(204 days)
The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.
The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows:
- Suitable for intraoperative, intraluminal, and interstitial brachytherapy.
- Can be used for surface treatments in combination with the suitable Varian flap.
- Equipped with stabilizing mandrins for easy insertion.
- MR Safe, if used without mandrins.
- CT compatible, if used without mandrins.
- Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks.
- Steam sterilizable.
- Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.
The provided text is a 510(k) premarket notification summary for the "Mould Probe MR Safe" device. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain information about the acceptance criteria and performance study outcomes related to an AI/ML device.
The document states:
- "Software Verification and Validation Testing: This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination."
Therefore, I cannot extract the requested information about acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML device from the provided text. The device in question is a physical medical instrument (brachytherapy applicator), not one that relies on AI/ML for its function.
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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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K241764
Trade/Device Name: Mould Probe MR Safe Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: June 18, 2024 Received: June 20, 2024
Dear Lynn Allman:
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 (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"
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(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 (OS) 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 Rule"). 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 medical devices and radiation-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-regulatory
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assistance/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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Mould Probe MR Safe
Indications for Use (Describe)
The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.
IORT - Intraoperative Radiation Therapy
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the alphanumeric string 'K241764' in a bold, sans-serif font. The characters are black against a white background. The string appears to be a code or identifier, possibly a serial number or product key.
Image /page/4/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.
Premarket Notification - 510(k) Summary
Mould Probe MR Safe
l. Submitter's Name
- Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Name: Lynn Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: 18 June 2024
II. Device Information
Proprietary Name: Mould Probe MR Safe Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ
- lll. Predicate Device Mould Applicator Set (K162615)
IV. Reference Device Interstitial Needles (K073133)
V. Device Description
The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows:
- Suitable for intraoperative, intraluminal, and interstitial brachytherapy. ●
- Can be used for surface treatments in combination with the suitable Varian flap.
- Equipped with stabilizing mandrins for easy insertion.
- MR Safe, if used without mandrins.
- CT compatible, if used without mandrins.
- Elastomer material construction provides increased flexibility for easy placement as ● well as luminal rigidity, which prevents kinks.
- . Steam sterilizable.
- Suitable for patient contact for up to 24 hours. The stainless steel mandrins are ● not intended to have patient contact.
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Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
VI. Intended Use/Indications for Use
The Mould Probe MR Safe is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.
Comparison of Technological Characteristics with the Predicate Device VII.
The following are the major changes that are a part of this 510(k):
- Change in material type of the probe connector material from titanium to PEEK. This 1. changes the MR condition of Mould Probe from MR Conditional to MR Safe.
- The clinical use of Mould probe MR Safe is contact for up to 24 hours. Full 2. biocompatibility for Mould Probe MR Safe 1.8 mm has been tested for contact duration of 24 hours.
-
- The Single use limitation has been removed from 1.8 mm Mould Probe MR Safe as the cleaning validation demonstrate it can be re-used for 25 cycles.
-
- As part of the Mould Probe MR Safe, the Mandrin is considered a principal component rather than a separately cleared device.
Minor changes include:
- Addition of the BRAVOS Afterloader system to the Compatible Afterloaders. .
- Availability of the Mould Probe MR Safe in kits with different quantities ●
- Mould Probe MR Safe, 1.8 mm diameter x 320 mm, with mandrin, pack of 5 o
- Mould Probe MR Safe, 1.8 mm diameter x 320 mm, with mandrin, pack of 10 O
- Mould Probe MR Safe, 1.8 mm diameter x 320 mm, with mandrin, pack of 20 O
- Addition of machine cleaning process for Mould Probe MR Safe.
- Removal of expiration dating per assessment of lifetime limited factors used to ● establish expiration date in the prior 510(k).
- . Removal of Mould Probe, ø 2.8 mm diameter x 320 mm
- . The description of intended environment has been clarified for use in other suitable radiation oncology rooms as appropriate.
The device comparison table below demonstrates the substantial equivalence of the subject Mould Probe MR Safe to the predicate Mould Applicator Set (K162615). The differences between the subject and predicate are indicated in purple fill. Features which are adapted from the reference device are explained in Table 2 and appear in grev fill in the table below. The indications for use and the intended use of the subject device are the same as the predicate device.
