CONTURA CAVITY MAINTENANCE CATHETER

K092323 · Senorx, Inc. · JAQ · Aug 19, 2009 · Radiology

Device Facts

• Record ID: K092323
• Device Name: CONTURA CAVITY MAINTENANCE CATHETER
• Applicant: Senorx, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Aug 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.

Device Story

Contura Cavity Maintenance Catheter is a dual-lumen silicone catheter featuring an inflatable distal balloon. It is designed for temporary placement within a lumpectomy cavity to serve as a placeholder. The device includes two proximal ports with Luer-type connectors, enabling balloon inflation/deflation and the application of intracavitary vacuum. It is intended to maintain the cavity space until it is replaced by the Contura MLB Applicator for brachytherapy. The device is used in a clinical setting by healthcare professionals.

Clinical Evidence

Bench testing only. Preclinical testing included dimensional stability of the inflated balloon, burst volume testing, balloon durability in an in vivo setting, and biocompatibility testing.

Technological Characteristics

Dual-lumen silicone catheter with inflatable distal balloon. Available in spherical balloon sizes from 3.5-5.0 cm diameter. Features proximal ports with Luer-type connectors for inflation/deflation and vacuum application.

Indications for Use

Indicated for temporary implantation in the lumpectomy cavity as a placeholder until exchange for the Contura MLB 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

• MammoSite Cavity Evaluation Device (K081179)

Reference Devices

• Contura MLB Applicator

Submission Summary (Full Text)

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## 5. 510(K) SUMMARY

Date prepared

July 28, 2009

Name SenoRx, Inc. AUG 1 9 2009 3 Morgan Irvine, CA 92618 T. 949.362.4800; F. 949.362.0300 Contact person Eben Gordon Vice President, RA/QA SenoRx, Inc. T. 949.362.4800; F. 949.362.0300 Device name Contura Cavity Maintenance Catheter Common name Cavity Maintenance Catheter Classification name Remote controlled radionuclide source applicator Classification regulation 21 CFR 892.5700 90 JAQ Predicate devices MammoSite Cavity Evaluation Device, K081179 Clearance date: 5/9/2008 Description The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size. Indications for use The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator. Summary of substantial Performance testing was conducted to evaluate and characterize the equivalence performance of the Contura Cavity Maintenance Catheter. Preclinical testing conducted included dimensional stability of the inflated balloon, burst volume testing, balloon durability in an in vivo setting, and biocompatibility testing. The Contura Cavity Maintenance Catheter performed as intended. The Contura Cavity Maintenance Catheter has the following similarities to the predicate device in that it: has a sub-set of the intended uses; same design; same patient contacting material; same operating principle; and same technological characteristics. The Contura Cavity Maintenance Catheter is substantially equivalent predicate device when used as a placeholder until it is exchanged for a brachytherapy applicator (e.g. Contura MLB Applicator).

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

## 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

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG 1 9 2009

Re: K092323

Trade/Device Name: Contura Cavity Maintenance Catheter Regulation Number: 21 CFR 892.5700 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: JAQ Dated: July 31, 2009 Received: August 4, 2009

Dear Mr. Job:

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 vour 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/cdrh/mdr/ 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 yours,

Sammy M. Morris

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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## 4. INDICATIONS FOR USE

510(k) Number (if known): (५०५2323

Device Name: Contura Cavity Maintenance Catheter

Indications for Use:

The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use

(21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-O in Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_

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