(239 days)
Varian UNIQUE (K101751)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard linear accelerator technology and treatment techniques.
Yes
The device is described as a "radiotherapy delivery system" and a "medical linear accelerator that delivers therapeutic radiation to patient," which directly indicates its use for treatment.
No
The primary purpose of the VenusX radiotherapy delivery system is therapeutic (delivering radiation treatment), not diagnostic. While it has a "photon diagnostic kV X-ray radiation beam producing component," this is likely for positioning or verification of the treatment area rather than for disease diagnosis.
No
The device description explicitly states it is a "medical linear accelerator" and includes components like a "photon therapeutic 6 MV X-ray radiation beam producing component" and a "photon diagnostic kV X-ray radiation beam producing component," which are hardware. The performance studies also mention hardware verification and validation testing.
Based on the provided information, the VenusX radiotherapy delivery system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing blood, urine, tissue samples, etc.
- VenusX Function: The VenusX system is a medical linear accelerator that delivers therapeutic radiation to the patient's body for treatment. It does not analyze specimens outside the body.
- Intended Use: The intended use clearly states "to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This is a therapeutic, not diagnostic, application involving direct interaction with the patient.
- Device Description: The description details a system that produces and delivers radiation beams to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with IVD devices.
Therefore, the VenusX radiotherapy delivery system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The VenusX Radiotherapy System is a medical linear accelerator that delivers therapeutic radiation to patient in accordance with the physician's prescription. It supports CRT /IMRT Treatment Techniques (Mode). The system consists of a photon therapeutic 6 MV X-ray radiation beam producing component with a photon diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized medical practitioners.
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)
The following performance data were provided in support of the substantial equivalence determination.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electromagnetic compatibility (EMC) testing was conducted on the subject device. The system complies with the following standards:
- IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Bench Test
The VenusX was thoroughly tested on bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed based on the risk assessment of the device, and the recommendations outlined in the applicable FDA guidance documents, ISO and IEC standards. VenusX conforms to the following standards:
- ANSI AAMIES/IEC60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-1:2020 Medical electrical equipment - Part 2-1: Requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
- IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
- IEC 62274:2005 Medical electrical equipment— Safety of radiotherapy record and verify systems
- IEC 62366-1:2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
- IEC 61217:2011 Radiotherapy equipment - Coordinates, movements, and scales
Test results met all the pre-determined acceptance criteria.
Cybersecurity
In addition to the bench testing, the VenusX was also thoroughly tested to verify that its cybersecurity objectives are fully met, and security risk control measures are effective. Specifically, the following cybersecurity testing was conducted:
— Security requirement testing that demonstrates requirement was implemented correctly.
— Threat mitigation testing demonstrating effective risk control measures according to the threat modeling.
— A closed box testing of known vulnerability scanning by qualified external testers, with reference to Section 9.4 of "IEC 62443-4-1 Security for industrial automation and control systems Part 4-1: Secure product development lifecycle requirements ".
- Penetration testing by qualified external testers.
The results of the cybersecurity testing showed that VenusX meets the cybersecurity requirements under Section524B(b) of FD&C Act.
Hardware and Software Verification and Validation Testing
Hardware and software verification and validation process were conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards.
Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions," issued June 2023. The software for this device is considered as a "enhanced" level of concern.
Biocompatibility Testing
Biocompatibility testing was conducted on the Carbon fiber couch top in accordance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Biocompatibility testing conducted for the VenusX included the following:
- ISO 10993-5 Cytotoxicity Test
- ISO 10993-10 Skin Sensitization Test
- ISO 10993-10 Skin Irritation Test
Test results met all the pre-determined acceptance criteria.
CONCLUSION OF NON-CLINICAL TESTING VIII.
The results of testing showed that VenusX conforms to the defined user needs and intended uses and that there were no software DRs (Discrepancy Reports) remaining which had a priority of Safety Intolerable or Customer Intolerable.
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.
Varian UNIQUE (K101751)
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.
Varian On Board Imaging (OBI) (K042720)
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2024
LinaTech LLC Jonathan Yao President 1294 Kifer Road #705 Sunnyvale, California 94086
Re: K232489
Trade/Device Name: VenusX Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: March 12, 2024 Received: March 12, 2024
Dear Jonathan Yao:
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.
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).
1
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.
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 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,
D.G.K.
