(46 days)
Not Found
No
The device description focuses on mechanical adapters for patient positioning and fixation, with no mention of AI/ML technologies or related concepts like image processing, algorithms, or data analysis.
No
The device is described as an adapter system for cranial fixation during CT scanning and TomoTherapy treatment. Its purpose is to securely hold a patient in position, not to directly treat a condition or disease. It facilitates the use of a therapeutic system (TomoTherapy) but is not therapeutic itself.
No
The device is designed for cranial fixation during CT scanning and treatment, holding the patient securely in the same position for both diagnostic imaging and therapy. It does not perform any diagnostic function itself.
No
The device description explicitly details physical adapters (InterFix™ CT Adapter and InterFix™ Tabletop Adapter) designed to attach to hardware (CT scanner and TomoTherapy HiArt System tabletops) and accept other physical headrings/frames. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this 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.
- Device Function: The Interfix Patient Adapters are mechanical devices designed for physical fixation of the patient's head during medical imaging (CT scanning) and treatment (TomoTherapy). They do not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The stated intended use is "For cranial fixation during CT scanning and treatment." This clearly describes a physical support and positioning function, not a diagnostic test.
The device is a medical device used in conjunction with imaging and treatment systems, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.
Product codes (comma separated list FDA assigned to the subject device)
IYE, TYE
Device Description
The Interfix Patient Adapters consists of two adapters, the InterFix™ CT Adapter which attaches to the CT scanner tabletop and the InterFix™ Tabletop Adapter for attachment to the TomoTherapy HiArt System tabletop. The adapters are designed to accept the Integra Radionics headrings, such as the Gill-Thomas-Cosman relocatable headring. Universal Compact Head Ring (UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame.
The purpose of the Interfix system is to hold a patient securely and in the same position during the diagnostic CT scan and TomoTherapy HiArt Treatment. The adapters can be used to aid the user in aligning the patient to the lasers; however, the prescan is still required to ensure that the patient is in the correct position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanning
Anatomical Site
cranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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.
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Integra Radionics Interfix™ Patient Adapters 510(k) Summary
Submitter's Name and Address:
Integra Radionics 22 Terry Avenue Burlington, MA 01803 781-565-1227 (Telephone) 781-238-0645 (Fax)
Contact Person and Telephone Number:
Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. Tel.: (781) 565-1227
Date Summary was Prepared: August 30, 2007.
Name of the Device:
| Trade Name: | Integra Radionics Interfix™ Patient Adapters. |
|---|---|
| Common Name: | Stereotactic Radiation Treatment Planning System and Accessories. |
| Classification Name: | Accelerator, Linear, Medical |
| 21 CFR 892.5050, Product Code IYE |
Classification Panel: Radiology
Substantial Equivalance:
The modified device is intended for cranial fixation during CT scanning and treatment with the Tomo Therapy HiArt system. Cranial fixation is within the indications for use of the predicate devices. The technological characteristics are similar to those found with the following predicate devices: LCM-2 Linac Couch-Mount System cleared via 510(k) K924632 on April 7, 1993. Knife Radiosurgery System cleared via 510(k) K912630 on November 4, 1991.
The Interfix Patient Adapters consists of two adapters, the InterFix™ CT Adapter which attaches to the CT scanner tabletop and the InterFix™ Tabletop Adapter for attachment to the TomoTherapy HiArt System tabletop. The adapters are designed to accept the Integra Radionics headrings, such as the Gill-Thomas-Cosman relocatable headring. Universal Compact Head Ring
1
(UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame.
The purpose of the Interfix system is to hold a patient securely and in the same position during the diagnostic CT scan and TomoTherapy HiArt Treatment. The adapters can be used to aid the user in aligning the patient to the lasers; however, the prescan is still required to ensure that the patient is in the correct position.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Blvd, Rockville MD 20850. The text is black and the background is white.
OCT 16 2007
Mr. Kevin J. O'Connell Manager Regulatory Affairs Integra Radionics. Inc. 22 Terry Ave. BURLINGTON MA 01803
Re: K072454
Trade/Device Name: Integra Radionics Interfix™ Patient Adapters Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: TYE Dated: August 30, 2007 Received: August 31, 2007
Dear Mr. O'Connell:
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.
Image /page/2/Picture/9 description: The image shows a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal, with the word "Occidental" underneath. There are four stars below the word "Occidental". The seal is surrounded by a dotted border.
moting Public Hoults lating and OP,
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Page 2 -
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely vours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K072454
Device Name: Integra Radionics Interfix™ Patient Adapters Indications For Use:
For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.
PRESCRIPTION USE X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomi M. Whay
Division of Reproductive, Abdominal and Radiological Device 510(k) Number
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