(35 days)
The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.
This submission for the SAVI Applicator Kit (K080565) from Cianna Medical, Inc. is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparability rather than extensive new clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel, high-risk device.
Based on the provided text, a detailed table of acceptance criteria and reported device performance, as well as an effect size from an MRMC study, sample size for training/test sets, or information about expert ground truth adjudication, are not explicitly stated or applicable in the context of this 510(k) submission.
Here's a breakdown of the available information according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided as a quantifiable table with specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity). The submission's "Performance Data Summary" states: "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
The conclusion further states: "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices."
This implies that the performance demonstration was to show that the SAVI Applicator performs at least as well (or equivalently) to its predicate devices for its intended use, rather than meeting specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, often supported by bench testing and sometimes small clinical studies for specific aspects if there are significant technological differences. The document does not describe a traditional clinical study with a "test set" in the context of AI or diagnostic device performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided. As there's no described "test set" and ground truth establishment in the context of AI or diagnostic performance, this information is not present.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No information provided. This is unlikely for a device of this nature and type of submission (510(k) for substantial equivalence of an accessory device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable/Not provided. The SAVI Applicator is a physical medical device (an accessory to brachytherapy equipment), not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable/Not provided in the context of a "test set" evaluation. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, meaning it meets the same functional and safety requirements that previous similar devices have already established.
8. The Sample Size for the Training Set
Not applicable/Not provided. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
Summary of Device and Approval Context:
The SAVI Applicator is an "accessory to commercially available remote afterloading equipment used during brachytherapy procedures." Its function is to "provide pathways from which a prescribed radiation dose is delivered to the treatment area."
The approval (K080565) is based on a 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices (Biolucent Applicator K062830, K061241, K070659).
The "Performance Data Summary" indicates that "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." This typically involves bench testing, material compatibility, and engineering analyses to ensure the device performs as intended and is as safe and effective as the predicate devices.
Key FDA Limitation: The FDA, in its approval letter (K080565), imposed a specific warning: "The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This highlights that while the device was found substantially equivalent for its intended accessory use, its potential broader implication as a replacement therapy had not been proven and required a specific disclaimer.
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Cianna Medical, Inc. 510(k) Submission- Special SAVI Applicator Kit
| 5. 510(k) Summary of Safety and Effectiveness | |
|---|---|
| APR - 4 2008 | |
| Device Name: | SAVI Applicator |
| Device Model Number: | RTK-006RTK-008RTK-010 |
| Classification Name: | Remote Controlled Radionuclide Applicator System(JAQ),21 CFR, 892.5700 |
| Device Classification: | Class II |
| Predicate devices: | Biolucent Applicator (K062830, K061241,K070659) |
| Manufacturer: | Cianna Medical6 Journey, Suite 125Aliso Viejo, CA 92656 |
| Owner/Operator Number: | 9044581 |
| Establishment RegistrationNumber: | 2032338 |
| Official Contact: | Gary MocnikCianna Medical.6 Journey, Suite 125Aliso Viejo, CA 92656Phone: (949) 360-0059 x134gmocnik@ciannamedical.com |
Intended Use:
The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
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Device Description:
The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.
Technological Characteristics Summary
The SAVI Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.
Performance Data Summary
Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device.
Conclusion:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human services aspect of the department. The seal is black and white.
APR - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Mocnik Vice President, Regulatory Affairs and Quality Systems Cianna Medical, Inc. 6 Journey, Suite 125 ALISO VIEJO CA 92656
Re: K080565 Trade/Device Name: SAVI Applicator Kit Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: February 29, 2008 Received: March 5, 2008
Dear Mr. Mocnik:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings. The safety and effectiveness of this device for use as replacement for whole breast irradiation in the treatment of breast cancer have not been established.
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Page 2 - Mr. Gary Mocnik
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 0805b5
Device Name: SAVI Applicator Kit
Indications for Use:
The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
OR
Over-The-Counter Use
Prescription Use X (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 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.