This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) 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 interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.

Device Description

The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.

AI/ML Overview

This document describes a 510(k) premarket notification for the "HDR Miami Applicator." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on comparing the new device's design, materials, intended use, and performance characteristics to those of the predicate device, rather than requiring extensive clinical studies to prove effectiveness from scratch.

Therefore, the provided document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria. It focuses on asserting substantial equivalence.

Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are not detailed in terms of quantitative performance metrics, but rather the device's characteristics being "substantially equivalent" to the predicate. The "reported device performance" is essentially that it functions similarly to the predicate.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (as stated in the document)
Design and Construction Similarity to Predicate Device	"This device is similar in design and construction... to the predicate devices."
Identical Materials to Predicate Device	"...utilizes the identical materials... to the predicate devices."
Same Intended Use as Predicate Device	"...and has the same intended use... to the predicate devices." Intended use: "Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system." More specifically, "placed in the vicinity of the cervix via the vagina just as described for the predicate device."
Same Performance Characteristics as Predicate Device	"...and has the same... performance characteristics to the predicate devices."
No New Issues of Safety or Effectiveness compared to Predicate	"No new issues of safety or effectiveness are introduced by using this device."
Biocompatibility (no new issues)	"No new issues of biocompataibility are raised with regard to this device."
Compatibility with existing HDR systems	"Designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A)."

Study Details (Information Not Provided in this Document for Performance Testing)

The document is a 510(k) premarket notification, which is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not present a study with detailed performance data against specific acceptance criteria in the manner one might expect for a novel device requiring a PMA, or a device with new technological characteristics.

Here's why the requested study details are largely absent:

Sample sizes used for the test set and the data provenance: Not applicable for a substantial equivalence claim based on design/material similarity. No clinical test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
Adjudication method: Not applicable.
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 device is a physical applicator for radiotherapy, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. As above, this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for the 510(k) is the established safety and effectiveness of the predicate device.
The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of What the Document Conveys:

Device Name: HDR Miami Applicator
Intended Use: Used in brachytherapy to deliver intra-cavitary radiation therapy, specifically placed in the vicinity of the cervix via the vagina, similar to the predicate device. It is an accessory to the Varisource and Gammamed systems.
Predicate Device: Nucletron Miami Vaginal Applicator (K953946)
Demonstration of Acceptance/Compliance: The manufacturer asserts that the device is "substantially equivalent" to the predicate device because it is "similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics." They also state, "No new issues of safety or effectiveness are introduced by using this device." The FDA agreed with this assessment, hence the 510(k) clearance.
Regulatory Context: This is a Class II device (21 CFR 892.5700 - Remote controlled radio-nuclide applicator system). No specific performance standards have been established by the FDA for this type of device under Section 514 of the Food, Drug, and Cosmetic Act.

In essence, the "study" for this device's acceptance criterion is the comparison to the predicate device, and the "proof" is the detailed submission to the FDA outlining these similarities, which the FDA then reviewed and cleared. Performance is inferred to be equal to the predicate without independent, novel clinical studies.

Summary

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APR = 8 2002

Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

December 30, 2001

1. General Provisions

Common/Usual Name: Remote Controlled Radionuclide Applicator System

Proprietary Name:

HDR Miami Applicator

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550

2. Name of Predicate Devices:

Manufacturer	K Number
Nucletron Miami Vaginal Applicator	K953946

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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3. Classification

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

4. Performance Standards

Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

Intended Use and Device Description న్.

Biocompatibility 6.

No new issues of biocompataibility are raised with regard to this device.

7. Summary of Substantial Equivalence

This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 8 2002

Re: K020176

Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550

Trade/Device Name: HDR Miami Applicator HDR Brachytherapy Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system

Regulatory Class: II Product Code: 90 JAQ Dated: January 7, 2002 Received: January 18, 2002

Dear Mr. Mick:

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.

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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: To be assigned

KO 20176

Device Name: HDR Miami Applicator

Indications for Use:

Prescription Use ✓

Yurid A. Stepanov

(Division Sign Division of Rep and Radiologic 510(k) Numb

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.