2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy.

Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors are now treated by internal exposure to radiation emitted from sealed radioactive sources.

Two common modalities of this are Low Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina.

HDR Miami Applicator: This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K89113) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and intrauterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.

HDR Compatible Tandern and Ovoid Applicators: The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intra-cavitary treatment of cancer of the vagina and cervix.

CT Compatible F/S/D Applicators: CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

HDR CT Compatible Split Ring Applicator: The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

CCT HDR Tandem Ring Applicator with Rectal Retractor: The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/ Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

Device Description

2/3 Channel Endometrial Applicator Sets: The 2/3 Channel Endometrial Applicator is designed for the treatment of the endometrium and cervix. The applicator set includes 3 intrauterine tubes that are available in 3 cm and 5 cm configurations. These intrauterine tubes can be assembled using only 2 or all 3 intrauterine tubes, depending on the patient requirements. The only change to the device will be the labeling that the device is now MR Conditional.

Henschke Applicator Set: The Henschke Applicator is based on "Henschke style" geometry for brachytherapy of the endometrium and cervix. This applicator is similar in design to the Fletcher Applicator with the exception of semispherical ovoids. These ovoids are ideal for patients with narrow vaginas due to their small size, the ovoid tube is closer to the surface on the side of the cervix while maintaining distance within the fornices. The tandem is inserted into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional.

Fletcher (FSD) Applicator Set: The Fletcher Applicators are based on "Fletcher style" geometry for brachytherapy of the endometrium and cervix. The ovoids are cylindrical to create equal spacing in the vaginal fornices for a symmetrical dose distribution in this area. The tandem is inserted to into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional.

Miami Applicator Set: The Miami Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The design incorporates 7 treatment channels around the periphery of the cylinder body and includes a center channel that can accommodate an intrauterine tube. The intrauterine tubes are available with either a 30° angled tip or in a straight (0° angle) configuration. A stump plug is provided to seal the end of the applicator when an intrauterine tube is not required. Build-up caps are available for the cylinder body to provide added spacing between the mucosa and radioactive source. This applicator provides additional treatment options, with the peripheral channels, to increase the dose to the target area while limiting the dose to normal tissue. The only change to the device will be the labeling that the device is now MR Conditional.

Ring & Tandem Applicator Sets: The Ring & Tandem Applicator is based on the Stockholm technique for brachytherapy of the endometrium and cervix. The applicator consists of a ring tube and intrauterine tube that, when combined, create a fixed geometry and form a 90° angle. Build up caps of different diameters are provided for the ring tube that provide additional spacing between the radioactive source and mucosa. Including the Vienna Ring and Tandem Accessory Kit. The only change to the device will be the labeling that the device is now MR Conditional.

Segmented Vaginal Applicator Set: The Segmented Vaginal Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The intrauterine tubes are available in different angles and lengths to meet anatomical requirements. The four individual segment design allows the applicator length to be adjustable based on the treatment volume. Additionally, the segments are available in different diameters to match the patient's anatomy. The only change to the device will be the labeling that the device is now MR Conditional.

Split Ring Applicator Sets: The Splicator's patented design combines the benefits of several other intracavitary applicators. The ring tubes can be configured as a closed/complete ring or separated/" split' into four different distances, symmetrically or asymmetrically with the spacing bracket. Build-up caps of different diameters fit over the ring tubes to provide additional tissue spacing distance between the radioactive source and the cervix. The only change to the device will be the labeling that the device is now MR Conditional.

Vienna System: The Mick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Mick CT HDR Tandem I Ring Applicator and is indicated for High Dose Rate irradiation of the uterus and cervix. The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Mick CT HDR Tandem Ring Applicator. Pre-bent interstitial needles are intended to be used with the Vienna System but they are not manufactured by Mick 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) interstitial needles around the circumference of the ring to enhance the standard HDR treatment. The Vienna 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 needles. The Needle Collectors are part of the Vienna System and 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 and is MR Conditional.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for various radionuclide applicator systems. The core purpose of this submission is to add MR Conditional labeling to existing devices, meaning the devices are safe for use in specific MR environments. The letter explicitly states that there have been no changes to the devices themselves or their intended use, only to their labeling.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to demonstrating that the existing devices are indeed MR Conditional and comply with relevant safety standards for MR environments, specifically regarding radiofrequency-induced heating.

Based on the provided information, here's an analysis to address your request:

Acceptance Criteria and Study to Prove MR-Conditional Status

The primary acceptance criteria for this submission is to demonstrate that the various applicator sets are "MR Conditional" as per relevant standards (which are not explicitly detailed in the document but implied by the testing). This typically means ensuring that the device does not pose a safety hazard (e.g., excessive heating, significant artifact, or device malfunction) when exposed to a specified MR environment.

The study that proves the device meets the acceptance criteria for MR Conditional labeling is "Computational Modeling of Mick Radio-Nuclear Instruments HDR Brachytherapy Intracavitary Applicators for Radiofrequency-Induced Heating Evaluation Final Report."

