ACCULEAF

K021338 · Direx Systems Corp. · IYE · Jan 7, 2003 · Radiology

Device Facts

• Record ID: K021338
• Device Name: ACCULEAF
• Applicant: Direx Systems Corp.
• Product Code: IYE · Radiology
• Decision Date: Jan 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years

Device Story

AccuLeaf is a LINAC-based Micro-Multi-Leaf-Collimator (MMLC) used in conformal stereotactic radiotherapy and radiosurgery. System components include MMLC module, LINAC interface module, workstation (with AccuLeaf-CS software), and distribution module. Device operates in conjunction with a LINAC, treatment couch, and data files containing aperture parameters. Radiation oncologists use the system to shape the LINAC beam to match tumor geometry, replacing traditional customized beam shaping blocks or circular/cut block collimators. By enabling finely shaped radiation fields, the device allows for targeted dose delivery to tumors while sparing surrounding normal tissue and critical organs.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance validation.

Technological Characteristics

LINAC-based MMLC system. Components: MMLC module, LINAC interface, workstation, distribution module. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-4 standards. Operates as an accessory to a linear accelerator for beam shaping.

Indications for Use

Indicated for patients requiring radiation therapy, including conformal stereotactic radiotherapy and radiosurgery, where precise beam shaping is required to target tumor volumes while sparing surrounding healthy tissue and critical organs.

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

• BrainLAB Med. GmbH's Micro-Multi Leaf Collimator (K970586)

Submission Summary (Full Text)

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

## 510(K) SUMMARY

# AccuLeaf 510(k) Number Koz | 33 S

## Applicant's Name:

Direx Systems Corp. 11 Mercer Road, Natick Business Park Natick, MA 01760 United States of America

Tel: [phone] Fax: [phone]

## Contact Person:

Larisa Gershtein Tel: [phone] Fax: [phone]

Trade Name: AccuKnife

Model:

AccuLeaf

## Classification Name:

Medical Linear Accelerator

## Classification:

The FDA has classified this type of devices as class II (product code 90 IYE, Regulation No. 892.5050) and they are reviewed by the Radiology Panel.

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

### Predicate Devices:

> BrainLAB Med. GmbH's Micro-Multi Leaf Collimator (K970586)

#### Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, AccuLeaf complies with the following voluntary standards: IEC 60601-1 (1990) +A1 (1993) +A2 (1995); IEC 60601-1-1 (2000); IEC 60601-1-2 (1993); IEC 60601-1-4 (2000).

### Intended Use:

The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years

#### Device Description:

AccuLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used during both conformal stereotactic radiotherapy and conformal stereotactic radiosurgery. It enables shaping the LINAC beam according to tumor shape and clinical demands. The device is composed of the MMLC module, the LINAC interface module, the Workstation (with AccuLeaf-CS), and the Distribution module. The device is operated in conjunction with a LINAC, its treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required during radiotherapy/ radiosurgery.

#### Substantial Equivalence:

Based on validations and performance testing results, Direx Systems Corp. believes that AccuLeaf is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 7 2003

Ms. Larisa Gershtein OA Manager DiREX Systems Corp. 11 Mercer Road NATICK MA 01760

Re: K021338 Trade/Device Name: AccuLeaf Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation system Regulatory Class: II Product Code: 90 IYE

Dated: October 7, 2002 Received: October 11, 2002

Dear Ms. Gershtein:

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 (PMA), it may be subject to 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 systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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

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 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

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

Enclosure

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

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K021338

#### Device Name:

AccuLeaf

#### Indications for Use:

The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years

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

510(k) Number L021338

Prescription Use (Per 21 CFR 801.109)

OR

Over the Use

Counter

David A. Leymon

(Division Sign-Off Division of Reproductive, I and Radiological Devic 7-6 510(k) Number