THE NOMOS MINICRANE

K964740 · Nomos Corp. · JAI · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K964740
• Device Name: THE NOMOS MINICRANE
• Applicant: Nomos Corp.
• Product Code: JAI · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Intended Use

The NOMOS MINICRANE is intended to be used as an accessory to radiation therapy patient support assemblies. The MINICRANE is used to provide a simple method for indexing the patient/table a prescribed distance.

Device Story

The NOMOS MINICRANE is a mechanical accessory for radiation therapy patient support assemblies; it attaches to table side rails or fixation devices like the NOMOGrip. The device features an arm of variable length and a battery-operated digital micrometer. It functions by measuring and displaying the table position in millimeters relative to a set origin. Operated by a technologist in a clinical radiation therapy setting, it allows for precise table movement to predefined points along the Y-axis. By providing accurate indexing, it assists in consistent patient positioning for treatment, potentially improving the accuracy of radiation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical accessory for radiation therapy tables; includes a battery-operated digital micrometer for position display. Attaches to table rails or fixation devices. Dimensions vary by arm length. No software or connectivity features.

Indications for Use

Indicated for use as an accessory to radiation therapy patient support assemblies to display the prescribed distance of patient indexing.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• NOMOS CRANE (K941927)

Submission Summary (Full Text)

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FEB 11 1997
510(k) MINICRANE 11/19/96 Page 17
K964740

# Appendix 1 510(k) Summary (pursuant to 513(l))

## Summary of Safety and Effectiveness
## The NOMOS® MINICRANE™

Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act

## I. General Information:

Classification Name: Accessory to Powered Radiation Therapy Patient Support Assembly

Common/Usual Name: Caliper

Trade/Proprietary Name: NOMOS® MINICRANE™

Applicant's Name and Address:

Marvin L. Sussman, Ph. D.
Vice President Product Assurance and Support
NOMOS Corporation (NOMOS)
2591 Wexford Bayne Road (Suite 400)
Sewickley, PA 15143

## II. Name of predicate device(s):

NOMOS CRANE (K941927)

## III. Classification:

Powered Radiation Therapy (RT) Patient Support Assembly Accessories are Class II (21 CFR 892.5770).

## IV. Performance Standards:

No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description:

Intended Use: The NOMOS MINICRANE is intended to be used as an accessory to radiation therapy patient support assemblies. The MINICRANE is used to provide a simple method for indexing the patient/table a prescribed distance.

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510(k) MINICRANE 11/19/96 Page 18

Device Description: The MINICRANE is an accessory to radiation therapy patient support assemblies which attaches to the an appropriate part of the radiation therapy table (table) such as the side (hand) rails or a fixation device such as the NOMOGrip. The arm of the MINICRANE is available in a number of lengths to accommodate various treatment positions. The MINICRANE locks onto the table or fixation device. Patient access to the treatment table is not obstructed and the table can be freely adjusted in the X, Y, and Z axes. The arm of the MINICRANE incorporates a battery-operated digital micrometer which displays, in millimeters, the position of the table with respect to an origin. The micrometer may be set to display the value in inches, however, the Operator's Manual instructs the user to set the micrometer to display millimeters. With the MINICRANE attached to the treatment table, a technologist can move the table to a predefined point in the Y axis. The coordinate of the MINICRANE will identify this point within the limits of accuracy of the stability of the treatment table.

## VI. Summary of Substantial Equivalence:

Indications: The indications for the NOMOS MINICRANE are the same as those for the predicate NOMOS CRANE; i.e., to display the prescribed distance of patient indexing.

Design: The design of the NOMOS MINICRANE is similar in concept to the relevant feature of predicate NOMOS CRANE.

Materials: The materials used in the NOMOS MINICRANE are similar to those used in the relevant feature of the predicate NOMOS CRANE.

Manufacturing: The manufacturing processes used in the NOMOS MINICRANE are similar to specific aspects used in the manufacture of NOMOS CRANE.

Specifications: The specifications of the NOMOS MINICRANE are similar to the predicate NOMOS CRANE.

Conclusions: The indications, design, materials, manufacturing, and specifications of the NOMOS MINICRANE do not raise any new issues relating to safety and effectiveness.

NOMOS thus considers the NOMOS MINICRANE equivalent to the predicate NOMOS CRANE.

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 premarket 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 lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits.” 42 Fed. Reg. 42,520 et seq. (1977).

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