(190 days)
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No
The summary describes a treatment planning system for radiosurgery and radiotherapy, focusing on software, hardware, and QA procedures. There is no mention of AI, ML, or related concepts.
Yes
The 'Intended Use' section clearly states that the device is for "radiosurgery and radiotherapy treatment," which are therapeutic medical procedures.
No
The device is described as a system for "radiosurgery and radiotherapy treatment," and it includes "treatment planning software" and "stereotactic hardware." It focuses on delivering radiation for treatment rather than diagnosing medical conditions.
No
The device description explicitly states that the system consists of "treatment planning software, stereotactic hardware and a protocol of extensive verification and QA procedures". This indicates the presence of hardware components in addition to the software.
Based on the provided information, the XKnife-4 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that XKnife-4 is for "stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment." This describes a system used for delivering radiation therapy to a patient's body, not for testing samples (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition.
- Device Description: The description focuses on treatment planning software, stereotactic hardware, and QA procedures related to delivering radiation treatment. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The XKnife-4 system's function is to plan and facilitate the delivery of radiation therapy, which is a treatment modality, not a diagnostic process involving in vitro testing.
N/A
Intended Use / Indications for Use
XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Radionics Software Applications, Inc. XKnife-3 System, Radionics Software Applications, Inc. XPlan-1 System
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.
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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).
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§ 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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510(k) Summary of Safety and Effectiveness for Radionics Software Applications, Inc. XKnife-4
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
1
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.
2
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 (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597 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.
3
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