(32 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning methods using fiducial markers.
No
The device is a treatment planning system, not a device that directly administers therapy. It is used to plan LINAC-based radiotherapy treatment.
No
The device is described as a "radiosurgery and radiotherapy treatment planning system" that uses "non-stereotactic CT image sets" to "generate a treatment plan." It does not mention diagnosing conditions.
No
The device is described as a "module of the XKnife RT system" and a "radiosurgery and radiotherapy treatment planning system." While it utilizes software for planning, the description implies it is part of a larger system that likely includes hardware components (LINAC based treatment, external fiducial markers). The focus is on the planning system, not solely a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The XKnife RT 3 with Non-Stereotactic Module is a treatment planning system. It uses medical images (CT scans) to plan radiation therapy for patients. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "radiosurgery and radiotherapy treatment planning." This is a therapeutic application, not a diagnostic one based on in vitro analysis.
Therefore, based on the provided information, this device falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sufficient testing has been completed to insure that the module can import, localize and generate a treatment plan using a non-stereotactic CT scan.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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.: (781) 272-1233 Fax: (781) 272-2428
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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, conveying a sense of care and global reach.
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.
2
Page 2
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (800) 638-2041 or Manufacturers, International and Collisation 1866.
(301) 443-6597 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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 _________________________________________________________________________________________________________________________________________________________________