(27 days)
Not Found
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices. The description focuses on standard radiation treatment planning functionalities and hardware.
No
The device is a treatment planning system for radiation therapy, which is a tool used in the delivery of therapeutic treatment, rather than directly providing therapy itself.
No
The device is described as a "stereotactic LINAC-based ration treatment planning system" that "localizes lesions" and "provides stereotactic planning system for treatment of tumors." This indicates a therapeutic planning function, not a diagnostic one.
No
The device description explicitly states that the system consists of both stereotactic treatment planning software and hardware to immobilize and localize the patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that XPlan 2.2 is a "stereotactic LINAC-based radiation treatment planning system" used for "treatment of tumors." This describes a system used for planning and delivering medical treatment directly to a patient, not for examining specimens in vitro (outside the body).
- Device Description: The description mentions "stereotactic treatment planning software and hardware to immobilize and localize the patient." This further reinforces its role in patient-specific treatment planning and delivery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro analysis, or providing information for diagnosis based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on planning and facilitating radiation therapy treatment.
N/A
Intended Use / Indications for Use
XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
Product codes
90 MUJ
Device Description
The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT scans, MR scans, and digitized angiographic film
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Section 6: 510(k) Summary
DEC 0 3 2001 XPlan 2.2 with the BodySystem 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements 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 November 2, 2001.
- 2.0 The name of the device is the Radionics XPlan 2.2 with the Body System. The common name is Stereotactic Radiation Treatment Planning System and Accessories, and its classification name is X-ray radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics XPlan 2.1 Stereotactic Radiation Treatment Planning System Software was cleared via 510(k), K001700, on June 28, 2000 and the Med-Tec (Medical Intelligence) BodyFix System was cleared via 510(k), K001052, on August 30, 2000.
- 4.0 The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.
- 5.0 The device like its predicates is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Health Care Group LP 22 Terry Avenue BURLINGTON MA 01803
Re: K013661
Trade/Device Name: XPLAN 2.2 With the Body System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 MUJ Dated: November 2, 2001 Received: November 6, 2001
Dear Mr. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be device 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 encreated of the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, ulcretore, market and act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (600 a0010). Existing major regulations affecting your device can be it may of subjoct to actively soulations, 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 I loast of advised that I Dr o resum that your device complies with other requirements of the Act that I Dri has intace a coulations administered by other Federal agencies. You must or any I oderal bather act 's requirements, including, but not limited to: registration and listing Compry with and rece broquientently as 801); good manufacturing practice requirements as set (21 CFR Part 607), acoming (21 CFR Part 820); and if applicable, the electronic fordin in the quality bytochlo (QB) 28) 285 (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 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 | (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 Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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): K013661
Device Name: Radionics XPlan 2.2 with the Body System
Indications for Use:
XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR XPlan 2.2 Willi the Body System Noaniao 100 with the Body System provides scans, and digitized anglographic film. At har and of the 2015 - 1991 - 1991 - 1991 - 1991 therapy treatments are delivered over multiple fractions.
(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,
and Radiological Devices
510(k) Number. K013661
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