(259 days)
No
The summary describes a radiation therapy device and its components, focusing on hardware, software control for dose delivery, and quality assurance tools. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned is for controlling the device and performing verification testing, not for AI/ML functions.
Yes
The device is explicitly described as a "radiation therapy device intended for targeted treatments" and is used to "deliver a prescribed dose of low energy radiation" for cancer patients, which falls under the definition of a therapeutic device.
No
This device is designed for therapeutic radiation treatments to deliver a prescribed dose of radiation to target volumes, not for diagnosing medical conditions. While it includes tools for quality assurance of radiation delivery, these are for verifying the proper functioning of the treatment system, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a mobile cart, control console, computer, monitor, electrometer, X-ray source, quality assurance tools, and various applicators and stands. While software is mentioned as controlling the radiation dose, it is an integral part of a larger hardware system.
Based on the provided text, the INTRABEAM device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the INTRABEAM is for "radiotherapy treatments" and "to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments." This describes a therapeutic device that delivers radiation directly to the patient's body.
- Device Description: The description reinforces this by calling it a "radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients."
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or disease progression based on the analysis of these samples.
- Reagents, calibrators, or controls used for in vitro testing.
The INTRABEAM is a therapeutic device used to treat cancer by delivering radiation directly to the affected area within the patient's body. This falls under the category of a medical device, but specifically a therapeutic one, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
Product codes (comma separated list FDA assigned to the subject device)
JAD
Device Description
The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, 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 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 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 700 system are:
- INTRABEAM Workplace - mobile cart containing the following:
- Control Console 700 (CC700) O
- Computer with Software Version 5.0 O
- Touchscreen monitor and mouse O
- UNIDOS Romeo Electrometer o
- V-guide O
- 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 INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Sterilization and Shelf Life
The INTRABEAM was assessed for Sterility and Shelf-iffe information per recommendations in FDA 's Sterility guidance document and were deemed to demonstrate substantial equivalence.
Biocompatibility
The device consists of patient-contacting materials; therefore, a biocompatibility assessment was performed in accordance with FDA's biocompatibility guidance documents. The biocompatibility evaluation demonstrated substantial equivalence.
Performance Testing - Bench
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the defined specifications. Software verification testing has been performed to demonstrate that software is performing as intended.
The following parameters/specifications were tested in conformity with the relevant requirements:
- EMC, Wireless, Electrical, Mechanical, and Thermal Safety
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC 60601-1-2 "Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" and were found to comply.
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC TR 60601-4-2 "Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems" and were found to comply.
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator and INTRABEAM Needle Applicator (as detachable parts) were assessed for conformity with the relevant requirements of IEC 60601-1 "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance" and were found to comply.
-
Radiation Safety
The therapeutic X-ray equipment of INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC 60601-2-8 "Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV" and were found to comply. -
System Level Verification
The system level testing verified that the device performed according to requirements. -
Software Verification and Validation
Software documentation was provided in accordance with FDA's software guidance documents. Enhanced documentation was submitted for INTRABEAM (Model: 700) and its accessories. 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. Also, the FDA's cybersecurity recommendations were fulfilled. -
Usability / Human Factors
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator and INTRABEAM Needle Applicator (as detachable parts) were assessed for conformity with the relevant requirements of IEC 60601-1-6 "Medical electrical equipment – Part1-6: General requirements for basic safety and essential performance - Collateral standard: Usability". And the FDA's recommendations for human factors validation are fulfilled.
All the performance testing evaluations demonstrated substantial equivalence.
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.
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.
K951764, K171885, K233236, K121653, K110590, K130549
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
January 10, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle and a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text to the right of the square.
