(256 days)
The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.
The Navigator System utilizes a high resolution optical tracking system to determine and monitor the position of optical markers attached to the patient as the means to locate and monitor the position and orientation of the patient, relative to treatment isocenter. The Navigator System consists of the following major components: a. A high resolution optical camera array and illuminator. b. A computer workstation. c. An optical positioning device. d. An optical calibration device.
Based on the provided text, there is no information available regarding specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters requested.
The document is a 510(k) summary for a medical device (Navigator Patient Head/Neck Positioning and Position Monitoring System), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria.
Here's why the requested information cannot be provided from the given text:
- No Acceptance Criteria or Device Performance: The document explicitly states under "Performance Standards" that "Performance standards for this type of system have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic act." This indicates there are no official, pre-defined quantitative acceptance criteria discussed or met in this submission.
- No Study Details: The summary does not describe any specific performance study with a test set, ground truth, expert involvement, or sample sizes. The substantial equivalence is established by "comparison of functions and features and the use of an essentially identical optical position location device from the same commercial manufacturer," not by a detailed performance study.
- No Mention of AI or MRMC: The device description does not involve artificial intelligence, and therefore an MRMC comparative effectiveness study with AI assistance is not mentioned or relevant to this submission.
- No Standalone Performance: Since no studies are described, there is no mention of standalone (algorithm-only) performance.
- No Training Set Information: There is no discussion of a training set, as the submission relies on substantial equivalence.
Therefore, the table and other requested details cannot be populated from the provided text. The document is primarily a regulatory filing demonstrating equivalence, not a scientific publication detailing performance evaluation.
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JUL 1 - 2005
510(k) Summary Navigator Patient Head/Neck Positioning and Position Monitoring System
1. Submitter Information
| Contact: | Leigh Spotten |
|---|---|
| Director of Quality and Regulatory Affairs | |
| North American Scientific, Inc. | |
| 20200 Sunburst Street | |
| Chatsworth, CA 91311 | |
| Email: Leigh.Spotten@nasmedical.com | |
| Phone: (818) 734-8600 Ext. 209 |
2. General Provisions
| Common/Usual Name: | Patient Positioning and Monitoring System |
|---|---|
| Proprietary Name: | Navigator Patient Positioning and Monitoring System |
| Classification: | Class II |
3. Predicate Devices
The system addressed in this submission is substantially equivalent to the following predicate devices:
| Device | Clearance Number | Clearance Date |
|---|---|---|
| (1) RadioCamerasTM Localization andPositioning System | K000246 | 1/7/2000 |
| (2) RadioCamerasTM System Head/NeckApplication | K994355 | 3/22/2000 |
| (3) BATTM Ultrasound Localization andPositioning System | K981424 | 7/17/1998 |
This substantial equivalence was established by comparison of functions and features and the use of an essentially identical optical position location device from the same commercial manufacturer.
4. Intended Use
This submission describes a system intended for use with a linear accelerator in Radiation Therapy(RT)/stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.
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510(k) Summary
Navigator Patient Head/Neck Positioning and Position Monitoring System
5. System Description
The Navigator System utilizes a high resolution optical tracking system to determine and monitor the position of optical markers attached to the patient as the means to locate and monitor the position and orientation of the patient, relative to treatment isocenter.
The Navigator System consists of the following major components:
- a. A high resolution optical camera array and illuminator.
- b. A computer workstation.
- c. An optical positioning device.
- d. An optical calibration device.
6. Performance Standards
Performance standards for this type of system have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic act.
7. Biocompatibility
The materials used in system components that contact the patient are USP classified for skin contact or 510(k) cleared. These materials have a long history of safe use in dental applications. Their use in this system does not raise any new issues related to safety and effectiveness.
8. Summary of Substantial Equivalence
This system is similar in design, construction, materials, intended use, and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this system.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leigh Spotten Director of Quality and Regulatory Affairs NOMOS Corporation 200 W. Kensinger Dr., Suite 100 CRANBERRY TOWNSHIP PA 16066
Re: K042875
JUL 1 - 2005
Trade/Device Name: nTrak Patient Position and Monitoring System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ
Dated: June 9, 2005 Received: June 10, 2005
Dear Mr. Spotten:
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.
If your device is classified (see above) into either class II (Special Controls) or 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 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); 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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This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | () | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
510(k) Number (if known): _ K042875
Device Name: nTRAK Patient Positioning and Monitoring System
Indications for Use:
The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
Division Division of Reproductive and Radiological Devic 5 10(k) Number
Page 1 of 1
§ 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.