The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor. The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems. Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap.

AI/ML Overview

The information provided is for a 510(k) premarket notification for the Vienna System, an accessory to a remote controlled radionuclide applicator system used in brachytherapy. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of diagnostic accuracy.

Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics for an AI/device algorithm are not applicable to this type of regulatory submission. The document emphasizes mechanical design, material equivalence, and intended use as the basis for clearance.

Here's a breakdown of the relevant information from the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of design, construction, materials, intended use, and performance characteristics (which are mechanical/functional in nature, not diagnostic accuracy). The core "acceptance" is that "No new issues of safety or effectiveness are introduced by using this device."
Reported Device Performance: No quantitative performance metrics (ee.g., sensitivity, specificity, accuracy) are reported because the device is an accessory for brachytherapy application, not a diagnostic or AI-driven decision support system. The performance is inferred by its equivalence to predicate devices and its ability to function as intended without altering the indication of use of the main applicator.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. It's a review of a medical device accessory's design and materials.

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)

Not applicable. There is no "ground truth" establishment in the context of diagnostic assessment for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication for diagnostic outcomes.

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

Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study or AI improvement metrics are relevant.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth for diagnostic purposes is used. The "ground truth" in this context is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI algorithm.

Summary of Relevant Information from the Document:

Device Name: Vienna System
Regulatory Class: II (21 CFR 892.5700)
Product Code: JAQ
Intended Use: As an accessory to the Mick CT HDR Tandem/Ring Applicator for High Dose Rate irradiation of the uterus and cervix. It enhances the standard HDR treatment by enabling the introduction of up to nine interstitial needles.
Key Argument for Clearance: Substantial Equivalence to predicate devices (K030110, K122840, K080934).
Basis for Substantial Equivalence:
- Similar in design and construction.
- Utilizes the same materials (Acetal for Build-Up Cap, Titanium for Colpostat/Tandem material).
- Has the same intended use and performance characteristics (mechanical/functional).
- Crucially, "No new issues of safety or effectiveness are introduced by using this device."
Manufacturing: According to Good Manufacturing Practices (GMPs) as defined in 21 CFR part 820.
Biocompatibility: No new issues raised regarding materials.
Performance Testing: "Performance Test Results or In vitro Testing / In vivo Testing are not applicable to the Vienna System" because no new issues of safety or effectiveness are raised and the fundamental scientific technology is unchanged from the predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2015

Mick Radio-Nuclear Instruments, Inc. % Mr. Chuck Smith Manager, Quality Assurance 521 Homestead Avenue MOUNT VERNON NY 10550

Re: K142597

Trade/Device Name: Vienna System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 9, 2015 Received: January 12, 2015

Dear Mr. Smith:

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. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

for

Robert Ochs, Ph.D. Acting 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) K142597

Device Name Vienna System

Indications for Use (Describe)

The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix. The Viema System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. Pre-bent interstital needles are intended to be used with the Vienna System but they are not manufactured by Nfick Radio-Nuclear Instruments, Inc. and are not part of this submission.

Build-Up Caps

When used with the CT HDR Tandem/Ring Applicator, the Vienna Build-Up Caps enable the introduction of up to nine (9) interstital needles around the circumference of the ring to enhance the standard HDR treatment. The Viema System is not designed to be used with any Rectal Retractor due to the introduction of the interstitial needles.

Needle Collectors

When used in conjunction with the Vienna Build-Up Caps, the Needle Collectors will maintain and control the positioning of an array of up to nine (9) interstitial needle Collectors are part of the Vienna System ans as such, are not designed to be used with any Rectal Retractor.

The Vienna System is designed to be used as an accessory with the Applicator and this does not alter the indications for use.

Type of Use (Select one or both, as applicable)
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[2] Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol on the left, followed by the company name "Eckert & Ziegler" in black text. The symbol is made up of two horizontal bars with an oval in the middle.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

Traditional 510(k) Summary for compliance with CFR 807.92

September 12, 2014

1. General Provisions

Trade/Proprietary:Name	Vienna System.
Common Name:	Brachytherapy Applicator
ClassificationName:	Accessory to Remote Controlled Radionuclide ApplicatorSystem (21 CFR 892.5700 - Product Code JAQ)
OwnerNameAddress	Mick Radio-Nuclear Instruments,Inc. 521 Homestead AvenueMount Vernon, New York10550 (914) 667-3999
FaxContact Name	(914) 665-8834Chuck SmithManager, Quality Assurance / Regulatory
Contact email	Affairs chuck@micknuclear.com

1. Device Name: Vienna System

Name of Predicate Device: 3.