Carl Zeiss Meditec AG Chaitali Gawde Senior Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, California 94588
Re: K241174
Trade/Device Name: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) Regulation Number: 21 CFR 892.5900 Regulation Name: X-Ray Radiation Therapy System Regulatory Class: Class II Product Code: JAD Dated: April 26, 2024 Received: December 13, 2024
Dear Chaitali Gawde:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241174
Device Name
INTRABEAM (700); And accessories (INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
Indications for Use (Describe) The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
| 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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4
In accordance with 21 CFR 807.92 the K241174 510(k) Summary for the INTRABEAM (Model No: 700), and accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, and INTRABEAM Needle Applicator) is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec AG
Rudolf-Eber-Strasse 11
73447 Oberkochen
Germany |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact Name | Anke Seitz
Head of Regulatory and Clinical Affairs Innovation
MCS
Rudolf- Eber- Str. 11
Oberkochen, Germany 73447
+49 7364 20 8613 Phone
E-mail: anke.seitz@zeiss.com (preferred) |
| Primary Correspondent | Chaitali Gawde
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(224) 300-3992 Phone
E-mail: chaitali.gawde@zeiss.com (preferred) |
| Secondary Correspondent | Paul Swift
Head of Regulatory and Clinical Affairs, Americas
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(817) 925.8507 Phone
E-mail: paul.swift@zeiss.com (preferred) |
Date Prepared:
January 09, 2025
5
2. DEVICE
| Device Trade Name: | INTRABEAM (Model No: 700), and accessories (INTRABEAM
SMART Stand, INTRABEAM SMART Spherical Applicator,
INTRABEAM Spherical Sizer Set, and INTRABEAM Needle
Applicator) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | 21 CFR 892.5900 X-ray radiation therapy system |
| Regulatory Class: | II |
| Product Code: | JAD |
LEGAL MARKETED PREDICATE DEVICE 3.
| Predicate Device Name: | INTRABEAM 600 (K162568) |
|---|---|
| Classification: | 21 CFR 892.5900 X-ray radiation therapy system |
| Regulatory Class: | II |
| Product Code: | JAD |
4. DEVICE DESCRIPTION SUMMARY
The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, 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 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 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 700 system are:
- INTRABEAM Workplace - mobile cart containing the following:
- Control Console 700 (CC700) O
- Computer with Software Version 5.0 O
- Touchscreen monitor and mouse O
- UNIDOS Romeo Electrometer o
- V-guide O
- 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 INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
6
The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.
INTENDED USE/INDICATIONS FOR USE ર.
The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
6. SUBSTANTIAL EQUIVALENCE
Table 1. Subject to Predicate Device Comparison Table - Indications for Use
| Item | Subject Device
INTRABEAM
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
Assessment |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| 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 | 21 CFR 892.5900 | Identical |
| Device Class | Class II | Class II | Identical |
| Product Code | JAD | JAD | Identical |
| Classification
Name | System, Therapeutic, X-Ray | System, Therapeutic, X-Ray | Identical |
| Use Environment | Operating room or practitioner's
office | Operating room or practitioner's
office | Identical |
| Indications for Use | The INTRABEAM is intended
for use in radiotherapy
treatments.
The INTRABEAM SMART
Spherical Applicator is used with
the INTRABEAM to deliver a
prescribed dose of intraoperative | 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 | Equivalent –
new accessories
were added |
| Item | Subject Device
INTRABEAM
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
Assessment |
| | radiation to the treatment margin
or tumor bed during intracavity
and intraoperative radiotherapy
treatments.
The safety and effectiveness of
the INTRABEAM as a
replacement for whole breast
irradiation in the treatment of
breast cancer has not been
established.
The INTRABEAM Needle
Applicator (comprising the
Needle Applicator and guide
shafts) is intended for use in
combination with the
INTRABEAM to
intraoperatively administer
radiation to tissue including
irradiation of intracranial tumors. | 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 | |
| Item | Subject Device
INTRABEAM
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
Assessment |
| | The INTRABEAM SMART
Stand is designed as an
instrument support and
positioning unit for the
INTRABEAM.
The INTRABEAM Spherical
Sizer Set shall support the doctor
(surgeon and/or radiation
oncologist) in assessing which
spherical-shaped applicator shall
be used for the radiation therapy
procedure, involving
INTRABEAM. | 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. | |
7
8
Table 2. Subject to Predicate Device Comparison Table – INTRABEAM main device
| Item | Subject Device
INTRABEAM (Model: 700)
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
Assessment |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | INTRABEAM 700 | INTRABEAM 600 | N/A |
| System
Component
Storage Cart | INTRABEAM Workplace – a
fully enclosed cart that
provides dedicated storage
space for each component
secured inside the cart | INTRABEAM Workplace – a
fully enclosed cart that
provides dedicated storage
space for each component
secured inside the cart | Identical |
| System
Components on
Cart | Control Console 700
(CC700) | Control Console 600 (CC600) | Equivalent- subject
device makes use of a
different power
supply concept.