Here's how the information provided aligns with your specific points:

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

Acceptance Criteria (Implicit for MR Conditional Labeling)	Reported Device Performance and Compliance
Device is safe for use in a specified MR environment (no significant radiofrequency-induced heating).	Results = MR Conditional. The submission states, "Computational Modeling of Mick Radio-Nuclear Instruments HDR Brachytherapy Intracavitary Applicators for Radiofrequency-Induced Heating Evaluation Final Report. Results = MR Conditional." This indicates the computational modeling demonstrated satisfactory performance regarding RF-induced heating.
Device integrity and function are maintained in specified MR environment.	Not explicitly detailed in the "Performance Test Results" section, but implicitly covered by the "MR Conditional" result. The document states "no new issues of safety or effectiveness are raised."
Minimal or acceptable image artifact in MR environment.	Not explicitly detailed in the "Performance Test Results" section; the focus of the reported study was "Radiofrequency-Induced Heating Evaluation." This is a common aspect of MR Conditional testing but not explicitly stated as having been evaluated in the provided text.
Proper labeling and instructions for use reflecting MR Conditional status.	The purpose of the Special 510(k) is to "add MR Conditional labeling" and modify "Instructions for Use for each of the listed devices to add MR Conditional labeling to each of them." This implies the acceptance criteria for labeling will be met by including this information.
No new issues of safety or effectiveness are raised by the modification (i.e., adding MR labeling).	The submission explicitly states, "No new issues of biocompatibility are raised with regard to the modification of the devices for MR Conditional labeling." and "By introducing this device, no new issues of safety or effectiveness are raised." This serves as a key acceptance criterion.

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

Sample Size for Test Set: This was a computational modeling study, not a study involving a "test set" of patients or physical devices in the traditional sense for performance evaluation (e.g., clinical images). The "sample size" would refer to the computational models of the various applicator sets. The document references the "GYN 1 Applicator Family" and "GYN II Applicator Family" as the devices being re-labeled, which includes multiple distinct applicators (e.g., CT/MR Fletcher, CT/MR Henschke FSD, CT/MR Split Ring, CT/MR Segmented Vaginal, CT/MR Miami, CT/MR 2/3 Channel Endometrial, CT/MR Ring & Tandem). Each of these would have been computationally modeled.
Data Provenance: The study was a "Computational Modeling" study which is a form of in silico (computer simulation) analysis. The document does not specify the country of origin of the modeling data or if it was retrospective/prospective in a clinical sense. Given it's a 510(k) submission to the FDA, the assessment was likely conducted to meet US regulatory requirements.

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)

This was a computational modeling study for MR safety, not a study relying on expert human readers to establish ground truth for clinical diagnostic purposes. Therefore, the concept of "experts establishing ground truth for the test set" (e.g., radiologists) is not applicable here. MR safety testing (including computational modeling) is typically conducted by engineers and physicists specializing in MR compatibility, following established standards (e.g., ASTM, ISO). The document does not specify the number or qualifications of the individuals who performed or validated the computational modeling.

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

Not applicable. As noted, this was a computational modeling study focused on MR safety (RF-induced heating). Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies where human reviewers disagree on findings.

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

No. This was a submission for MR Conditional labeling of medical devices (applicators), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not relevant to this submission.

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

Not applicable as this is not an algorithm/AI device. The "standalone" performance here relates to the inherent physical properties of the device in an MR environment, specifically its heating characteristics, which was assessed via computational modeling.

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

The "ground truth" for MR Conditional status in a computational modeling study is derived from established physics principles of electromagnetic interaction with materials, validated computational methods, and adherence to relevant international standards for MR safety testing (e.g., ASTM F2182 for RF-induced heating, ISO/TS 10974). The "Final Report" of the computational modeling likely presents this "ground truth" in terms of calculated temperature increases within the simulated device and surrounding tissue.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device and its assessment for MR Conditional labeling. This is not a machine learning or AI device.

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

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features a stylized caduceus, a symbol associated with medicine and healing.

March 20, 2020 Mick Radio-Nuclear Instruments, Inc. James Hurlman Director QA/RA 521 Homestead Avenue Mount Vernon, New York 10550 Re: K200221 Trade/Device Name: CT/MR 2/3 Channel Endometrial, CT/MR Segmented Vaginal, CT/MR Miami, CT/MR Fletcher, CT/MR Henschke FSD, CT/MR Split Ring Applicator Sets, CT/MR Ring & Tandem, including Vienna Accessory Kit Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ, IWJ

Dear James Hurlman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 28, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6641, Thalia.Mills(@fda.hhs.gov.

