Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Device Description

Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications.

Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device.

Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask.

The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Embrace Thermoplastic, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is marketed as substantially equivalent to predicate devices, meaning its performance is considered acceptable if it is comparable to these devices. The acceptance criteria are implicitly defined by the performance characteristics of the predicate devices.

Attribute	Acceptance Criteria (Predicate Devices Range)	Reported Embrace Thermoplastic Performance
Intended Use	Support and immobilize patients receiving external beam radiation therapy	Support and immobilize patients receiving external beam radiation therapy
Composition	Polycaprolactone	Polycaprolactone
Melting Temperature	160 - 170 degrees F	160 - 170 degrees F
Rigidity	1.388 lbs/in² (Klarity) to 3.459 lbs/in² (Aquaplast)	1.080 lbs/in²
Shrinkage	1.5 % (Aquaplast) to 1.9 % (Klarity)	1.1 %
Features	Available as perforated and non-perforated sheets	Available as perforated and non-perforated sheets
Sheet Thickness	2.4 mm and 3.2 mm	2.4 mm and 3.2 mm
Non-Low Temperature Thermoplastic Frame	Yes	Yes
Attaches to Patient Support Device	Yes	Yes
Radiolucency @ 6 MeV (0 degrees)	0.9844 (Klarity) to 0.9915 (Aquaplast)	0.9888
Radiolucency @ 6 MeV (45 degrees)	0.9783 (Klarity) to 0.9872 (Aquaplast)	0.9827
Radiolucency @ 10 MeV (0 degrees)	0.9880 (Klarity) to 0.9935 (Aquaplast)	0.9885
Radiolucency @ 10 MeV (45 degrees)	0.9855 (Klarity) to 0.9906 (Aquaplast)	0.9891
Radiolucency @ 18 MeV (0 degrees)	0.9914 (Klarity) to 0.9949 (Aquaplast)	0.9934
Radiolucency @ 18 MeV (45 degrees)	0.9868 (Klarity) to 0.9924 (Aquaplast)	0.9904
Measured Thickness (3.2 mm sample)	3.2 mm (Klarity) to 3.54 mm (Aquaplast)	3.2 mm
Mfr Recommended Melting Temp. (°F)	165	160
Mfr Recommended Heating Time (Minutes)	2 (Klarity) to 4 (Aquaplast)	2
Time To Transparency (Seconds)	41 (Aquaplast) to 60 (Klarity)	49
Mfr Recommended Cooling Time (Minutes)	5	5
Available Forming time (Seconds)	29 (Klarity) to 50 (Aquaplast)	54

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a distinct "test set" in the context of typical machine learning or diagnostic device studies. Instead, samples of each thermoplastic material (Embrace, Klarity, Aquaplast) were used for bench testing. The exact number of individual samples tested for each attribute (e.g., number of rigidity measurements) is not provided, but it implies a sufficient number for representative physical and radiation attenuation measurements.
Data Provenance: The data is generated from bench testing of the actual materials. No mention of geographical origin or retrospective/prospective nature is applicable as it's not human subject data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for physical properties (rigidity, shrinkage, melting point, etc.) and radiation attenuation for this type of medical device is established through instrumental measurements and standardized testing methods, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the "ground truth" is derived from direct instrumental measurements, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study is focused on the physical and radiation-attenuation properties of a thermoplastic material used for patient immobilization. It does not involve human readers interpreting medical images or making diagnoses, thus an MRMC study is not relevant.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical product (a thermoplastic), not an algorithm or software. Therefore, there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used in this study is based on direct physical measurements and instrumental radiation attenuation measurements. These are objective, quantifiable properties of the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and the study involves bench testing of its properties. There is no machine learning model being trained, and therefore no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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K120335

MAY - 3 2012

Image /page/0/Picture/2 description: The image shows the logo for Bionix. The logo consists of a circle with a stylized "B" inside, followed by the word "BIONIX" in block letters. A registered trademark symbol appears to the upper right of the "X".

Corporate Office

5154 Enterprise Blvd., Toledo, Ohio 43612

May 3, 2012

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92

1. Submitter Information:
a. Applicant:	Bionix Development Corporation5154 Enterprise Blvd.Toledo, Ohio 43612
b. Contact:	James Huttner M.D., Ph.D.Vice President, New Product DevelopmentPhone: (419) 727-8421Fax: (419) 727-4430Email: jhuttner@bionix.com
2. Device Name:
a. Trade Name:	Embrace Thermoplastic
b. Common Name:	Thermoplastic (moldable)
c. Classification Name:	Accessory to Accelerator, Linear, Medical(Per CFR section 892.5050)
3.	Intended Use:

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4. Substantial Equivalence Device(s):

Embrace Thermoplastic from Bionix Development Corporation is similar in composition, design and function to the following moldable low-temperature thermoplastics currently in use as accessories to radiation therapy systems, and used to support and immobilize a patient in a fashion that assists in reproducible positioning of that patient when receiving a course of external beam radiation therapy for the treatment of cancer or other medical conditions:

a. Klarity Thermoplastic manufactured and legally marketed by Larson Products, Inc., Columbus, Ohio. This device is listed under regulation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class II device. This device has been cleared by the FDA under K022708.
b. Aquaplast Thermoplastic manufactured and legally marketed by WFR/Aquaplast Corporation, Avondale, Pennsylvania. This device is listed under regulation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class II device. This device has been cleared by the FDA under K935067.

