(96 days)
The CushionCast™ Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.
The CushionCast™ is moldable stabilization cushions for radiation therapy patients. This product targets customers who require stabilization cushions for patients who are undergoing radiation therapy. The CushionCast™ is needed in order to mold to the shape of the patient's head to immobilize any movement during radiation therapy.
The cushion is constructed with a biocompatible and water resistant fabric and internal components, which include low viscosity casting resins that are sealed in pouches and polystyrene beads as filler material. To activate the cushion, the pouches are popped, and the internal components are mixed for 2 minutes. The plug inserted in the vent tube is removed prior to the molding process. The vent tube serves to expel excess air to allow for an accurate mold. The mixture of the Part A and Part B liquid plastics should yield a hardened mold. The fully cured mold provides a dimensionally stable cushion required by radiotherapy systems.
The provided text describes a medical device called the CushionCast™ Moldable Cushion and its 510(k) summary, which includes a claim of substantial equivalence to a predicate device, the Klarity Mold Cushions. However, the document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details of a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness study results as requested in the prompt.
The document mentions a "design verification study" was conducted to ensure dimensional stability and equivalent performance to the predicate, but it does not provide any specifics about this study, its methodology, or its results.
Based on the information provided, I cannot fulfill your request for a detailed description of acceptance criteria and the study proving the device meets them with the specific points you listed. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with quantifiable acceptance criteria.
Therefore, I must state that the requested information (items 1-9) is not present in the provided text.
The only relevant snippet is:
"A design verification study was conducted to ensure that the dimensional stability of the CushionCast™ meets necessary requirements. The study also indicated that the CushionCast™ performs equivalently to the Klarity Mold Cushions. It is reasonable to conclude that the CushionCast™ and Klarity Mold Cushion are substantially equivalent with respect to use, safety, and effectiveness."
This statement confirms a study was done for "dimensional stability" and "equivalent performance," but it does not provide any of the specifics to answer your numbered prompts.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
IZI Medical Products LLC % Mr. Oiang Cao Manager of Quality Assurance and Regulatory Affairs 5 Easter Court Suite J OWINGS MILLS MD 21117
Re: K162265
Trade/Device Name: CushionCast" Moldable Cushion Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 29, 2016 Received: October 4, 2016
Dear Mr. Cao:
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.
Michael D'Hara
For
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162265
Device Name CushionCast Moldable Cushion
Indications for Use (Describe)
The CushionCast Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.
Type of Use (Select one or both, as applicable)
X 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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5.0 510(k) Summary
510(k) Owner
IZI Medical Products LLC 5 Easter Court, Suite J Owings Mills, MD 21117 Phone: (410) 594-9403 Fax: (410) 594-0540 Contact Person: Qiang Cao, Quality Assurance and Regulatory Affairs Manager
Date Summary Prepared: August 10th, 2016
Device Name
Trade Name: CushionCast™ Moldable Cushion
Common or Usual Name: moldable cushion
Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050)
Product Code: IYE
Predicate Devices
Klarity Mold Cushions (K132124)
Prior Submissions
There were no prior submissions for the subject device.
Device Description
The CushionCast™ is moldable stabilization cushions for radiation therapy patients. This product targets customers who require stabilization cushions for patients who are undergoing radiation therapy. The CushionCast™ is needed in order to mold to the shape of the patient's head to immobilize any movement during radiation therapy.
The cushion is constructed with a biocompatible and water resistant fabric and internal components, which include low viscosity casting resins that are sealed in pouches and polystyrene beads as filler material. To activate the cushion, the pouches are popped, and
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the internal components are mixed for 2 minutes. The plug inserted in the vent tube is removed prior to the molding process. The vent tube serves to expel excess air to allow for an accurate mold. The mixture of the Part A and Part B liquid plastics should yield a hardened mold. The fully cured mold provides a dimensionally stable cushion required by radiotherapy systems.
Intended Use of the Device
The CushionCast™ Moldable Cushions are designed for the positioning and repositioning of patients receiving radiation therapy or other treatment. The moldable cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing a radiation therapy or other treatment in a clinic or hospital setting.
Patient Population
The device is intended for use in patients undergoing external-beam radiation therapy or other teatment.
Environment of Use
The device is intended for use by a trained healthcare professional in a healthcare facility.
Claim of Substantial Equivalence
This product is substantially equivalent to existing patient positioning cushions currently being marketed as accessories to radiation therapy systems.
The equivalent device is Klarity Mold Cushion (AccuCushion) marketed by Klarity (K132124).
The Klarity Mold Cushions has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150°F. To use the Klarity Mold cushion, a therapist must first place the cushion in an oven or in a hot water bath to heat it to about 150 F. At this temperature the cushion becomes moldable by hand and will remain moldable for about 5 to 8 minutes as it cools to room temperature.
The CushionCast™ is constructed with a biocompatible and water resistant fabric shell and internal components, which include small polystyrene beads and casting resins that are sealed in pouches. The mixture of Part A and Part B casting resins yields a durable mold with a hardening time approximately between 5 to 7 minutes after mixing. Fully cured molds provide a dimensionally stable cushion.
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Like the Klarity Mold cushion, IZI CushionCast™ hardens to create a firm support cushion, conforming to and stabilizing the patient. The cushions also conform to the structure underneath the cushion, providing a means to specifically locate a patient on a treatment table or other support device.
Based on the similarity of design and construction of the CushionCast™ and the Klarity Mold Cushions, it is reasonable to expect that these devices will have similar properties and should function in a substantially equivalent fashion. Both devices are intended for use in positioning and re-positioning patients during radiation therapy procedures and are employed in clinically similar fashions.
A design verification study was conducted to ensure that the dimensional stability of the CushionCast™ meets necessary requirements. The study also indicated that the CushionCast™ performs equivalently to the Klarity Mold Cushions. It is reasonable to conclude that the CushionCast™ and Klarity Mold Cushion are substantially equivalent with respect to use, safety, and effectiveness.
§ 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.