UF BRACHYTHERAPY STAND

K023430 · University of Florida · IYO · Jun 24, 2003 · Radiology

Device Facts

• Record ID: K023430
• Device Name: UF BRACHYTHERAPY STAND
• Applicant: University of Florida
• Product Code: IYO · Radiology
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.

Device Story

Manual, mechanical system; includes ultrasound probe stabilizing stand and stepping unit. Clamps to table top or side-rails. Used by clinicians during prostate brachytherapy implant procedures to align ultrasound probes. Provides stable positioning for imaging and needle guidance. Benefits patient by facilitating accurate probe alignment during planning and implantation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual, mechanical system; includes ultrasound probe stabilizing stand and stepping unit; table-top or side-rail clamp mounting.

Indications for Use

Indicated for patients undergoing prostate brachytherapy implant procedures requiring ultrasound probe alignment for planning and performance.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Barzell-Whitmore Maroon Bells, Inc.: Brachystepper Stepping Unit/ Needle Guide Template, Brachystand Support and Manual Adjustment Accessory (K972672)

Submission Summary (Full Text)

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JUN 2 4 2003

Applicant: Shands Teaching Hospital and Clinics, Inc.

UF Brachytherapy Stand Traditional 510(k) Premarket Notification

## K$\phi$2343$\phi$

510(k) SUMMARY—UF Brachytherapy Stand

| Submitter Name: | Shands Teaching Hospital and Clinics, Inc.<br>University of Florida |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 1600 S.W. Archer Road<br>Gainesville, FL 32610-0315 |
| Contact Person: | Jodi Mansfield<br>Chief Operating Officer |
| Phone Number:<br>Fax Number: | 352-265-0440<br>352-265-0231 |
| Date Prepared: | October 4, 2002 |
| Device Trade Name: | UF Brachytherapy Stand |
| Device Common Name: | Transducer, Ultrasound, Diagnostic |
| Classification Name and<br>Number: | Transducer, Ultrasound, Diagnostic<br>21 CFR 892.1570, 90 ITX |
| Predicate Device: | K972672, Barzell-Whitmore Maroon Bells, Inc .: Brachystepper<br>Stepping Unit/ Needle Guide Template, Brachystand Support and<br>Manual Adjustment Accessory |
| Device Description: | The UF Brachytherapy Stand is a manual, mechanical system that<br>includes an ultrasound probe stabilizing stand and a stepping unit. It<br>is for use clamped to a table top or side-rails. |
| Intended Use: | The UF Brachytherapy Stand is intended to be used to provide<br>ultrasound probe alignment in planning and performing a prostate<br>brachytherapy implant procedure. |
| Conclusion: | This device, with respect to materials, device characteristics and<br>intended use, is substantially equivalent to the predicate device. |

000027

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which may represent the flow of information or resources within the department. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Ms. Patsy J. Trisler, J.D., RAC Senior Consultant Biologics Consulting Group 5610 Wisconsin Avenue, #304 CHEVY CHASE, MD 20815

Re: K023430

Trade/Device Name: UF Brachytherapy Stand Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 IYO and KXK Dated: March 28, 2003 Received: April 1, 2003

Dear Ms. Trisler:

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 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

Page 2

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Device Name:

UF Brachytherapy Stand

Indications for Use:

The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> |
|------------------------------------------|----------|
|------------------------------------------|----------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K023430

Section 4.0
(Optional Format 1-2-96)