(49 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
No
The device aids in positioning for radiotherapy, which is a therapeutic intervention, but the device itself does not directly administer therapy or provide a therapeutic effect. It is a tool used in the administration of therapy.
No
The device aids in positioning for radiotherapy administration, which is a treatment, not a diagnostic process. It does not identify or characterize diseases or conditions.
No
The description explicitly states the device is an "online EPID" and operates "in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system." An EPID (Electronic Portal Imaging Device) and an MMLC are hardware components used in radiotherapy. While there might be software involved in processing the EPID data and controlling the MMLC, the device as described is not solely software.
Based on the provided information, the TrackPort device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TrackPort's Intended Use: The intended use of TrackPort is to "aid in target-to-beam relative positioning for administration of radiotherapy." This is a process performed on the patient's body during treatment, not on a sample taken from the body.
- Device Description: The description indicates it's an "online EPID," which is a type of imaging device used in radiotherapy.
- Lack of Mention of Biological Samples: There is no mention of analyzing biological samples in the provided text.
Therefore, TrackPort falls under the category of a medical device used for treatment guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system
Product codes
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
all body procedures
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)
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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.
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
Re: K072529
Trade/Device Name: TrackPort Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 29 2007 Received: September 7, 2007
Dear Ms. Gershtein:
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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use Statement
K072529 510(k) Number (if known): _
Device Name: TrackPort
Indications for Use:
TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR § 801.109)
OR
Over the Counter Use
Tony M Whing
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
437 Turnpike Street . Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - mailpromo@direxusa.com