(259 days)
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.
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)
- Computer with Software Version 5.0
- Touchscreen monitor and mouse
- UNIDOS Romeo Electrometer
- 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 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.
The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (INTRABEAM 700) to a legally marketed predicate device (INTRABEAM 600). The document focuses on regulatory compliance, safety, and performance testing to demonstrate equivalence, rather than providing details of a clinical study designed to prove the device meets specific acceptance criteria in a clinical setting with human subjects.
Therefore, the document does not contain the information requested regarding acceptance criteria and the specifics of a study proving the device meets those criteria, particularly in the context of AI assistance or human reader performance. The "Performance Testing - Bench" section describes non-clinical system testing, software verification, and compliance with various IEC standards (EMC, Electrical, Mechanical, Thermal Safety, Radiation Safety, Usability/Human Factors), which are important for device safety and functionality but are not clinical performance "acceptance criteria" as would be evaluated in a multi-reader multi-case (MRMC) study or a standalone AI performance study.
The document primarily relies on demonstrating substantial equivalence to a predicate device through:
- Identical or equivalent indications for use.
- Similar technological characteristics.
- Compliance with relevant safety and performance standards (e.g., IEC 60601-series).
In summary, none of the requested information regarding acceptance criteria for clinical performance, test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details are present in the provided text. The document focuses on bench testing and regulatory compliance, not clinical efficacy or AI performance metrics.
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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.
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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
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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
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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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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 AGRudolf-Eber-Strasse 1173447 OberkochenGermany |
|---|---|
| Applicant Contact Name | Anke SeitzHead of Regulatory and Clinical Affairs InnovationMCSRudolf- Eber- Str. 11Oberkochen, Germany 73447+49 7364 20 8613 PhoneE-mail: anke.seitz@zeiss.com (preferred) |
| Primary Correspondent | Chaitali GawdeSenior Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(224) 300-3992 PhoneE-mail: chaitali.gawde@zeiss.com (preferred) |
| Secondary Correspondent | Paul SwiftHead of Regulatory and Clinical Affairs, AmericasCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(817) 925.8507 PhoneE-mail: paul.swift@zeiss.com (preferred) |
Date Prepared:
January 09, 2025
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2. DEVICE
| Device Trade Name: | INTRABEAM (Model No: 700), and accessories (INTRABEAMSMART Stand, INTRABEAM SMART Spherical Applicator,INTRABEAM Spherical Sizer Set, and INTRABEAM NeedleApplicator) |
|---|---|
| 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.
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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 DeviceINTRABEAM(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
|---|---|---|---|
| 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 |
| ClassificationName | System, Therapeutic, X-Ray | System, Therapeutic, X-Ray | Identical |
| Use Environment | Operating room or practitioner'soffice | Operating room or practitioner'soffice | Identical |
| Indications for Use | The INTRABEAM is intendedfor use in radiotherapytreatments.The INTRABEAM SMARTSpherical Applicator is used withthe INTRABEAM to deliver aprescribed dose of intraoperative | The INTRABEAM 600 isindicated for radiation therapytreatments.The INTRABEAM SphericalApplicators are indicated for usewith the INTRABEAM 600 todeliver a prescribed dose of | Equivalent –new accessorieswere added |
| Item | Subject DeviceINTRABEAM(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
| radiation to the treatment marginor tumor bed during intracavityand intraoperative radiotherapytreatments.The safety and effectiveness ofthe INTRABEAM as areplacement for whole breastirradiation in the treatment ofbreast cancer has not beenestablished.The INTRABEAM NeedleApplicator (comprising theNeedle Applicator and guideshafts) is intended for use incombination with theINTRABEAM tointraoperatively administerradiation to tissue includingirradiation of intracranial tumors. | radiation to the treatment marginor tumor bed during intracavityand intraoperative radiotherapytreatments.The INTRABEAM SphericalApplicators used with theINTRABEAM 600 are able todeliver a prescribed dose ofintraoperative radiation inconjunction with whole breastirradiation, based upon themedical judgment of thephysician.The safety and effectiveness ofthe INTRABEAM 600 as areplacement for whole breastirradiation in the treatment ofbreast cancer has not beenestablished.The Needle Applicator set(comprising the NeedleApplicator and guide shafts) isintended for use in combinationwith the INTRABEAM 600 tointraoperatively administerradiation to tissue includingirradiation of intracranial tumors.The INTRABEAM FlatApplicator is intended to supplya specified radiation dose duringapplications in combination withthe INTRABEAM 600,• during intraoperativeradiotherapy, on a surgicallyexposed surface or in a tumorbed.• during treatment of tumors onthe body surface.The INTRABEAM FlatApplicator is designed to delivera flat radiation field at a distanceof 5mm from its circularapplication surface in water.The INTRABEAM SurfaceApplicator is intended to supply | ||