Daniel M. Krainak, Ph.D. Assistant Director 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232489
Device Name VenusX
Indications for Use (Describe)
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510(k) SUMMARY - K232489
As required by 21 CFR 807.92
SUBMITTER l.
| Submitter's Name: | LinaTech
1294 Kifer Road #705
Sunnyvale, CA 94086, USA |
|----------------------------|--------------------------------------------------------------------------------------------------|
| Primary Contact
Person: | Jonathan Yao
Phone: (408) 733 2051
Fax: (408) 733 2045
E-mail: Jonathanyao@LinaTech.com |
| Date Prepared: | 11 April 2024 |
II. DEVICE
lll.
| Proprietary Name: | VenusX |
|---|---|
| Common/Usual Name: | Medical Linear Accelerator |
| Classification Name: | Medical charged-particle radiation therapy system |
| Regulation: | 21 CFR §892.5050 |
| Regulatory Class: | Class II |
| Product Code: | IYE |
| PREDICATE DEVICE | |
| Predicate Devices: | Varian UNIQUE (K101751) |
| Reference Device: | Varian On Board Imaging (OBI) (K042720) |
IV. DEVICE DESCRIPTION
Device Description: The VenusX Radiotherapy System is a medical linear accelerator that delivers therapeutic radiation to patient in accordance with the physician's prescription. It supports CRT /IMRT Treatment Techniques (Mode). The system consists of a photon therapeutic 6 MV X-ray radiation beam producing component with a photon diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located
outside the treatment room.
4
V. INTENDED USE AND INDICATIONS FOR USE
| Intended Use: | The intended use is the same with precision radiotherapy as the predicate device. VenusX does not support stereotactic radiosurgery.
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
VI. TECHNOLOGICAL CHARACTERISTICS
| Summary
Of Technological
Characteristics: | Both the VenusX and the predicate device contain similar
technological characteristics and functional scientific technology
to deliver radiation therapy by authorized medical practitioners.
A subset of technological characteristics and features of the
current device is different from the predicate. The
biocompatibility of patient-contacting components remains the
same as the predicate device. The results of the verification,
validation and safety standards testing demonstrate that there
are no changes to the safety profile of the device. |
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The feature comparison chart below notes the similarities and differences between predicate, reference, and subject device.
5
The feature comparison with predicate device:
| Attribute/ Feature | Predicate Device
Varian UNIQUE
K101751 | Subject Device
LinaTech VenusX |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The UNIQUE is intended to
provide stereotactic
radiosurgery and precision
radiotherapy for lesions,
tumors and conditions
anywhere in the body when
radiation treatment is
indicated. | The VenusX radiotherapy
delivery system is intended
to provide precision
radiotherapy for lesions,
tumors, and conditions
anywhere in the body where
radiation treatment is
indicated. |
| Indications for Use | The UNIQUE is indicated for
stereotactic radiosurgery and
precision radiotherapy for
lesions, tumors and
conditions anywhere in the
body when radiation
treatment is indicated. | The VenusX radiotherapy
delivery system is intended
to provide precision
radiotherapy for lesions,
tumors, and conditions
anywhere in the body where
radiation treatment is
indicated. |
| Photon Energy (MV)
available | 6 | 6x (FFF) |
| Dose Rates | 100 - 600 cGy/min
for FF mode | 600、800、1000 cGy/min
for FFF mode |
| SAD (cm) | 100 | 90 |
| Maximum standard
treatment field size | 40cmx40cm | 40cmx40cm |
| Number of MLC leaves | 120 | 101 leaves in each of two
orthogonal layers |
| Maximum leaf over
travel distance (cm) | 14 | Upper layer 20
Lower layer 14 |
| Average leaf
transmission (%) | ≤ 2.0 | ≤ 0.05 |
| Leaf end physical
position accuracy (cm) | ≤ ± 0.1 | ≤ ± 0.1 |
| Attribute/ Feature | Predicate Device
Varian UNIQUE
K101751 | Subject Device
LinaTech VenusX |
| Maximum leaf speed
(cm/sec) is greater than
2.5 | Yes | Yes |
| Electron
Treatment
Mode | No | No |
| Non-arc photon
treatment mode
programmable MU
maximum dose is larger
than 1999 MU | Yes | Yes |
| Patient support surface:
couch pedestal with
carbon fiber couch top
for improved MV
imaging | Yes | Yes |
| Microwave Source is
Magnetron | Yes | Yes |
| Interface for External
System Gating | Yes | Yes |
| MV Detector size | 30cm x 40cm | 43cm x 43cm |
| MV Pixel | 1024 x 768 | 2816×2816 |
| Radiation dose for MV
Image is less than 1MU | Yes | Yes |
| Image registration with
planning image | Yes | Yes |
| Basis of image
registration are for
minimum of | soft tissue, bony anatomy,
fiducial markers, digital
representation of treatment
apertures. | soft tissue, bony anatomy,
fiducial markers, digital
representation of treatment
apertures. |
| Data Interface is using
DICOM RT/3.0 data and
with image | Yes | Yes |
| Attribute/ Feature | Predicate Device
Varian UNIQUE
K101751 | Subject Device
LinaTech VenusX |
| Record treatment
delivery results | Yes | Yes |
| Treatment Techniques
(Mode) | CRT, IMRT | CRT, IMRT |
| Compatible TPS and OIS
for the VenusX and
compare with predicate. | UNIQUE is compatible with a
