Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.

Device Description

The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Needle Guide for BK Medical ultrasound transducers) and its comparison to a predicate device. The information is presented in the context of demonstrating substantial equivalence, not a study proving specific performance metrics against acceptance criteria.

Specifically, the document does not contain a study with acceptance criteria and reported device performance as typically understood for a detailed clinical or analytical validation study for an AI/ML device. The provided text is a summary of a regulatory submission (510(k)) that focuses on showing the new device is "substantially equivalent" to an already approved device. This process primarily relies on comparing technological characteristics and intended use.

Therefore, many of your requested points cannot be answered from the provided text. I will indicate where the information is missing or not applicable based on the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be fully generated as the document does not specify formal acceptance criteria for device performance or report specific performance metrics in a study. The comparison table focuses on technological characteristics and intended use for substantial equivalence.

Acceptance Criteria	Reported Device Performance (from text)
Formal Acceptance Criteria (e.g., accuracy, precision for needle guidance)	Not provided in the document. The document aims to demonstrate substantial equivalence, not to quantify specific performance against defined metrics.
Intended Use Equivalence: "Needle guide provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy."	Met: The "Conclusion" states, "The needle guides in this application have same intended use and the same characteristics as the predicate device."
Technological Characteristics Equivalence: (e.g., Needle Guide angle, Pre-sterilized, Removable options, For use with variety of Needles, Materials, Single Use/Disposable, Device Description)	Met: The table in the "510(k) Summary continue" section explicitly compares these characteristics, showing them to be the same or similar, leading to the conclusion of substantial equivalence.

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

Sample Size: Not applicable. This document is not a report of a performance study that uses a test set of data. It is a regulatory submission for substantial equivalence.
Data Provenance: Not applicable.

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

Not applicable. No ground truth establishment from experts for a test set is described in this regulatory submission.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set is described.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical needle guide, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical needle guide.

7. The type of ground truth used

Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for the 510(k) submission is the existence and characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary

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

510(k) Summary continue

	Biopsy guides in this submission	K043425
Intended Use	Needle Guide for BK Medical transducer 88xx"Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy.	The Needle Guide provides guidance for a needle, catheter, biopsy apparatus or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform biopsy or precise needle placement.
Indications for use	Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy.	The Needle Guide provides guidance for a needle, catheter, biopsy apparatus or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform biopsy or precise needle placement.
Needle Guide angle	Fixed and Various	Various
Pre-sterilized	Yes	Yes
Removable options for Ultrasonic probe	Yes	Yes
For use with variety of Needles	Yes	Yes
Materials	MABS (incl. BaSO4)MABS (incl. BaSO4) and stainless steel	Nylon and ABS
Single Use / Disposable	Yes	Yes
Device description	The Needle Guide system consists of 3-4 primary components (depending on the intended transducer) which are used to provide alignment with an ultrasound transducer, in order to guide a needle in relation to the ultrasound image	The Needle Guide system consists of 4 primary components which are used to provide alignment with an ultrasound transducer, in order to guide a needle in relation to the ultrasound image.

78814; 8815; 8824

ﺘﺮ ﺗﻘ

Conclusion: The needle guides in this application have same intended use and the same characteristics as the predicate device.

B-K Medical therefore believes that the devices in this submission are substantially equivalent to the device in K043425.

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

510(k) Summary

K083667
Page 2 of 2

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 +45 44528199 Fax: Establishment registration number: 9680269

Contact person: Lars Oksby Hansen Date prepared: 08 December 2008

Trade name: Needle Guide for 8814 (UA1335), for 8815 (UA1336), for 8824 (UA8824).

Common name: Needle Guide

Classification:

Diagnostic Ultrasound Transducer ITX (21 CFR 892.1570) Class II

Identification of predicate, legally marketed device:

Sheathes Needle Guide System (K043425)

Device description:

Intended use.

Purpose:

Needle Guide for BK Medical transducer 88xx * Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy.

The device is for use by medical professionals in a physician office or Intended environment: hospital environment.

*8814; 8815; 8824

Technological characteristics compared to the predicate device.

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

Comparison with Sheathes Needle Guide System (K043425) �

Continue on next page

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is arranged vertically, with 'Public Health' on the first line and 'Service' on the second line. The font appears to be a serif typeface, and the text is black against a white background.

Food and Drug Administration 9200 Corporate Boulevard

FEB - 2 2009

Rockville MD 20850

Mr. Lars Oksby Hansen Regulatory Manager B-K Medical APS Mileparken 34, DK-2730, Herlev DENMARK

Re: K083667

Trade/Device Name: Needle guide for 8814 (UA1335). Needle guide for 8815 (UA1336), and Needle guide for 8824 (UA1337)

Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: ITX Dated: December 8, 2008 Received: December 11, 2008

Dear Mr. Hansen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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 os 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDH's Office of Surveillance and Biometrics' (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 Manufactures, 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.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morri Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Indications for Use

510(k) Number (if known) k 083667

Needle guide for 8814 (UA1335), Needle guide for 8815 (UA1336), Device Name: Needle guide for 8824 (UA1337).

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 1 of

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.