| Item | Subject DeviceINTRABEAM(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
| The INTRABEAM SMARTStand is designed as aninstrument support andpositioning unit for theINTRABEAM.The INTRABEAM SphericalSizer Set shall support the doctor(surgeon and/or radiationoncologist) in assessing whichspherical-shaped applicator shallbe used for the radiation therapyprocedure, involvingINTRABEAM. | a specified radiation dose duringapplications in combinationwith the INTRABEAM 600.• during intraoperativeradiotherapy, on a surgicallyexposed surface or in a tumorbed.• during treatment of tumors onthe body surface.The INTRABEAM SurfaceApplicator is designed to delivera flat radiation field directly atthe applicator's surface. |
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Table 2. Subject to Predicate Device Comparison Table – INTRABEAM main device
| Item | Subject DeviceINTRABEAM (Model: 700)(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
|---|---|---|---|
| Device Name | INTRABEAM 700 | INTRABEAM 600 | N/A |
| SystemComponentStorage Cart | INTRABEAM Workplace – afully enclosed cart thatprovides dedicated storagespace for each componentsecured inside the cart | INTRABEAM Workplace – afully enclosed cart thatprovides dedicated storagespace for each componentsecured inside the cart | Identical |
| SystemComponents onCart | Control Console 700(CC700) | Control Console 600 (CC600) | Equivalent- subjectdevice makes use of adifferent powersupply concept.Safety is proven byestablished methods |
| Item | Subject DeviceINTRABEAM (Model: 700)(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
| Computer, TouchscreenMonitor, Mouse, (Keyboardfunctionality is available viathe touchpad) | Computer, TouchscreenMonitor, Keyboard, Mouse | IEC 60601-1 and IEC60601-2-8 | |
| UNIDOS RomeoElectrometer | UNIDOS E (Dosimeter) | Equivalent -UNIDOS RomeoElectrometer is thesuccessor model andcleared under(K951764) | |
| Ionization ChamberV-guide | Ionization ChamberV-guide | Identical | |
| Radio Modules | RFID Reader | N/A | Equivalent - RFIDreader will not havean impact on the useof the device. |
| Network | Wireless or LAN | LAN | Equivalent - used forconnection of PC withhospital network |
| Connectivity | - Picture Archiving andCommunication System(PACS)- ZEISS SMART Service- ZEISS Server / Cloud -Health Data Platform(HDP) | - Picture Archiving andCommunication System(PACS) | Equivalent -additionalconnectivity featuresin the subject device,no impact on theintended use of thedevice. |
| Applicatorsrequired forTreatment | Yes | Yes | Identical |
| Method oftreatment /application | IntraoperativeIntracavitaryInterstitialPost-Operative | IntraoperativeIntracavitaryInterstitialPost-Operative | Identical |
| Radiation Source | XRS 4 | XRS 4 | Identical |
| Software onComputer | Version 5.0 | Version 4.0 | Equivalent - UpdatedSoftware Version |
| Controller Set | 40keV50keV | 40keV50keV | Identical |
| Energy range used | 40keV50keV | 40keV50keV | Identical |
| Energy ofradiation emitted | Max 50keV | Max 50keV | Identical |
| Item | Subject DeviceINTRABEAM (Model: 700)(K241174) | Predicate DeviceINTRABEAM 600(K162568) | SubstantialEquivalenceAssessment |
| 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 DeviceINTRABEAM SMARTSpherical Applicator(K241174) | Predicate DeviceINTRABEAM SphericalApplicator (K121653) | SubstantialEquivalenceAssessment |
| Device Name | INTRABEAM SMARTSpherical Applicator | INTRABEAM SphericalApplicator | 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 ofapplicator sizes | Eight (8) | Eight (8) | Identical |
| ApplicatorDiameters | 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:PolyetherimideShaft: Polyetherimide | Sphere:Polyetherimide (Ultem1000)Shaft: Ultem 1000 andstainless steel | Equivalent - Stainlesssteel no longer used,does not affect theintended use of thedevice. |
| Sterilization | Supplied sterile;EO Sterilization | Supplied non-sterile. Userperforms steam sterilization. | Equivalent –sterilization is carriedout in both. |
| Number of uses | Single-Use | Multiple uses. Can besterilized 100 times by theuser. | Equivalent - there is noimpact on the use ofthe device. |
| Primary Packaging | Lid: Tyvek®Blister: PETG transparent | N/A | Equivalent – Primarypackaging was notrequired before, asdevice was sterilizedby the user. |
| Connectivity | RFID tag | N/A | Equivalent - RFID tagwill not have an impacton the use of thedevice. |
| Sizing support tool | INTRABEAM Spherical SizerSet- Gamma sterilization- Single-Use- 8 different sizes- Base Material:polycarbonate- Color Batch Material:Acrylnitril-Butadien-Styrol | N/A | Equivalent –INTRABEAMSpherical Sizer Set willsupport the user to pickappropriateINTRABEAMSMART SphericalApplicator |
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| Table 3. Subject to Predicate Device Comparison Table - INTRABEAM SMART Spherical Applicator |
|---|
| ---------------------------------------------------------------------------------------------- |
{12}------------------------------------------------
| Item | Subject DeviceINTRABEAM SMARTSpherical Applicator(K241174) | Predicate DeviceINTRABEAM SphericalApplicator (K121653) | SubstantialEquivalenceAssessment |
|---|---|---|---|
| - Primary Packaging:Tyvek® andlaminate film transparentpeel PET-O/PP |
{13}------------------------------------------------
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).
§ 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.