Sertera Biopsy Device

K150169 · Hologic, Inc. · KNW · Aug 14, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150169
• Device Name: Sertera Biopsy Device
• Applicant: Hologic, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Aug 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue, and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

Device Story

Sertera Biopsy Device is a disposable, hand-held, spring-loaded core biopsy instrument used primarily for ultrasound-guided breast biopsies. Operated by a physician, the device features a hand piece that advances an inner needle with a side aperture into tissue; a sharpened outer cutting cannula then extends over the aperture to excise the tissue sample. The device is available in 12 and 14 gauge needle sizes. It is designed for one-handed operation to facilitate minimally invasive tissue collection. The output is a core tissue specimen used for diagnostic evaluation. The device benefits patients by providing a minimally invasive method to obtain tissue samples for diagnosis.

Clinical Evidence

Bench testing only. The device met all acceptance criteria for design verification and validation, demonstrating equivalent performance to the predicate devices.

Technological Characteristics

Disposable, hand-held, spring-loaded core biopsy instrument. Available in 12 and 14 gauge needle sizes. Mechanism involves an inner needle with a side aperture and a sharpened outer cutting cannula. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous core biopsy of soft tissue and tumors of the breast for diagnostic purposes. Not intended for use in bone.

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

• Achieve Programmable Automatic Biopsy Needle (K960064)
• Monopty Disposable Core Biopsy Instrument (K922939)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2015

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

Re: K150169

Trade/Device Name: Sertera Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: July 16, 2015 Received: July 17, 2015

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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): N/A

Device Name: Sertera Biopsy Device

Indications For Use: The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

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)

{3}------------------------------------------------

# 6.0 510(k) Summary

6.1 Date: January 19, 2015

# 6.2 510(k) Submitter:

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Brenda M. Geary P: 508.263.8819 F: 508.263.8872

#### 6.3 Establishment Registration Number: 1222780

6.4 Trade Name: Sertera Biopsy Device

6.5 Common/Usual Name: Biopsy Instrument, 21.CFR.Reg 876.1075 Product Code: KNW

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

#### 6.8 PREDICATE DEVICES

6.8.1 Tradename: Achieve Programmable Automatic Biopsy Needle Submitter / 510(k) Holder: (Bauer Medical) CareFusion (Cardinal Health) 510(k) #: K960064 Classification code: KNW and Regulation: 21.CFR.876.1075.

6.8.2 Tradename: Monopty Disposable Core Biopsy Instrument Submitter / 510(k) Holder: C.R. Bard, Inc. 510(k) #: K922939 Classification code: KNW and Regulation: 21.CFR.876.1075.

# 6.9 DEVICE DESCRIPTION

The Hologic Sertera Biopsy Device is a spring-loaded core biopsy device to be used primarily in ultrasound-guided breast biopsies. The Sertera Biopsy Device is a disposable, hand-held springloaded core biopsy device that is fully operable with one hand. The Sertera Biopsy Device consists of a hand piece, which advances an inner needle with a side aperture to penetrate into the tissue, and a sharpened outer cutting cannula that extends over the aperture with sufficient force to slice the tissue. The Sertera Biopsy Device is available with 12 and 14 gauge needles.

{4}------------------------------------------------

# 6.10 INTENDED USE:

The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue, and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

## 6.11 Comparison to Predicate Devices:

| | ACHIEVE<br>(K960064) | MONOPTY<br>(K922939) | Sertera Biopsy Device<br>(SUBJECT DEVICE) | COMPARISON TO<br>PREDICATES |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Intended for use in<br>obtaining core biopsy<br>samples from soft<br>tissue such as breast,<br>kidney, liver, prostate<br>and various soft tissue<br>masses. Not intended<br>for use in bone. | The core needle<br>biopsy device is<br>intended for use in<br>obtaining biopsies<br>from soft tissues such<br>as liver, kidney,<br>prostate, spleen,<br>lymph nodes and<br>various soft tissue<br>tumors. It is not<br>intended for use in<br>bone. | The Sertera Biopsy<br>Device is intended to<br>obtain percutaneous<br>core biopsy samples<br>from soft tissue, and<br>tumors of the breast.<br>When used for breast<br>biopsy, the product is<br>for diagnosis only. It is<br>not intended for use<br>in bone. | SUBJECT DEVICE is<br>substantially<br>equivalent to both<br>predicate devices |
| | Method of<br>Use | Minimally-invasive<br>excision of breast<br>tissue. After local<br>anesthetic is<br>applied and incision<br>is made, biopsy<br>needle is<br>introduced to<br>breast. Physician<br>targets area of<br>interest and<br>collects tissue. | Minimally-invasive<br>excision of breast<br>tissue. After local<br>anesthetic is<br>applied and incision<br>is made, biopsy<br>needle is<br>introduced to<br>breast. Physician<br>targets area of<br>interest and collects<br>tissue. | Minimally-invasive<br>excision of breast<br>tissue. After local<br>anesthetic is<br>applied and incision<br>is made, biopsy<br>needle is<br>introduced to<br>breast. Physician<br>targets area of<br>interest and collects<br>tissue. |
| | | Mechanism<br>of Action | Collection of<br>specimens into<br>needle aperture,<br>and inner cannula<br>excision of<br>specimen. | Collection of<br>specimens into<br>needle aperture,<br>and inner cannula<br>excision of<br>specimen. |
| | | | Mode of<br>Operation | Handheld biopsy<br>device |

{5}------------------------------------------------

## 6.12 Performance Testing

Bench testing of the Sertera Biopsy Device demonstrated equivalent performance to the predicate devices, and met all acceptance criteria.

## 6.13 CONCLUSION

The Sertera Biopsy Device met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The Sertera Biopsy Device is substantially equivalent to the legally marketed predicate devices (Care Fusion Achieve Programmable Automatic Biopsy Needle and C.R. Bard Inc.'s Monopty Disposable Core Biopsy Instrument).