The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.

Device Description

The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the proposed devices will be delivered with a protective tube.

AI/ML Overview

This document pertains to the 510(k) summary for the Biopsy Handy / MRI Biopsy Handy devices, establishing their substantial equivalence to predicate devices. As such, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, the submission focuses on demonstrating safety and effectiveness through establishing substantial equivalence to previously cleared predicate devices. The "study" in this context refers to the comparison made between the new device and the predicate devices, rather than a clinical trial with specific performance metrics.

Therefore, many of the requested categories about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

Not applicable for performance metrics. This document does not detail specific acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in a clinical context, nor does it report such performance metrics. The "acceptance criteria" for this submission would be related to meeting the FDA's requirements for demonstrating substantial equivalence, including biocompatibility, sterility, packaging, and MR-testing.

Acceptance Criteria Category (for Substantial Equivalence)	Reported Device Performance/Compliance
Intended Use (Match Predicate)	Identical
Technology, Design, Material (Similarity to Predicate)	Identical or similar
Biocompatibility	Demonstrated safety and effectiveness
Sterility	Demonstrated safety and effectiveness
Packaging	Demonstrated safety and effectiveness
MR-testing (for MRI Biopsy Handy)	Demonstrated safety and effectiveness

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a comparison to predicate devices, not a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This information is not relevant to a substantial equivalence submission comparing device characteristics.

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

Not applicable. There is no "test set" or adjudication process described in this document in the context of clinical performance evaluation.

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

Not applicable. This device is a semi-automatic biopsy system, not an AI/ML-driven diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This device is a physical medical instrument, not a standalone algorithm.

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

Not applicable. "Ground truth" in the context of clinical performance evaluation is not relevant to this submission. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML or data-driven model.

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

Not applicable. There is no "training set" described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for SOMATEX Medical Technologies GmbH. Above the company name is the number k/02771. The SOMATEX logo has a registered trademark symbol next to it.

Rheinstraße 7d | D-14513 Teltow

JUN 2 4 2011

510(k) SUMMARY

Biopsy Handy / MRI Biopsy Handy

Submitter:

Somatex Medical Technologies GmbH Rheinstrasse 7d 14513 Teltow Germany Phone: +49 3328 3076 13 +49 3328 3076 99 Fax:

Official Correspondent: Susanne Raab

Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, MA 02139 Phone: 617 547 0628 Fax: 617 520 2136 e-mail: sbraab@comcast.net

Biopsy Handy / MRI Biopsy Handy Trade Name:

Common Name: Semiautomatic Biopsy System

Biopsy Instrument, 21 C.F.R. 876.1075 Classification Name:

Regulatory Class:

Product Code: KNW

Device Description: The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the

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einstraße 7d | D-1451 3328 30 76-0 | Fax +49 (0) 3328 30 76 @somatex.com | www.somatex.com

proposed devices will be delivered with a protective tube.

The Biopsy Handy and MRI Biopsy Handy are intended to Intended Use: obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.

The Biopsy Handy and MRI Biopsy Handy are substantially equivalent to the Speedybell manufactured by Biopsybell S.A.S., which has been cleared by FDA on August 17, 2001 (K010735), and the Daum Biopsygun manufactured by Daum Corp., which has been cleared by FDA on March 6, 1998 (K974576). Specifically, the proposed devices and the predicate devices are all intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. In addition, the proposed devices and the predicate device Speedybell are indicated to be used with ultrasound or CT-Guidance techniques. Finally, both the MRI Biopsy Handy and the predicate device Daum Biopsygun are indicated to be used with magnetic resonance imaging (MRI) techniques.

Furthermore, the Biopsy Handy and MRI Biopsy Handy are identical or similar in technology, design and material to the

Substantial Equivalence:

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MADE IN GERM.

Rheinstraße 7d | 0-14513 Teltow Tel +49 [0] 3328 30 76-0 | Fax +49 [0} 3328 30 76-95 info@somatex.com | www.somatex.co

predicate devices. Both the proposed and the predicate devices consist of the same primary components and the component materials of the proposed device and the predicate devices are substantially equivalent.

Based on the same intended use and the similiarities in technolgy, design and materials, the Biopsy Handy and MRI Biopsy Handy are substantially equivalent to their predicate devices. The minor technological differences between the proposed devices and the predicate devices do not raise new questions of safety and effectiveness.

Finally, biocompatibility, sterility, packaging and MRtesting demonstrate the safety and effectiveness of the proposed devices.

Date Prepared:

February 24, 2011

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

Somatex Medical Technologies GmbH % Ms. Susanne Raab Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, Massachusetts 02139

JUN 2 4 2011

Re: K102771

Trade/Device Name: Biopsy Handy/MRD Biopsy Handy Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 23, 2011 Received: June 24, 2011

Dear Ms. Raab:

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

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Page 2 - Ms. Susanne Raab

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name: Biopsy Handy / MRI Biopsy Handy

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OL

Nil RP Qyle fortkn

ivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102771
Page 1 of 1

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.