(222 days)
The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch.
The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge.
The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform.
The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.
The provided document describes a 510(k) premarket notification for the CIVCO Medical Solutions Body Pro-Lok™ Respiratory Plate with Cushion and Body Pro-Lok™ Respiratory Belt. The document focuses on demonstrating substantial equivalence to a predicate device and addresses safety and effectiveness through non-clinical testing.
Based on the provided text, the device is a patient positioning system intended to assist in radiation therapy and imaging. The acceptance criteria and the "study" that proves the device meets them are related to non-clinical testing for safety and compatibility rather than clinical performance or diagnostic accuracy. Therefore, many of the typical questions regarding AI/algorithm performance, ground truth, and expert consensus are not directly applicable to this type of device submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria are implicit in the ASTM standards cited, which dictate passing or failing tests for specific physical properties. The reported performance is whether the device passed or no artifact was observed.
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|
| Respiratory Plate with Cushion: | |
| - RF heating | Addressed by scientific rationale. (Implicitly accepted if rationale is sound). |
| - Magnetically Induced Torque | Addressed by scientific rationale. (Implicitly accepted). |
| - Magnetically Induced Displacement Force | Addressed by scientific rationale. (Implicitly accepted). |
| - Image Artifact (ASTM F2119-07 guidance) | No artifact was observed. |
| - Biocompatibility (ISO 10993-5, 10993-10) | Testing completed for patient-contacting materials. (Implicitly passed, as no adverse findings are mentioned). |
| Respiratory Belt: | |
| - RF heating (ASTM F2182-11a) | Passed the acceptance criteria. (Safe for 1.5 T and 3.0 T field strengths). |
| - Magnetically Induced Torque (ASTM F2052-14) | Passed the acceptance criteria. (Safe for 1.5 T and 3.0 T field strengths). |
| - Magnetically Induced Displacement Force (ASTM F2213-06) | Passed the acceptance criteria. (Safe for 1.5 T and 3.0 T field strengths). |
| - Image Artifact (ASTM F2119-07 guidance) | Image artifact was observed near the pressure gauge and BPL002 clamp component. Information regarding the size of each artifact has been included in the Instructions for Use. (This indicates acceptance with mitigation through labeling). |
| - Biocompatibility (ISO 10993-5, 10993-10) | Testing completed for patient-contacting materials. (Implicitly passed, as no adverse findings are mentioned). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The "test set" would be the submitted physical devices themselves, or representative samples, used for the non-clinical testing.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) conducted in accordance with referenced ASTM and ISO standards. Country of origin of the data is not specified beyond the compliance with international standards. The testing is prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This is a non-clinical device safety and compatibility testing, not a diagnostic or AI performance study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- Not applicable. This involves objective physical testing according to standards, where results are measured against defined pass/fail criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This is a non-clinical device submission for a patient positioning system, not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests (RF heating, torque, displacement, image artifact, biocompatibility), the "ground truth" is defined by the objective physical measurements and established pass/fail criteria of the referenced ASTM and ISO standards. For example, a temperature increase above a certain threshold would be a "fail".
8. The Sample Size for the Training Set
- Not applicable. This is a physical device submission, not an AI or machine learning product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is a physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
MEDTEC, Inc. d/b/a CIVCO Medical Solutions % Ms. Amanda Stahle Regulatory Affairs Specialist 1401 8th Street SE ORANGE CITY IA 51041
Re: K153026
Trade/Device Name: Body Pro-Lok" Respiratory Plate with Cushion, Body Pro Lok™ Respiratory Belt Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, LNH Dated: May 20, 2016 Received: May 23, 2016
Dear Ms. Stahle:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Federal 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 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocklo
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Respiratory Plate with Cushion; Respiratory Belt
Indications for Use (Describe)
The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like icon on the left, with curved lines around it. To the right of the icon, the text "CIVCO MEDICAL SOLUTIONS" is displayed in blue, with "CIVCO" in a larger font size than "MEDICAL SOLUTIONS". The logo appears to be for a medical technology or solutions company.
Section 5 - 510(k) Summary
A. Submitter Information
| Submitter Name & Address: | MEDTEC, Inc.d/b/a CIVCO Medical Solutions1401 8th St. SEOrange City, IA 51041 |
|---|---|
| Contact Person: | Amanda Stahle, Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com |
| Date Summary Prepared: | October 14, 2015 |
| Trade Name: | Body Pro-LokTM Respiratory Plate with Cushion; Body Pro-LokTM Respiratory Belt |
| Common Name: | Respiratory Plate with Cushion; Respiratory Belt |
| Classification Names &Numbers: | Medical charged-particle radiation therapy system (892.5050)System, Nuclear Magnetic Resonance Imaging (892.1000) |
| Device Class: | Class II |
| Review Panels: | Radiology |
| Product Codes: | IYE, LNH |
B. Predicate Devices
The proposed devices are substantially equivalent to the following predicate devices:
| Predicate Devices | Manufacturer |
|---|---|
| Compression Bridge and Compression Belt included in CDR SystemsPrecision Patient Positioning System (K122888) | CDR Systems, Inc. |
The purpose of this 510(k) is to 1) modify the design of the Respiratory Plate by attaching an inflatable Cushion, 2) expand the indications for use of the Respiratory Belt to include use in the MR environment, and 3) identify intended use statements for the proposed devices.
