(46 days)
To enable head and neck immobilization for patient placement during radiation therapy planning and treatment.
The Integra Immobilization System consists of three device options which may be used as the patient simulation and treatment circumstances indicate. All three options of the System utilize the same thermoplastic, all three are designed with high strength carbon fiber, with foam core to provide a strong but light weight support base and all three provide head, neck and shoulder immobilization for patients undergoing simulation or radiation therapy using the exact same attachment of the thermoplastic to the carbon fiber board.
The "Integra ce Extension" option to the Varian Exact Couch provides a means to attach the extension securely to the end of the Exact Couch utilizing Varian's end of table design. The board provides rigid support to the head and shoulders by means of its carbon fiber and foam core construction.
The "Integra ci Insert" option to the Varian Exact Couch provides the means to provide head, neck and shoulder immobilization on a CT Scanner couch or a Varian Exact Treatment Table. This insert fits into a mating recess in the CT table overlay or a similar insert space in the Exact Treatment Table.
The "Integra co Cantilever Board" option provides head, neck and shoulder immobilization as part of a stand alone carbon fiber and foam core board. The board is constructed utilizing carbon fiber surfaces with a foam interior. The result is an extremely stong but light weight board. The overall design of the board provides comfortable patient support and a means to index the board to the table or overlay that it rests upon.
The Integra Immobilization System utilizes the method of head, neck and shoulder fixation that is also commonly found in radiation therapy departments and has been repeatedly shown to be safe and effective in immobilizing the head, neck and shoulders. The thermoplastic from Orfit is heated in a water bath to a temperature that makes the thermoplastic moldable. The material is removed from the bath, dried and placed over the patients head, neck and shoulders. It is stretched over the head, neck and shoulders, molded to conform to the patients head, neck and shoulder contour and attached to the support board in such a way that the patient is firmly held in place and yet can be released from the position very quickly if needed. As the thermoplastic cools, it hardens and thus permanently maintains the patient contour for repeated identical immobilizations required during a course of treatment.
The provided text is a 510(k) Premarket Notification Summary for the Integra™ Immobilization System. This is a medical device submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically seen for AI/ML-driven devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document. The document primarily details the device description, its intended use, and a comparison to a predicate device to establish substantial equivalence based on technological characteristics.
Instead of providing the requested table for acceptance criteria and performance (which is not present), I will summarize the key information available in the document that aligns with an equivalence demonstration for a non-AI/ML device.
Summary of Device Equivalence Information (as presented in the 510(k) Summary):
-
Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit): Substantial equivalence to the predicate device (Orfit Industries Raycast Immobilization Systems and Thermoplastics, K991319) in terms of construction, form, function, and safety and effectiveness.
- Reported Device Performance: The document does not provide specific performance metrics in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it asserts that the Integra Immobilization System is "substantially equivalent to the Orfit boards in construction, form and function." This equivalence is based on the comparison of technological characteristics.
-
Sample Size and Data Provenance:
- Not Applicable. This type of device (physical immobilization system) does not involve data in the sense of a test set for algorithmic evaluation. Therefore, there are no sample sizes for test sets or data provenance cited.
-
Number of Experts and Qualifications:
- Not Applicable. The evaluation of this device is based on its physical design and materials, and comparison to an established predicate, rather than an expert review of algorithmic outputs or study data.
-
Adjudication Method:
- Not Applicable. There is no adjudication process described as there is no diagnostic or interpretive output requiring expert consensus.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI-assisted diagnostic or interpretive device, so an MRMC study is irrelevant to its evaluation.
-
Standalone Performance:
- Not Applicable. "Standalone performance" in the context of AI refers to the algorithm's performance without human intervention. This device is a physical immobilization system and does not have an "algorithm."
-
Type of Ground Truth Used:
- Not Applicable. No ground truth data (e.g., pathology, outcomes data) is used because the device's function is mechanical immobilization, not diagnostic or predictive. The "truth" here is essentially that it effectively immobilizes the patient, which is established through its design and similarity to the predicate.
-
Sample Size for the Training Set:
- Not Applicable. There is no training set for this type of device.
-
How Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
Key Information from the Document that demonstrates equivalence:
The applicant established substantial equivalence by comparing the Integra Immobilization System to the predicate device, the Orfit Industries Raycast Immobilization Systems and Thermoplastics (K991319), across several technological characteristics:
- Intended Use: Both devices are intended to retain/immobilize the head, neck, and shoulders of the patient during radiation therapy simulation or treatment.
- Construction: Both utilize carbon fiber over foam core board construction (Orfit also uses HPL in some cases).
- Thermoplastic Head Immobilization: Both use thermoplastic masks.
- Head and Neck Restraint: Both use non-invasive thermoplastic masks.
- Head Positioning: Both use head holders and foam wedges.
- Thermoplastic Mask Release: Both use a foam insert to hold the mask in a slot for release.
The document states, "The Diacor Integra Head and Neck Immobilization boards are substantially equivalent to the Orfit boards in construction, form and function." This statement, coupled with the detailed comparison table, forms the basis of their claim for meeting the FDA's regulatory requirements for this type of device via the 510(k) pathway.
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DIACOR, INC., 3191 SOUTH 3300 EAST, SUITE 100A, SALT LAKE CITY, UT 84109 /801-467-0050 / FAX 801-487-3258
Image /page/0/Picture/2 description: The image shows the word "DIACOR" in white letters against a black background. A horizontal line runs through the middle of the word, bisecting each letter. The font is bold and sans-serif, giving the word a strong and modern appearance. The overall design is simple and eye-catching.