Safety is proven by
established methods |
| Item | Subject Device
INTRABEAM (Model: 700)
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
Assessment |
| | Computer, Touchscreen
Monitor, Mouse, (Keyboard
functionality is available via
the touchpad) | Computer, Touchscreen
Monitor, Keyboard, Mouse | IEC 60601-1 and IEC
60601-2-8 |
| | UNIDOS Romeo
Electrometer | UNIDOS E (Dosimeter) | Equivalent -
UNIDOS Romeo
Electrometer is the
successor model and
cleared under
(K951764) |
| | Ionization Chamber
V-guide | Ionization Chamber
V-guide | Identical |
| Radio Modules | RFID Reader | N/A | Equivalent - RFID
reader will not have
an impact on the use
of the device. |
| Network | Wireless or LAN | LAN | Equivalent - used for
connection of PC with
hospital network |
| Connectivity | - Picture Archiving and
Communication System
(PACS)
- ZEISS SMART Service
- ZEISS Server / Cloud -
Health Data Platform
(HDP) | - Picture Archiving and
Communication System
(PACS) | Equivalent -
additional
connectivity features
in the subject device,
no impact on the
intended use of the
device. |
| Applicators
required for
Treatment | Yes | Yes | Identical |
| Method of
treatment /
application | Intraoperative
Intracavitary
Interstitial
Post-Operative | Intraoperative
Intracavitary
Interstitial
Post-Operative | Identical |
| Radiation Source | XRS 4 | XRS 4 | Identical |
| Software on
Computer | Version 5.0 | Version 4.0 | Equivalent - Updated
Software Version |
| Controller Set | 40keV
50keV | 40keV
50keV | Identical |
| Energy range used | 40keV
50keV | 40keV
50keV | Identical |
| Energy of
radiation emitted | Max 50keV | Max 50keV | Identical |
| Item | Subject Device
INTRABEAM (Model: 700)
(K241174) | Predicate Device
INTRABEAM 600
(K162568) | Substantial
Equivalence
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-Ray 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 |
| Does fall-off (in water) | ~ 1/r3 | ~ 1/r3 | Identical |
| Maximum Power Range | 2W (50kV x 40 $\mu$ A) | 2W (50kV x 40 $\mu$ A) | Identical |
| Maximum Beam Current | 40 $\mu$ A | 40 $\mu$ A | Identical |
| System Quality Assurance 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 V5 | Radiance V4 | Equivalent -
Radiance 4
(K171885)
Radiance 5
(K233236) |
| Compatible Applicators | – INTRABEAM SMART Spherical Applicator (K241174)
– INTRABEAM Needle Applicator (K110590) | – INTRABEAM Spherical Applicator (K121653)
– INTRABEAM Flat Applicator Set (K130549)
– INTRABEAM Surface Applicator Set (K130549)
– INTRABEAM Needle Applicator (K110590) | Equivalent – new compatible applicator is introduced for INTRABEAM 700 |
| Stand | INTRABEAM SMART Stand: - Wireless Module
- RFID Module with auto-draping functionality
- auto-balancing
- active vibration damping & application modes | NC32 INTRABEAM Floor Stand | Equivalent - SMART Stand offers more functions for INTRABEAM 700 |
| Item | Subject Device
INTRABEAM SMART
Spherical Applicator
(K241174) | Predicate Device
INTRABEAM Spherical
Applicator (K121653) | Substantial
Equivalence
Assessment |
| Device Name | INTRABEAM SMART
Spherical Applicator | INTRABEAM Spherical
Applicator | N/A |
| Energy source | X-ray source | X-ray source | Identical |
| Maximum Voltage
(kV) | 50 kV or 40 kV | 50 kV or 40 kV | Identical |
| Maximum Current
(μΑ) | 40 μΑ | 40 μΑ | Identical |
| Number of
applicator sizes | Eight (8) | Eight (8) | Identical |
| Applicator
Diameters | Spherical Diameter:
1.5 cm; 2 cm; 2.5 cm; 3 cm;
3.5 cm; 4 cm; 4.5 cm and 5 cm | Spherical Diameter:
1.5 cm; 2 cm; 2.5 cm; 3 cm;
3.5 cm; 4 cm; 4.5 cm and 5 cm | Identical |
| Materials | Sphere:
Polyetherimide
Shaft: Polyetherimide | Sphere:
Polyetherimide (Ultem
1000)
Shaft: Ultem 1000 and
stainless steel | Equivalent - Stainless
steel no longer used,
does not affect the
intended use of the
device. |
| Sterilization | Supplied sterile;
EO Sterilization | Supplied non-sterile. User
performs steam sterilization. | Equivalent –
sterilization is carried
out in both. |
| Number of uses | Single-Use | Multiple uses. Can be
sterilized 100 times by the
user. | Equivalent - there is no
impact on the use of
the device. |
| Primary Packaging | Lid: Tyvek®
Blister: PETG transparent | N/A | Equivalent – Primary
packaging was not
required before, as
device was sterilized
by the user. |
| Connectivity | RFID tag | N/A | Equivalent - RFID tag
will not have an impact
on the use of the
device. |
| Sizing support tool | INTRABEAM Spherical Sizer
Set
- Gamma sterilization
- Single-Use