Sincerely,

Michael D. O'Hara

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

Mick Radio-Nuclear Instruments, Inc. February 28, 2020 % Mr. James Hurlman Director QA/RA 521 Homestead Avenue MOUNT VERNON NY 10550 Re: K200221 Trade/Device Name: 2/3 Endometrial Applicator Sets, Segmented Vaginal Applicator, HDR Miami Applicator, HDR Compatible Tandem and Ovoid Applicators, CT Compatible F/S/D Applicators, HDR CT Compatible Split Ring Applicator, and CT HDR Tandem Ring Applicator with Rectal Retractor Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAO, IWJ Dated: January 22, 2020 Received: January 29, 2020

Dear Mr. Hurlman:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Enclosure

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Indications for Use

510(k) Number (if known) K200221

Device Name

2/3 Endometrial Applicator Sets, Segmented Vaginal Applicator, HDR Compatible Tandem and Ovoid Applicators, CT Compatible F/S/D Applicators, HDR CT Compatible Split Ring Applicator, and CT HDR Tandem Ring Applicator with Rectal Retractor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Special 510(k) Summary for compliance with CFR 807.92

March 3, 2020

1. General Provisions

Common Name:	Radionuclide brachytherapy source (JAQ) and Manualradionuclide applicator system (IWJ).
Proprietary Name:	The GYN 1 Applicator Family - Intracavitary- CT/MR Fletcher,- CT/MR Henschke FSD,- CT/MR Split Ring Applicator SetsThe GYN II Applicator Family- CT/MR Segmented Vaginal,- CT/MR Miami,- CT/MR 2/3 Channel Endometrial,- CT/MR Ring & Tandem, including Vienna Accessory Kit
Owner Name	Mick Radio-Nuclear Instruments, Inc.
Address	521 Homestead AvenueMount Vernon, New York 10550
Telephone	(914) 667-3999
Fax	(914) 665-8834
Contact Name	Isaac Strickland
Contact email	isaac.strickland@micknuclear.com

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2. Name of Predicate Device:

Original510(k) #	Trade/ Device Name	RegulationNumber	RegulatoryClassification	ProductCode	Review Panel
K993472	Segmented Vaginal Applicator	21 CFR 892.5700	Class II	JAQ	Radiology
K020176	HDR Miami Applicator HDR Brachytherapy Applicator	21 CFR 892.5700	Class II	JAQ	Radiology
K040704	HDR Compatible Tandem and Ovoid Applicators (Henschke)	21 CFR 892.5700	Class II	JAQ	Radiology
K063381	CT F/S/D Compatible Applicators	21 CFR 892.5700	Class II	JAQ	Radiology
K063382	HDR CT Compatible Split Ring Applicator	21 CFR 892.5700	Class II	JAQ	Radiology
K122840	CT HDR Tandem/Ring Applicator with Rectal Retractor	21 CFR 892.5700	Class II	JAQ	Radiology
K871216	2/3 Endometrial Applicator Sets	21 CFR 892.5650	Class I	IWJ	Radiology

3. Reason for this Special 510(k) Premarket Notification

The purpose for this bundled submission is the modification of the labeling and Instructions for Use for each of the listed devices to add MR Conditional labeling to each of them.

4. Classification

This devices are classified as listed in the table above.

5. Intended Use and Device Description

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5. Intended Use and Device Description con't.:

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are not manufactured by Mick 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) interstitial needles around the circumference of the ring to enhance the standard HDR treatment. The Vienna 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 needles. The Needle Collectors are part of the Vienna System and 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 and is MR Conditional.

6. Drawings

Drawings of the devices are in the Device Description section of this submission.

7. Manufacturing Process

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

8. Biocompatibility

No new issues of biocompatibility are raised with regard to the modification of the devices for MR Conditional labeling.

9. Summary of Substantial Equivalence

There have been no changes to the devices or their intended use. Performance Test Results

In vitro Testing

Not applicable to the modification for the device. By introducing this device, no new issues of safety or effectiveness are raised.

In vivo Testing

Not applicable for the modification for the device.

Functional Testing

Computational Modeling of Mick Radio-Nuclear Instruments HDR Brachytherapy Intracavitary Applicators for Radiofrequency-Induced Heating Evaluation Final Report. Results = MR Conditional.

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10. Summary of Similarities and Differences

These devices are identical in design, manufacture, construction and materials and have the same intended use and performance characteristics to their original 510(k)'s. The modification to the devices will be to put MR Conditional labeling on both the individual product labeling and the IFU's. The fundamental scientific technology is unchanged from the original predicate device.

11. Comparison Table

The Table below compares the modification of these devices to the predicate device (Original 510(k). Included in these tables are a comparison of the materials and intended uses of these devices.

Original510(k) #	Trade/ Device Name	Predicate Device(Original 510(k))	Modified Device
K993472	Segmented Vaginal Applicator	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing - Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K020176	HDR Miami Applicator HDR Brachytherapy Applicator	Materials - MR Conditional	Same
		MR Testing – Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K040704	HDR Compatible Tandem and Ovoid Applicators (Henschke)	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K063381	CT F/S/D Compatible Applicators	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K063382	HDR CT Compatible Split Ring Applicator	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K122840	CT HDR Tandem/Ring Applicator with Rectal Retractor	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same
K871216	2/3 Endometrial Applicator Sets	Materials - MR Conditional	Same
		MR Testing - Not Complete	MR Testing – Complete
		MR Conditional Labeling - No	MR Conditional Labeling - Yes
		Intended Use	Same

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.