(97 days)
No
The summary describes an optical tracking system for patient positioning in radiation therapy. While it mentions "real time tracking" and "spatial registration," there is no explicit mention of AI, ML, deep learning, or any related terms. The description focuses on the optical nature of the system and its function in tracking and registration, which can be achieved through traditional image processing and geometric algorithms.
No.
The device is described as an optical tracking system intended for localizing and registering patient position during radiation therapy. It is an accessory to radiotherapy, which is a therapeutic treatment, but the device itself does not directly treat the patient; it facilitates the precise delivery of the therapeutic radiation.
No
The device is used for tracking patient position during radiation therapy, which is a treatment procedure, not for diagnosing a condition.
No
The device description explicitly states it is an "optical tracking system" and an "accessory of 3 dimensional radiotherapy," indicating it includes hardware components for optical tracking.
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 the device is for "localization of patient position in the conduct of radiation therapy" and "tracking patient position to linear accelerators." This describes a device used on the patient during a medical procedure, not a device used to test samples from the patient (which is the core definition of an IVD).
- Device Description: The description reinforces this by stating it "tracks patient position before and during a radiotherapy treatment session."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on laboratory tests.
Therefore, the DynaTrac System, as described, falls under the category of a medical device used for patient positioning and tracking during radiation therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment.Patient Tracking System is an optical system for tracking patient position Patient Tracking System is an optical system to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.
Product codes
90 IYE
Device Description
DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
ExacTrac (K983660)
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
APR = 5 2004
K03405
APPENDIX 7: 510 (K) SUMMARY
510(k) Summary As required by 807.92 For DynaTrac System Cod. 50-1A Prepared on December 17, 2003
Submitted by: 3D Line Medical Systems Reston Executive Center 12100 Sunset Hills Road Reston, VA 20190
Tel. 703-467-8420
Itax: 703-467-8421
Contact Person: Nader Salehi, Vice President
Device Trade Name: DynaTrac System
Common Name: optical patient tracking system for radiation therapy
Classification: Medical charged-particle radiation therapy system device Class II, Sec. 21 CFR 892.5050
Predicate Device: ExacTrac (K983660)
Manufactured by: BrainLab USA, Inc., Bldg. 4A, Mailstop E233, 3100 Hansen Way, Palo Alto, CA 94304
Description of the Device: DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.
Intended Use for the Device: It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment.
1
Substantial Equivalence to Predicate Device: DynaTrac has the same intended use and Davoluntial Dquiraliso to ExacTrac. There are no technical differences that raise issues of safety and effectiveness.
2
Image /page/2/Picture/12 description: The image shows a circular seal or logo. The seal contains a stylized graphic of three abstract human figures in profile, stacked vertically. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged around the left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2004
Mr. Nader Salehi Vice President 3D Line USA, Inc. Reston Executive Center 12100 Sunset Hills Road, Suite 150 RESTON VA 20190
Re: K034051
Trade/Device Name: DynaTrac System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: December 22, 2003 Received: January 9, 2004
Dear Mr. Salehi:
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 (PMA), 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.
3
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 the 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" (21CFR Part 807.97) you may obtain. 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. Boyden
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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Applicant: _3D Line USA, Inc. ________________________________________________________________________________________________________________________________________________
K034051_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ DynaTrac System_
Indication For Use:
Patient Tracking System is an optical system for tracking patient position Patient Tracking System is an optical system to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductiv and Radiological Devices 510(k) Number
Prescription Use