RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE

K041997 · Radionics, A Division of Tyco Healthcare Group LP · MUJ · Aug 27, 2004 · Radiology

Device Facts

• Record ID: K041997
• Device Name: RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
• Applicant: Radionics, A Division of Tyco Healthcare Group LP
• Product Code: MUJ · Radiology
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment intended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.

Device Story

Radionics XKnife RT 3 with Non-Stereotactic Module is a software module for radiotherapy treatment planning; enables use of non-stereotactic CT image sets for isocenter specification; replaces requirement for stereotactic frames; supports LINAC-based, collimated beam radiosurgery and radiotherapy. Used by clinicians in clinical settings to import, localize, and generate treatment plans. Output assists healthcare providers in planning radiation delivery; facilitates non-stereotactic treatment workflows; potentially benefits patients by expanding access to precise radiotherapy without frame-based immobilization.

Clinical Evidence

Bench testing only. No clinical data provided. Testing verified the module's capability to import, localize, and generate treatment plans using non-stereotactic CT scan data.

Technological Characteristics

Software module for LINAC-based radiotherapy treatment planning. Operates on computer systems to process CT image sets. Enables non-stereotactic isocenter specification. Connectivity and specific software architecture not detailed.

Indications for Use

Indicated for patients requiring radiosurgery and radiotherapy treatment using stereotactic or non-stereotactic, collimated beam, computer-planned, LINAC-based systems.

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 XPlan 2.2 with Body (K013488)
• Radionics XKnife System (K981055)
• Stereotactic KTF System (K032724)

Submission Summary (Full Text)

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### AUG 2 7 2004

12 510(k) Summary

K\$\phi\$41997

# Radionics XKnife RT 3 with Non Stereotactic Module 510(k) Summary

This summary of the 510(k) safety and effectiveness information is submitted in accordance I his summal y of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, MA 01803 Tel.: [phone] Fax: [phone]

This summary was prepared on July 21, 2004.

- 2.0 The name of the device is the Radionics XKnife RT 3 with Non Stereotactic Module. The I he liaine of the device is the Racioning System, and its classification name is Medical charged-particle radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics XPlan 2.2 with the Body The above device is substantial equilt count of the subscriber 03, 2001; Radionics XX nife for System was cleared via 510(k), 1875 vir , 510(k), K981055, on September 29, 1998; and Stereofactic KTF System was eleared Titles (1) - 1) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 cleared via 510(k), K032724, on October 9, 2003. .
- 4.0 The device is a module of the XKnife RT system that allows radiotherapy treatment The device is a module of the IT image sets. As in traditional radiation treatment planning use non-steroomede of integent (rather than a stereotactic frame) now provide a reference from which an isocenter may be specified.
- 5.0 XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment ARIllie KT 5 will Nor-Gerotactic receotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.
- 6.0 Sufficient testing has been completed to insure that the module can import, localize and generate a treatment plan using a non-stereotactic CT scan.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 27 2004

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Healthcare LP 22 Terry Ave. BURLINGTON MA 01803

Re: K041997

Trade/Device Name: Radionics XKnife RT3 with Non Stereotactic Module Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 MUJ Dated: July 23, 2004 Received: July 26, 2004

Dear Mr. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosare) to tegary to tegary and the Medical Device Ameridaents, or to conimeres prior to may 20, 20, 20, 20, 2017 the provisions of the Federal Food, Daug, uevices that have been resulted t require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, marrov mo es Act include requirements for annual registration, listing of general ooneroly provisions proctice, 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 If your device is olassilved (600 as a vy ols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additional vonitors, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Drissance of our device complies with other requirements of the Act that FOX has made a decermination as administered by other Federal agencies. You must comply and CEPD P of any I edical statutes and regalations as but not limited to: registration and listing (21 CFR Part with an the 7te 310quirements) ; good manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820); and if applicable, the electronic product quality Systems (QD) isgms (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin harketing your antial equivalence of your device to a legally premarket notification. The PDA Inding of sacontral equive 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 811), please If you desire specific advice for your dones on our best be of the regulation number at the top of the 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 Additionally, for questions off the promotion and and one of e regulation entitled, "Misbranding Other of Compliance at (301) 37 1 1007. 1207.97) you may obtain. Other general by relerence to prematics nonited in (210) it is a may be obtained from the Division of Small mornation on your responsionaliss and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Collisation 1866.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brydon

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

Enclosure

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#### ODE Indications for Use Statement

510(k) Number (if known): K041997

Device Name: Radionics XKnife RT 3 with Non Stereotactic Module

Indications for Use:

XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment Arthire rer o mintended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------OR Prescription Use (Per 21 CFR § 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, a - i Radiological Devices 10(k) Number _________________________________________________________________________________________________________________________________________________________________