INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR

K130549 · Carl Zeiss Meditec, Inc. · JAD · Jun 26, 2013 · Radiology

Device Facts

• Record ID: K130549
• Device Name: INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: JAD · Radiology
• Decision Date: Jun 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTRABEAM® System is a system for radiotherapy treatment. The INTRABEAM® Flat Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System. - During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. - During treatment of tumors on the body surface. The INTRABEAM® Flat Applicator is designed to deliver a flat radiation field at a distance of 5 mm from its circular application surface in water. The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System. - During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. - During treatment of tumors on the body surface. The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

Device Story

INTRABEAM Flat and Surface Applicators are accessories to the INTRABEAM System, a miniature, high-dose rate, low-energy (50 kV, 40 µA) X-ray source. Applicators attach to the system to deliver uniform radiation doses to cancer lesions at or near tissue surfaces. Flat Applicators deliver radiation at a 5 mm distance; Surface Applicators deliver radiation directly at the surface. Used in clinical settings (OR or clinic) by trained medical professionals for intraoperative radiotherapy or surface tumor treatment. The device enables targeted radiation delivery to tumor cavities or body surfaces, potentially improving local tumor control while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technical specifications, and intended use comparisons to the predicate device.

Technological Characteristics

Applicators are accessories to a 50 kV, 40 µA X-ray source. Available in multiple diameters (1.0 cm to 6.0 cm). Flat Applicators provide a uniform field at 5 mm depth; Surface Applicators provide a uniform field at the surface. Materials are identical between applicator types. System is a standalone therapeutic X-ray unit.

Indications for Use

Indicated for patients requiring radiotherapy during intraoperative procedures on surgically exposed surfaces or tumor beds, and for treatment of tumors on the body surface, when used with the INTRABEAM System.

Regulatory Classification

Identification

An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Axxent® Surface Applicator (K083734)

Submission Summary (Full Text)

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K130549
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Carl Zeiss Meditec Premarket Notification 510(k) INTRABEAM Flat and Surface Applicators March 2013

Section 2: 510(k) Summary

# JUN 2 6 2013

# 510(k) SUMMARY (per 21 CFR §807.92)

# INTRABEAM* Flat Applicator and INTRABEAM* Surface Applicator used with the INTRABEAM System

#### General Information

Manufacturer:

Carl Zeiss Meditec AG Location: Oberkochen Carl-Zeiss-Strasse 22 73447 Oberkochen, Germany Est. Reg. No. 9615010

Contact Person:

Sarah Harrington, MS. MBA Staff Regulatory Specialist Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 Phone: [phone] FAX: [phone] Email: [e-mail]

#### Device Name/Classification

Trade/Proprietary name:

INTRABEAM® Flat Applicator used with the INTRABEAM® System

INTRABEAM® Surface Applicator used with the INTRABEAM® System

Common/Usual Name: Classification name: Classification: Product Code:

X-ray radiation therapy system System, Therapeutic, X-ray Class II (21 CFR 892.5900) JAD

## Predicate Device

Company: · Device:

Xoft, Inc. Axxent® Surface Applicator, K083734

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# Intended Use for INTRABEAM Flat Applicator and INTRABEAM Surface Applicator

The INTRABEAM® System is a system for radiotherapy treatment.

#### Indications for Use: INTRABEAM Flat Applicator

The INTRABEAM® Flat Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.

- During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. .
- During treatment of tumors on the body surface. ●

The INTRABEAM® Flat Applicator is designed to deliver a flat radiation field at a distance of 5 mm from its circular application surface in water.

## Indications for Use: INTRABEAM Surface Applicator

The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.

- During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. .
- During treatment of tumors on the body surface. .

The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

#### Device Description

The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the turnor cavity. The INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are accessories to the INTRABEAM System that have been developed to provide radiotherapy to cancer lesions at or near the tissue surface. There are six sizes of INTRABEAM Flat Applicators in a set. The sizes are 1.0 cm, 2.0 cm, 3.0 cm, 4.0 cm, 5.0 cm and 6.0 cm in diameter. The INTRABEAM Surface Applicators are available in the four sizes. These sizes are 1.0 cm, 2.0 cm and 4.0 cm. The four smaller sizes of INTRABEAM Flat Applicators (size 1.0 to 4.0 cm) have the same dimensions and appearance as the INTRABEAM Surface Applicators (sizes 1.0 to 4.0 cm).

The INTRABEAM System has a maximum voltage of 50 kV and a maximum current of 40 µA. The INTRABEAM Flat Applicator and the INTRABEAM Surface Applicator provide a uniform dose of radiotherapy distributed across a flat surface. The applicators are made from the same materials. From a technical point of view, the INTRABEAM Flat and Surface Applicators are basically the same, but are optimized for treating different tissue depths.

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Carl Zeiss Meditec Premarket Notification 510(k) INTRABEAM Flat and Surface Applicators March 2013

## Substantial Equivalence

The predicate device is the Axxent Surface Applicator (K083734) manufactured by Xoft, Inc. The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy and Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically. The device delivers 50 kVp x-ray radiation to shallow tissue depths over small targeted areas. The Axxent Surface Applicator is similar to the INTRABEAM Flat Applicator and INTRABEAM Surface Applicator in target site, clinical use, principles of operation and indications for use.

#### Summary

The INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are equivalent to the currently marketed Axxent Surface Applicator in design, principle of operation and application. Based on the information provided in the 510(k) and the comparison to the currently marketed predicate, the INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are safe and effective with regards to the intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 a stylized symbol that resembles an abstract caduceus, with three diagonal lines representing the staff and a wavy line representing the snake.

Public Health Service

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

June 26, 2013

Carl Zeiss Meditec, Inc. % Sarah Harrington, MS, MBA Staff Regulatory Specialist 5160 Hacienda Drive DUBLIN CA 94568

Re: K130549

Trade/Device Name: INTRABEAM Flat Applicator & INTRABEAM Surface Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: May 16, 2013 Received: May 17, 2013

Dear Ms. Harrington:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (reporting of medical 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.

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### Page 2 - Ms. Harrington

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers()ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K130549

Device Name: INTRABEAM* Surface Applicator used with INTRABEAM* System

Indications for Use:

The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.

- During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. D
- During treatment of tumors on the body surface. .

The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Arlene D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K130549 510(k)_