(50 days)
The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The CAPRI Applicator is provided sterile for single use and is disposable.
The provided text describes a 510(k) summary for the CAPRI™ Applicator, a brachytherapy applicator. This type of regulatory submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a standalone study with defined acceptance criteria and statistical analysis.
Based on the provided document, the following observations can be made regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for algorithmic or diagnostic devices. Instead, it states:
| Criterion | Reported Performance |
|---|---|
| Substantial Equivalence | "All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices." (Predicate devices: BioLucent's Applicator (K061241) and Nucletron's Miami Applicator (K953946)) |
| Intended Use | "Substantially equivalent in intended use... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." |
| Principle of Operation | "Substantially equivalent in... principle of operation... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." |
| Technological Characteristics | "Substantially equivalent in... technological characteristics... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." Also states: "The CAPRI Applicator has similar physical and technical characteristics to the predicate devices." |
| Safety and Efficacy | "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CAPRI Applicator is determined by VivaRay, to be substantially equivalent to existing legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a "test set" in the context of an AI/algorithmic device evaluation. The CAPRI™ Applicator is a physical medical device (brachytherapy applicator). Therefore, concepts like retrospective/prospective data, country of origin of data, and sample sizes for test sets are not applicable to the evidence presented for this device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to the CAPRI™ Applicator as it is a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth from images or other data.
4. Adjudication Method:
This information is not applicable for the same reasons mentioned in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is relevant for evaluating the impact of AI on human reader performance (e.g., radiologists interpreting images). Since the CAPRI™ Applicator is a physical brachytherapy applicator and not an AI-powered diagnostic tool, an MRMC study was not conducted and is not relevant to its submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This type of study is relevant for AI algorithms. As the CAPRI™ Applicator is a physical device, a standalone algorithm performance study was not conducted and is not relevant.
7. Type of Ground Truth Used:
Ground truth, in the context of AI/diagnostic algorithms, refers to the definitive correct answer for a given case. For the CAPRI™ Applicator, the "ground truth" equivalent would be its manufacturing specifications, material properties, and functional performance, which are evaluated through verification and validation testing (e.g., mechanical, biocompatibility, sterilization, dimensional accuracy). The document states: "All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices."
8. Sample Size for the Training Set:
This information is not applicable as the CAPRI™ Applicator is a physical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons mentioned in point 8.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the CAPRI™ Applicator to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria and statistical results for an AI or diagnostic algorithm. The evidence presented relates to the physical and technical characteristics, intended use, and principle of operation being similar to the predicates, supported by "necessary verification and validation testing." The structure of the information requested (points 1-9) is primarily geared towards AI/algorithmic devices, which the CAPRI™ Applicator is not.
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Section 6
. 510(k) Summary
16992822
6. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | VivaRay, Inc. | |
|---|---|---|
| TRADE NAME: | CAPRI™ Applicator | NOV - 3 2009 |
| COMMON NAME: | Brachytherapy Applicator | |
| CLASSIFICATIONNAME: | Remote Controlled Radionuclide Applicator System, 21 CFR,892.5700 | |
| DEVICECLASSIFICATION: | Class II | |
| PRODUCT CODE | JAQ |
PREDICATE DEVICES: BioLucent's Applicator (K061241) Nucletron's Miami Applicator (K953946)
Substantially Equivalent To:
The CAPRI Applicator is substantially equivalent in intended use, principal of operation and technological characteristics to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946).
Description of the Device Subject to Premarket Notification:
The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma.
The CAPRI Applicator is provided sterile for single use and is disposable.
Indication for Use:
The CAPRI Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
Technical Characteristics:
The CAPRI Applicator has similar physical and technical characteristics to the predicate devices.
VivaRay, Inc. CAPRI Applicator Page 11 of 56 Premarket Notification
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Performance Data:
All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CAPRI Applicator is determined by VivaRay, to be substantially equivalent to existing legally marketed devices.
VivaRay, Inc. CAPRI Applicator Page 12 of 56 Premarket Notification
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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. George Hermann President VivaRay, Inc. 3264 Alpine Road PORTOLA VALLEY CA 94028
Re: K092822
Trade/Device Name: CAPRI™ Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system ·Regulatory Class: II Product Code: JAQ Dated: September 10, 2009 Received: September 14, 2009
NOV - 3 2009
Dear Mr. Herman:
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 (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.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
INDICATIONS FOR USE STATEMENT
92822
510(k) Number (if known):
Device Name: CAPRITM Applicator
Indications for Use:
The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ X (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Page _ of _
signature
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.