(90 days)
Not Found
No
The device description and intended use clearly describe a passive thermoplastic material used for physical immobilization. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on biocompatibility, not algorithmic performance.
No.
The device is used to fabricate custom positioning and immobilization devices for radiation therapy, which supports the delivery of therapy but is not a therapeutic device itself.
No
This device is described as a thermoplastic material used to fabricate custom positioning and immobilization devices for radiation therapy, making it a treatment aid, not a diagnostic device.
No
The device is a thermoplastic material used to fabricate physical immobilization devices, which is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fabricate custom positioning and immobilization devices for radiation therapy." This is a physical device used externally on the patient for positioning during treatment.
- Device Description: The description details a "thermoplastic material" used to create "custom supports, positioning and immobilization devices." It describes the physical properties and how it's used to conform to the patient's body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or providing diagnostic information.
The device is clearly intended for external physical support and immobilization during radiation therapy, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device consists of a thermoplastic material which is intended to be used in a handling frame by radiotherapists in fabricating custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body during radiotherapy applications.
The intended use of this device which is subject to premarket notification of custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body for use during radiation therapy.
These low temperature thermoplastic sheets may be used to fabricate custom positioning and immobilization devices for radiation therapy. These sheets may be formed directly against the patient's skin to produce immobilizer for any part of the body. The immobilizer should be used any time precise, repeatable positioning of a patient is required.
Product codes (comma separated list FDA assigned to the subject device)
90IWB, 90 LHN
Device Description
Radio-plast Thermoplastic Sheet Material for patient immobilization and positioning.
This device consists of a thermoplastic material which is intended to be used in a handling frame by radiotherapists in fabricating custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body. The device in its application consists of a conforming net of rigid thermoplastic material effecting immobilization. This thermoplastic material is intended for the fabrication of custom supports, positioning and immobilizing devices for use in radiotherapy.
The Rehabilitation Division, Smith & Nephew, Inc. thermoplastic material for the radiotherapy positioning application will consist of Radio-plast material in 1/16 inch (1.6mm), 3/32 inch (2.4mm) and 1/8 inch (3.2 mm) thicknesses, in various perforation patterns, with perforation percentages of 42%. Radio-plast will be marketed for both in sheets and in precut shapes to fit various frames designed by MED-TEC, Inc. and other suppliers currently on the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, breast, neck and chest and foot, and other parts of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiotherapists
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)
Biocompatibility Testing Results:
Cytotoxicity (Elution Test): Radio-plast (Aquaplast) meets the requirements of USP 23 and ISO 10993-5, and exhibited mild reactivity.
Cytotoxicity (Agar Diffusion Test): Radio-plast (Aquaplast) meets the requirements of USP 23 and ISO 10993-5, and exhibited slight reactivity.
FHSA Primary Dermal Irritation: Radio-plast (Aquaplast) was found to be nonirritating to the skin of New Zealand rabbits.
Dermal Sensitization (Magnusson, Kligman Maximization Test): Radio-plast (Aquaplast) was found to have a weak potential for sensitization.
Biocompatibility testing established that Aquaplast thermoplastic is substantially equivalent to the legally marketed thermoplastic, Aquaplast.
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.
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
§ 892.5050 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.
0
K981115
JUN 25 1998
510(k) SUMMARY:
Rehabilitation Division
Smith & Nephew, Inc. One Quality Drive, P.O. Box 1005 Germantown, WI 53022-8205 U.S.A 414-251-7840, Telefax: 414-251-775
Smith = Nephew
Submitter: Rehabilitation Division Smith & Nephew, Inc. One Quality Drive N104 W13400 Donges Bay Road Germantown, WI 53022
Phone: (414)251-7840 FAX: (414)251-7758
| Official Correspondent: | Cordell C. Hoffins |
|---|---|
| Correspondent phone: | (414) 253-3069 |
| Date Prepared: | March 23, 1998 |
Name of the Device: Common name of Device: Proprietary Name: Classification name: Product Code: Product Class:
Thermoplastic for Radiotherapy Positioning Immobilization and positioning device, for use in radiotherapy. Radio-plast System, Radiation Therepy, Radionuclide 90IWB II
Legally marketed equivalent device:
MED-TEC, Inc. "Uni-Frame", K933227, in particular the "Aquaplast" splinting thermoplastic material used in this device. .
