(85 days)
Not Found
K 935067
No
The description focuses on mechanical immobilization and repositioning, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
No
The device is used for patient immobilization and repositioning during radiation therapy, which is a therapeutic treatment. However, the device itself does not directly treat the patient; it assists in the delivery of a therapeutic treatment.
No
The device is designed to immobilize and reposition patients during radiation therapy treatments, not to diagnose medical conditions.
No
The device description explicitly details a physical headholder designed to attach to a treatment table and interact with other physical components (head rest, prone pillow, masks) for patient immobilization. This is a hardware device.
Based on the provided information, the AccuFix Tilting Radiotranslucent Headholder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states the device is used to immobilize and reposition patients undergoing radiation therapy. It interacts directly with the patient's head, not with a biological sample taken from the patient.
- The intended use is for patient positioning and immobilization during radiation therapy. This is a therapeutic procedure, not a diagnostic test performed on a sample.
The device is a medical device used in a clinical setting for patient treatment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and. Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attacles to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder. in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatpacht sessions
Product codes
90 IYE
Device Description
The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and. Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attacles to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder. in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatpacht sessions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
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)
Not Found
Reference Device(s)
K 935067
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Re: K021124
Trade/Device Name: AccuFix Tilting Radiotranslucent Headholder Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 29, 2002 Received: April 8, 2002
Dear Mr. Kirk:
Mr. J. Damon Kirk
30 Lawlins Park
President and Technical Director WFR/AQUAPLAST Corporation
WYCKOFF NJ 07481-1443
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 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,
1
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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 vours.
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
14021124
PREMARKET NOTIFICATION INDICATION FOR USE
The Acculix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and. Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attacles to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder. in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatpacht sessions
J. Damon Kirk
J. Damon Kirk
u, 26/2001
Premarket Notification 510(k) Number K
Prescription Use
✓
Nancy C. Hodgson
(Division Sign-Off)
Division of Reproduc and Radiological Devices 510(k) Number