INTRABEAM 600

K162568 · Carl Zeiss Meditec, AG · JAD · Dec 15, 2016 · Radiology

Device Facts

• Record ID: K162568
• Device Name: INTRABEAM 600
• Applicant: Carl Zeiss Meditec, AG
• Product Code: JAD · Radiology
• Decision Date: Dec 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTRABEAM 600 is indicated for radiation therapy treatments. The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irraciation of intracranial tumors. The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600, 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 5mm from its circular application surface in water. The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600. 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 600 is a mobile X-ray radiation therapy workstation for targeted, minimally invasive tumor treatment. System utilizes XRS 4 X-ray source; electrons accelerated by electrical field hit gold target to generate 50keV low-energy X-rays. Device includes Control Console 600 (CC600), computer with software, touchscreen, and various applicators (spherical, needle, flat, surface) to deliver prescribed radiation doses. Used in operating rooms or clinics by physicians; integrated software and control unit manage dose delivery. Includes quality assurance tools (PAICH, PDA, ionization chamber) to verify system function. Compatible with Radiance treatment planning software. Provides targeted radiation to tumor beds or lesions; benefits include localized treatment delivery during surgery or as contact therapy.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1 (general safety), IEC 60601-2-8 (therapeutic X-ray safety), IEC 60601-1-6 (usability), and IEC 60601-1-2 (EMC). System-level verification confirmed performance requirements. Software verification and validation performed per FDA guidance.

Technological Characteristics

Mobile workstation with XRS 4 X-ray source (50keV, 40μA, 2W max power). Dose fall-off ~1/r3 in water. Components: CC600 console, touchscreen, UNIDOS E dosimeter, ionization chamber. Connectivity: DICOM compliant. Software: Version 4.0. Applicators: Spherical, Needle, Flat, Surface. Standards: IEC 60601-1, IEC 60601-2-8, IEC 60601-1-6, IEC 60601-1-2.

Indications for Use

Indicated for radiation therapy in cancer patients; includes intraoperative, intracavity, interstitial, and contact radiotherapy for tumors or tumor beds. Spherical applicators used for treatment margins/tumor beds, including intraoperative radiation with whole breast irradiation. Needle applicator for tissue irradiation, including intracranial tumors. Flat and surface applicators for surgically exposed surfaces, tumor beds, or body surface tumors.

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

• INTRABEAM System (K051055)
• INTRABEAM System (K090584)
• INTRABEAM System w/ Needle Applicator (K110590)
• INTRABEAM System w/ Spherical Applicators (K121653)
• INTRABEAM System w/ Flat and Surface Applicators (K130549)

Reference Devices

• Radiance (K153368)

Submission Summary (Full Text)

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

December 15, 2016

Carl Zeiss Meditec AG % Calley Herzog Senior Consultant Biologics Consulting 400 N. Washington St. Suite 100 ALEXANDRIA VA 22314

Re: K162568

Trade/Device Name: INTRABEAM 600 Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 5, 2016 Received: December 6, 2016

Dear Calley Herzog:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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'Hara

For

Robert Ochs. Ph.D. 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) K162568

Device Name

INTRABEAM 600

Indications for Use (Describe)

The INTRABEAM 600 is indicated for radiation therapy treatments.

The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.

The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irraciation of intracranial tumors. The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600,

· 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 5mm from its circular application surface in water.

The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600.

· 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 16px;">☑</span> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size: 16px;">☐</span> </div> |

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# 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the INTRABEAM 600 is provided below.

| Device Common<br>Name: | Therapeutic X-ray System |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | INTRABEAM 600 |
| Applicant: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena<br>Germany |
| Contact: | Dr. Christian Muenster<br>Director Regulatory and Clinical Affairs<br>[phone]<br>[e-mail] |
| Prepared by: | Calley Herzog<br>Biologics Consulting Group [e-mail]<br>Phone: [phone] |
| Date Prepared: | November 22, 2016 |
| Classification<br>Regulation: | 21 CFR 892.5900, Class II, X-ray radiation therapy system |
| Panel: | Radiology |
| Product Code: | JAD - Therapeutic X-ray System |
| Primary Predicate: | K051055 - INTRABEAM System |
| Additional<br>Predicates: | K090584 - INTRABEAM System<br>K110590 - INTRABEAM System w/ Needle Applicator<br>K121653 - INTRABEAM System w/ Spherical Applicators<br>K130549 - INTRABEAM System w/ Flat and Surface Applicators |

Indication for Use:

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The INTRABEAM 600 is indicated for radiation therapy treatments.

The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.

The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.

The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600,

- . 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 5mm from its circular application surface in water.

The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600.

- . 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 600 is a radiation therapy device intended for targeted treatments of selected lesions for minimally invasive, intraoperative, interstitial, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.

The INTRABEAM 600 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 600 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.

The main components of the INTRABEAM 600 system are:

- INTRABEAM Workplace mobile cart containing the following: .
- । Control Console 600 (CC600)

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- Computer with Software Version 4.0 |
- Touchscreen monitor, keyboard and mouse
- Dosimeter (UNIDOS E)
- | V-guide
- XRS 4 X-ray Source ●
- Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization ● Chamber Holder
- radiance Third party treatment planning simulation software .

The applicators used with the INTRABEAM 600 are identical to the applicators cleared in previous 510(k)s.

#### Performance Data:

#### Electrical Safety Testing

The INTRABEAM 600 was assessed for conformity with the relevant requirements of IEC 60601-1: 2005+ A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and was found to comply.

