Mick Valencia Applicator Set

K230155 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Aug 30, 2023 · Radiology

Device Facts

• Record ID: K230155
• Device Name: Mick Valencia Applicator Set
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Aug 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Mick Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.

Device Story

The Mick Valencia Applicator is a passive, reusable accessory for remote afterloading brachytherapy. It consists of a tungsten-shielded applicator with a plastic cap, available in 20mm and 30mm diameters. The device is placed on the patient's intact skin and locked into position; it serves as a physical guide for a radioactive source delivered from an external HDR afterloader via a transfer tube. The applicator provides a defined path for the source to deliver a specific dose distribution to the target volume. It does not control the afterloader or the radiation dose. Used in clinical settings by radiation oncologists, physicists, dosimetrists, and therapists. The system is a closed path, preventing source contact with bodily fluids. Benefits include precise, homogeneous dose delivery to surface lesions while shielding surrounding tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and performance comparisons to the predicate device. Bench testing was performed to verify connection integrity to transfer tubes.

Technological Characteristics

Materials: Tungsten, plastic, stainless steel. Principle: Passive guide for HDR brachytherapy source. Form factor: 20mm and 30mm diameter applicators. Connectivity: Mechanical click-fit connection to HDR afterloader transfer tubes. Sterilization: Provided non-sterile; reusable, cleanable, and disinfectable. MR status: MR unsafe.

Indications for Use

Indicated for patients with skin or surface lesions (benign or malignant) requiring HDR brachytherapy treatment, regardless of age, gender, or ethnicity.

Regulatory Classification

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.

Predicate Devices

• Valencia Skin Applicator Set (K073107)

Submission Summary (Full Text)

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August 30, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and 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.

Mick Radio-Nuclear Instruments, Inc. % James Hurlman Director, Quality Management & Regulatory Affairs 521 Homestead Avenue MOUNT VERNON NY 10550

Re: K230155

Trade/Device Name: Mick Valencia Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ Dated: August 2, 2023 Received: August 3, 2023

Dear James 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 may, 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 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

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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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Locon Werder

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230155

### Device Name

MICK Valencia Applicator Sets

Indications for Use (Describe)

The intended use of the MICK Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------|
| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| | <span></span> 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 MICK, a BEBIG Medical company. The word "MICK" is written in large, blue, sans-serif font. Below the word "MICK" is the phrase "A BEBIG Medical company" written in a smaller, orange, sans-serif font.

Mick Radio-Nuclear Instruments, Inc. A BEBIG Medical Company

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

Main: [phone] Fax: [phone] Toll Free: +1 877 597 MRNI E-Mail: [e-mail]

### Traditional 510(k) Summary of Safety and Effectiveness Information As required by section 807.92(c) K230155

August 28, 2023

#### 1. General Provisions

| Common Name: | Remote controlled radionuclide brachytherapy source (JAQ |
|-------------------|----------------------------------------------------------|
| Proprietary Name: | Mick Valencia Applicator Set |
| Owner Name | Mick Radio-Nuclear Instruments, Inc. |
| Address | 521 Homestead Avenue<br>Mount Vernon, New York 10550 |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Name | Isaac Strickland |
| Contact email | [e-mail] |

#### Name of Predicate Device: 2.

| Original<br>510(k) # | Trade/ Device Name | Regulation<br>Number | Regulatory<br>Classification | Product<br>Code | Review Panel |
|----------------------|------------------------------|----------------------|------------------------------|-----------------|--------------|
| K073107 | Valencia Skin Applicator Set | 21 CFR 892.5700 | Class II | JAQ | Radiology |

#### 3. Classification

Class 2, Product Code: JAQ Regulation Number: 21 CFR 892.5700

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#### 4. Intended Use

The intended use of the Mick Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.

#### Device Description 5.

The Mick Valencia Applicator is used for remote afterloading treatment on intact skin/surface. The applicator with associated plastic cap is placed onto the patient, locked into position, and connected to the remote afterloading equipment (via transfer tube) to facilitate the brachytherapy treatment in accordance with the physician approved treatment parameters. The radioactive source travels from the machine into the applicator and deliver the desired dose distribution to the defined treatment volume. When the treatment is completed, the source returns to the machine. The applicator is disconnected from the treatment unit and removed from the patient.

The applicator does not control the treatment unit, it strictly provides a treatment path for the radioactive source. The Mick Valencia applicator is temporarily placed during the treatments designed as a closed system to prevent the radioactive source from coming in contact with bodily fluids.

The device is the same as the legally marketed device cited, both in design and materials.

Image /page/4/Picture/6 description: The image shows two sets of metal objects. Each set contains two objects that appear to be probes or sensors. The objects have a cylindrical base and a rounded or cylindrical top, with a thin metal rod extending from the side.

MICK Valencia Skin Applicator

Elekta Valencia Skin Applicator

Image /page/4/Figure/9 description: The image shows a technical drawing with several dimensions labeled. The dimensions include Dim. A, Dim. B, Dim. C, Dim. D, and Dim. E. The drawing also labels the source cable and shielding of the device. Additionally, a measurement of 3.75 is shown on the right side of the image.

