(35 days)
Not Found
No
The summary describes a mechanical applicator for brachytherapy and does not mention any AI or ML components or functions.
Yes
The device is used to deliver a prescribed radiation dose for treatment in brachytherapy procedures, which is a therapeutic function.
No
The SAVI Applicator Kit is described as an accessory to remote afterloading equipment used during brachytherapy procedures, designed to deliver radiation dose. This function is therapeutic, not diagnostic.
No
The device description clearly states it is an "expandable cylindrical device with radially positioned catheters" and is "provided sterile and is a single use device," indicating it is a physical hardware device used in brachytherapy procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SAVI Applicator Kit is an accessory for remote afterloading equipment used during brachytherapy procedures. Brachytherapy is a form of radiotherapy where a radiation source is placed inside or next to the area requiring treatment. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The description details a device inserted into a target volume to deliver radiation. This aligns with a therapeutic function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SAVI Applicator's function is to deliver radiation for treatment, which is a therapeutic activity.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device.
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.
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.
Not Found
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
§ 892.5700 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.
0
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-006 |
| RTK-008 | |
| RTK-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 Medical |
| 6 Journey, Suite 125 | |
| Aliso Viejo, CA 92656 | |
| Owner/Operator Number: | 9044581 |
| Establishment Registration | |
| Number: | 2032338 |
| Official Contact: | Gary Mocnik |
| Cianna Medical. | |
| 6 Journey, Suite 125 | |
| Aliso Viejo, CA 92656 | |
| Phone: (949) 360-0059 x134 | |
| gmocnik@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.
1
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
2
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
4
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)
Aonith thon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number.