Product Description: Radio-plast Thermoplastic Sheet Material for patient immobilization and positioning ..
This device consists of a thermoplastic material which is intended to be used in a handling frame by radiotherapists in fabricating custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body. The device in its application consists of a conforming net of rigid thermoplastic material effecting immobilization. This thermoplastic material is intended for the fabrication of custom supports, positioning and immobilizing devices for use in radiotherapy.
The Rehabilitation Division, Smith & Nephew, Inc. thermoplastic material for the radiotherapy positioning application will consist of Radio-plast material in 1/16 inch (1.6mm), 3/32 inch (2.4mm) and 1/8 inch (3.2 mm) thicknesses, in various perforation patterns, with perforation percentages of 42%. Radio-plast will be marketed for both in sheets and in precut shapes to fit various frames designed by MED-TEC, Inc. and other suppliers currently on the market.
Image /page/0/Picture/16 description: The image shows the text "Page 1 of 3". This indicates that the image is the first page of a three-page document. The text is written in a clear, legible font.
Image /page/0/Picture/17 description: The image shows a stylized letter "R" in a bold, sans-serif font. The letter is predominantly black, with a small white area within the upper portion of the "R", creating a visual contrast. To the lower right of the letter, there is a circled "R" symbol, indicating a registered trademark.
1
Intended use:
This device consists of a thermoplastic material which is intended to be used in a handling frame by radiotherapists in fabricating custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body during radiotherapy applications.
Intended use subject to 510(k) premarket notification:
The intended use of this device which is subject to premarket notification of custom supports, positioning and immobilization devices for the head, neck, breast, neck and chest and foot, and other parts of the body for use during radiation therapy.
Technological Characteristics
The immobilizing characteristics of Radio-plast thermoplastics are substantially equivalent to the currently marketed "Aquaplast" splinting thermoplastics, and consist of the same material under different proprietary names.
Radio-plast (Aquaplast) has been shown in bio-compatibility studies to cause mild cytotoxicity and a weak potential for sensitization, and is substantially equivalent to the currently marketed Aquaplast splinting material.
Radio-plast thermoplastic is NOT sold as "Sterile".
Solid Radio-plast is approximately equivalent to 1.5 times its thickness of water, determined using a teletherapy type cobalt 60 beam.
Biocompatibility Testing Results
Biocompatibility testing of Radio-plast (Aquaplast) indicated that the thermoplastic material exhibits the following characteristics:
Cytotoxicity (Elution Test): Radio-plast (Aquaplast) meets the requirements of USP 23 and ISO 10993-5, and exhibited mild reactivity.
Cytotoxicity (Agar Diffusion Test): Radio-plast (Aquaplast) meets the requirements of USP 23 and ISO 10993-5, and exhibited slight reactivity.
FHSA Primary Dermal Irritation: Radio-plast (Aquaplast) was found to be nonirritating to the skin of New Zealand rabbits.
2
Dermal Sensitization (Magnusson, Kligman Maximization Test): Radio-plast (Aquaplast) was found to have a weak potential for sensitization.
Biocompatibility testing established that Aquaplast thermoplastic is substantially equivalent ot the legally marketed thermoplastic, Aquaplast.
Conclusion:
Radio-plast thermoplastic is substantially equivalent to the legally marketed Aquaplast thermoplastic in radiotherapy immobilization applications.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Cordell C. Hoffins Smith Nephew, Inc. One Quality Drive PO Box 1005 Germantown, WI 53022-8205 Re: K981115
Radio-plast (Radiotherapy positioning device) Dated: March 23, 1998 Received: March 2, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN 21 CFR 892.5750/Procode: 90 IWB
Dear Mr. Hoffins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ 1_ of_1_
510 (k) NUMBER (IF KNOWN) : _ K981115 DEVICE NAME: RADIO - PLAST INDICATIONS FOR USE:
These low temperature thermoplastic sheets may be used to fabricate custom positioning and immobilization devices for radiation therapy. These sheets may be formed directly against the patient's skin to produce immobilizer for any part of the The immobilizer should be used any time precise, body . repeatable positioning of a patient is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of device regualtion (ODE)
Prescription Use ✗ OR Over-The-Counetr-Use __
(Per 21 CFR 801.109) Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number