INNOCURE IMRT FILTER (COMPENSATORS)

K052383 · Innocure, LLC · IXI · Mar 29, 2006 · Radiology

Device Facts

• Record ID: K052383
• Device Name: INNOCURE IMRT FILTER (COMPENSATORS)
• Applicant: Innocure, LLC
• Product Code: IXI · Radiology
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Innocure Intensity Modulating Radiation Therapy Compensators are intended to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Device Story

Innocure IMRT Compensators are physical beam-shaping devices used in external beam radiation therapy. The device consists of precision-milled solid blocks (Aluminum 6061T6 or Brass 360) or molds (Styrofoam/Polyurethane) filled with Cerrobend or Tungsten metal powder. These filters are mounted to a linear accelerator block tray and placed in the radiation beam path between the source and the patient. The device modulates radiation intensity and shape based on the patient's specific therapy plan. It is operated by radiation therapy professionals in a clinical setting. By compensating for tissue heterogeneities or protecting healthy tissue, the device enables precise delivery of IMRT, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Aluminum (6061T6), Brass 360, Styrofoam/Polyurethane molds, Cerrobend, or Tungsten metal powder. Function: Passive radiation beam attenuation/shaping. Form factor: Solid blocks or filled molds mounted to linear accelerator block trays. No software or electronic components.

Indications for Use

Indicated for patients undergoing external beam radiation therapy requiring beam intensity modulation or shaping to compensate for missing tissue, tissue heterogeneities, or to protect underlying tissue.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• Southeastern Radiation Products, Inc., .Decimal Tissue Compensator/Intensity Modulator (K040804)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a date that appears to be stamped on a document. The date reads "MAR 29 2006". The text is in a simple, sans-serif font and is slightly faded, suggesting it was stamped with ink.

Image /page/0/Picture/1 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'K052382'. The characters are written in a casual, slightly slanted style, and the overall impression is that of a handwritten code or identifier.

Image /page/0/Picture/2 description: The image shows the logo for "innocure" with the tagline "Helping You Help Others". The logo features a stylized black lighthouse to the left of the text. The text is in a bold, sans-serif font.

# Premarket Notification 510(k) Summary as required by 21 CFR 807.92

#### Date summary was prepared:

February 15, 2006

## Manufacturer's Name:

Innocure, LLC 201 East Southern Avenue Suite 201 Tempe, AZ 85282-5133

#### Contact Person:

Donald W. Collins, Ph.D. Chairman and CTO 201 East Southern Avenue Suite 201 Tempe, AZ 85282-5133

| Phone: | 480-966-0980 |
|--------|-----------------------------|
| Fax: | 480-345-2850 |
| Cell: | 602-319-8620 |
| Email: | [e-mail] |

## Trade Name:

Innocure Intensity Modulating Radiation Therapy Compensators including:

Innocure IMRT Filter™ Innocure IMRT Radiation Blocking Filter™ Innocure Radiation Wound Protective Blocking Filter™

## Common Name:

Compensating Filters

## Classification Name:

Radiation Therapy Beam Shaping Block (21 CFR §892.5710, Product Code: IXI)

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for "innocure" with the tagline "Helping You Help Others". To the left of the text is a black and white graphic that resembles a lighthouse. The lighthouse has a black circle at the top, and the rest of the lighthouse is made up of vertical lines.

# Predicate Device:

Southeastern Radiation Products, Inc., K040804, ".Decimal Tissue Compensator/Intensity Modulator".

# Device Descriptions:

An "Innocure IMRT Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan and field identification. The Compensator device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block tray.

An "Innocure IMRT Radiation Blocking Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The Blocking device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.

An "Innocure Radiation Wound Protective Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.

## Intended Use:

Innocure Intensity Modulating Radiation Therapy Compensators are intended to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

## Technological Characteristics:

Innocure manufactures Intensity Modulated Radiation Therapy (IMRT) filters from a solid Aluminum (6061T6) block, solid Brass 360 block, and a reverse Styrofoam or Polystyrene Mold block to be filled with Molten Cerrobend or Tungsten Powdered Metal.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for "innocure" with the tagline "Helping You Help Others". To the left of the text is a black graphic that resembles a lighthouse. The lighthouse is wide at the bottom and tapers to a point at the top, with a black circle above it.

# Conclusions:

The subject devices, "Innocure "Innocure IMRT Fiiter™ (Compensators)", "Innocure IMRT Radiation Blocking Filters™ (Compensators)" and "Innocure Radiation Wound Protective Filters™ (Compensators)" for Radiation Therapy have the same intended use and similar characteristics as the predicate device and does not introduce new issues of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle.

Public Health Service

MAR 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Donald W. Collins, Ph.D. Chairman and CTO Innocure, LLC 201 East Southern Avenue Suites 201 & 202 TEMPE AZ 85282-5133

Re: K052383

Trade/Device Name: Innocure Intensity Modulating Radiation Therapy Compensators including: Innocure IMRT Filter™, Innocure IMRT Radiation Bolcking Filter™, Innocure Radiation Wound Protective Blocking FilterTM Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: February 15, 2006 Received: February 21, 2006

Dear Dr. Collins:

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. 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 (Special Controls) or class III (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 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); good manufacturing practice requirements as set forth in the quality of your (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Higdon

Namey C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Annocure. The logo features two stylized figures standing side by side, with circular heads and tall, triangular bodies. To the right of the figures is the word "annocure" in a bold, sans-serif font. Below the word "annocure" is the tagline "Helping You Help Others" in a smaller font, followed by the trademark symbol.

#### Indications for Use

#### K052383 510(k) Number:

Innocure Intensity Modulating Radiation Therapy Device Name: Compensators including:

> Innocure IMRT Filter™ Innocure IMRT Radiation Blocking Filter™ Innocure Radiation Wound Protective Blocking Filter™

Indications for Use: Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Prescription Use YES (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

Innocure, LLC

**Tab 4**