(47 days)
Not Found
No
The 510(k) summary describes patient positioning devices and does not mention any AI or ML capabilities.
No.
The device's intended use is for patient support and positioning during imaging procedures, not for treating or diagnosing medical conditions.
No
Explanation: The device description clearly states its purpose is to "aid in the support and positioning of patients during MR, radiological, and other procedures," not to diagnose medical conditions or generate diagnostic information. It is a patient support device, not a diagnostic one.
No
The device description explicitly states "Various sizes and shapes of patient positioning devices are offered," indicating a physical hardware component. The intended use also describes supporting and positioning patients, which is a physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are used to "aid in the support and positioning of patients during MR, radiological, and other procedures." This describes a physical support function for the patient during imaging procedures.
- Device Description: The description reinforces this by stating they are "patient positioning devices" and "patient support devices."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and instruments used in a laboratory setting or at the point of care for analyzing biological samples.
Therefore, the function of this device is entirely external to the patient and related to their physical positioning during imaging, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
Product codes (comma separated list FDA assigned to the subject device)
LNH, IYE
Device Description
CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment
Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned.
Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, radiological
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): 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.
K972842, K080072, K093738, K935000, K954225
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
CIVCO MR & Radiological Patient Positioning Devices Addendum
KIII 34C
Page 1 of 3
JUN 2 8 2011
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (As required by 21 CFR 807.92)
CIVCO MR & Radiological Patient Positioning Devices
A. General Information
| Submitter's Name: | MEDTEC, Inc. dba CIVCO Medical Solutions | |
|---|---|---|
| Address: | 1401 8th Street SE, Orange City, Iowa 51041 | |
| Telephone No .: | phone (712) 737-8688 | fax: (712) 737-8654 |
| Contact Person: | Ms. Jenny Jones, Senior Quality Engineer |
Establishment Registration Number: 1937223
MEDTEC, Inc. dba CIVCO Medical Solutions is registered as a medical device manufacturer.
| Device Trade: | MR & Radiological Patient Positioning Devices |
|---|---|
| Device Common: | MR & Radiological Patient Positioning Devices |
| Device Classification Name: | MR & Radiological Patient Positioning Devices |
| Classification: | Class II under 21 CFR 892.1000 & 892.5050 |
|---|---|
| Classification Panel: | MR & Radiology |
| Classification Procode: | LNH & IYE |
Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
B. Device Description
CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment
Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned.
Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.
C. Indications for Use/Intended Use
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
1
D. Predicate Device(s)
CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these identical Class II products cleared for use in an MR environment.
Identification of legally marketed device to which MEDTEC, Inc., doing business as CIVCO Medical Solutions, is claiming equivalence:
- Head and Neck Immobilization System .
- O Kevlar Head and Shoulder Baseplate (Type-S Overlay)
- · 20CFHNSUB2 MR Kevlar Type-S Overlay
- O Kevlar Head and Shoulder Baseplate (Type-S Overlay)
- Body Immobilization System .
- o Body Immobilization Rails-Only System (Rails and Lok-Bars)
- MTSBRT051 Rails-Only System 53cm Prodigy .
- MTSBRT050 Rails-Only System 53cm Interloc .
- MTSBRT056 Rails-Only System 53cm Exact 1
- MTSBRT053 Rails-Only System 50cm Prodigy I
- MTSBRT052 Rails-Only System 50cm Interloc 트
- 트 MTSBRT057 Rails-Only System 50cm Exact
- I MTSBRT055 Rails-Only Lok-Bar
- o Body Immobilization Bridges (Body Pro-Lok Bridges)
- MTSBRT039 Body Pro-Lok Bridge (Type1B) .
- MTSBRT007 Body Pro-Lok Bridge (Type 2) 지
- MTSBRT031 Body Pro-Lok Bridge (Type 3) .
- o Body Immobilization Respiratory Plate
- MTSBRT003 Respiratory Plate 트
- o Body Immobilization Forehead Brace
- MTSBRT018 Forehead Brace l
- o Body Immobilization Patient Hand Grips
- . MTSBRT005 Patient Hand Grips
- MTSBRT0051 Patient Hand Grips (Mirror) ■
- o Body Immobilization Clam-Lok Cushion
- MTSBRT202 Clam-Lok Cushion .
- o Body Immobilization Shoulder Bridges
- MTSBRT038 Shoulder Bridge 2 .
- o Body Immobilization Rails-Only System (Rails and Lok-Bars)
E. Substantial Equivalence Summary
MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following 510k's: K972842. K080072. K093738, K935000 and K954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because the proposed devices have equivalent intended uses, manufacturing, quality systems, device body contacting category and safety parameters.
2
| Parameter | MR & Radiological Patient
Positioning Devices | Predicate Device
Patient Positioning Devices |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | CIVCO Patient Positioning Devices
are used to aid in the support and
positioning of patients during MR,
radiological, and other procedures | CIVCO Patient Positioning Devices are used
to aid in the support and positioning of
patients during radiological and other
procedures |
| Manufacturing | Same. | Machined, injection molded, formed,
assembled, painted |
| Quality Systems | Same. | FDA/QSR cGMP 21CFR Part 820. ISO 9001 / ISO 13485 |
| Device Body
Contact Category | Same. | Surface devices, intact skin; limited contact
duration (