Eviva Stereotactic Guided Breast Biopsy System

K180233 · Hologic, Inc. · KNW · Apr 10, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180233
• Device Name: Eviva Stereotactic Guided Breast Biopsy System
• Applicant: Hologic, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of 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 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 procedure.

Device Story

Hand-held, vacuum-assisted biopsy device; used for stereotactic-guided breast tissue sampling. Operates via pneumatic firing mechanism; clinician rotates device using thumbwheel and clock-position window to acquire tissue 360°. System utilizes remote tissue retrieval. Operated by clinicians in clinical settings. Footswitch-controlled console provides pressure and vacuum to activate internal cutting and acquisition mechanisms. Provides tissue samples for histologic examination; assists in partial or complete removal of imaged abnormalities. Benefits include minimally invasive tissue acquisition for diagnostic assessment.

Clinical Evidence

Bench testing only. Testing included functional performance, biocompatibility, sterilization, and package testing. All testing met acceptance criteria for design verification and validation.

Technological Characteristics

Vacuum-assisted biopsy instrument; pneumatic firing mechanism; hand-held form factor with thumbwheel rotation and clock-position window; remote tissue retrieval; console-driven pressure/vacuum energy source. Class II device.

Indications for Use

Indicated for patients requiring diagnostic sampling of breast abnormalities via stereotactic guidance to obtain tissue for histologic examination.

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

• ATEC Breast Biopsy System (K042290)

Submission Summary (Full Text)

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April 10, 2018

Hologic. Inc Ms. Brenda Geary Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752

Re: K180233

Trade/Device Name: Eviva Stereotactic Guided Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 8, 2018 Received: February 9, 2018

Dear Ms. Geary:

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, 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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

> > Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180233

#### Device Name

Eviva Stereotactic Guided Breast Biopsy System

#### Indications for Use (Describe)

The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of 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 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 procedure.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 6.0 510(k) Summary

#### January 11, 2018

#### 6.1 510(k) Submitter

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Brenda Geary P: 508.263.8819 F: 844.223.4956

#### 6.2 Establishment Registration Number: 1222780

- 6.3 Trade Name: Eviva Stereotactic Guided Breast Biopsy System
- 6.4 Common/Usual Name: Biopsy Instrument, 21CFR.876.1075

#### 6.5 Product Code: KNW

- 6.6 Classification: Class II
- 6.7 Panel: Gastroenterology/Urology

#### 6.8 Predicate Device

| Tradename: | ATEC Breast Biopsy System |
|----------------------------|---------------------------|
| Submitter / 510(k) Holder: | Hologic, Inc. |
| 510(k) #: | K042290 |
| Classification code: | KNW |
| Regulation: | 21.CFR.876.1075 |

### 6.9 Device Description

The Eviva Stereotactic Guided Breast Biopsy System is a hand-held biopsy device that is marketed for guidance with stereotactic imaging. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of 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 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 procedure.

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# HOLOGIC, Inc.

Premarket Notification Eviva Stereotactic Guided Breast Biopsy System

#### 6.10 Intended Use:

The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of 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 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 procedure.

| Attribute | Predicate Device<br>ATEC Breast Biopsy System<br>(K042290) | Subject Device<br>Eviva Stereotactic Breast Biopsy<br>System | Status |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | The ATEC Breast Biopsy System is<br>intended to provide breast tissue for<br>histologic examination with partial or<br>complete removal of the imaged<br>abnormality. The extent of the<br>histologic abnormality cannot be<br>reliably determined from its<br>mammographic appearance.<br>Therefore, the extent of the removal of<br>the imaged evidence of an abnormality<br>does not predict the extent of removal<br>of histologic abnormality, e.g.,<br>malignancy. When the sampled<br>abnormality is not histologically<br>benign, it is essential that the tissue<br>margins be examined for completeness<br>of removal using standard surgical<br>procedure. | The Eviva Stereotactic Guided<br>Breast Biopsy System is indicated<br>to provide breast tissue samples for<br>diagnostic sampling of breast<br>abnormalities under stereotactic<br>breast biopsy guidance. The Eviva<br>device is intended to provide breast<br>tissue for histologic examination<br>with partial or complete removal of<br>the imaged abnormality. The extent<br>of histologic abnormality cannot be<br>reliably determined from its<br>mammographic appearance.<br>Therefore, the extent of removal of<br>the imaged evidence of an<br>abnormality does not predict the<br>extent of removal of histologic<br>abnormality, e.g., malignancy.<br>When the sampled abnormality is<br>not histologically benign, it is<br>essential that the tissue margins be<br>examined for completeness of<br>removal using standard surgical<br>procedure. | Subject device is<br>substantially<br>equivalent to<br>predicate device |
| Method of Use | Vacuum-assisted device to remove<br>breast tissue in a minimally invasive<br>manner.<br>For use with Ultrasound, Stereotactic<br>or MRI.<br>Requires additional Introducer<br>accessory for marker. | Vacuum-assisted device to remove<br>breast tissue in a minimally<br>invasive manner.<br>For use only in Stereotactic.<br>Integrated Introducer for marker. | Subject device is<br>substantially<br>equivalent to<br>predicate device |
| Mechanism for<br>Action | Manually fired.<br>Rotate all device to acquire tissue<br>360°. | Pneumatic firing mechanism.<br>Rotate using thumbwheel and using<br>"clock position" window. | Subject device is<br>substantially<br>equivalent to<br>predicate device |
| | Tissue retrieval part of device. | Remote tissue retrieval. | |

#### 6.11 Comparison to Predicate Device:

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# HOLOGIC, Inc. Premarket Notification Eviva Stereotactic Guided Breast Biopsy System

| Attribute | Predicate Device<br>ATEC Breast Biopsy System<br>(K042290) | Subject Device<br>Eviva Stereotactic Breast Biopsy System | Status |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Mode of<br>Operation | Tissue acquisition, press down<br>footswitch and hold.<br><br>Pressure and Vacuum from Console<br>activate internal mechanism to cut<br>and acquire tissue. | Tissue acquisition, press down<br>footswitch and hold.<br><br>Pressure and Vacuum from Console<br>activate internal mechanism to cut<br>and acquire tissue. | Subject device is<br>substantially<br>equivalent to<br>predicate device |

### 6.12 Performance Testing:

Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria.

#### 6.13 Conclusion:

The Eviva Stereotactic Guided Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The Eviva Stereotactic Guided Breast Biopsy System is substantially equivalent to the legally marketed predicate device (Hologic's ATEC Breast Biopsy System K042290).