Premarket Notification [510(k)] Summary
April 6, 2005
MAY 2 3 2005
Trade Name: : Integra™ Immobilization System
Common Name: Head and Neck Immobilization System
Classification Name: Medical Linear Accelerator Accessory, 90 IYE (per 21 CFR section 892.5050)
| Manufacturer's Name: | DIACOR, Inc. |
|---|---|
| Address: | 3191 South 3300 EastSalt Lake City, Utah 84109 |
| Corresponding Official: | Glenn Waterman |
| Title: | President and CEO |
| Telephone: | 800-342-2679 |
| Fax: | 801-487-3258 |
Predicate: Orfit Industries Raycast Immobilization Systems and Thermoplastics, K991319
Device Description: The Integra Immobilization System consists of three device options which may be used as the patient simulation and treatment circumstances indicate. All three options of the System utilize the same thermoplastic, all three are designed with high strength carbon fiber, with foam core to provide a strong but light weight support base and all three provide head, neck and shoulder immobilization for patients undergoing simulation or radiation therapy using the exact same attachment of the thermoplastic to the carbon fiber board.
The "Integra ce Extension" option to the Varian Exact Couch provides a means to attach the extension securely to the end of the Exact Couch utilizing Varian's end of table design. The board provides rigid support to the head and shoulders by means of its carbon fiber and foam core construction.
The "Integra ci Insert" option to the Varian Exact Couch provides the means to provide head, neck and shoulder immobilization on a CT Scanner couch or a Varian Exact Treatment Table. This insert fits into a mating recess in the CT table overlay or a similar insert space in the Exact Treatment Table.
The "Integra co Cantilever Board" option provides head, neck and shoulder immobilization as part of a stand alone carbon fiber and foam core board. The board
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is constructed utilizing carbon fiber surfaces with a foam interior. The result is an extremely stong but light weight board. The overall design of the board provides comfortable patient support and a means to index the board to the table or overlay that it rests upon.
The Integra Immobilization System utilizes the method of head, neck and shoulder fixation that is also commonly found in radiation therapy departments and has been repeatedly shown to be safe and effective in immobilizing the head, neck and shoulders. The thermoplastic from Orfit is heated in a water bath to a temperature that makes the thermoplastic moldable. The material is removed from the bath, dried and placed over the patients head, neck and shoulders. It is stretched over the head, neck and shoulders, molded to conform to the patients head, neck and shoulder contour and attached to the support board in such a way that the patient is firmly held in place and yet can be released from the position very quickly if needed. As the thermoplastic cools, it hardens and thus permanently maintains the patient contour for repeated identical immobilizations required during a course of treatment.
Intended Use: The Integra Immobilization System is intended to immobilize the head, neck and shoulders of the patient during radiation therapy simulation or treatment.
Technological Characteristics: See the attached Predicate Comparison Table
| # | Feature | Orfit Industries Thermo-plasticand Hardware, K991319 | Diacor, Inc. Integra ImmobilizationSystem |
|---|---|---|---|
| 1. | Intended Use | The Raycast ImmobilizationSystems Hardware andThermoplastic Materials are usedto retain and reproduce apatient's position during radiationtherapy. | The Integra ImmobilizationSystem is intended to immobilizethe head, neck and shoulders ofthe patient during radiationtherapy simulation or treatment |
| 2. | Carbon FiberOver FoamCore BoardConstruction | HPL and Carbon Fiber OverFoam Core Board Construction | Carbon Fiber Over Foam CoreBoard Construction |
| 3. | ThermoplasticHeadImmobilization | Yes | Yes |
| 4. | Head andNeck Restraint | Non-invasive thermoplastic mask | Non-invasive thermoplastic mask |
| 5. | HeadPositioning | Head Holder and Foam Wedges | Head Holder and Foam Wedges |
| 6. | ThermoplasticMask Release | Foam Insert to Hold Mask in Slot | Foam Insert to Hold Mask in Slot |
Predicate Comparison Table
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The Diacor Integra Head and Neck Immobilization boards are substantially equivalent to the Orfit boards in construction, form and function.
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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like figure in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH & HUMAN..." but the full text is not clear due to the image quality. The bird-like figure in the center is composed of three curved lines, suggesting movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
Mr. Glenn Waterman President and CEO DIACOR, Inc. 3191 South 3300 East Suite 100A SALT LAKE CITY UT 84109
Re: K050888
Trade/Device Name: Integra Immobilization System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 6, 2005 Received: April 7, 2005
Dear Mr. Waterman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revened your counted on substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the closed of to togally mant date of the Medical Device Amendments, or to devices that have been May 20, 1910, 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 do not roquite approvial 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 (Premarket it your device to such additional controls. Existing major regulations affecting your Apporal), It they of coole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA are roo bail of 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 FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a acternination and yoursered by other Federal agencies. You must comply with all the rederal statues and regalations and limited to registration and listing (21 CFR Part 807); labeling Act S requirements, moduling, but not mixer it is in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
10.0 legin This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA miding of saosantial oquice 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), pleased If you desire specific advice for your device on our laceming regarities (
contact the 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 prematics notification "(21 CFR Also, please note the regulation entires, "Whisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general mornational and Consumer Assistance at its toll-free number (800). Drvision of Small Manufacturers, International and Collion!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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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Tab 3
Indications For Use
510(k) Number: KOSO888
Device Name: Integra Immobilization System
Indications for Use:
To enable head and neck immobilization for patient placement during radiation therapy planning and treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel H. Burnham
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use V (per 21 CFR 801.109) OR
Over-The-Counter Use_
N/A