(63 days)
No
The description focuses on data storage, retrieval, and processing for radiotherapy systems, with no mention of AI or ML algorithms for analysis or decision support.
No.
The device is a data management system that stores, retrieves, and processes data for radiotherapy systems; it does not directly treat patients.
No
The device is a data management system for storing, retrieving, and processing data related to radiotherapy, not for diagnosing conditions.
Yes
The device is described as a "data management system" that provides "storage, applications and interfaces" for accessing, modifying, and validating data. It explicitly states it is a "stand-alone data management system" and its modifications are limited to integrating with other systems. The description focuses entirely on software functionalities and data handling, with no mention of included hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery." This relates to managing data for radiation treatment delivery, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on managing data for radiation delivery systems (CyberKnife, Radixact) and treatment planning systems. It's a data management system for clinical workflow in radiation oncology.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on sample analysis
The device is a data management system for a clinical treatment process (radiotherapy), not a diagnostic test performed on biological specimens.
N/A
Intended Use / 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.
Product codes
IYE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
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.
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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) |
|---|---|
| -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
3
Image /page/3/Picture/0 description: The image contains the Accuray logo. The logo consists of a stylized symbol on the left and the word "ACCURAY" on the right. The symbol is a blue abstract design, and the word "ACCURAY" is also in blue. There is a registered trademark symbol next to the word.
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
4
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.
5
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.