SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM

K050724 · C.R. Bard, Inc. · ITX · Apr 18, 2005 · Radiology

Device Facts

• Record ID: K050724
• Device Name: SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: ITX · Radiology
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sure-Point® Midline Stepping and Stabilization Systems are indicated for use to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy. A specific application is the treatment of prostate cancer.

Device Story

System facilitates brachytherapy procedures for prostate cancer treatment. Components include needle template, stepping head, locking knob, and articulated arm mounted on a procedure table. Device uses patient weight for stabilization. Stepping head holds ultrasound transducer; locking mechanism enables precise 3D placement of radioactive seeds. Operated by clinicians in a clinical setting. Output is mechanical stabilization and alignment of ultrasound probe and needles to guide seed implantation, aiding clinical decision-making regarding precise dose delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical stabilization system. Components: needle template, stepping head, locking knob, articulated arm. Dovetail connections, clamps, and screws. No electronic or software components described.

Indications for Use

Indicated for patients undergoing brachytherapy for the treatment of prostate cancer, requiring precision ultrasound probe alignment and radioactive seed implantation.

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

• Sure-Point® Midline Stepping and Stabilization System (K050724)

Submission Summary (Full Text)

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16050724

# APR 1 8 2005

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### SUBMITTER INFORMATION: A.

| Submitter's Name: Address: | C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, GA 30014 |
|------------------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Lorraine R. Pata |
| Contact Person's Telephone Number: | 770-784-6160 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | March 11, 2005 |

#### DEVICE NAME: B.

Trade Name(s):

Common / Usual Name: Classification Names:

Sure-Point® Midline Stepping and Stabilization System Stepping and Stabilization Device 90 ITX - Accessory to Diagnostic, Ultrasound transducer 21 CFR 892.5730

#### PREDICATE DEVICE NAME: C.

Sure-Point® Midline Stepping and Stabilization System Trade Names:

#### DEVICE DESCRIPTION: D.

The Sure-Point Midline Stepping and Stabilization System is comprised of three The Sure-Foint Midline Stepping and Classic Needle Needle Needle Template, Components - the Midline Stopping - Locking Knob and the Midline Patient Midline Articulated Am a procedure table utilizing the patient's weight Board. The System is Slaatod on a proper stabilization. The Sure-Point Midline Stepping head is mounted onto the Midline Articulated Arm which in turn is Stepling Thead Is Intounted Unio mating "dovetail connections", clamps and connected to the pations being multing Stepping head serves to screws. Dunny a brachytherapy proceared the same the template, while the Securely Trold an Gitraoound transcal lock facilitates precise three dimensional Midine Articulated Amil was olacement of radioactive seed implantation.

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#### Intended Use: E.

Sure-Point® Midline Stepping and Stabilization Systems are indicated for Sure-Folltw Midine Olepping and Grobe alignment and radioative seed
use to allow precision ultrasound probe alignment and radion is the use to allow precision unrasound probo alignments. A specific application is the treatment of prostate cancer.

## Technological Characteristics Summary: F.

The subject SURE-POINT® MIDLINE Stepping and Stabilization System have The subject SUNC-FORN - MIDEINE Stopping and fundamental scientific technology as the predicate device.

### Performance Data Summary: G.

The appropriate design verification and validation activities for the The appropriate design vehicution and valuation
modification of the SURE-POINT® MIDLINE Stepping and Stabilization System were conducted.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine R. Pata Regulatory Affairs Specialist

Re: K050724

APR 1 8 2005

Trade/Device Name: SURE-POINT® MIDLINE Stepping and Stabilization System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: ITX and KXK Dated: March 11, 2005 Received: March 21, 2005

Dear Ms. Pata:

C. R. Bard, Inc

8195 Industrial Blvd.

COVINGTON GA 30014

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one 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 the enorosate to the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the clayments 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 do not require approval or a provisions of the Act. The general controls provisions of the Act at floor sabject to 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 (Premarket n your do rever to such additional controls. Existing major regulations affecting your Apploval), It they of babled to rederal 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 I toase of devised that i revice complies with other requirements of the Act or any I DA has made a acterininations administered by other Federal agencies. You must comply with all the I caran suitees and regulating, 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) (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) I mis letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket nothleation: "The PDA mailig of oassification 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 If you desire specific actied for your development mimbers, based on the regulation number at the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation emilies, formation on your responsibilities under the Act from the 807.97). Tou may obtain other general missistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bard Urological Division, C.R. Bard, Inc. SURE-POINT® MIDLINE Stepping and Stabilization System Premarket Notification [510(k)]

| 1.3 | Indications for Use Statement | | | |
|-----|-------------------------------|---------|--|--|
| | 510(k) Number (if known): | K050724 | | |

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The SURE-POINT MIDLINE Stepping and Stabilization System is indicated for use to allow The SURE-FOINT MIDENE Otcpling and cradioactive seed implantation in brachytherapy precision - unrasound - alignification is the treatment of prostate cancer.

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| Prescription Use | <span style="text-decoration: overline;"></span> | OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |
|----------------------|--------------------------------------------------|----|-----------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1/2/96) |

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