This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes. Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units. Reusable, non-sterile. Materials: Delrin and Aluminum.

AI/ML Overview

The provided document K972672 is a 510(k) summary for a medical device called BRACHYSTEPPER, which includes a stepping unit, a needle template guide, and a support and manual adjustment accessory.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative manner as would be expected for a complex AI/software device. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.

The acceptance criteria for a 510(k) submission generally involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the BRACHYSTEPPER, this would imply that its physical and functional characteristics are comparable to the predicate devices.

Acceptance Criteria Category	Description	Reported Device Performance (based on Substantial Equivalence Claim)
Function	The device should provide pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units.	The BRACHYSTEPPER Stepping Unit is substantially equivalent to the B & K Stepper (K905198 & K914945) and Civco Ultra-Step. The BRACHYSTEPPER Needle Guide Template is substantially equivalent to Civco Seed Implant Needle Guide (K875241) and B & K Stepper Matrix (K905198 & K914945). The BRACHYSTAND Support and Manual Adjustment Accessory is substantially equivalent to "Martin" Immobilizing Device (K850571) and Ultra-Step Ultrasound Probe/Stepper Fixation Device. This implies that the BRACHYSTEPPER system performs these functions comparably to the predicate devices.
Scientific Basis	The device should effectively provide pre-insertion fixation, gross/fine adjustment, and precise incremental lateral probe advancement to aid in volume determination and seed implantation during brachytherapy.	The device's scientific basis for facilitating accurate positioning and guiding needles is considered equivalent to the predicate devices.
Design	Reusable, non-sterile.	The BRACHYSTEPPER is described as reusable and non-sterile, consistent with similar predicate devices for brachytherapy procedures.
Materials	Delrin and Aluminum.	The materials used (Delrin and Aluminum) are considered appropriate and comparable to materials used in predicate devices, ensuring similar biocompatibility and durability.
Intended Use	Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy in adult males with suspected or known prostate cancer.	The intended use for the BRACHYSTEPPER is identical to the established uses of the predicate devices.
Technological Characteristics	Manually-powered, mechanical system for probe fixation, stepping, and needle guidance.	The BRACHYSTEPPER's manually-powered, mechanical nature for probe fixation, stepping, and guiding needles is considered substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" or any clinical study involving patient data for the BRACHYSTEPPER device itself. This 510(k) submission is for a mechanical medical device, not a diagnostic or AI-powered imaging device that would typically involve a test set for performance evaluation. The substantial equivalence is based on the comparison of the device's design, materials, function, and intended use with existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no test set or clinical performance study for the device is described, there is no mention of experts establishing ground truth. The review process implicitly involves FDA reviewers with expertise in medical devices and relevant clinical fields, who evaluate the substantial equivalence claim.

4. Adjudication Method for the Test Set

As there is no test set described, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The BRACHYSTEPPER is a mechanical device, not an AI or imaging system, so such a study would not be relevant in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation (as would be typical for an algorithm) was not performed. This device is a component of a brachytherapy system, designed to assist medical practitioners.

7. The Type of Ground Truth Used

Given the nature of the device (mechanical support and guidance system), the concept of "ground truth" as it applies to diagnostic accuracy or AI performance is not directly applicable. The "proof" of meeting acceptance criteria is through engineering comparison to existing predicate devices, demonstrating similar physical properties, functional capabilities, and intended use, which implicitly assumes the predicate devices provide a "ground truth" for safe and effective mechanical operation within their intended clinical context.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing would be based on engineering principles and knowledge.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this information is not applicable.

Summary

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

K972672

Page 27

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII.

Submitter's Name A.

JUL 2 9 1997

1. Address
  Barzell-Whitmore Maroon Bells, Inc. 1921 Waldemere Street, Suite 310 Sarasota, Florida 34239
1. Phone Number
  (941) 917-8493
1. Contact Person
  Willet F. Whitmore, M.D.
1. Summary Preparation Date
  June 23, 1997

Device Name B.

1. Trade/Proprietary Name
  BRACHYSTEPPER Stepping Unit BRACHYSTEPPER Needle Template Guide BRACHYSTAND Support and Manual Adjustment Accessory
1. Common/Usual Name
  Ultrasonic Pulsed Echo Imaging System and Accessories

Manual Radionuclide Applicator System and Accessories

1. Classification Name
  Ultrasonic Pulsed Echo Imaging System and Accessories

Manual Radionuclide Applicator System and Accessories

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

Predicate Device C.

なと思い
1. The BRACHYSTEPPER Stepping Unit is substantially-equivalent to the following legally-marketed devices ("Predicate Devices"):

Device Name:	B & K Stepper
Manufacturer:	Brnel & Kjaer Medical
510(k) Number:	K905198 & K914945
Substantial Equivalence Date:	8/28/91 & 6/26/92

Civco Ultra-Step Device Name: Civco Instruments Manufacturer: Unknown 510(k) Number: Unknown Substantial Equivalence Date:

1. Predicate Devices for the BRACHYSTEPPER Needle Guide Template are:
  Civco Seed Implant Needle Guide Device Name: Civco Medical Instruments Manufacturer: K875241 510(k) Number: Substantial Equivalence Date: 4/14/88

Device Name:	B & K Stepper Matrix
Manufacturer:	Brnel & Kjaer Medical
510(k) Number:	K905198 & K914945
Substantial Equivalence Date:	8/28/91 & 6/26/92

1. Predicate Device for the BRACHYSTAND Support and Manual
  Adjustment Accessory for the brachytherapy system are:

Device Name:	"Martin" Immobilizing Device
Manufacturer:	Mick Radio-Nuclear Instruments, Inc.
510(k) Number:	K850571
Substantial Equivalence Date:	3/26/85
Device Name:	Ultra-Step Ultrasound Probe/StepperFixation Device
Manufacturer:	Civco Medical Instruments Co., Inc.
510(k) Number:	Unknown
Substantial Equivalence Date:	Unknown

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

Device Description D.

1. Function
  This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes.
1. Scientific Basis
  Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units.
1. Significant Physical/Performance Characteristics
- a) Design

Reusable, non-sterile.

Materials b)
Delrin and Aluminum
c) Physical Properties
Not Applicable

E. Intended Use Statement

1. Disease/Conditions
  Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy.
1. Patient Population
  Males with suspected or known prostate cancer.

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

i F. Technological Characteristics Summary

Manually-powered, mechanical brachytherapy system designed to provide pre-insertion fixation of ultrasound imaging probes, radiologic stepping units and needle guide templates used during prostatic brachytherapy. This system also facilitates accurate positioning of the ultrasound imaging probe, and a guide for needles carrying a radioactive seed for implantation.

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

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH" are written in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barzell-Whitmore Maroon Bells, Inc. c/o Marian Harding Cochran Regulatory Consultant ACCUREG, Inc. 300 NW 82nd Avenue, Suite 402 Plantation, FL 33324

Re: K972672

Brachystepper Stepping Unit/Needle Guide Template Brachystand Support and Manual Adjustment Accessory Dated: July 14, 1997 Received: July 16, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Cochran:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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.

JUL 2 9 1997

If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h. Liao Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

: INDICATIONS FOR USE STATEMENT IX.

510(k) Number (if known): K972672

Brachystepper Device Name: Stepping Unit ( Needle emplate Bruchy stand Manual Support and Indications for Use:

This device is indicated for use in adult males with known or suspected prostate cancer.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K972672

(Optional Format 1-2-96)

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.