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.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for K981115 describes a thermoplastic material for radiotherapy positioning. This submission focuses on demonstrating substantial equivalence to an existing legally marketed device (Aquaplast), rather than providing detailed performance data from a clinical study with acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific test sets, expert consensus, and multi-reader multi-case studies is not applicable to this type of submission. The provided document details biocompatibility testing as its primary method of demonstrating equivalence.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Radio-plast / Aquaplast)
Biocompatibility - Cytotoxicity (Elution Test): Meets requirements of USP 23 and ISO 10993-5	Exhibited mild reactivity
Biocompatibility - Cytotoxicity (Agar Diffusion Test): Meets requirements of USP 23 and ISO 10993-5	Exhibited slight reactivity
Biocompatibility - FHSA Primary Dermal Irritation: Non-irritating to skin	Found to be non-irritating to the skin of New Zealand rabbits
Biocompatibility - Dermal Sensitization: Weak potential for sensitization	Found to have a weak potential for sensitization
Immobilizing Characteristics: Substantially equivalent to Aquaplast	Consists of the same material under different proprietary names; shown to be substantially equivalent.
Radiation Attenuation: Equivalent to 1.5 times its thickness of water	Approximately equivalent to 1.5 times its thickness of water (determined using a teletherapy type cobalt 60 beam)

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of clinical images or patient data.
- For biocompatibility testing, New Zealand rabbits were used for the FHSA Primary Dermal Irritation and Dermal Sensitization tests. The sample size for these animal tests is not explicitly stated.
- The data provenance for the biocompatibility tests is presumably from internal lab testing or contracted testing. Country of origin is not specified. The studies are implicitly prospective for the specific tests performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a material, not an AI or diagnostic imaging device that requires expert ground truth for interpretation of medical images. The "ground truth" for biocompatibility is established by the test methods themselves and established biological responses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human interpretation of data requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical material, not an algorithm. However, the biocompatibility tests and radiation attenuation measurements are standalone evaluations of the material's properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Ground truth is established by the specified standards (USP 23, ISO 10993-5) and standardized animal testing protocols (e.g., FHSA, Magnusson, Kligman Maximization Test).
- For immobilizing characteristics and radiation attenuation: The ground truth is based on physical and material science measurements compared to the predicate device.
The sample size for the training set:
- Not applicable. No "training set" in the context of machine learning or AI is relevant here.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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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 ..

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Intended use:

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.

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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.

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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

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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

Regulation Number and Section

§ 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.