C. Device Descriptions
The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch.
The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | ⓮ 319.248.6757 | ⓿ 319.248.6660 |
|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | ⓮ 319.248.6757 | ⓿ 319.248.6660 |
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | ⓮ +31(0) 182.394495 | ⓿ +31(0) 182.395014 |
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | ⓮ 712.737.8688 | ⓿ 712.737.8654 |
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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like graphic on the left, followed by the company name in blue, sans-serif font. Below the company name, the words "MEDICAL SOLUTIONS" are written in a smaller, sans-serif font, also in blue.
WWW.CIVCO.COM
system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge.
The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform.
The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital. The following models are included in this submission:
| DeviceFamily | Part No. | Device Name |
|---|---|---|
| RespiratoryPlate withCushion | BPL007 | Respiratory Plate Cushion |
| RespiratoryPlate withCushion | BPL008 | Respiratory Plate, Wide |
| RespiratoryBelt | MTSBRT004 | Respiratory Belt |
| RespiratoryBelt | BPL002 | Respiratory Belt |
| RespiratoryBelt | BPL006 | Rail Clamp for Respiratory Belt |
| RespiratoryBelt | MTSBRT035 | Pressure Gauge Replacement |
D. Indications for Use/Intended Use Statements
Indications for Use: The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
System Intended Use: The device is part of a system intended to immobilize, position and reposition patients undergoing stereotactic radiation therapy including SBRT.
Device-Specific Intended Use: The device is intended to apply abdominal compression for managing movement and tumor motion during respiration while maintaining maximum comfort to the patient.
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | ☎ 319.248.6757 | ⓞ 319.248.6660 |
|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | ☎ 319.248.6757 | ⓞ 319.248.6660 |
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | ☎ +31(0) 182.394495 | ⓞ +31(0) 182.395014 |
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | ☎ 712.737.8688 | ⓞ 712.737.8654 |
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Image /page/5/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the company name in blue, sans-serif font. Below the company name, the words "MEDICAL SOLUTIONS" are written in a smaller font size.
E. Comparison of Technological Characteristics
Technological characteristics that have changed between the proposed and predicate devices include changes in design and materials. Both the proposed Respiratory Plate with Cushion and predicate device consist of an abdominal compression plate indexed to a system bridge, but the proposed device also includes a cushion mounted to the compression plate. Both the proposed Respiratory Belt and predicate device are pneumatic abdominal respiratory belts with Velcro straps to tighten and secure the device around the patient, but the proposed device attaches to the system platform whereas the predicate device is free-standing. Different materials were used to manufacture the proposed devices and were selected with MR safety and effectiveness considerations.
F. Non-Clinical Testing and Literature Review
Non-clinical testing was completed to confirm that the proposed devices are as safe and effective as the predicate devices and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness. For the Respiratory Plate with Cushion, a scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. The Respiratory Plate with Cushion was tested for image artifact using ASTM Standard F2119-07 as guidance. No artifact was observed.
The Respiratory Belt was tested for MR safety and compatibility in accordance with ASTM Standards F2182-11a, F2052-14, and F2213-06, and was also tested using ASTM Standard F2119-07 as guidance. The Respiratory Belt passed the acceptance criteria for RF heating, magnetically induced torque, and magnetically induced displacement force and demonstrate that the device is safe for use in field strengths of 1.5 T and 3.0 T. Image artifact was observed near the pressure gauge and BPL002 clamp component, and information regarding size of each artifact has been included in the Instructions for Use.
The devices are intended for limited contact duration (<24 hours) for surface devices (skin). Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5 and ISO 10993-10.
A literature review was conducted to support the intended use statements. The literature demonstrates that these devices are safely and effectively used in applying abdominal compression for managing movement and tumor motion during respiration.
G. Conclusion
This premarket submission for the Respiratory Plate with Cushion and Respiratory Belt has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | P 319.248.6757 | F 319.248.6660 |
|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | P 319.248.6757 | F 319.248.6660 |
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | P +31(0) 182.394495 | F +31(0) 182.395014 |
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | P 712.737.8688 | F 712.737.8654 |
§ 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.