BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY

K972672 · Barzell-Whitmore Maroon Bells, Inc. · ITX · Jul 29, 1997 · Radiology

Device Facts

• Record ID: K972672
• Device Name: BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
• Applicant: Barzell-Whitmore Maroon Bells, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy.

Device Story

The Brachystepper system is a manually-powered, mechanical apparatus used during prostatic brachytherapy. It provides pre-insertion fixation of transrectal ultrasound imaging probes, radiologic stepping units, and needle guide templates. The device facilitates gross and fine adjustment of the ultrasound probe and provides a guide for needles used to implant radioactive seeds into the prostate. It is used in a clinical setting to assist physicians in the volume determination of the prostate and the accurate positioning of needles for seed implantation. The system is reusable and non-sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manually-powered mechanical system. Materials: Delrin and Aluminum. Components include a stepping unit, needle template guide, and support/manual adjustment accessory. Reusable, non-sterile design.

Indications for Use

Indicated for adult males with known or suspected prostate cancer.

Regulatory Classification

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.

Predicate Devices

• B & K Stepper (K905198 & K914945)
• Civco Ultra-Step (Unknown)
• Civco Seed Implant Needle Guide (K875241)
• B & K Stepper Matrix (K905198 & K914945)
• Martin Immobilizing Device (K850571)
• Ultra-Step Ultrasound Probe/Stepper Fixation Device (Unknown)

Submission Summary (Full Text)

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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

- 2. Phone Number
[phone]

- 3. Contact Person
Willet F. Whitmore, M.D.

- 4. 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

- 2. Common/Usual Name
Ultrasonic Pulsed Echo Imaging System and Accessories

Manual Radionuclide Applicator System and Accessories

- 3. Classification Name
Ultrasonic Pulsed Echo Imaging System and Accessories

Manual Radionuclide Applicator System and Accessories

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#### 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:

- 2. 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 |

- 3. 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<br>Fixation Device |
| Manufacturer: | Civco Medical Instruments Co., Inc. |
| 510(k) Number: | Unknown |
| Substantial Equivalence Date: | Unknown |

1

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#### Device Description D.

- 1. Function
This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes.

- 2. Scientific Basis
Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units.

- 3. 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.

- 2. Patient Population
Males with suspected or known prostate cancer.

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### 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.

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## : 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)