested information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
- Adjudication method for the test set: Not applicable, no clinical test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a biopsy system, not an AI algorithm.
- The type of ground truth used: Not applicable, no clinical test set.
- The sample size for the training set: Not applicable, this is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable, this is a physical medical device.
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Mammotome Biopsy System for Molecular Imaging
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Mammotome Biopsy System for Molecular Imaging 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Company:
Ethicon Endo-Surgery. LLC 475 Calle C Guaynabo, Puerto Rico 00969 Establishment Registration 3005075853
Contact:
Asifa Vonhof, RAC Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Ph: 513-337-3118 Fax: 513-337-2314 E-mail: avonhof(@its.jnj.com
Date of Submission: December 15, 2009
Mammotome® Biopsy System for Molecular Imaging Proprietary Name:
Common Name: Biopsy Instrument
Regulation: 21 CFR 876.1075
Regulatory Class: II
Product Codes: KNW
Predicate Device: Mammotome MR Biopsy System K042753
Device Description: The Mammotome Biopsy System for Molecular Imaging (MI) consists of four major components: a disposable Biopsy Probe; a disposable Universal Targeting Set; a reusable Holster, and a reusable Control Module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a reusable control module cart, and a reusable interlock box.
APR 2 9 2010
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Mammotome Biopsy System for Molecular Imaging -
Intended Use: The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
10938999
- · 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 the 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.
Technological Characteristics: The Mammotome Biopsy System for Molecular Imaging (MI) is a modification to the environment for use of the currently marketed Mammotome MR Biopsy System. It represents a refinement in device labeling to assure safety in a Molecular Imaging environment. The configuration, technology, and principles of operation of the proposed and marketed devices are equivalent. New product codes are assigned to the Probe and Universal Targeting Set components for user clarification and revised instructions for use are provided for the new intended use environment.
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093899
Mammotome Biopsy System for Molecular Imaging
Performance testing: There are no changes in the performance requirements of the subject device with respect to those of the predicate device. Specifically, the technology, biocompatibility requirements, control module device, and principles of operation of the subject and predicate devices are equivalent. Mitigation of risk associated with use of the subject device in the new environment ensures equivalent performance to that of the predicate device.
Clinical testing: Clinical testing was not performed in support of this submission.
Conclusion: The claim of substantial equivalence of the Mammotome Biopsy System for Molecular Imaging to the predicate device is based on the comparison of the intended use, product technical characteristics, and performance characteristics.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Asifa Vonhof, RAC Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
APR 2 9 2010
Re: K093899
Trade/Device Name: Mammotome® Biopsy System for Molecular Imaging Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: April 26, 2010 Received: April 27, 2010
Dear Asifa Vonhof:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Federal 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Asifa Vonhof, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely your Mark N. Melkerson Director Division of Surgical, Orthoried And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
To be assigned KO97899 510(k) Number: Mammotome Biopsy System for Molecular Imaging Device Name:
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 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.
| Prescription Use X | AND/OR | Over-The-Counter Use _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
Neil R.P. Ogden-Focinka
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093899
§ 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.