(145 days)
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
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.
This 510(k) submission (K080072) is for "MRI Patient Positioning Devices" and focuses on demonstrating substantial equivalence to previously cleared devices. The core of the submission revolves around proving the safety and effectiveness of these devices for use in an MRI environment, as they were previously Class I exempt and are now being cleared for MRI use.
The document does not provide a typical "study" with specific acceptance criteria and reported device performance in the way one might expect for an AI/software device or a diagnostic device. Instead, the "study" is a series of tests to ensure MRI compatibility and safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|
| Safety for use in an MRI environment | "These products have been tested to demonstrate that they can be safely used in an MRI environment." (No specific quantitative metrics or test results are provided in this summary, but the FDA clearance implies these tests were satisfactory.) |
| Equivalent intended uses | Claimed: "the proposed devices have equivalent intended uses... as compared to the predicate devices." (The intended use "aid in the support and positioning of patients during an MRI" is consistent with the predicate devices' presumed function.) |
| Equivalent manufacturing materials | Claimed: "the proposed devices have equivalent... manufacturing materials... as compared to the predicate devices." |
| Equivalent operating principles | Claimed: "the proposed devices have equivalent... operating principals... as compared to the predicate devices." (As simple positioning devices, their operating principle is passive support.) |
| Equivalent physical, operational specifications | Claimed: "the proposed devices have equivalent... physical, operational specifications as compared to the predicate devices." |
| No significant differences affecting safety and effectiveness | Claimed: "There are no significant 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." (The key 'difference' is the MRI testing, which is presented as an addition to safety, not a compromise.) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to the physical devices themselves. The sample size would be the number of physical MRI Patient Positioning Devices tested for MRI compatibility. This number is not disclosed in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" in the context of device performance for physical products like patient positioning devices (especially for MRI compatibility) typically involves engineering tests, material compatibility assessments, and MRI safety protocols, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI assistant for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's main claim (MRI safety) would be established through:
- Engineering Standards and Test Results: Compliance with recognized MRI safety standards (e.g., ASTM F2503 for "MR Safe," "MR Conditional," "MR Unsafe"). These standards outline specific tests for magnetic attraction, RF-induced heating, image artifact, etc.
- Material Compatibility: Assessment of the materials used in the devices for their magnetic properties and potential for heating in an MRI environment.
- Regulatory Compliance: Meeting the requirements of the FDA for safe medical devices.
The document only states "These products have been tested to demonstrate that they can be safely used in an MRI environment," implying these types of tests were performed.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Ko 80072
JUN - 4 2008
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | CIVCO Medical102 First Street SouthKalona, IA 52247-9589USAPhone: 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: | IXQIYE |
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
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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.
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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.
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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 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
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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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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
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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.