SAVI PREPARATION DEVICE

K101411 · Cianna Medical, Inc. · JAQ · Jul 12, 2010 · Radiology

Device Facts

• Record ID: K101411
• Device Name: SAVI PREPARATION DEVICE
• Applicant: Cianna Medical, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2

Intended Use

The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

Device Story

Specialized catheter with distal inflatable balloon; temporarily implanted in lumpectomy cavity. Functions as placeholder to maintain cavity access and assist in sizing/selection of SAVI brachytherapy applicator. Exchanged for final brachytherapy applicator after selection. Used in clinical setting by physicians. Sterile, single-use, disposable device.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Specialized catheter with distal inflatable balloon. Sterile, single-use, disposable. No electronic, software, or energy-based components.

Indications for Use

Indicated for temporary implantation in lumpectomy cavities to access the cavity, assist in selecting the appropriate SAVI brachytherapy applicator, and serve as a placeholder until exchanged for the brachytherapy applicator.

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

• Contura Cavity Maintenance Catheter (K002222)
• Contura Cavity Maintenance Catheter (K092323)
• Mammosite Cavity Evaluation Device (K081179)

Submission Summary (Full Text)

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#### Section 6

"

K/014/11...

510(k) Summary

#### 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: | Cianna Medical |
|---------------------------|-----------------------------------------------------------------------|
| TRADE NAME: | SAVI PREPARATION DEVICE |
| COMMON NAME: | Remote Controlled Radionuclide Source accessory |
| CLASSIFICATION<br>NAME: | Remote Controlled Radionuclide Applicator System, 21 CFR,<br>892.5700 |
| DEVICE<br>CLASSIFICATION: | Class II |
| PRODUCT CODE | JAQ |
| PREDICATE DEVICES: | Contura Cavity Maintenance Catheter (K002222) |

intenance Catheter (K092323) Mammosite Cavity Evaluation Device (K081179)

### Substantially Equivalent To:

The SAVI Preparation Device is substantially equivalent in intended use, principal of operation and technological characteristics to the Contura Cavity Maintenance Catherer (K092323) and the Mammosite Cavity Evaluation Device (K081179).

# Description of the Device Subject to Premarket Notification:

The SAVI Preparation Device is a specialized catheter with an inflatable balloon at the distal end. The SAVI Preparation Device is temporarily implanted in the lumpeon at the access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytheray applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

The SAVI Preparation Device is provided sterile for single use and is disposable.

#### Indication for Use:

The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy application and serve as a placeholder until it is exchanged for the SAVI brachytherapy applipation.

### Technical Characteristics:

The SAVI Preparation Device has similar physical and technical characteristics to the

Cianna Medical SAVI Preparation Device

Premarket Notification

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# Section 6

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predicate devices.

### Performance Data:

All necessary verification and validation testing has been performed for the SAVI Preparation Device 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 SAVI Preparation Device is determined by Cianna Medical, to be substantially equivalent to existing legally marketed devices.

Cianna Medical SAVI Preparation Device .

Premarket Notification

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

# 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. Gary Mocnik Vice President, Regulatory Affairs and Quality Systems Cianna Medical 6 Journey, Suite 125 ALISO VIEJO CA 92656

JUL 12 2010

Re: K101411

Trade/Device Name: SAVI Preparation Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAO Dated: May 14, 2010 Received: May 26, 2010

Dear Mr. Mocnik:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely vours.

Amed. Hf

Donald J. St Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KJ0|411

## Device Name: SAVI PREPARATION DEVICE

Indications for Use:

The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

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

### Concurrence of CDRH, Office of Dovice Evaluation (ODE)

OR

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

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(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101411