CAPRI APPLICATOR

K092822 · Vivaray, Inc. · JAQ · Nov 3, 2009 · Radiology

Device Facts

• Record ID: K092822
• Device Name: CAPRI APPLICATOR
• Applicant: Vivaray, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Story

The CAPRI Applicator is a single-use, disposable, sterile device designed for brachytherapy. It is temporarily inserted into the vagina or rectum to facilitate radiation treatment of carcinoma. The device features multiple lumens that serve as pathways for the delivery of a prescribed radiation dose to the target site. It is intended for use by clinicians in a clinical setting. The device functions as a physical guide for radiation sources, enabling precise dose delivery to the treatment area, thereby assisting in the therapeutic management of carcinoma.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Single-use, disposable, sterile brachytherapy applicator. Features multiple lumens for radiation source delivery. Physical and technical characteristics are similar to predicate devices.

Indications for Use

Indicated for use during brachytherapy procedures to provide pathways for the delivery of a prescribed radiation dose to a treatment area in patients undergoing carcinoma treatment.

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

• BioLucent's Applicator (K061241)
• Nucletron's Miami Applicator (K953946)

Submission Summary (Full Text)

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## Section 6

. 510(k) Summary

16992822

#### 6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | VivaRay, Inc. | |
|---------------------------|-----------------------------------------------------------------------|--------------|
| TRADE NAME: | CAPRI™ Applicator | NOV - 3 2009 |
| COMMON NAME: | Brachytherapy Applicator | |
| CLASSIFICATION<br>NAME: | Remote Controlled Radionuclide Applicator System, 21 CFR,<br>892.5700 | |
| DEVICE<br>CLASSIFICATION: | Class II | |
| PRODUCT CODE | JAQ | |

PREDICATE DEVICES: BioLucent's Applicator (K061241) Nucletron's Miami Applicator (K953946)

#### Substantially Equivalent To:

The CAPRI Applicator is substantially equivalent in intended use, principal of operation and technological characteristics to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946).

### Description of the Device Subject to Premarket Notification:

The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma.

The CAPRI Applicator is provided sterile for single use and is disposable.

#### Indication for Use:

The CAPRI Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

#### Technical Characteristics:

The CAPRI Applicator has similar physical and technical characteristics to the predicate devices.

VivaRay, Inc. CAPRI Applicator Page 11 of 56 Premarket Notification

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# Performance Data:

All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices.

## Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CAPRI Applicator is determined by VivaRay, to be substantially equivalent to existing legally marketed devices.

VivaRay, Inc. CAPRI Applicator Page 12 of 56 Premarket Notification

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Image /page/2/Picture/0 description: The image is a seal for 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 an abstract image of what appears to be an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. George Hermann President VivaRay, Inc. 3264 Alpine Road PORTOLA VALLEY CA 94028

Re: K092822

Trade/Device Name: CAPRI™ Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system ·Regulatory Class: II Product Code: JAQ Dated: September 10, 2009 Received: September 14, 2009

NOV - 3 2009

Dear Mr. Herman:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 5. Indications for Use Statement

# INDICATIONS FOR USE STATEMENT

92822

510(k) Number (if known):

Device Name: CAPRITM Applicator

Indications for Use:

The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use _ X (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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signature

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