(90 days)
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Not Found
No
The summary describes a physical head and neck cushion for patient positioning, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is described as an aid for patient positioning during radiation or other treatment, and it forms to the back of the patient's head to eliminate movement. This function is supportive and assistive for a medical procedure rather than directly treating a condition or disease.
No
The device is described as a "Radiographic head holder System" intended for patient positioning during radiation or other treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "Radiographic head holder System" and a "MoldCare Head & Neck Cushion," indicating a physical, hardware-based device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in patient positioning for radiation or other treatment. This is a physical positioning device used on the patient, not a test performed on a biological sample outside the body.
- Device Description: The description confirms it's a "Radiographic head holder System" and a "cushion" that forms to the patient's head. This aligns with a physical support device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for physical positioning during medical procedures.
N/A
Intended Use / Indications for Use
The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.
Product codes
90 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
Head & Neck
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.
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Donald F. Riibe Vice President of Operations Med-Tec. Inc. 1401 8th Street S.E. P.O. Box 320 Orange City, IA 51041-0320 K982624
Re:
Moldcare Head & Neck Cushion Model # MT-ACL-14242 Dated: July 23, 1998 Received: July 28, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Riibe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".
Sincerely yours,
Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): _ KG82624
Device Name: MoldCare Head & Neck Cushion
Indications For Use:
MED-TEC, INC. has a Radiographic head holder System to be manufactured by MED-TEC, INC.
| Classification Name: | Head & Neck Cushion accessory for Radiographic head
holder |
|----------------------|---------------------------------------------------------------|
| Common/Usual Name: | Radiographic head holder |
| Proprietary Name: | MoldCare Head & Neck Cushion |
The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.
Classification: Since this device The MT-ALC-14242 is used with Class I equipment, therefore we believe it is a Class I device.
(PLEASE DO NOT WRIGHT BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin A. Lynn
(Division Sign-Off
enrod ve, Abdominal, ENT 510
Prescription Use
Per 21 CFR 801.109)
OR
Over - The - Counter Use (Optional Format 1-2-96)