MICK Valencia Skin Applicator

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| Set | Model | Description | Dim A | Dim B | Dim C | Dim D | Dim E |
|------------------|---------|-----------------------------|-------|-------|-------|--------|-------|
| 1503<br>(BEBIG) | 1503-20 | Valencia applicator<br>20mm | 20 | 28 | 95 | 91.25 | 105 |
| | 1503-30 | Valencia applicator<br>30mm | 30 | 36 | 115 | 111.25 | 129 |
| 1504<br>(Varian) | 1504-20 | Valencia applicator<br>20mm | 20 | 28 | 113 | 109.25 | 123 |
| | 1504-30 | Valencia applicator<br>30mm | 30 | 36 | 113 | 109.25 | 127 |

#### 6. 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.

#### 7. Non-Clinical Tests

Non-clinical testing is performed on the Mick Valencia Applicator connection to the transfer tube (the transfer tubes are supplied by the Afterloader manufacturer). These are bench top tests, performed on every applicator produced.

#### 8. Afterloader Compatibility

The Mick Valencia Applicator Set is compatible with the following HDR afterloaders, BEBIG Medical GmbH model Saginova®. Varian model GammaMedplus™ and Varian model Bravos afterloaders. The Mick Valencia Applicator sets are not compatible with Elekta afterloaders.

#### 9. Biocompatibility

The materials in the subject device are the same as the previously cleared predicate device and thus, there are no new biocompatibility concerns.

#### 10. Summary of Similarities and Differences

The Mick Valencia Applicator Sets are substantially equivalent in design, manufacture, construction and materials and have the same intended use and performance characteristics to the predicate device. The fundamental scientific technology is unchanged from the original predicate device. The connectors used on the Mick Valencia Applicator sets, to attach to the afterloaders transfer tubes, are substantially equivalent to the predicate device in their fundamental design for a standard click fit type connector.

Some differences from the predicate device are as follows;

1) Our device has more of a dome shape then the predicate device,

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- 2) the shaft and tube diameters are slightly thicker, and
- 3) the Mick Valencia Applicator set comes with two marker caps; one of the marker caps is used for applicator placement, while the other cap is placed on the target area for treatment.
- 4) The Mick Valencia Applicator set comes in two sizes, in 20 mm & 30 mm diameters and both sizes are compatible with the BEBIG Medical GmbH model Saginova®, the Varian model GammaMedplus™ and the Varian model Bravos afterloaders.

#### 11. Comparison Table

The MICK Valencia Applicator Set has the same functionality, performance and design as the predicate device the Nucletron/Elekta Valencia Skin Applicator. The equivalence is based on a comparison of clinical, technical and biological aspects of the two devices. The following table identifies the clinical, technical and biological aspects of the predicate device and the MICK Valencia Skin Applicator Set:

| Equivalence Table | Predicate Device<br>Nucletron/Elekta<br>Valencia Skin Applicator<br>K073107 | MICK Valencia Skin<br>Applicator Sets<br>K230155 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------|
| Clinical Aspects | | |
| Intended Purpose: HDR Brachytherapy of<br>skin/surface lesions | Yes | Yes |
| Suitable for any patient with skin/surface lesions<br>(benign or malignant) regardless of their age,<br>gender, ethnicity or predisposition. | Yes | Yes |
| Can be used for any site on the body surface that<br>has been prescribed HDR Brachytherapy<br>treatment | Yes | Yes |
| Applicator is placed in direct contact with the<br>treatment area/skin surface. | Yes | Yes |
| Long term side effects are limited to a slight mark<br>or discoloration of the skin and/or hair loss in the<br>treatment area and is dependent on the<br>prescription dose | Yes | Yes |
| Patient is under the care of a Radiation<br>Oncologist, physicists, dosimetrists and radiation<br>therapists trained in Radiation Oncology and,<br>specifically, brachytherapy techniques | Yes | Yes |
| Technical Aspects | | |
| Available in 20 mm and 30mm diameter | Yes | Yes |
| Only one source position is used for the<br>treatment | Yes | Yes |
| Source delivery through a single channel (transfer | Yes | Yes |
| | | |
| tube) | | |
| Tungsten shielded applicator with reinforced<br>shielding in the dome to reduce dose from the<br>backside of the applicator | Yes | Yes |
| Includes flattening filter for homogeneous dose<br>distribution | Yes | Yes |
| Plastic caps available: providing a flat surface<br>improved homogeneous dose | Yes | Yes |
| Filtering low dose scatter radiation | Yes | Yes |
| Improved applicator positioning by<br>imprinting skin surface | Yes | Yes |
| 2 types of caps available (with and without<br>a marker) | Yes | Yes |
| The device is reusable | Yes | Yes |
| The applicator can be cleaned and disinfected | Yes | Yes |
| Applicator is MR unsafe | Yes | Yes |
| Provides and unobstructed path for the<br>radioactive source | Yes | Yes |
| Connects securely to remote afterloading<br>brachytherapy equipment via transfer tubes | Yes | Yes |
| Biological Aspects | | |
| The applicators are made from the same<br>materials. (tungsten, plastic caps, stainless steel) | Yes | Yes |
| The applicators have the same manufacturing<br>process | Yes | Yes |
| The applicators come in direct contact with skin<br>surface | Yes | Yes |
| Caps are provided for treatment to provide<br>filtration of scatter radiation. | Yes | Yes |
| The applicators are made from materials that are<br>biocompatible | Yes | Yes |
| Provided Non-Sterile | Yes | Yes |

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#### Summary of technological considerations: 12.

The Mick Valencia Applicator Set is substantially equivalent to the cleared predicate device Valencia Skin Applicator Set, 510(k): K073107