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.

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.

AI/ML Overview

Let's break down the information provided about the Cianna Medical SAVI Applicator Kit (K081677) to address your questions.

It's important to note that this 510(k) submission is for a medical device (applicator) used in brachytherapy, not an AI or software-as-a-medical-device (SaMD) product. Therefore, many of the questions related to AI performance metrics, ground truth establishment, and training/test sets for algorithms are not directly applicable or discussed in this type of submission. The focus here is on demonstrating substantial equivalence to predicate devices through physical performance testing and intended use.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics that would be analogous to sensitivity, specificity, or accuracy for an AI system. Instead, the performance testing focuses on demonstrating the integrity, suitability, and substantial equivalence of the device through engineering and biocompatibility tests.

The typical acceptance criteria for a device like this would revolve around its physical properties, sterility, dimensional accuracy, material compatibility, and functionality as an accessory to existing brachytherapy equipment.

Acceptance Criteria (Implied by context)	Reported Device Performance (Summary from text)
Device Integrity	"Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." (No specific quantitative results are provided in this summary, but the FDA's clearance implies successful completion of such tests.)
Suitability for Intended Use	"Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." (Implied to be suitable as an accessory to remote afterloading equipment for delivering radiation.)
Substantial Equivalence to Predicates	"The SAVI Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics." "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."
Sterility	"The SAVI Applicator is provided sterile and is a single use device." (This implies testing to ensure sterility standards are met.)
Biocompatibility	(Not explicitly stated in the summary, but required for medical devices. Testing would have been performed to ensure the materials are safe for human contact.)
Dimensional Accuracy/Fit	(Not explicitly stated in the summary, but required for proper function and compatibility with remote afterloading equipment. Testing would have been performed.)

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of an AI/SaMD study for this device. The "test set" for this physical device would involve a series of engineering tests on a sample of manufactured applicators to verify physical properties, rather than a clinical dataset for an algorithm. The document does not provide details on the number of units tested for physical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable. The "ground truth" for a physical medical device like the SAVI applicator is established through engineering and biological testing against predefined specifications and regulatory standards, not expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images for an AI system). For a physical device, performance is typically assessed against objective test methods and specifications.

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 question is not applicable. The SAVI Applicator is a physical medical device, not an AI system or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The SAVI Applicator is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be:

Engineering specifications: Compliance with design drawings, material properties, and dimensional tolerances.
Sterility standards: Confirmation of adherence to established sterilization protocols.
Biocompatibility standards: Evidence that the materials are safe for human contact per ISO 10993 or equivalent standards.
Functionality verification: Demonstrating that the device can successfully integrate and function with remote afterloading equipment as intended.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI system that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As there is no AI algorithm, there is no training set or ground truth in that context.

Summary

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K081677

Cianna Medical. 510(k) Submission- Special SAVI Applicator Kit

6. 510(k) Summary of Safety and Effectiveness

Device Name:	SAVI Applicator JUL 22 2008
Device Model Number:	SAVI-006SAVI-008SAVI-010
Classification Name:	Remote Controlled Radionuclide Applicator System(JAQ),21 CFR, 892.5700
Device Classification:	Class II
Predicate devices:	SAVI Applicator (K080565)Wright Vaginal Cuff Applicator (K980601)Comfort Catheters (K032372)Shielded Rectal Applicator Set (K033371)
Manufacturer:	Cianna Medical6 Journey, Suite 125Aliso Viejo, CA 92656
Establishment RegistrationNumber:	2032338
Official Contact:	Gary MocnikCianna Medical6 Journey, Suite 125Aliso Viejo, CA 92656Phone: (949) 360-0059

Intended Use:

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Device Description:

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

Strut Adjusted Volume Implant (SAVI)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Mocnik V.P. Regulatory Affairs and Quality Systems Cianna Medical, Inc. 6 Journey, Suite 125 ALISO VIEJO CA 92656

JUL 2 2 2008

Re: K081677

Trade/Device Name: SAVI Applicator Kit Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 10, 2008 Received: June 19, 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 a replacement for whole breast irradiation in the treatment of breast cancer have not been established.

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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 labcling.

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) 276-0120. 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,

Valerith

Donna-Bea Til lman, 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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_0816 77

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

X	OR	Over-The-Counter Use
Prescription Use		(Optional Format 1-2-96)
(Per 21 CFR 801.109)

signature

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K081677

Regulation Number and Section

§ 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.