KLARITY

• K Number: K022708
• Device Name: KLARITY
• Manufacturer: LARSON PRODUCTS, INC.
• Date Cleared: 2002-11-12 ( 90 days)
• Product Code: IYE
• Regulation Number: 892.5050
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K935067
• Predicate For: K120335

Intended Use

Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy professionals for the external support and stabilization of patients undergoing radiation therapy treatment in a licensed clinical setting.

Device Description

Klarity™ is a "low temperature" Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F. (68° C.). Heating is best done by immersion in hot water. Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Substantially equivalent to Aquaplast™ Thermoplastic ([K935067](https://510k.innolitics.com/search/K935067)) in chemical composition, method of manufacture, physical appearance, physical characteristics, and intended use.",
      "Pliant and moldable by hand when heated to 155° F (68° C).",
      "To be used for stabilization of patients undergoing external beam Radiation Therapy.",
      "To be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions."
    ],
    "Reported Device Performance": [
      "Klarity™ is equivalent to the predicate device in its chemical composition, method of manufacture, physical appearance, physical characteristics and intended use, verified by knowledge of the chemistry of the predicate device and physical testing.",
      "Klarity™ is a 'low temperature' Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F (68° C).",
      "Klarity™ Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.",
      "Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not applicable. The submission is for a material (thermoplastic) used for patient stabilization, not a diagnostic or AI device that relies on a test dataset of patient data. The 'testing' involved physical characteristics of the material itself and comparison to a predicate device.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. Ground truth for patient data is not relevant for this device. The 'ground truth' for substantial equivalence was established via comparison to the predicate device and physical characteristics validated by experts in manufacturing and materials science (implied by the nature of the tests).",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable.",
  "5. 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": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a thermoplastic for patient stabilization, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with or without AI assistance is not applicable.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Substantial equivalence was established by comparing the device's chemical composition, manufacturing method, physical appearance, physical characteristics (mass density, radiation transmission, bolus effect, moldability, shrinkage), and intended use to a legally marketed predicate device (Aquaplast™ Thermoplastic). The 'ground truth' is the known characteristics and successful use case history of the predicate device itself, along with the results of physical testing on the Klarity™ material.",
  "8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set of data.",
  "9. How the ground truth for the training set was established": "Not applicable."
}

Summary

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*Klarity™ thermoplastic for patient stabilization - 510(k) submission

K022708 Premarket Notification 510(k) Summary

7/9/02

	NOV 12 2002
Trade Name:	Klarity®
Common Name:	Thermoplastic (moldable)
FDA Classification Name:	Accelerator, Linear, Medical
Medical Specialty	Radiology
Product Code	IYE
Device Class	2
Regulation Number	892.5050
Applicant:	Larson Products, Inc.2844 Banwick RoadColumbus, OH 43232
Contact:	Peter M. LarsonPresidentLarson Products, Inc.(ph) 614-235-9100(fax) 614-235-0004email: [e-mail]
Date Prepared	July 9, 2002

• · Klarity Thermoplastic is substantially equivalent to Aquaplast™ Thermoplastic, manufactured and sold by WFR Aquaplast Corporation, based in Lawlins Park, New Jersey. Aquaplast™ is registered under 510(k) Number K935067.
• · Klarity™ is a "low temperature" Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F. (68° C.). Heating is best done by immersion in hot water.
• · Klarity™ Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.
• Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use.
• · A common application of Klarity™ Thermoplastic will be as a "head mask", where perforated thermoplastic is shaped around a patient's head and then firmly attached to a support board to hold the patient's head in a fixed position for repeat radiation therapy treatments.

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• Klarity™ is equivalent to the predicate device in its chemical composition, method of manufacture, physical appearance, physical characteristics and intended use. The equivalence is verified by knowledge of the chemistry of the predicate device and physical testing. Physical testing includes detailed measurements of mass density, transmission of radiation. bolus effect, and comparison of moldability and shrinkage on simulated patient (wooden dummy).
• · Use of "low-temperature" thermoplastics is commonly taught to all licensed U.S. Radiation Therapists. and these materials are in common use at Radiation Oncology clinics throughout the U.S. and the world.
• Safety, utility and medical effectiveness of these materials is affirmed by successful use of predicate device since 1982 for radiation therapy patient stabilization.

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Image /page/2/Picture/1 description: The image shows a black and white logo of the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HUMAN SERVICES" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2002

Mr. Peter M. Larson President Larson Products, Inc. 2844 Banwick Road. COLUMBUS OH 43232 Re: K022708

Trade/Device Name: Klarity Thermoplastic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: August 12, 2002 Received: August 14, 2002

Dear Mr. Larson:

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 (sec 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); 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

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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Page_of_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:
LARSON PRODUCTS, INC.

2644 BANWICK AD COLUMBUS OH 43232 [phone] FAX [phone] Email: [e-mail]

www.larsonproducts.com

STATEMENT OF INDICATIONS FOR USE

Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy rently onals for the external support and stabilization of patients undergoing radiation therapy freatment in a licensed clinical setting,

Patty Yerin

te 8/9/02

Peter M. Larson

Premarket Notification [510(k)] Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDIND)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Urind A. Symm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K022708
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

ਾਕ

Over-The-Counter Use_

(Optional Pormat 1-2-96)

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.