The device included in this submission are substantially equivalent to the legally marketed predicate devices cited in the following table:

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Image /page/4/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol on the left and the company name "Eckert & Ziegler" on the right. The symbol is made up of a maroon rectangle on top, a maroon oval in the middle, and another maroon rectangle on the bottom. The text is in a simple, sans-serif font.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

New Device	Predicate Device	Manufacturer	K Number
Vienna System(Cat. # 0720)	CT HDR Tandem/RingApplicator with Rectal Retractor	Mick Radio-Nuclear	K030110
	HDR CT CompatibleTandem/Ring Applicator with 2Piece Rectal Retractor	Mick Radio-NuclearInstruments Inc	K122840
	Nucletron Vienna Ring CT-MR Applicator	Nucletron B. V.	K080934

4. Reason for this Traditional 510(k) Premarket Notification

The purpose of this 510(k) submission is to obtain clearance to market a new device that is designed to be used with the Mick CT HDR Tandem/Ring Applicator with Rectal Retractor (Catalog # 0407). The accessories enhance the CT HDR Tandem/Ring Applicator, without changing the intended use of the applicator.

5. Classification

The device is classified as a class II device according to 21 CFR 892.5700.

6. Intended Use and Device Description

The device that is submitted for clearance in this 510(k) is intended to be used with the Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor and is intended for use in Brachytherapy. It is indicated for use where high dose rate (HDR) irradiation of the uterus and cervix is an accepted clinical practice. The applicator is designed to be compatible with the sealed sources found in High Dose Rate After-Loaders and does not modify or change the source, source packaging or remote source positioning mechanisms found on these after-loaders.

The use of the Vienna System with the CT HDR Tandem / Ring Applicator does not alter the intended use of the applicator. There are no special controls needed for this device.

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Image /page/5/Picture/0 description: The image contains the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol to the left of the company name. The symbol is made up of a maroon oval shape between two maroon rectangles.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor.

The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems.

Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap. The inserted needles can be clipped to the Needle Collector to provide an easy means of indexing and organizing the needles and to ensure needle stabilization at the insertion site. When used with rigid interstitial needles, it is possible to achieve asymmetric alteration of the dose distribution. Rigid interstitial needles are not supplied by Mick Radio-Nuclear Instruments, Inc. and must be purchased separately.

7. Drawings

Drawings of each of the components of the Vienna System are provided in Vol 9.

8. Manufacturing Process

The Vienna System is manufactured according to Good Manufacturing Practices (GMPs) as defined in 21CFR part 820. The processes used to fabricate these accessories are similar to those used for the predicate device described in this 510(k) notification.

9. Biocompatibility

No new issues of biocompatibility are raised with regard to the use of materials in manufacturing the Vienna System.

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Image /page/6/Picture/0 description: The image contains the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol to the left of the company name. The symbol is made up of a maroon oval shape between two maroon rectangles.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

10. Summary of Substantial Equivalence

The Vienna System is similar in design and construction, utilizes the same materials, and has the same intended use and performance characteristics of the predicate devices. The fundamental scientific technology is unchanged from the original predicate devices. No new issues of safety or effectiveness are introduced by using this device. Therefore, Performance Test Results or In vitro Testing / In vivo Testing are not applicable to the Vienna System. By introducing the Vienna Systems, no new issues of safety or effectiveness are raised.

11. Comparison Table

The tables below compare the individual accessory to its predicate device. tables are a comparison of the materials and intended uses of these devices.

Device / TradeName	CT HDRTandem/ RingApplicator w/RectalRetractor	Nucletron ViennaRing CT-MRApplicator	HDR CTCompatibleTandem/ RingApplicator w/ 2Piece RectalRetractor	ViennaSystem
K Number	K030110 (MickRadio Nuclear)	K080934(Nucletron)	K122840 (MickRadio-Nuclear)	To bedetermined
Intended Use	High dose rateBrachytherapytreatment of theuterus andcervix	High dose rateBrachytherapytreatment of theuterus and cervix	High dose rateBrachytherapytreatment of theuterus and cervix	High dose rateBrachytherapytreatment of theuterus andcervix
Shielding	No	No	No	No
Build-Up CapMaterial	Acetal	Acetal	Acetal	Acetal
Colpostat /Tandem Mat'I	Titanium	Composite FiberTubing	Titanium	Titanium
NeedleCollector Mat'l	N/A	N/A	N/A	PPSU

Vienna System (Catalog # 0720)

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.