NOMOS SLIT COLLIMATOR (BEAK)

K974310 · Nomos Corp. · IYE · Feb 6, 1998 · Radiology

Device Facts

• Record ID: K974310
• Device Name: NOMOS SLIT COLLIMATOR (BEAK)
• Applicant: Nomos Corp.
• Product Code: IYE · Radiology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® (K940412) Multileaf Intensity Modulating Collimator. Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

Device Story

NOMOS Slit Collimator (BEAK) is a tungsten block accessory for the MIMiC Multileaf Intensity Modulating Collimator; provides secondary collimation of radiation beams exiting the MIMiC system. Device allows delivery of treatment slices with 1-8 mm thickness; functions similarly to secondary collimators or beam-shaping blocks used in linear accelerators. Used in clinical radiation therapy/radiosurgery settings; operated by trained medical personnel. Output is a physically shaped radiation beam; enables precise dose delivery for patient treatment. No software or electronic components; purely mechanical beam-shaping device.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Tungsten block; secondary collimator; slit widths 1-8 mm at isocenter; mechanical device; no energy source; no software; no connectivity.

Indications for Use

Indicated for use in radiosurgery or radiation therapy procedures requiring secondary collimation of radiation beams to achieve specific slice thicknesses (1-8 mm) in patients undergoing treatment with the NOMOS MIMiC Multileaf Intensity Modulating Collimator.

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

• Radionics Software Applications, Inc. (RSA) X-Knife (K953482)
• RSA Linac-Based Stereotactic Radiosurgery System (K923522)
• Heustis Compu-Cutter (K940145)

Reference Devices

• NOMOS MIMiC Multileaf Intensity Modulating Collimator (K940412)

Submission Summary (Full Text)

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

Act

K974310

## November 14, 1997

#### General Provisions 1.

Common/Usual Name:

Proprietary Name

Collimator

NOMOS Slit Collimator (BEAK™)

Applicant Name and Address

NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143

#### Name of Predicate Devices 2.

- Radionics Software Applications, Inc. (RSA) X-Knife (K953482); .
- RSA Linac-Based Stereotactic Radiosurgery System (K923522). .
- Blocks prepared at the user site using the Heustis Compu-Cutter (K ● 940145).

#### Classification 3.

The NOMOS Slit Collimator is an accessory to a medical charged-particle radiation therapy system or a beam shaping block:

- RS collimators are reviewed by the Center for Devices and Radiological ● Health's Division of Reproductive, Abdominal, ENT and Radiological Devices Classification Panel and were placed into Class II 21CFR 892.5050 (IYE).
- Beam shaping blocks are reviewed by the Center for Devices and . Radiological Health's Division of Reproductive, Abdominal, ENT and Radiological Devices Classification Panel and were placed into Class II 21CFR 892.5710 (IXI).

. )

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. (1977).

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#### Performance Standards 4.

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

#### Intended Use and Device Description 5.

Collimator (BEAKTM) is intended for use in NOMOS The Slit Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® (K940412) Multileaf Intensity Modulating Collimator. Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

Description: The Slit Collimator (BEAK) is tungsten block whose purpose is to provide secondary collimation for the radiation beam exiting from the NOMOS MIMiC (K940412). The MIMiC has the capability of delivering treatment slices whose width is either 8 mm or 16 mm. The Slit collimator, by providing secondary collimation of the 8 mm beam, allows slices to be delivered that are 1 - 8 mm in thickness without the need to modify the control mechanisms built into the MIMiC that ensure that leaf (vane) movement is functioning correctly. In this sense, the Slit Collimator serves the same purpose as the secondary collimators provided with radiosurgical systems or the secondary collimators, commonly called blocks, that are used with radiation therapy linear accelerators.

#### 6. Biocompatibility

Not applicable.

### 7. Summary of Substantial Equivalence

The design similarities between this device and the predicate devices are:

- The NOMOS Slit Collimator has the same basic design as the RS collimator ● (RDA X-Knife (K953482)) except for the slit vs. circulator shape of the collimator;
- The NOMOS Slit Collimator has the same intended use as the predicate RS . collimator or blocks; i.e., to collimate or shape the output beam produced by a linear accelerator or LINAC for RT/RS procedures;
- The NOMOS Slit Collimator uses the same radiodense material; i.e., tungsten.
- The design differences between the NOMOS Slit Collimator and the RS . Collimator and blocks is primarily in the shape of the aperture (i.e., the Slit Collimator is rectangular shaped while the RS collimator is circular and the blocks may be slit or irregular shape.

The NOMOS Slit Collimator is similar in design, materials, intended use, indications, contraindications and performance specifications to previously

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cleared devices. By introducing the NOMOS Slit Collimator, therefore, no new issues of safety or effectiveness are raised.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

e 1998 128

Marvin L. Sussan, Ph.D. Nomos Corporation 2591 Wexford Bayne Road Sewickley, PA 15143

Re:

K974310 Nomos Slit Collimator (BEAK) November 14, 1997 Dated: Received: November 17, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Dr. Sussan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

N'Liau Yu-

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: NOMOS BEAK™ Slit Collimator

Indications for Use:

The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® Multileaf Intensity Modulating Collimator (K940412). Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

ﺮ

OR Over-The Counter Use (Optional Format 1-2-95)

Daniel G. Hageman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

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