BEAM BLOCK TRAYS

K964840 · Aktina Medical Physics Corp. · IYE · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K964840
• Device Name: BEAM BLOCK TRAYS
• Applicant: Aktina Medical Physics Corp.
• Product Code: IYE · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy.

Device Story

Beam Block Trays support beam shaping/defining blocks for external photon radiation therapy; used in radiation oncology departments; operated by medical physicists or radiation therapists. Device holds shielding blocks in position relative to radiation beam; ensures accurate dose delivery to target tissue while sparing healthy tissue. Benefits include precise beam modulation and patient safety during radiotherapy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Support tray for radiation therapy beam shaping blocks. Materials and construction identical to predicate. Class II device (21 CFR 892.5050).

Indications for Use

Indicated for use as a support for beam shaping or beam defining blocks during external beam (photon) radiation therapy in patients requiring radiation treatment.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• MED-TEC, Inc. Beam Blocking Trays (K944315)

Submission Summary (Full Text)

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FEB 11 1997
K964340

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

October 16, 1996

## 1. General Provisions

**Common/Usual Name:** Beam Block Trays or Shadow Trays
**Proprietary Name:** Beam Block Trays
**Applicant Name and Address:**
Aktina Medical Physics Corporation
360 North Route 9W
Congers, NY 10920

## 2. Name of Predicate Devices:

(1) MED-TEC, Inc. Beam Blocking Trays (K944315)

## 3. Classification

This device is classified as a class II device according to 21 CFR 892.5050

## 4. Performance Standards

Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

## 5. Intended Use and Device Description

This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy.

## 6. Biocompatibility

No issues of biocompatibility 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

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 seq. (1977).

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characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.