The INTRABEAM 600 was assessed for conformity with the relevant requirements of IEC 60601-2-8: 2010+A1:2015 Medical electrical equipment Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV and was found to comply.

The INTRABEAM 600 was assessed for conformity with the relevant requirements of IEC 60601-1-6: 2010 + A1:2013 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability and was found to comply.

#### Electromagnetic Compatibility Testing

The INTRABEAM 600 was assessed for conformity with the relevant requirements of IEC 60601-1-2: Ed. 3 / 2007Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests and was found to comply.

#### System Level Verification

The system level testing verified that the device performed according to requirements.

#### Safety of Therapeutic X-Ray

The INTRABEAM was tested and shown to comply with the requirements of IEC 60601-2-8:2010+A1:2015 Medical electrical equipment Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV. The INTRABEAM 600 passed all tests.

#### Environmental Testing

The system performed according to requirements under the expected conditions of use.

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### DICOM Conformity Assessment

The DICOM Conformance Statement was provided.

#### Software Verification and Validation

Software documentation was provided in accordance with FDA's software guidance documents. The results of verification and validation testing demonstrate that the software performs in accordance with its established requirements and will therefore meet user needs and intended uses.

#### Device Comparison Table:

| Item | Proposed Device<br>INTRABEAM 600 | Predicate Device<br>INTRABEAM System<br>(K051055) | SE Assessment |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | INTRABEAM 600 | INTRABEAM System<br>(INTRABEAM PRS 500 with<br>XRS 4) | N/A |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | N/A |
| Regulation Name | X-ray radiation therapy system | X-ray radiation therapy system | Identical |
| Regulation | 21 CFR 892.5900, Class II | 21 CFR 892.5900, Class II | Identical |
| Product Code | JAD: System, Therapeutic, X-Ray | JAD: System, Therapeutic, X-Ray | Identical |
| Use Environment | Operating room or<br>practitioner's office | Operating room or practitioner's<br>office | Identical |
| System Component<br>Storage Cart | INTRABEAM Workplace – a<br>fully enclosed cart that provides<br>dedicated storage space for<br>each component secured inside<br>the cart | Components were provided with a<br>cart for storage and transportation | Similar |
| System<br>Components on<br>Cart | Control Console 600 (CC600)<br>Computer, Touchscreen<br>Monitor, Keyboard, Mouse | Control Console PRS 500<br>INTRABEAM User Terminal<br>(keyboard with touchpad, mouse) | Similar<br>Similar<br>Identical<br>Identical<br>Similar |
| | UNIDOS E (Dosimeter) | UNIDOS E (Dosimeter) | Identical |
| | Ionization Chamber | Ionization Chamber | Identical |
| | V-guide | X-Block and V-Block guide | Similar |
| Method of<br>treatment /<br>application | Intraoperative<br>Intracavitary<br>Interstitial<br>Post-Operative | Intraoperative<br>Intracavitary<br>Interstitial<br>Post-Operative | Identical |
| Radiation Source | XRS 4 | XRS 4 | Identical |
| Item | Proposed Device<br>INTRABEAM 600 | Predicate Device<br>INTRABEAM System<br>(K051055) | SE Assessment |
| General mode of<br>operation of the X-<br>Ray source | Electrons are emitted by<br>cathode, accelerated by an<br>electrical field along a drift tube<br>inside the X-Ray source and hit<br>a gold target resulting in the<br>generation of X-rays | Electrons are emitted by cathode,<br>accelerated by an electrical field<br>along a drift tube inside the X-<br>Rays source and hit a gold target<br>resulting in the generation of X-<br>rays. | Identical |
| Maximum<br>radiation output | 0.6Gy/min<br>(at 2cm from isocenter) | 0.6Gy/min<br>(at 2cm from isocenter) | Identical |
| Maximum photon<br>energy | 50keV | 50keV | Identical |
| Geometry of dose<br>emitted (without<br>applicator) | Mostly spherical | Mostly spherical | Identical |
| Dose fall-off (in<br>water) | ~1/r3 | ~1/r3 | Identical |
| Maximum Power<br>Range | 2W (50kV x 40μA) | 2W (50kV x 40μA) | Identical |
| Maximum Beam<br>Current | 40μ A | 40μ A | Identical |
| System Quality<br>Assurance (SQA)<br>Tools | Probe Adjuster Ionization<br>Chamber Holder (PAICH)<br>Photo Diode Array (PDA)<br>Ionization Chamber (IC) | Probe Adjuster Ionization<br>Chamber Holder (PAICH)<br>Photo Diode Array (PDA)<br>Ionization Chamber (IC) | Identical |
| Radiation<br>Treatment<br>Planning Software | Radiance (K153368) | None | New feature for subject<br>device - it is<br>compatible with<br>previously cleared third<br>party software. |
| Compatible<br>Applicators | INTRABEAM Spherical<br>Applicators<br>INTRABEAM Flat Applicator<br>Set (K130549)<br>INTRABEAM Surface<br>Applicator Set (K130549)<br>INTRABEAM Needle<br>Applicator (K110590) | INTRABEAM Spherical<br>Applicators | Similar - the subject<br>device is compatible<br>with the listed<br>previously cleared<br>applicators. No changes<br>made to the applicators. |

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#### Substantial Equivalence Summary:

Based on the comparison of intended use, indications for use and technological characteristics, the subject device is similar to the predicate device. Any differences between the devices was shown to be equivalent with performance, safety and software testing. Therefore, the INTRABEAM 600 can be found substantially equivalent to the predicate device as cleared in K051055.