(63 days)
The iDMST™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
The subject device, iDMS™ Data Management System, is essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System. This submission simply establishes the iDMS™ System as a stand-alone data management system and reflects its integration with Accuray's robotic radiosurgery and ring gantry systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System. As such, modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System which is a next generation TomoTherapy® Treatment System.
The iDMS™ System is a data management system that provides storage, applications and interfaces to access, add, modify, export, delete, and validate patient, user and system data for Accuray's radiotherapy, stereotactic radiotherapy, and stereotactic radiosurgery delivery systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System, as well as treatment planning systems, including the Precision™ Treatment Planning System. The IDMS™ System can store and retrieve treatment plans and delivery data for multiple systems.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria and study results for the iDMS™ Data Management System. The document is a 510(k) summary for FDA clearance and primarily focuses on establishing substantial equivalence to a predicate device.
While it mentions "Testing was completed to verify that all hardware and software perform as designed, as well as regression testing to verify the integrity of existing features. Testing demonstrated that the iDMS™ System performance is equivalent to the predicate, the CDMS features," it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the iDMS™ Data Management System is "essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System," and that "modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System." This suggests that the system's performance might be considered equivalent to the predicate device without requiring a new, extensive clinical study if the modifications are minor and do not alter fundamental performance characteristics.
Therefore,Based on the provided text, I cannot answer your request.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Accuray Incorporated % Ms. Elizabeth Osuna Regulatory Affairs Project Manager 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K161144
Trade/Device Name: iDMS™ Data Management System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 23, 2016 Received: April 26, 2016
Dear Ms. Osuna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K161144 |
|---|---|
| Device Name | iDMST™ Data Management System |
| Indications for Use (Describe) | The iDMST™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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Precise, innovative tumor treatments™
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant
Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: (408) 716-4600 Fax: (408) 789-4249
Contact Person
Elizabeth Osuna Regulatory Affairs Project Manager
Date Prepared
April 21, 2016
Device Name
| Trade Name: | iDMS™ Data Management System |
|---|---|
| Common Name: | Radiosurgery/radiotherapy data management system |
| Classification Name: | Medical charged particle radiotherapy device |
| Regulatory Class: | Class II |
| Product Code: | IYE |
Predicate Device
CyberKnife® Robotic Radiosurgery System (last cleared K150873)
Device Description
The subject device, iDMS™ Data Management System, is essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System. This submission simply establishes the iDMS™ System as a stand-alone data management system and reflects its integration with Accuray's
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robotic radiosurgery and ring gantry systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System. As such, modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System which is a next generation TomoTherapy® Treatment System.
The iDMS™ System is a data management system that provides storage, applications and interfaces to access, add, modify, export, delete, and validate patient, user and system data for Accuray's radiotherapy, stereotactic radiotherapy, and stereotactic radiosurgery delivery systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System, as well as treatment planning systems, including the Precision™ Treatment Planning System. The IDMS™ System can store and retrieve treatment plans and delivery data for multiple systems.
Indications for Use
The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
Intended Use
The iDMS™ Data Management System is intended to provide secure data server operations for radiation oncology facilities. Data services provided include support for multiple treatment delivery and planning systems, connectivity to radiation oncology information systems, access to remote network access services; local database access to add, modify, export, delete, review, validate, archive, and restore patient, user and system data; import, export, review, and archive patient medical images and records, provide access to administrative tools used to approve, discontinue, or disallow delivery of treatment plans; automated generation of digitally reconstructed radiographs (DRRs); import, retrieve, and export measured beam data, and access report generation tools to view, print, sign, and save patient, utilization, and worklist reports.
Intended users include physicians, radiation oncologists, dosimetrists, medical physicists, radiation therapists and administrative personnel of a radiation oncology facility. Secondary users include installation, maintenance and service engineers.
The iDMS™ Data Management System is intended for use in a clinic or hospital environment.
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Substantial Equivalence
The subject device, the iDMS™ System is substantially equivalent to the data management features in the predicate system, the CyberKnife® System, in intended use, principles of operation, technological characteristics and labeling.
The energy source, design, materials and other physical properties are the same or equivalent to the predicate systems. Testing included in the premarket notification demonstrates that the performance characteristics of the device are equivalent to the data management performance of the predicate CDMS.
Testing was completed to verify that all hardware and software perform as designed, as well as regression testing to verify the integrity of existing features. Testing demonstrated that the IDMS™ System performance is equivalent to the predicate, the CDMS features.
§ 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.