H.A.M. APPLICATOR

K961601 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Dec 23, 1996 · Radiology

Device Facts

• Record ID: K961601
• Device Name: H.A.M. APPLICATOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The H.A.M. Applicator is intended to be used as an accessory to high-dose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.

Device Story

H.A.M. Applicator functions as accessory to HDR remote-controlled radionuclide systems; positions radioactive sources in precise geometric relationship to treatment volume. Device consists of liquid silicone rubber body containing 3-24 embedded hollow tubes; tubes spaced 1cm laterally, 5mm from treatment surface. System includes H.A.M. Sandwich clamping device and Martin Arm/Clamp for table attachment. Used by physicians in clinical settings for superficial tumor treatment or intraoperative radiation therapy (IORT) during surgical exposure. Device facilitates delivery of radiation dose to target tissue via HDR system source-guide tubes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: liquid silicone rubber. Design: 3-24 embedded hollow tubes spaced 1cm on center laterally, 5mm from treatment surface. Function: accessory for positioning radioactive sources in HDR brachytherapy. Includes mechanical clamping components (H.A.M. Sandwich, Martin Arm/Clamp).

Indications for Use

Indicated for patients requiring high-dose-rate (HDR) brachytherapy for superficial tumors (external use) or tumor/tumor bed treatment during intraoperative procedures (IOHDR).

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.

Reference Devices

• Martin Arm/Clamp

Submission Summary (Full Text)

{0}

K96/601

# Attachment 2

## Premarket Notification [510(k)] Summary

DEC 23 1996

**Trade Name:** H.A.M. Applicator

**Common Name:** Applicator for remote controlled afterloading brachytherapy

**Classification Name and Number:** Remote controlled radionuclide applicator system (accessory), JAQ (per 21 CFR 892.5700)

**Class II, Radiology Panel (90)**

**Description:** The H.A.M. (Harrison-Anderson-Mick) Applicator system consists of the H.A.M. Applicator, the H.A.M. Sandwich (a clamping device) source-guide tubes, when required by certain HDR systems, and a Martin Arm/Clamp (a preamended device manufactured by Martin Medizin-Technik) which attaches the H.A.M. Sandwich to the operating table. The H.A.M. Applicator is manufactured from liquid silicone rubber and contains between three and twenty-four embedded hollow tubes. The tubes are spaced 1cm on center laterally and are positioned 5mm from the treatment surface.

**Intended Use:** The H.A.M. Applicator is intended to be used as an accessory to high-dose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.

**Technological Characteristics:** The technological characteristics of the H.A.M. Applicator and the predicate device are the same in that both are meant to position radioactive sources in a specific, known geometrical relationship to the treatment volume as prescribed by the physician.

**Prepared by:** Felix W. Mick, President
Mick Radio-Nuclear Instruments, Inc.
P.O. Box 99
1470 Outlook Avenue
Bronx, NY 10465
Tel: [phone]
Fax: [phone]

**Date:** 22 September 1996