MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING

K093899 · Ethicon Endo-Surgery, LLC · KNW · Apr 29, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093899
• Device Name: MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended 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 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.

Device Story

System consists of disposable biopsy probe, universal targeting set, reusable holster, and control module; includes vacuum tubing, canister, cart, and interlock box. Designed for use in molecular imaging environments. Operates by vacuum-assisted tissue extraction to obtain breast tissue samples for histologic examination. Used by clinicians to sample or partially remove palpable or imaged breast abnormalities. Output is physical tissue sample for pathology. Provides diagnostic information to guide clinical decision-making regarding malignancy and surgical margins.

Clinical Evidence

No clinical data was performed in support of this submission; substantial equivalence is based on technical and performance characteristic comparisons.

Technological Characteristics

System includes disposable biopsy probe, universal targeting set, reusable holster, and control module. Vacuum-assisted mechanical tissue extraction. Equivalent to predicate in technology, biocompatibility, and principles of operation. Designed for use in molecular imaging environments.

Indications for Use

Indicated for patients with breast abnormalities requiring diagnostic tissue sampling. Used for partial or complete removal of imaged breast abnormalities or partial removal of palpable breast abnormalities (e.g., fibroadenoma, fibrocystic lesions).

Regulatory Classification

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.

Predicate Devices

• Mammotome MR Biopsy System (K042753)

Submission Summary (Full Text)

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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: [phone] 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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#### 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 [phone] or [phone] 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