commercially available
independent third-party
Radiation Treatment
Planning System (TPS), Such
as Eclips TPS, and also to
compatible with the ARIA
Radiation Therapy
Management System (FDA
No.: K173838) (OIS). | VenusX is compatible with a
commercially available
independent third-party
compatible with TiGRT TPS
(FDA No.: K090893)
( TPS ) and also ARIA
(FDA No.: K173838) (OIS)
system. |
6
7
8
The feature comparison with reference device:
| Attribute / Feature | Reference Device
Varian OBI K042720 | Subject Device
LinaTech VenusX |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Varian On-Board
Imager device (OBI) is used
for verification of correct
patient position in relation
to isocenter and
verification of the
treatment fields in relation
to anatomical and/or
fiducial landmarks. | The VenusX's Cone Beam CT
Imager device (CBCT) is
used for verification of
correct patient position in
relation to isocenter and
verification of the
treatment fields in relation
to anatomical and/or
fiducial landmarks. |
| kV imaging | Yes | Yes |
| Cone-beam CT image
Reconstruction | Yes | Yes |
| General type of
Reconstruction
method/algorithm | FDK (Feldkamp-Davis-
Kress) algorithm | FDK (Feldkamp-Davis-Kress)
algorithm |
| Dose per CBCT
acquisition | ≤ 1.4cGy | ≤ 2cGy |
| CBCT acquisition mode
(pixels / degrees) | 512×512
reconstruction
matrix / 200°
(head) or
360° (body) | 512×512
reconstruction
matrix / 360° |
9
VII. SUMMARY OF PERFORMANCE TESTING
The following performance data were provided in support of the substantial equivalence determination.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electromagnetic compatibility (EMC) testing was conducted on the subject device. The system complies with the following standards:
- IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Bench Test
The VenusX was thoroughly tested on bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed based on the risk assessment of the device, and the recommendations outlined in the applicable FDA guidance documents, ISO and IEC standards. VenusX conforms to the following standards:
- ANSI AAMIES/IEC60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical eguipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-1:2020 Medical electrical equipment - Part 2-1: Requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
- IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
- IEC 62274:2005 Medical electrical equipment— Safety of radiotherapy record and verify systems
- IEC 62366-1:2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
- IEC 61217:2011 Radiotherapy equipment - Coordinates, movements, and scales
Test results met all the pre-determined acceptance criteria.
10
Cybersecurity
In addition to the bench testing, the VenusX was also thoroughly tested to verify that its cybersecurity objectives are fully met, and security risk control measures are effective. Specifically, the following cybersecurity testing was conducted:
— Security requirement testing that demonstrates requirement was implemented correctly.
— Threat mitigation testing demonstrating effective risk control measures according to the threat modeling.
— A closed box testing of known vulnerability scanning by qualified external testers, with reference to Section 9.4 of "IEC 62443-4-1 Security for industrial automation and control systems Part 4-1: Secure product development lifecycle requirements ".
- Penetration testing by qualified external testers.
The results of the cybersecurity testing showed that VenusX meets the cybersecurity requirements under Section524B(b) of FD&C Act.
Hardware and Software Verification and Validation Testing
Hardware and software verification and validation process were conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards.
Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions," issued June 2023. The software for this device is considered as a "enhanced" level of concern.
Biocompatibility Testing
Biocompatibility testing was conducted on the Carbon fiber couch top in accordance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Biocompatibility testing conducted for the VenusX included the following:
- ISO 10993-5 Cytotoxicity Test
- ISO 10993-10 Skin Sensitization Test
- ISO 10993-10 Skin Irritation Test
Test results met all the pre-determined acceptance criteria.
CONCLUSION OF NON-CLINICAL TESTING VIII.
The results of testing showed that VenusX conforms to the defined user needs and intended uses and that there were no software DRs (Discrepancy Reports) remaining which had a priority of Safety Intolerable or Customer Intolerable.
11
IX. CONCLUSION FOR SUBSTANTIAL EQUIVALENCE TO THE PREDICATE AND REFERENCE DEVICE
The VenusX is substantially equivalent to the UNIQUE (K101751) (predicate device). The intended use is the same with precision radiotherapy as the predicate device. VenusX does not support stereotactic radiosurgery. A subset of technological characteristics and features of the current device is different to the predicate. However, the Verification and Validation demonstrate that the device is as safe and effective as the predicate and reference device. Based on the comparison and analysis above, the VenusX (subject device) is substantially equivalent to the UNIQUE (K101751) (predicate device).