(199 days)
CIVCO MR & Radiological Patient Positioning Devices K111340
No
The device description and performance studies focus on mechanical function (forced air for transfer) and material properties (attenuation, buildup, MR safety). There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as an accessory for patient positioning and transfer, not as a device that directly treats a medical condition. Its function is to aid in procedures, but it does not provide therapy itself.
No.
The device is a patient positioning and transfer system, used to support and transfer patients during imaging and radiation therapy procedures, rather than to diagnose medical conditions.
No
The device description clearly indicates a physical system utilizing forced air for patient transfer and positioning, including components like a base board and blower hose, which are hardware. The performance studies also focus on physical properties like attenuation, build-up, and MR safety of these hardware components.
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 the support, positioning, and transfer of a patient for procedures like imaging (including MRI) and radiation therapy. This is a physical support and transfer function, not a diagnostic test performed on biological samples.
- Device Description: The device description focuses on its function as an accessory for patient support and transfer using forced air. It does not mention any interaction with biological samples or the analysis of such samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly intended for patient handling and positioning during medical procedures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LHN, IYE, FRZ
Device Description
The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
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)
Bench Testing: Bench testing for attenuation, build-up, and MR safety was conducted. Attenuation measurements were taken using a Unidose-E electrometer with a Farmer Chamber FC65-G placed at a depth of 10cm in solid water. Measurements were made with and without the base board using both 6MV and 10MV clinical photon energies. The average attenuation factor measured 3.33, with a median of 2.65.
Build-up measurements were also taken using a Unidose-E electrometer with a PTW Advanced Markus Plane Parallel Chamber at various depths in solid water. Measurements were made with and without the base board. The results show that the materials and dimensions used in the board produce a dose buildup effect with an approximate equivalence to 6mm of tissue.
The Zephyr "x-series" Patient Positioning and Transfer System was tested for MR safety with a magnet and hand-held metal detector. The board was then positioned on the MR patient table and slid into the MR without any detectable pull by the magnet. The blower hose did show a slight attraction when directly next to the magnet. It was placed into the bore near the isocenter and was easily removed.
Conclusion: Based on our industry knowledge and experience, both attenuation and buildup test results were found to be in line with patient positioning devices that are readily found on the market. All components, excluding the air blower, tested MR Safe and are labeled accordingly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Attenuation factor measured 3.33, with a median of 2.65.
Dose buildup effect with an approximate equivalence to 6mm of tissue.
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.
Patient Transfer Systems, Inc., AirPal Platform Powered Patient Transfer Device, CIVCO MR & Radiological Patient Positioning Devices K111340
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
§ 880.6775 Powered patient transfer device.
(a)
Identification. A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Image /page/0/Picture/1 description: The image shows the word "DIACOR" in white letters against a black background. The letters are bold and sans-serif. There is some noise and distortion in the image, particularly around the edges of the letters and the black background. The word appears to be a logo or brand name.
Precision comes standard." Since 1983.
JAN 1 7 2013
2550 Decker Lake Blvd. Suite 26 Salt Lake City, Utah 84119
Section 5 510(k) Premarket Notification Summary (As required by 21 CFR 807.92)
A. General Information
Date Prepared: December 19, 2012 Submitter's Name: Diacor Inc. 2550 Decker Lake Blvd. Suite 26, West Valley City, UT 84119 Address: Telephone No: 801-467-0050 Fax: 801-487-3258 Tamara Tialavea Contact Person:
Establishment Registration Number: 1721113
| Device Trade name: | Diacor Zephyr “x-series” Patient Positioning and Transfer System |
|---|---|
| Device Common name: | Patient Positioning and Transfer System |
| Device Classification name: | 1. Accessory to Medical Charged-Particle Radiation Therapy System - 892.5050 |
| 2. Accessory Magnetic Resonance Diagnostic Device - 21 CFR 892.1000 | |
| 3. Powered patient transfer device - 880.6775 |
B. Legally Marketed Predicate Devices
-
- Patient Transfer Systems, Inc., AirPal Platform Powered Patient Transfer Device, Product Code FRZ, Regulation Number: 880.6775 (510(k) Exempt)
-
- CIVCO MR & Radiological Patient Positioning Devices K111340
ﺯ Device Description
The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.
1
Indications for Use/Intended Use
The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
Technological Characteristics E.
The Zephyr "x-series" Patient Positioning and Transfer System uses the same technology as the two predicate devices combined: 1) a patient positioning Kevlar base board (predicate CIVCO Kevlar base plate) and, 2) a low pressure air pad patient transfer system (predicate AirPal Patient Transfer); therefore, Diacor claims substantial equivalence.
F. Testing
Clinical Testing: N/A
Animal Testing: N/A
Bench Testing: Bench testing for attenuation, build-up, and MR safety was conducted. Attenuation measurements were taken using a Unidose-E electrometer with a Farmer Chamber FC65-G placed at a depth of 10cm in solid water. Measurements were made with and without the base board using both 6MV and 10MV clinical photon energies. The average attenuation factor measured 3.33, with a median of 2.65.
Build-up measurements were also taken using a Unidose-E electrometer with a PTW Advanced Markus Plane Parallel Chamber at various depths in solid water. Measurements were made with and without the base board. The results show that the materials and dimensions used in the board produce a dose buildup effect with an approximate equivalence to 6mm of tissue.
The Zephyr "x-series" Patient Positioning and Transfer System was tested for MR safety with a magnet and hand-held metal detector. The board was then positioned on the MR patient table and slid into the MR without any detectable pull by the magnet. The blower hose did show a slight attraction when directly next to the magnet. It was placed into the bore near the isocenter and was easily removed.
Conclusion: Based on our industry knowledge and experience, both attenuation and buildup test results were found to be in line with patient positioning devices that are readily found on the market. All components, excluding the air blower, tested MR Safe and are labeled accordingly.
i - D.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2013
Ms. Tami Tialayea Chief Operations Officer Diacor, Inc. 2550 Decker Lake Blvd., Suite 26 WEST VALLEY CITY UT 84119
Re: K121929
Trade/Device Name: Zephyr "X-series" Patient Positioning and Transfer System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LNH, LHN, IYE, AND FRZ Dated: November 14, 2012 Received: November 16, 2012
Dear Ms. Tialavea:
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 idence 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, Drig 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, isting of devices, good manufacturing practice, labeling, or annual registations against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleding.
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 Fedral 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050.
3
Page 2-Ms. Tialavea
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/15809.html
the Center for Devices and Podical Houles/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH)CDRHOMICE (CDRH) for
note the regulation entitled "Michaeling (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the manner (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121929
Device Name: Zephyr "x-series" Patient Positioning and Transfer System
Indications for Use:
The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED) .
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
| Michael D. O'Hara | |
|---|---|
| (Division Sign Off) | |
| Division of Radiological Health | |
| Office of In Vitro Diagnostic and Radiological Health | |
| 510(k) | K121929 |
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