XKNIFE-4

K981055 · Radionics, Inc. · IYE · Sep 29, 1998 · Radiology

Device Facts

• Record ID: K981055
• Device Name: XKNIFE-4
• Applicant: Radionics, Inc.
• Product Code: IYE · Radiology
• Decision Date: Sep 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.

Device Story

XKnife-4 is a computer-based radiation treatment planning system for LINAC-based radiosurgery and radiotherapy. It processes clinical data to generate treatment plans for stereotactic, collimated beam delivery. The system supports the use of LINAC jaws and circular collimators to shape radiation beams. Used in clinical settings by trained professionals, the system facilitates the transfer of treatment parameters to the clinical delivery system. It includes quality assurance procedures to ensure accurate parameter transfer. The device benefits patients by enabling precise, computer-planned radiation delivery.

Clinical Evidence

Bench testing only. Nonclinical tests were conducted to validate the system design, including the use of LINAC jaws, and to demonstrate that the software meets all product requirements.

Technological Characteristics

Treatment planning software, stereotactic hardware, and LINAC-based beam shaping components (jaws and circular collimators). System supports computer-planned radiation delivery. Verification and QA procedures are integral to the system architecture.

Indications for Use

Indicated for patients requiring stereotactic, collimated beam, LINAC-based radiosurgery and radiotherapy 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

• XKnife-3 System
• XPlan-1 System

Submission Summary (Full Text)

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510(k) Summary of Safety and Effectiveness for Radionics Software Applications, Inc. XKnife-4

K981055

#### SUBMITTER 1.

Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 USA

Lisa Misterka Benati Contact Person: Senior Regulatory Engineer

#### NAME OF DEVICE 2.

Device Proprietary Name: XKnife-4 Radiation Treatment Planning System Device Common Name:

#### DEVICE CLASSIFICATION 3.

21 CFR 892.5900 X-ray Radiation Therapy System Class II:

#### DEVICE INTENDED USE 4.

XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.

#### PREDICATE DEVICES 5.

- Radionics Software Applications, Inc. XKnife-3 System .
- Radionics Software Applications, Inc. XPlan-1 System .

#### GENERAL SAFETY AND EFFECTIVENESS 6.

The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and

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installation sessions provide assurance that the user understands all aspects of the XKnife-4 System: mechanical, computer and software, plus its intended functionality. This information promotes safe and effective use of the device.

#### COMPARISON OF TECHNICAL CHARACTERISTICS 7.

The XKnife-4 system has similar technical characteristics as the commercially available XKnife-3 system. Both systems consist of treatment planning software, stereotactic hardware and a protocol of extensive verification and QA procedures to ensure proper transfer of the treatment parameters to the clinical delivery system. The XKnife-4 system also has similar technical characteristics as the commercially available XPlan-1 system. Both systems support the use of the LINAC jaws, in addition to a circular collimator, to further shape the radiation beam.

#### NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE 8.

The design of the XKnife-4 system, including the use of the LINAC jaws, has been thoroughly validated at the unit and system level. Nonclinical tests were conducted to demonstrate that the XKnife-4 software meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate devices cited above.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1998

Lisa Misterka Benati

Burlington, MA 01803

Senior Regulatory Engineer

Radionics Software Applications, Inc.

Re:

K981055 XKnife-4 Stereoactic RTP System Dated: July 13, 1998 Received: July 14, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Benati:

22 Terry Avenue

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal. Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Modical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 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/cdch/dsmaldsmaman.html",

Sincerely yours,

Lillian Yih, Ph.D.

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

Enclosure

l.

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510(k) Number (if known): K 981 051

# Device Name: XKnife-4 Stereotactic Radiosurgery and Radiotherapy Treatment Planning System

Indications For Use:

XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ilind C. Stym
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number . 1055

Prescription Use
(Per 21 CFR 801.109) ✓

OR

3/19/98

Over-The-Counter Use_

(Optional Format 1-2-96)

CONFIDENTIAL