- 8 different sizes
- Base Material:
polycarbonate - Color Batch Material:
Acrylnitril-Butadien-
Styrol | N/A | Equivalent –
INTRABEAM
Spherical Sizer Set will
support the user to pick
appropriate
INTRABEAM
SMART Spherical
Applicator |
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10
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| Table 3. Subject to Predicate Device Comparison Table - INTRABEAM SMART Spherical Applicator |
|---|
| ---------------------------------------------------------------------------------------------- |
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| Item | Subject Device
INTRABEAM SMART
Spherical Applicator
(K241174) | Predicate Device
INTRABEAM Spherical
Applicator (K121653) | Substantial
Equivalence
Assessment |
|------|----------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------|
| | - Primary Packaging:
Tyvek® and
laminate film transparent
peel PET-O/PP | | |
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NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY OF STUDIES 7.
Sterilization and Shelf Life
The INTRABEAM was assessed for Sterility and Shelf-iffe information per recommendations in FDA 's Sterility guidance document and were deemed to demonstrate substantial equivalence.
Biocompatibility
The device consists of patient-contacting materials; therefore, a biocompatibility assessment was performed in accordance with FDA's biocompatibility guidance documents.
The biocompatibility evaluation demonstrated substantial equivalence.
Performance Testing - Bench
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the defined specifications. Software verification testing has been performed to demonstrate that software is performing as intended.
The following parameters/specifications were tested in conformity with the relevant requirements:
- . EMC, Wireless, Electrical, Mechanical, and Thermal Safety
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC 60601-1-2 "Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" and were found to comply.
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC TR 60601-4-2 "Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems" and were found to comply.
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator and INTRABEAM Needle Applicator (as detachable parts) were assessed for conformity with the relevant requirements of IEC 60601-1 "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance" and were found to comply.
-
Radiation Safety ●
The therapeutic X-ray equipment of INTRABEAM (model no: 700) with INTRABEAM SMART Stand were assessed for conformity with the relevant requirements of IEC 60601-2-8 "Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV" and were found to comply. -
System Level Verification
The system level testing verified that the device performed according to requirements. -
Software Verification and Validation ●
Software documentation was provided in accordance with FDA's software guidance documents. Enhanced documentation was submitted for INTRABEAM (Model: 700) and its accessories. The results of verification and validation testing demonstrate that the software performs in accordance with its
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established requirements and will therefore meet user needs and intended uses. Also, the FDA's cybersecurity recommendations were fulfilled.
- Usability / Human Factors
The INTRABEAM (model no: 700) with INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator and INTRABEAM Needle Applicator (as detachable parts) were assessed for conformity with the relevant requirements of IEC 60601-1-6 "Medical electrical equipment – Part1-6: General requirements for basic safety and essential performance - Collateral standard: Usability". And the FDA's recommendations for human factors validation are fulfilled.
All the performance testing evaluations demonstrated substantial equivalence.
8. CONCLUSION
The indications for use are equivalent to the indications for use of the predicate devices; and therefore, are deemed to demonstrate substantial equivalence.
The technological characteristics and risk profile of the subject device are equivalent to the predicate devices; and therefore, are deemed to demonstrate substantial equivalence.
Testing methods are equivalent to those of the predicate devices and support substantial equivalence.
Accordingly, the INTRABEAM (Model: 700 and accessories) is substantially equivalent to the predicate device, the INTRABEAM 600 (K162568).