The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.

AI/ML Overview

This appears to be a 510(k) summary and FDA clearance letter for a medical device, specifically biopsy needle guides. This type of document is about regulatory clearance based on substantial equivalence to a predicate device, not typically a detailed study proving performance against acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set, ground truth for training set) are not applicable to this type of submission. This submission primarily focuses on comparing the technological characteristics of the new device to a legally marketed predicate device to demonstrate substantial equivalence, particularly regarding a change in delivery (from non-sterile to sterile).

However, I can extract information related to the device's characteristics and intended use, and frame the "acceptance criteria" based on the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description (Based on Predicate Device)	Reported Device Performance
Intended Use	Performing ultrasound-guided biopsies of the prostate.	The subject device performs ultrasound-guided biopsies of the prostate.
Target Organ	Prostate and similar soft tissue.	Designed for biopsies of the prostate and similar soft tissue.
Mechanism of Action	Fixed to ultrasonic probe, provides a predetermined path for a biopsy needle.	Functions by being fixed to the ultrasonic probe and providing a predetermined path for a biopsy needle.
Sterility	Not explicitly stated as a separate criterion for the predicate in this text, but the predicate was "delivered non sterile."	The new biopsy guides are "delivered sterile." (This is the primary difference and a key characteristic.)
Compatibility	Used with B-K Medical's ultrasound systems.	Compatible with B-K Medical's ultrasound systems.
Patient Population	Adult patients.	Intended for adult patients.
Environment of Use	Physician office or hospital environment.	For use by medical professionals in a physician office or hospital environment.
Technological Characteristics	Same major technological characteristics as the predicate device (e.g., materials, design, dimensions for guiding needles) with the exception of sterility.	The device maintains the "same major technological characteristics as the subject device" compared to the predicate, with the key difference being sterility.

Study Proving Device Meets Acceptance Criteria:

The document describes a 510(k) premarket notification submission. The "study" in this context is a comparison of the subject device (new biopsy guides) to a legally marketed predicate device (Targetscan biopsy kit, Targetscan biopsy needle guide - K073399) to establish substantial equivalence.

The core of the "proof" is the declaration that: "The predicate device has the same major technological characteristics as the subject device, see comparison below." The only mentioned difference is that the new biopsy guides are delivered sterile, whereas the predicate was delivered non sterile. This sterility change would typically involve validation studies (e.g., sterilization validation) which are part of the overall submission but not detailed in this summary.

Further Requested Information (Not Applicable to this type of 510(k) Summary):

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

N/A. This is a substantial equivalence submission for a physical medical device, not an AI/SaMD performance study using a test set of 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)

N/A. Ground truth for image interpretation or diagnosis is not relevant to this device's regulatory review.

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

N/A. Not an AI/SaMD performance study.

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

N/A. This device is a biopsy guide, not an AI/software product that assists human readers.

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

N/A. This device is a physical medical device, not an algorithm.

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

N/A. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this submission is that the predicate device is legally marketed and safe/effective for its intended use, and the new device is functionally identical with an added sterility benefit.

8. The sample size for the training set

N/A. Not an AI/SaMD.

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

N/A. Not an AI/SaMD.

Summary

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510(k) Summary:

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Establishment registration number: 9680269

JUL 2 2 2008

Contact person: Jens Rasmussen, Director of Quality Date prepared: 9 May 2008

Trade name: Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), Dual biopsy guide for 8818 (UA1329-S).

Common name: Biopsy needle guide

Classification:

Kit, needle biopsy FCG (CFR 876.1075) Class II

Identification of predicate, legally marketed device:

Targetscan biopsy kit, Targetscan biopsy needle guide (K073399)

Device description:

Intended use.

Purpose: Performing ultrasound guided biopsies of the prostate. Intended patient population: The intended population is adult patients. Intended environment: The device is for use by medical professionals in a physician office or hospital environment.

Technological characteristics compared to the predicate device.

The predicate device has the same major technological characteristics as the subject device, see comparison below.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 2 2008

Mr. Jens Rasmussen Director of Quality B-K Medical Mileparken 34, DK-2730 Herlev DENMARK

Re: K081323

Trade/Device Name: Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), and Dual biopsy guide for 8818 (UA1329-S)

Regulation Number: 21 CFR 876.1075

Regulation Name: Gastroenterology-urology biopsy instrument

Regulatory Class: II Product Code: FCG Dated: June 30, 2008 Received: July 7, 2008

Dear Mr. Rasmussen:

We have reviewed your Section 510(k) premarket notification of intent to market the device w ferenced 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Approvally, it ifal) of coole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/13 description: The image is a black and white circular logo. The logo contains the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are in a bold, stylized font in the center of the logo. The logo is surrounded by a dotted border and stars.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Hoalth's (CDRH 3) Office of Compliance at Une of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081323 __

Device Name:

Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), Dual biopsy guide for 8818 (UA1329-S)

Indications for Use:

Performing ultrasound guided biopsies of the prostate

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helena Roman

(Division Sign-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number

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.