(145 days)
Not Found
No
The description focuses on the physical properties and MRI compatibility of patient positioning devices, with no mention of AI or ML.
No
Explanation: The device is described as a patient positioning device used for support during MRI and its classification was reduced to Class I exempt, which generally does not include therapeutic devices. Its function is to position, not to treat or cure.
No
Explanation: The device is described as "Patient Positioning Devices" used to "support and positioning of patients during an MRI," and its purpose is to be "cleared for use in an MRI environment," none of which suggests a diagnostic function.
No
The device description explicitly states "Civco Patient Support Devices" and refers to "identical Class I products" which are physical patient positioning devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the support and positioning of patients during an MRI." This describes a physical support device used during an imaging procedure, not a test performed on a sample (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description reinforces that these are "Patient Support Devices" used for positioning.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of samples.
- Reagents, calibrators, or controls.
This device falls under the category of medical devices used to facilitate imaging procedures, not diagnostic tests performed on biological samples.
N/A
Intended Use / Indications for Use
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
Product codes
IXQ, IYE, TYE
Device Description
The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973842, K951808, K982624, K933227, K935300
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
Ko 80072
JUN - 4 2008
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | CIVCO Medical
102 First Street South
Kalona, IA 52247-9589
USA
Phone: 319-656-4447 |
|-------------------------|------------------------------------------------------------------------------------------------|
| | Fax:
877-218-0324 |
| Contact Person: | Jim Leong |
| Date of Summary: | December 17, 2007 |
| Trade/Proprietary Name: | MRI Patient Positioning Devices |
| Classification Name: | MRI Patient Positioning Devices |
| Product Code: | IXQ
IYE |
Intended Use:
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
Device Description:
The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.
Predicate Devices:
K973842 - Medtec Inc, Carbon Fiber Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck Cushion K933227 - Medtec Inc, Uni-Frame Head Immobilization System K935300 - Medtec Inc , Vac-Lok Immobilizatioin System
1
Substantial Equivelance:
CIVCO Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following 510k's K973842, K951808, K982624, K933227 and K953300. CIVCO Medical Instruments claims this equivalence because the proposed devices have equivalent intended uses, manufacturing materials, operating principals, and physical, operational specifications as compared to the predicate devices.
There are no signigficant differences between the proposed and predicate devices except that they have now been tested for use in an MRI environment. The product labeline, including brochures has been updated. These differences have no effect on safety and effectiveness. These products have been tested to demonstrate that they can be safely used in an MRI environment.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
CIVCO Medical Instruments Co., Inc. % Arthur Ward, Ph.D. Consultant AJW Technology Consulting, Inc. 962 Allegro Lane APOLLO BEACH FL 33572
Re: K080072
Trade/Device Name: MRI Patient Positioning Device Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: TYE Dated: April 21, 2008 Received: April 30, 2008
Dear Dr. Ward:
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.
3
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 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K080072
Device Name: MRI Patient Positioning Devices
Indications for Use:
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aon In Why
(Division Sign-Off)
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