(92 days)
Not Found
No
The summary describes a radiation therapy device and its components, focusing on dose delivery control via integrated software and quality assurance tools. There is no mention of AI, ML, or related concepts like image processing for analysis or decision-making. The performance studies focus on electrical safety, EMC, system verification, and software validation, without indicating any AI/ML-specific evaluations.
Yes
The device is indicated for radiation therapy treatments to deliver a prescribed dose of radiation to the treatment margin or tumor bed, which is a therapeutic intervention.
No
The device is described as a radiation therapy device intended for treatment, not for diagnosis.
No
The device description clearly lists multiple hardware components including a mobile cart, control console, X-ray source, and various applicators, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "radiation therapy treatments" and "to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments." This describes a therapeutic device that directly treats the patient with radiation.
- Device Description: The description reinforces this by calling it a "radiation therapy device intended for targeted treatments of selected lesions... within the body of cancer patients." It describes components related to generating and controlling radiation, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the INTRABEAM 600 and its associated applicators are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
treatment margin or tumor bed, breast, intracranial tumors, surgically exposed surface or in a tumor bed, body surface.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room or practitioner's office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051055, K090584, K110590, K121653, K130549
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
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.
1
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
2
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) | ☑ |
Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
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
Name: | Therapeutic X-ray System |
---|---|
Device Trade Name: | INTRABEAM 600 |
Applicant: | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | |
D-07745 Jena | |
Germany | |
Contact: | Dr. Christian Muenster |
Director Regulatory and Clinical Affairs | |
+49 7364 206985 | |
christian.muenster@zeiss.com | |
Prepared by: | Calley Herzog |
Biologics Consulting Group cherzog@biologicsconsulting.com | |
Phone: 720-883-3633 | |
Date Prepared: | November 22, 2016 |
Classification | |
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 | |
Predicates: | K090584 - INTRABEAM System |
K110590 - INTRABEAM System w/ Needle Applicator | |
K121653 - INTRABEAM System w/ Spherical Applicators | |
K130549 - INTRABEAM System w/ Flat and Surface Applicators |
Indication for Use:
4
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)
5
- 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.
6
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
INTRABEAM 600 | Predicate Device
INTRABEAM System
(K051055) | SE Assessment |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | INTRABEAM 600 | INTRABEAM System
(INTRABEAM PRS 500 with
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
practitioner's office | Operating room or practitioner's
office | Identical |
| System Component
Storage Cart | INTRABEAM Workplace – a
fully enclosed cart that provides
dedicated storage space for
each component secured inside
the cart | Components were provided with a
cart for storage and transportation | Similar |
| System
Components on
Cart | Control Console 600 (CC600)
Computer, Touchscreen
Monitor, Keyboard, Mouse | Control Console PRS 500
INTRABEAM User Terminal
(keyboard with touchpad, mouse) | Similar
Similar
Identical
Identical
Similar |
| | UNIDOS E (Dosimeter) | UNIDOS E (Dosimeter) | Identical |
| | Ionization Chamber | Ionization Chamber | Identical |
| | V-guide | X-Block and V-Block guide | Similar |
| Method of
treatment /
application | Intraoperative
Intracavitary
Interstitial
Post-Operative | Intraoperative
Intracavitary
Interstitial
Post-Operative | Identical |
| Radiation Source | XRS 4 | XRS 4 | Identical |
| Item | Proposed Device
INTRABEAM 600 | Predicate Device
INTRABEAM System
(K051055) | SE Assessment |
| General mode of
operation of the X-
Ray source | Electrons are emitted by
cathode, accelerated by an
electrical field along a drift tube
inside the X-Ray source and hit
a gold target resulting in the
generation of X-rays | Electrons are emitted by cathode,
accelerated by an electrical field
along a drift tube inside the X-
Rays source and hit a gold target
resulting in the generation of X-
rays. | Identical |
| Maximum
radiation output | 0.6Gy/min
(at 2cm from isocenter) | 0.6Gy/min
(at 2cm from isocenter) | Identical |
| Maximum photon
energy | 50keV | 50keV | Identical |
| Geometry of dose
emitted (without
applicator) | Mostly spherical | Mostly spherical | Identical |
| Dose fall-off (in
water) | ~1/r3 | ~1/r3 | Identical |
| Maximum Power
Range | 2W (50kV x 40μA) | 2W (50kV x 40μA) | Identical |
| Maximum Beam
Current | 40μ A | 40μ A | Identical |
| System Quality
Assurance (SQA)
Tools | Probe Adjuster Ionization
Chamber Holder (PAICH)
Photo Diode Array (PDA)
Ionization Chamber (IC) | Probe Adjuster Ionization
Chamber Holder (PAICH)
Photo Diode Array (PDA)
Ionization Chamber (IC) | Identical |
| Radiation
Treatment
Planning Software | Radiance (K153368) | None | New feature for subject
device - it is
compatible with
previously cleared third
party software. |
| Compatible
Applicators | INTRABEAM Spherical
Applicators
INTRABEAM Flat Applicator
Set (K130549)
INTRABEAM Surface
Applicator Set (K130549)
INTRABEAM Needle
Applicator (K110590) | INTRABEAM Spherical
Applicators | Similar - the subject
device is compatible
with the listed
previously cleared
applicators. No changes
made to the applicators. |
7
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.