VARISOURCE BREAST TEMPLATE SYSTEM

K023220 · Varian Medical Systems · JAQ · Oct 25, 2002 · Radiology

Device Facts

• Record ID: K023220
• Device Name: VARISOURCE BREAST TEMPLATE SYSTEM
• Applicant: Varian Medical Systems
• Product Code: JAQ · Radiology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a fixed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are fixed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

Device Story

VariSource Breast Template System is a mechanical tool for HDR brachytherapy; facilitates interstitial needle implantation in fixed geometric patterns (Paris geometry). Device consists of a breast bridge with a ratchet mechanism and templates with holes; holds templates in place on either side of the breast during needle insertion. Used in a brachytherapy treatment unit; operated by clinical staff. Device does not include needles; serves as a guide to ensure consistent needle spacing. Benefits include improved geometric accuracy for radiation delivery to breast or chest wall tumors. Device is non-sterile upon delivery; validated for autoclave sterilization.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel (ratchet) and USP Class VI polycarbonate (templates). Design: Breast bridge with ratchet mechanism for template spacing; triangular (Paris) geometry. Connectivity: None (mechanical tool). Sterilization: Autoclave (not supplied sterile).

Indications for Use

Indicated for high-dose rate (HDR) brachytherapy irradiation of the breast or chest wall in patients requiring interstitial implants for the treatment of breast carcinoma.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstital Needle Applicator (K952913)

Submission Summary (Full Text)

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KD23220

Image /page/0/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo is in black and white and features the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below "VARIAN" is the text "medical systems" in a smaller, sans-serif font.

cology Systems 0 Hansen Way o Alto, CA 94304-1038 [phone] www.varian.com

OCT 2 5 2002

## Premarket Notification [510(k)] Summary as required by 21 CFR 807.92

#### Date summary was prepared:

September 18, 2002

#### Submitter's Name:

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

#### Contact Person:

Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Phone [phone] FAX [phone] E-mail [e-mail]

#### Device Name:

VariSource Breast Template System

#### Classification Name:

System, Applicator, Radionuclide, Remote-Controlled

#### Predicate Device:

Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstital Needle Applicator

#### Intended Use:

The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a fixed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are fixed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the

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Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

# Technological Characteristics:

See the attached "Specification Comparison Chart", Tab G

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# SDD FEATURE COMPARISON

| Feature | Varian Part Description & Number.<br>Breast Bridge and Template System Pt #<br>AL13011000 | Predicate Device<br>Applicators for Varian VariSource<br>Remote High Dose Rate<br>Afterloader |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 1. Intended use | HDR Brachytherapy | HDR Brachytherapy |
| 2. Indications for use | See above | See above |
| 3. Target population | N/A | N/A |
| 4. Design | The Breast Bridge and Template System is<br>designed to make implanting needles,<br>particularly through the breast, in a fixed<br>geometric pattern easily achievable. The<br>design places templates with holes in a<br>triangular pattern (Paris geometry) on either<br>side of the breast. A ratchet mechanism<br>holds these templates in place while<br>needles are implanted through the Breast.<br>The Needles are NOT part of this product.<br>This product is simply a tool to make it easy<br>to insert needles in a fixed pattern. | Interstitial Needle Applicators |
| 5. Materials | Stainless Steel ratchet, polycarbonate (USP<br>class VI approved) templates | Stainless Steel |
| 6. Performance | N/A | N/A |
| 7. Sterility | Autoclave | Autoclave |
| 8. Biocompatibilty | Fully biocompatible Stainless Steel and<br>Polycarbonate used. | Fully biocompatible Stainless Steel<br>used. |
| 9. Mechanical safety | N/A | N/A |
| 10. Chemical safety | N/A | N/A |
| 11. Anatomical sites | Breast, Chest Wall | Breast, Chest Wall and others<br>including Prostate. |
| 12. Human factors | Controlled through VariSource Afterloader. | Controlled through VariSource<br>Afterloader. |
| 13. Energy used and/or<br>delivered | N/A | N/A |
| 14. Compatibility with the<br>environment and other<br>devices | Uses 18 gauge needles | Includes 18 gauge needles |
| 15. Where used | BrachyTherapy treatment unit | BrachyTherapy treatment unit |
| 16. Standards met | No applicable device standard | No applicable device standard |
| 17. Electrical safety | N/A | N/A |
| 18. Thermal safety | N/A | N/A |
| 19. Radiation safety | N/A | N/A |
| 20. Predicate Device<br>Clearance number | N/A | K952913 |
| | Varian Part Description & Number. | Predicate Device |
| Feature | Breast Bridge and Template System Pt #<br>AL13011000 | Applicators for Varian VariSource<br>Remote High Dose Rate<br>Afterloader - Interstitial Needle<br>Applicator |
| Needle material | Template is constructed from a stainless<br>steel ratchet and polycarbonate templates<br>Template facilitates the use of 18 ga.,<br>needles | Stainless steel shaft, Aluminium<br>coupling, Nylon suture button. |
| Needle dimensions | | 18-21 ga., 10 - 20 cm<br>Dia. 0.8 – 1.3 mm |
| Needle obturator | No | Yes |
| Needle obturator material | N/A | Tungsten |
| Needle cap material | N/A | Aluminium |
| Obturator cap material | N/A | Aluminium |
| Packaged individually with<br>obturator | N/A | Yes |
| Sterility | Not supplied sterile | Sterile via gamma radiation |
| Sterility assurance level | N/A | 10⁻⁶ |
| Sterilisation cycle validation | N/A | AAMI guideline for Gamma radiation<br>sterilisation (AAMI ST32 October,<br>1991) |
| Packaging | Packaged in an Aluminium tray. | Needles are packaged in a<br>polycarbonate tube with end caps<br>placed in a tyvek/mylar pouch and<br>heat sealed. |

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Note: While the template is not supplied sterile is have been validated for efficacy and suitability for autoclave sterilisation.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows a logo with a circular border containing text, and an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a similar shape, composed of three curved lines. The text around the border is not fully legible, but it seems to be part of a title or organization name.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Systems Varian Medical Systems 3100 Hansen Way F-055 PALO ALTO CA 94304

Re: K023220

Trade/Device Name: VariSource Breast Template System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II

Product Code: 90 JAQ Dated: September 19, 2002 Received: September 27, 2002

Dear Ms. Nash:

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 (OS) 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 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 this 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" (21 CFR Part 807.97). 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. Grigdon

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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XYZ390

Page 1 of 1

510(k) Number (if known). KO23390

Device Name: VariSource Breast Template System

Indications For Use:

The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a fixed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are fixed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David A. Leggett

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use