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 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.

AI/ML Overview

This document describes the FDA 510(k) clearance for the Sertera Biopsy Device. It does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and study methodologies, particularly concerning AI/algorithm performance.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

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

However, the specific acceptance criteria (e.g., maximum deflection, tissue sample size, cutting force, etc.) and the quantitative reported performance metrics are not provided in this summary. The table above only compares Intended Use, Method of Use, Mechanism of Action, and Mode of Operation, not performance metrics.

2. Sample sized used for the test set and the data provenance

The document mentions "Bench testing," which implies laboratory-based testing of the device itself. It does not provide details on the sample size (e.g., number of biopsies performed, number of devices tested) or data provenance for any clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as it focuses on the equivalence of a physical biopsy device, not an AI / algorithm that requires ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. This is not relevant for a physical biopsy device's performance testing described here.

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

There is no indication that an MRMC study was done, nor is there any mention of AI assistance. The Sertera Biopsy Device is a physical medical instrument for obtaining tissue samples.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

There is no indication of any algorithm or AI component in the Sertera Biopsy Device, so a standalone algorithm performance study would not be applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to AI/algorithm performance is not directly applicable to this document. For a biopsy device, performance validation would typically involve assessing the quality and quantity of tissue samples obtained, possibly against a histological standard or comparison to predicate device sample quality. However, the exact methods are not detailed.

8. The sample size for the training set

There is no mention of a training set as the device is a physical instrument, not an AI/algorithm.

9. How the ground truth for the training set was established

Not applicable as there is no mention of a training set or AI/algorithm.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

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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

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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(K960064)	MONOPTY(K922939)	Sertera Biopsy Device(SUBJECT DEVICE)	COMPARISON TOPREDICATES
IntendedUse	Intended for use inobtaining core biopsysamples from softtissue such as breast,kidney, liver, prostateand various soft tissuemasses. Not intendedfor use in bone.	The core needlebiopsy device isintended for use inobtaining biopsiesfrom soft tissues suchas liver, kidney,prostate, spleen,lymph nodes andvarious soft tissuetumors. It is notintended for use inbone.	The Sertera BiopsyDevice is intended toobtain percutaneouscore biopsy samplesfrom soft tissue, andtumors of the breast.When used for breastbiopsy, the product isfor diagnosis only. It isnot intended for usein bone.	SUBJECT DEVICE issubstantiallyequivalent to bothpredicate devices
	Method ofUse	Minimally-invasiveexcision of breasttissue. After localanesthetic isapplied and incisionis made, biopsyneedle isintroduced tobreast. Physiciantargets area ofinterest andcollects tissue.	Minimally-invasiveexcision of breasttissue. After localanesthetic isapplied and incisionis made, biopsyneedle isintroduced tobreast. Physiciantargets area ofinterest and collectstissue.	Minimally-invasiveexcision of breasttissue. After localanesthetic isapplied and incisionis made, biopsyneedle isintroduced tobreast. Physiciantargets area ofinterest and collectstissue.
		Mechanismof Action	Collection ofspecimens intoneedle aperture,and inner cannulaexcision ofspecimen.	Collection ofspecimens intoneedle aperture,and inner cannulaexcision ofspecimen.
			Mode ofOperation	Handheld biopsydevice

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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).

Regulation Number and Section

§ 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.