(253 days)
The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.
Varian Cervical Sleeves are brachytherapy applicator accessories. The cervical sleeves are used for insertion into the cervix prior to treatment and acts to guide the radioactive source to the correct locations for treatment. The sleeve can be sutured in place and left for a series of treatments. Presence of the sleeve helps to insure against perforation of the uterine wall by the distal end of the tandem.
The provided text describes a 510(k) premarket notification for the "Varian Cervical Sleeves." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance metrics and acceptance criteria for an AI/software device.
Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance metrics, sample sizes for test and training sets, ground truth establishment methods, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not applicable as this is a medical device clearance, not an AI/software performance study.
The document discusses the physical characteristics, intended use, and conducted verification and validation testing for the cervical sleeves, which are brachytherapy applicator accessories.
Here's an attempt to answer the relevant parts based on the provided text, while indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) are provided in the context of an AI/software study. The device is a physical accessory, and performance is demonstrated through conformance to standards and safety requirements.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Met testing requirements in conformance with ANSI/AAMI/ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1” for irritation, sensitization, and acute systemic injection. |
| Cleaning Validation | Cleaning validation test requirements have been met. |
| Quality Management | Hardware verification and validation testing conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard, and other FDA-recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. |
| Standards Conformance | Conforms in whole or in part with standards including: ISO 14971:2007, ISO 15223:2012, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-12:2012, ISO 11138-1:2006, ISO 11737-2:2009, AAMI/ANSI ST79:2010 +A2:2011, AAMI/ANSI ST81:2004 +R2010, ISO 14161:2009, IEC 62366:2007. |
| Safety and Effectiveness | Conclusion: Based on the verification, validation and non-clinical 10993 standard testing, the Varian Cervical Sleeves are as safe, effective and performs as well as or better than the legally marketed predicate device (K955844). (This is a statement of substantial equivalence, not a specific performance metric). Additionally, MR safe compatibility is noted as a technological characteristic and difference from the predicate, implying this was also assessed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is not a study involving a "test set" of patient data for an algorithm. The testing described relates to the physical device's characteristics (biocompatibility, sterility, material properties).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth in the context of an AI/software study is not relevant for the clearance of this physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. No MRMC study is performed or discussed; the device is a physical accessory, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical accessory and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For a physical device like cervical sleeves, the "ground truth" would relate to its physical properties, material compatibility, and adherence to manufacturing/safety standards. The text indicates that these were assessed through various ISO and AAMI/ANSI standards (e.g., biocompatibility standards like ISO 10993).
8. The sample size for the training set
This information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable.
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May 16, 2018
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K172675
Trade/Device Name: Varian Cervical Sleeves Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: April 19, 2018 Received: April 19, 2018
Dear Mr. Coronado:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Cervical Sleeves
Indications for Use (Describe)
The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.
| 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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Premarket Notification [510(k)] Summary Cervical sleeves
The following information is provided following the format of 21 CFR 807.92.
- Varian Medical Systems, Inc. I. Submitter's Name: 3120 Hansen Way C-260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado Phone: 650.424.5731 Fax: 650.842.5040 Date: August 2017 II. Trade Name: Varian Cervical Sleeves
Common Name: Cervical sleeves
Classification Name: Remote controlled radionuclide applicator system 21 CFR 892.5700, Class II Product Code: JAQ
- III. Predicate Device: Cervical sleeves: K955844
- IV. Device Description: Varian Cervical Sleeves are brachytherapy applicator accessories. The cervical sleeves are used for insertion into the cervix prior to treatment and acts to guide the radioactive source to the correct locations for treatment. The sleeve can be sutured in place and left for a series of treatments. Presence of the sleeve helps to insure against perforation of the uterine wall by the distal end of the tandem.
- The Varian Cervical Sleeves are intended for use for treatment of any case V. Intended Use Statement: where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.
Indications for Use The Varian Cervical Sleeves are intended for use for treatment of any case Statement where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.
VI. Technological Characteristics:
The differences between the cleared predicate device and this device are:
- · Low density polyethylene (with BaS04 for CT contrast) material;
- · MR safe compatibility
The similarities are:
- · Indications and Intended Use;
- · Use location;
- · Dimensions, Biocompatibility, Sterility, Sterilization & Packaging
VII. Summary of Hardware verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management performance
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Premarket Notification [510(k)] Summary Cervical sleeves
| testing: | System standard, ISO 14971 Risk Management Standard and the other FDArecognized consensus standards listed below. Test results showed conformanceto applicable requirements specifications and assured hazard safeguardsfunctioned properly.Biocompatibilty testing requirements in conformance with ANSI/AAMI/ ISO 109931 “Biological Evaluation of Medical Devices - Part 1” for irritation, sensitization,and acute systemic injection have been met.Cleaning validation test requirements have been met. | |
|---|---|---|
| Standardsconformance: | The Varian Cervical Sleeves conform in whole or in part with the followingstandards: | |
| ISO 14971:2007 | ISO 15223:2012 | |
| ISO 10993-1:2009 | ISO 10993-5:2009 | |
| ISO 10993-10:2002 | ISO 10993-12:2012 | |
| ISO 11138-1:2006 | ISO 11737-2:2009 | |
| AAMI/ANSI ST79:2010 +A2:2011 | AAMI/ANSI ST81:2004 +R2010 | |
| ISO 14161:2009 | IEC 62366:2007 | |
| Conclusion: | Based on the verification, validation and non-clinical 10993 standard testing, theVarian Cervical Sleeves are as safe, effective and performs as well as or better |
than the legally marketed device identified in section III above.
§ 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.