| Features and/orspecification | Predicate DeviceMould Applicator SetK162615 | Subject DeviceMould Probe MR Safe | Comparison |
|---|---|---|---|
| Device name | Mould Applicator Set | Mould Probe MR Safe | Device name has changed toreflect change in includedcomponents. |
Table 1 Comparison of Subject Device to Predicate Device
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varian
| A Siemens Healthineers Company | ||
|---|---|---|
| -- | -------------------------------- | -- |
| Features and/or | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| specification | Mould Applicator Set | Mould Probe MR Safe | |
| K162615 | |||
| As compared to the MouldApplicator Set, the Mould | |||
| Probe MR Safe includes only | |||
| the mould probe, probe | |||
| connector and mandrin. See | |||
| Design and Materials sections | |||
| in this table. | |||
| Intended Use | The Mould Applicator Set is | The Mould Probe MR Safe is | No change. |
| intended for IORT, interstitialand intraluminal treatments | intended for IORT, interstitialand intraluminal treatments | ||
| of cancer and treatments of | of cancer and treatments of | ||
| cancer or other superficial | cancer or other superficial | ||
| disease using HDR or PDR | disease using HDR or PDR | ||
| brachytherapy. | brachytherapy. | ||
| IORT - Intraoperative | IORT - Intraoperative | ||
| Compatible | Radiation TherapyGammaMedplus | Radiation TherapyGammaMedplus Afterloader | Now also compatible with |
| Afterloader | series | BRAVOS Afterloader system. | |
| BRAVOS Afterloader System | |||
| Design | Mould Probe Applicator Set | Mould Probe MR Safe | No change in design for 1.8 |
| mm Mould Probe | |||
| Mould ProbeDiameter: 1.8 or 2.8mm | 1.8 mm Mould ProbeDiameter:1.8mm | The ø 2.8 mm diameter x 320 | |
| Length: 320 mm | Length: 320 mm | mm has been discontinued. | |
| Supplied with | |||
| Mould probe MR safe, 1.8 | |||
| mm diameter x 320 mm, | |||
| with mandrin, pack of5/10/20* | |||
| *Refer to Packaging row in | |||
| this table | |||
| Mandrin (GM11003100) | Mandrin (GM11010470) | Substantially the same. | |
| [K073133] | Mould Probe MR Safe | ||
| includes mandrin. Refer to | |||
| Table 2 for comparison to | |||
| reference device. | |||
| The Mould Probe MR Safenow includes the mandrin as a | |||
| principle component. As such, | |||
| the mandrin will no longer use | |||
| the existing clearance | |||
| K073133, as the prior cleared | |||
| mandrin component is | |||
| Features and/or | Predicate Device | Subject Device | Comparison |
| specification | Mould Applicator Set | Mould Probe MR Safe | |
| K162615 | |||
| Leak stop buttons, pack of 50(GM11003810)[K152018] | None | composed of Titanium (probeconnector) and Stainless Steel(mandrin). | |
| Cleaning Cap, dark blue (packof 25) GM11010770[K152018] | The other components of theapplicator set are notincluded in the samepackaging as a set and arenow sold and clearedseparately. | ||
| Materials | 1.8mm Mould Probe:Polyamide (PA) | Mould probe MR safe, 1.8mm diameter x 320 mm:Polyamide (PA) | No change. |
| 2.8mm Mould Probe:Fluorinated ethylenepropylene (FEP) | The Ø 2.8 mm size has beendiscontinued. | ||
| Probe connector: Titanium | Probe connector: PEEKVictrex 450G | The connector materialchange to PEEK rendersMould Probe to be MR Safe. | |
| Mandrin: Stainless steel | Mandrin: Stainless steel | The material is diamagnetic,and it is non-conducting, hasnon-metallic properties andnon-magnetic properties.Refer to Table 2 for furtherinformation. | |
| Packaging | Individual | Individual and packs | Substantially the same. |
| The product is available asindividual and in packswith different quantities. | |||
| Mould probe MR safe, 1.8 mmdiameter x 320 mm, withMandrin: | |||
| Individual: | |||
| • 1 Mould Probe with 1Mandrin | |||
| In packs: | |||
| • pack of 5 | |||
| • pack of 10 | |||
| • pack of 20 | |||
| Reprocessing,Sterility and Shelflife | 1.8mm and 2.8mm MouldProbes:Manual Cleaning or Steamsterilization.1.8mm Mould Probe is asingle use productwhen steam sterilized | 1.8mm Mould Probe MRSafe:Manual Cleaning andDisinfection, MachineCleaning and Disinfection, orSteam sterilization. | Substantially the same. |
| The Single use limitation hasbeen removed from 1.8 mmMould probe as the cleaningvalidation demonstrate it canbe re-used for 25 cycles |
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varian
ens Healthineers Company
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varian
| A Siemens Healthineers Company | ||
|---|---|---|
| -- | -------------------------------- | -- |
| Features and/orspecification | Predicate DeviceMould Applicator SetK162615 | Subject DeviceMould Probe MR Safe | Comparison |
|---|---|---|---|
| Expiry date of 4 years for1.8mm. | Removal of expiration datefrom 1.8mm Mould ProbeMR Safe. | Additionally, 1.8mm can nowbe reprocessed throughmachine cleaning.The ø 2.8 mm size has beendiscontinued. | |
