K Number
K972672
Device Name
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
Date Cleared
1997-07-29

(13 days)

Product Code
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is indicated for use in adult males with known or suspected prostate cancer.
Device Description
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.
More Information

Not Found

No
The device description focuses on mechanical manipulation and support of an ultrasound probe, with no mention of image processing, AI, or ML.

No
This device is described as an "adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes" used for "pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement." Its function is to assist in imaging, not to directly treat a disease or medical condition.

No

The device is described as an "adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes," which aids in imaging, but does not itself provide a diagnosis. Its function is to facilitate the use of an imaging probe, which then generates images used for diagnosis by a separate system or clinician.

No

The device description explicitly states it is an "adjustable support and manipulation apparatus and system" made of physical materials (Delrin and Aluminum), indicating it is a hardware device, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD devices are used to examine specimens obtained from the human body. This device is used to support and manipulate an ultrasound probe during an imaging procedure on a patient. It does not analyze blood, urine, tissue, or any other bodily fluid or sample in vitro (outside the body).
  • The description clearly states its function is to assist with transrectal ultrasound imaging. This is an in vivo (within the body) imaging technique.
  • The materials and function described are consistent with a medical device used for procedural support, not for laboratory analysis.

The information provided describes a device that is an accessory to an ultrasound imaging system, designed to improve the accuracy and control of the ultrasound probe during a procedure. This falls under the category of a medical device, but not an IVD.

N/A

Intended Use / Indications for Use

Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy.
This device is indicated for use in adult males with known or suspected prostate cancer.

Product codes (comma separated list FDA assigned to the subject device)

90 ITX

Device Description

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.
Delrin and Aluminum
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

prostate

Indicated Patient Age Range

adult males

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K905198 & K914945, K875241, K905198 & K914945, K850571

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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/Stepper
Fixation Device
Manufacturer:Civco Medical Instruments Co., Inc.
510(k) Number:Unknown
Substantial Equivalence Date:Unknown

1

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)