5. Device Description:

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conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

6. Comparison to Predicate Devices:

The following table summarizes the comparison of Bionix Development Corporation Embrace Thermoplastic to predicate devices:

Carl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Attribute	Klarity Thermoplastic(Larson Products)	Aquaplast Thermoplastic(WFR/Aquaplast)	Embrace Thermoplastic(Bionix)
Intended Use	Support and immobilizepatients receiving externalbeam radiation therapy	Support and immobilizepatients receiving externalbeam radiation therapy	Support and immobilizepatients receiving externalbeam radiation therapy
Composition	Polycaprolactone	Polycaprolactone	Polycaprolactone
MeltingTemperature	160 - 170 degrees F	160 - 170 degrees F	160 - 170 degrees F
Rigidity	1.388 lbs/in²	3.459 lbs/in²	1.080 lbs/in²
Shrinkage	1.9 %	1.5 %	1.1 %
Features	Available as perforated andnon-perforated sheets	Available as perforated andnon-perforated sheets	Available as perforated andnon-perforated sheets
Sheet Thickness	2.4 mm and 3.2 mm	2.4 mm and 3.2 mm	2.4 mm and 3.2 mm
Non-LowTemperatureThermoplasticFrame(for handling)	Yes	Yes	Yes
Attaches toPatient SupportDevice	Yes	Yes	Yes
Radiolucency6 MeV	@0 degrees0.9844	@0 degrees0.9915	@0 degrees0.9888
	@ 45 degrees0.9783	@ 45 degrees0.9872	@ 45 degrees0.9827
· 10 MeV	0.9880	0.9935	0.9885
	0.9855	0.9906	0.9891
· 18 MeV	0.9914	0.9949	0.9934
	0.9868	0.9924	0.9904

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7. Bench Testing:

Samples of Embrace Thermoplastic (Bionix Development Corporation), Klarity Thermoplastic (Larson Products) and Aquaplast Thermoplastic (WFR/Aquaplast Corporation) were tested for radiation attenuation using medium energy (6 MeV (6x)), and high energy (10 MeV (10x) and 23 MeV (23x)) x-ray beams. The x-ray beams were delivered at two gantry angles, 0 degrees (GO) and 45 degrees (G45).

Radiation attenuation for the Embrace Thermoplastic at 6 MeV and 10 MeV was less than 2% and that at 18 MeV less than 1%, for gantry angles at both zero and 45 degrees. These data are comparable to the Aquaplast Thermoplastic and the Klarity Thermoplastic samples tested. This testing confirms the Embrace Thermoplastic is substantially equivalent to the predicate devices for radiation attenuation.

Further bench testing was performed to compare the physical characteristics and actual handling properties of Embrace Thermoplastic (Bionix Development Corporation) to Klarity Thermoplastic (Larson Products) and Aquaplastic (WFR/Aquaplast Corporation). This data is summarized in the following table. It can be seen from this evaluation that the material and handling characteristics and physical properties of the Embrace Thermoplastic are comparable to the properties of the predicate thermoplastic materials.

		MeasuredThickness(mm)	MfrRecommendedMelting Temp.(°F)	MfrRecommendedHeating Time(Minutes)	Time ToTransparency(Seconds)	MfrRecommendedCooling Time(Minutes)	AvailableForming time(Seconds)	Rigidity(lbs/squareinch)	Percent Shrinkage(24 Hrs)
Manufacturer	Material Tested
WFR/Aquaplast	3.2 mm Aquaplast	3.54	165	4	41	5	50	3.459	1.5%
Larson Products	3.2 mm Klarity	3.2	165	2	60	5	29	1.388	1.9%
Bionix	3.2 mm BDC Ther	3.2	160	2	49	5	54	1.080	1.1%

8. Clinical Testing:

No clinical testing was performed on the Embrace Thermoplastic material from Bionix Development Corporation.

9. Conclusion:

The similarity of design, features, composition, and performance indicate that Embrace Thermoplastic from Bionix Development Corporation will perform as well as the legally marketed Klarity Thermoplastic from Larson Products, Inc. and the legally marketed Aquaplast Thermoplastic from WFR/Aquaplast Corporation for the intended use of

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external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MAY - 3 2012

James Huttner M.D., Ph.D. Vice President, New Product Development Bionix Development Corporation 5154 Enterprise Blvd. TOLEDO OH 43612

Re: K120335

Trade/Device Name: Bionix Thermoplastic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 1, 2012 Received: February 8, 2012

Dear Dr. Huttner:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witi anow you to began made of substantial equivalence of your device to a legally marketed nonification. The I Drivenant of fication 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 Parts 801 and 11 you doen optice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement:

510(k) Number (if known): (Not Known) | K / 20 33 5
Device Nomer Dianiu Thermanlestie Device Name: Bionix Thermoplastic Indications for Use:

Prescription Use × Over-The-Counter Use AND/OR .(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

(Division Sign-Off)

office of In 8198

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.