| Biocompatibility | Full biocompatibility | Full biocompatibility | The clinical use of Mouldprobe MR Safe is suitable forpatient contact for up to 24hours. Full biocompatibilityfor Mould Probe 1.8 mm hasbeen tested for contactduration of 24 hours.The 2.8 mm size has beendiscontinued. |
| Compatibilitywith theenvironment andother devices | MR conditional 1.5 and 3 TCT compatible | MR Safe, if used withoutMandrinsCT compatible, if usedwithout Mandrins | Mould Probe is MR Safe andCT compatible after Mandrinremoval, prior to entering theMR environment. |
| Intendedenvironment | Brachytherapy treatmentroom. | Radiation therapy orradiation oncologydepartment in a hospitalenvironment. | Clarification of intendedenvironment.Mould Probe MR Safe is to beused in a shielded, dedicatedroom/space for radiationtherapy. |
Table 2 Comparison of Subject Device to Reference Device
| Features and/orspecification | Reference DeviceInterstitial NeedlesK073133(Compatible with MouldProbe Applicator Set) | Subject DeviceMould Probe MR Safe | Comparison |
|---|---|---|---|
| Design | Mandrin (GM11003100)Stainless steel | Mandrin (GM11010470)Stainless steel | No change. |
| Materials | Probe connector: TitaniumMandrin: Stainless steel | Probe connector: PEEKVictrex 450GMandrin: Stainless steel | The probe connectormaterial change fromTitanium to PEEK rendersMould Probe to be MR Safe. |
Summary of Performance Testing (Non-Clinical Testing) VIII.
The following performance data was provided in support of the substantial equivalence determination.
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Image /page/9/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo and text are both black and are set against a white background.
Biocompatibility Testing:
The biocompatibility evaluation for the subject device was conducted according to ISO 10993-1:2020: 'Biological Evaluation of a Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process" and the FDA Guidance: "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process". This includes the following tests:
- Cytotoxicity
- Irritation
- Delayed Type Hypersensitivity
- Material Mediated Pyrogens
- Acute Systemic Toxicity
Cleaning, Disinfection, Sterilization, Reprocessing:
Mould Probe MR Safe is supplied nonsterile. Sterilization testing for the subject device was conducted according to ANSI/AAMI, ASTM and ISO standards to assess the effectiveness of the provided cleaning, disinfection and sterilization procedures for the device.
Electrical Safety and Electromagnetic Compatibility (EMC):
A review report with applicable clauses of IEC 60601-2-17 to Mould Probe MR Safe, along with evidence for successful implementation of the clauses has been conducted. The result of this review is that Mould Probe MR Safe meets the requirements of the abovementioned clauses.
Magnetic Resonance Testing (MR):
Mould Probe MR Safe is made from non-metallic, non-magnetic materials. It is MR Safe after Mandrin removal and prior to entering the MR environment. Therefore, no tests according to ASTM F2052-21, ASTM F 2213-17, ASMT F2182-19E02 are required.
Software Verification and Validation Testing:
This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination.
Product verification and Validation testing
Mould Probe MR Safe has undergone formal design verification and validation testing; and it demonstrates that Mould Probe MR Safe performs as intended. Testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
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Image /page/10/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.
Use of Consensus Standards:
The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy.
| Standard | |||
|---|---|---|---|
| AAMI ANSI ST108:2023 | ASTM F3208-20 | ISO 10993-17 | ISO 17665-1 |
| ANSI AAMI ST79:2017 | IEC 60601-2-17 | ISO 10993-18 | ISO 14971:2019 |
| ANSI AAMI ST8:2013/(R) 2018 | ISO 10993-1 | ISO 10993-23 | ASTM D4332-22 |
| ANSI AAMI ST98:2022 | ISO 10993-2 | ISO 11138-1 | |
| ANSI AAMI ISO TIR 17665-2 | ISO 10993-5 | ISO 11737-1 | |
| ASTM D4169-22 | ISO 10993-10 | ISO 11737-2 | |
| ASTM F2503-23 | ISO 10993-11 | ISO 17664-1 | |
| ASTM F3293-18 | ISO 10993-12 | ISO 17664-2 |
Table 3 List of Consensus Standards
IX. Clinical Testing
No animal or clinical studies were conducted.
X. Determination of Substantial Equivalence to the Predicate Device
The intended use and indications for use are the same as the predicate device. There is no change to the principle operation of the device. Varian believes the major technological characteristics are substantially equivalent to the predicate device and the differences do not raise new questions of safety and effectiveness. The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers Mould Probe MR Safe to be as safe and effective as the predicate and to perform at least as well as the predicate device (K162615).
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.