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 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)
- 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.

AI/ML Overview

This document is a 510(k) premarket notification for the INTRABEAM 600, a radiation therapy system. It focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting a study to prove they are met in the traditional sense of a clinical trial for a novel device.

The "acceptance criteria" here are essentially compliance with safety and performance standards for an X-ray radiation therapy system, and the "study" is a series of engineering tests and comparisons to a previously cleared device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Compliance with Standards/Requirements)	Reported Device Performance
Electrical Safety: Conformity with IEC 60601-1: 2005+A1:2012	Device was assessed and found to comply.
Therapeutic X-ray Safety: Conformity with IEC 60601-2-8: 2010+A1:2015	Device was assessed and found to comply. Passed all tests.
Usability: Conformity with IEC 60601-1-6: 2010+A1:2013	Device was assessed and found to comply.
Electromagnetic Compatibility (EMC): Conformity with IEC 60601-1-2: Ed. 3 / 2007	Device was assessed and found to comply.
System Level Functionality: Device performs according to requirements.	System level testing verified that the device performed according to requirements.
Safety of Therapeutic X-Ray: (Specific to therapeutic X-ray aspects beyond general safety)	Device was tested and shown to comply with the requirements of IEC 60601-2-8:2010+A1:2015. (Passed all tests.) (This appears to be a reiteration of the therapeutic X-ray safety above, but emphasizes successful completion of tests.)
Environmental Performance: Device performs under expected conditions of use.	The system performed according to requirements under the expected conditions of use.
DICOM Conformity: Conformance with DICOM standards.	A DICOM Conformance Statement was provided. (Implies conformity)
Software Verification and Validation: Software performs in accordance with established requirements.	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. (Implies successful V&V)
Substantial Equivalence to Predicate Device (K051055): Similar intended use, indications for use, and technological characteristics, with differences shown to be equivalent through performance, safety, and software testing.	Based on comparison, the subject device is similar to the predicate. Differences were shown to be equivalent with performance, safety, and software testing. Therefore, it is found substantially equivalent.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a "sample size" in terms of patients or a clinical dataset for a performance study. The testing described is primarily focused on engineering compliance verification and validation of the device itself (electrical safety, EMC, software, etc.).
Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal engineering tests conducted by Carl Zeiss Meditec AG, likely at their facilities in Germany, as the applicant is based there. These are premarket tests, so they are not retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The "ground truth" for the engineering tests would be the specifications and standards themselves (e.g., IEC standards, internal design requirements). The engineers conducting and verifying these tests would be the "experts," qualified in electrical engineering, software engineering, medical device safety, etc., but their specific number and qualifications are not detailed.

4. Adjudication method for the test set:

Not applicable. The tests are compliance checks against objective standards and functional requirements. There's no subjective interpretation or "adjudication" in the clinical sense.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This device is an X-ray radiation therapy system, not an AI-powered diagnostic or decision support tool. It does not involve "human readers" interpreting images with or without AI assistance. The "radiance" software mentioned is a treatment planning simulation software, not an AI for image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This concept is not directly applicable to the INTRABEAM 600. It's a medical device that delivers radiation, not an algorithm that performs a diagnostic task. Its "performance" is about its physical and software functionality according to specifications and safety standards. The software verification and validation are essentially "standalone" checks of the software's functional correctness.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this PMA is primarily:
- International and national medical device safety and performance standards: e.g., IEC 60601 series.
- Internal design specifications and requirements: for system functionality, electrical safety, software behavior, etc.
- The predicate device (INTRABEAM System K051055): for demonstrating substantial equivalence in terms of intended use, indications, and technological characteristics.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set" in the context of learning from data. The software within the device is designed and developed based on established engineering principles and programming, not trained on a dataset.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" for an AI/machine learning algorithm.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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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 CommonName:	Therapeutic X-ray System
Device Trade Name:	INTRABEAM 600
Applicant:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 JenaGermany
Contact:	Dr. Christian MuensterDirector Regulatory and Clinical Affairs+49 7364 206985christian.muenster@zeiss.com
Prepared by:	Calley HerzogBiologics Consulting Group cherzog@biologicsconsulting.comPhone: 720-883-3633
Date Prepared:	November 22, 2016
ClassificationRegulation:	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
AdditionalPredicates:	K090584 - INTRABEAM SystemK110590 - INTRABEAM System w/ Needle ApplicatorK121653 - INTRABEAM System w/ Spherical ApplicatorsK130549 - 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 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 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 DeviceINTRABEAM 600	Predicate DeviceINTRABEAM System(K051055)	SE Assessment
Device Name	INTRABEAM 600	INTRABEAM System(INTRABEAM PRS 500 withXRS 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 orpractitioner's office	Operating room or practitioner'soffice	Identical
System ComponentStorage Cart	INTRABEAM Workplace – afully enclosed cart that providesdedicated storage space foreach component secured insidethe cart	Components were provided with acart for storage and transportation	Similar
SystemComponents onCart	Control Console 600 (CC600)Computer, TouchscreenMonitor, Keyboard, Mouse	Control Console PRS 500INTRABEAM User Terminal(keyboard with touchpad, mouse)	SimilarSimilarIdenticalIdenticalSimilar
	UNIDOS E (Dosimeter)	UNIDOS E (Dosimeter)	Identical
	Ionization Chamber	Ionization Chamber	Identical
	V-guide	X-Block and V-Block guide	Similar
Method oftreatment /application	IntraoperativeIntracavitaryInterstitialPost-Operative	IntraoperativeIntracavitaryInterstitialPost-Operative	Identical
Radiation Source	XRS 4	XRS 4	Identical
Item	Proposed DeviceINTRABEAM 600	Predicate DeviceINTRABEAM System(K051055)	SE Assessment
General mode ofoperation of the X-Ray source	Electrons are emitted bycathode, accelerated by anelectrical field along a drift tubeinside the X-Ray source and hita gold target resulting in thegeneration of X-rays	Electrons are emitted by cathode,accelerated by an electrical fieldalong a drift tube inside the X-Rays source and hit a gold targetresulting in the generation of X-rays.	Identical
Maximumradiation output	0.6Gy/min(at 2cm from isocenter)	0.6Gy/min(at 2cm from isocenter)	Identical
Maximum photonenergy	50keV	50keV	Identical
Geometry of doseemitted (withoutapplicator)	Mostly spherical	Mostly spherical	Identical
Dose fall-off (inwater)	~1/r3	~1/r3	Identical
Maximum PowerRange	2W (50kV x 40μA)	2W (50kV x 40μA)	Identical
Maximum BeamCurrent	40μ A	40μ A	Identical
System QualityAssurance (SQA)Tools	Probe Adjuster IonizationChamber Holder (PAICH)Photo Diode Array (PDA)Ionization Chamber (IC)	Probe Adjuster IonizationChamber Holder (PAICH)Photo Diode Array (PDA)Ionization Chamber (IC)	Identical
RadiationTreatmentPlanning Software	Radiance (K153368)	None	New feature for subjectdevice - it iscompatible withpreviously cleared thirdparty software.
CompatibleApplicators	INTRABEAM SphericalApplicatorsINTRABEAM Flat ApplicatorSet (K130549)INTRABEAM SurfaceApplicator Set (K130549)INTRABEAM NeedleApplicator (K110590)	INTRABEAM SphericalApplicators	Similar - the subjectdevice is compatiblewith the listedpreviously clearedapplicators. No changesmade 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.

Regulation Number and Section

§ 892.5900 X-ray radiation therapy system.

(a)
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.(b)
Classification. Class II.