K Number
K220539
Device Name
Klarity SRS Baseplate, Klarity Promise Baseplate
Date Cleared
2022-11-01

(249 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy. 2. Klarity Promise Baseplate: The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary describes a physical immobilization device for radiation therapy and does not mention any software, algorithms, or AI/ML capabilities.

No
The device is described as assisting in positioning and immobilizing patients for radiation therapy, which is a therapeutic treatment. However, the device itself does not directly treat a disease or condition; it facilitates the delivery of a therapeutic treatment.

No
The device is used for positioning and immobilization during radiation therapy and diagnostic imaging, not for generating a diagnosis itself.

No

The device description clearly indicates physical components (baseplate, thermoplastic mask) used for patient positioning and immobilization, which are hardware.

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used for positioning and immobilizing patients during radiation therapy and diagnostic imaging. This is a physical function related to patient treatment and imaging, not the analysis of biological samples (like blood, urine, or tissue) outside the body.
  • Device Description: While a device description is not provided, the intended use strongly suggests a physical device used for patient support and immobilization.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing biological samples.
    • Providing diagnostic information based on the analysis of biological samples.
    • Reagents, calibrators, or controls typically associated with IVD tests.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is entirely focused on the physical positioning and immobilization of the patient during medical procedures.

N/A

Intended Use / Indications for Use

  1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
  2. Klarity Promise Baseplate: The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

head, brain, and neck

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

Not Found

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)

Not Found

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.

Not Found

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.

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November 1, 2022

Klarity Medical & Equipment (GZ) Co., Ltd. % Peter Larson PRES/CEO Klarity Medical Products, LLC 600 Industrial Parkway HEATH OH 43056

Re: K220539

Trade/Device Name: Klarity SRS Baseplate, Klarity Promise Baseplate Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: September 23, 2022 Received: September 26, 2022

Dear Peter 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Dan Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K220539

Device Name

  1. Klarity SRS Baseplate

2.. Klarity Promise Baseplate

Indications for Use (Describe)

1. Klarity SRS Baseplate:

The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

2. Klarity Promise Baseplate

The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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