(114 days)
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors.
Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.
Klarity Vacuum Cushions: The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment.
Klarity Mold Cushions: The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.
The provided text describes two medical devices, Klarity Vacuum Cushions and Klarity Mold Cushions, and their 510(k) submission for substantial equivalence. It does not contain information about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The submission focuses on demonstrating equivalence to predicate devices based on design, construction, intended use, and functioning, rather than presenting new performance data against statistical acceptance criteria.
Therefore, many sections of the requested information cannot be filled from the provided text.
Here's a summary of what can be extracted and what is missing:
Klarity Patient Immobilization Devices: Acceptance Criteria and Study Information
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not specified | Not specified | The 510(k) submission demonstrates substantial equivalence to predicate devices based on design and intended use, not through specific performance metrics and acceptance criteria. No quantitative performance data, such as precision, accuracy, or stability over time, is provided for either Klarity Vacuum Cushions or Klarity Mold Cushions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The submission relies on a comparison to predicate devices rather than independent testing of a specific sample size.
- Data Provenance: Not applicable, as no new performance data or clinical study results are presented. The claims are based on the similarity to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth was established by experts for a test set, as no independent performance study was conducted. The equivalence is established by comparing device characteristics to predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The submission is not focused on demonstrating an improvement in human reader performance with AI assistance, as these are physical immobilization devices without an AI component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not applicable. These are physical patient immobilization devices, not algorithms. The concept of "standalone performance" as it relates to AI algorithms does not apply here.
7. Type of Ground Truth Used:
- Not applicable. The basis for clearance is substantial equivalence to predicate devices. This means the device is deemed safe and effective because it shares similar technological characteristics and intended use with devices already on the market (Klarity Vacuum Cushions to Bionix SecureVac Immobilization System, and Klarity Mold Cushions to Civco MoldCare/AccuForm™). No "ground truth" in the clinical performance sense was established for these specific Klarity devices.
8. Sample Size for the Training Set:
- Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
Summary of Device Equivalence Justification provided in the 510(k) submission:
-
Klarity Vacuum Cushions:
- Predicate Device: The SecureVac Immobilization System (K040773) manufactured by Bionix Development Corporation.
- Basis for Equivalence:
- Similar Construction: Both use polyurethane coated nylon material and are filled with small polystyrene spheres.
- Similar Function: Both are sealed airtight with self-closing valves. Both work by evacuating air, causing the cushion to contract and hold a rigid, patient-conforming shape.
- Similar Clinical Use: Both are used for positioning and repositioning patients during external-beam radiation therapy in the same manner.
- Conclusion: Based on similarity in design, construction, and function, it is reasonable to expect similar properties, attenuation factors, and performance regarding use, safety, and effectiveness.
-
Klarity Mold Cushions:
- Predicate Device: The MoldCare head and neck cushion (K982624) marketed by Civco (now AccuForm™).
- Basis for Equivalence:
- Similar Intended Use: Both are designed for positioning and repositioning patients receiving external-beam radiation therapy.
- Similar Outcome: Both harden to create a firm, patient-conforming support cushion.
- Differing Mechanism (but achieving similar function):
- Predicate (MoldCare): Polystyrene spheres mixed with a water-activated resin, hardening after water application (approx. 10 minutes).
- Klarity Mold Cushions: Polystyrene spheres surrounded by a 1/16" layer of polycaprolactone thermoplastic. This material softens at 150°F (using oven or hot water bath) and becomes moldable for 5-8 minutes as it cools, then hardens. The thermoplastic technology is noted as commonly used in other radiation therapy devices (e.g., Klarity thermoplastic masks, 510(k)#022708).
- Conclusion: Despite a different hardening mechanism, the devices achieve the same clinical function of conforming to and stabilizing the patient for radiation therapy, leading to a conclusion of substantial equivalence in use, safety, and effectiveness.
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Klarity Patient Immobilization Devices
510(K) submission
.
| V1 | 21ﮧ ﮐﮯ ﻟﯿﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩﯼ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩﯼ ﺍﯾﺮﺍﻥ ﻓﺮﺍﻧﺴﯿﺴﯽ ﺍﯾﺮﺍﻥ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﮯ ﺷﮩﺮ ﺍ | r | 1 | A | 211 |
|---|---|---|---|---|---|
| ////3 |
| Device 1: | Klarity Vacuum Cushions |
|---|---|
| Date Prepared: | July 1, 2013 |
| Submitter: | Klarity Medical Products, LLC80 Westgate DriveNewark, Ohio 43055Tel: 740.788.8107 |
| NOV 0 1 2013 | |
| Est. Registration # | 1530561 |
| Contact Person: | Peter M LarsonPresidentKlarity Medical Products, LLCEmail: peter@klaritymedical.com |
| Trade Name: | Klarity Vacuum Cushions |
| Common Name: | Vacuum Cushion Immobilization System |
| Manufacturing Site: | Klarity Medical Products, LLC80 Westgate DriveNewark, Ohio 43055Tel: 740.788.8107 |
| Classification Name: | Medical charged-particle radiation therapy system, |
| Classification: | Class 2 devices, 892.5050, IYE |
| Predicate Device: | The SecureVac Immobilization System manufactured andmarketed by Bionix Development Corporation of Toledo, Ohio.This device was classified as Class II by FDA and was givenmarketing clearance and assigned document control numberK040773. |
| Intended Use: | The Klarity vacuum cushions are designed for the positioning andrepositioning of patients receiving external-beam radiation therapy. |
| Claim of Substantial Equivalence: | This product is substantially equivalent to existing patientpositioning vacuum bags currently being marketed asaccessories to radiation therapy systems.One equivalent device is the SecureVac Immobilization Systemmanufactured and marketed by Bionix Development Corporationof Toledo Ohio. This device was classified as Class II by FDA |
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and was given marketing clearance and assigned document control number K040773.
The Bionix SecureVac Immobilization System consists of vacuum bags constructed with polyurethane coated nylon material and filled with small polystyrene spheres. Each bag is sealed airtight and fitted with a self-closing valve for ease of use. When air is evacuated. the SecureVac cushion contracts to hold a rigid shape over the course of the radiation therapy treatment.
The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment.
The Klarity Vacuum Cushions function similarly to the Bionix Secure Vac Systems. In clinical practice both devices are used in the same manner. The cushion is placed on a treatment table or baseboard, and the patient is then positioned on top of the vacuum cushion. A vacuum pump is connected to the check valve on the cushion and the air is evacuated. As the air is removed, the cushion compresses around the polystyrene spheres forming a rigid structure that conforms to the anatomy of the patient. When the air is completely evacuated the vacuum pump is disconnected. The cushion now forms a rigid indentation conforming to the anatomy of the patient. For each therapy session the patient can easily duplicate his/her previous position by slipping into the preformed depression made in the cushion, which enhances the accuracy of the radiation treatment.
Based on the similarity of design and construction of the Klarity Vacuum Cushions and the Bionix SecureVac Immobilization System, it is reasonable to expect that these devices will have similar propertics and attenuation factors, and should function in substantially equivalent fashion during the radiation therapy process. Both devices are intended for use in positioning and repositioning patients during radiation therapy procedures and are employed in clinically identical fashions. Therefore, it is reasonable to conclude that the Klarity Vacuum Cushions and the Bionix SecureVac Immobilization System are substantially equivalent with respect to use, safety and effectiveness.
CONFIDENTIAL: Not to be reproduced outside of Klarity Medical Products. LLC without written permission
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| Device 2: Klarity Mold Cushions | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------- |
| Date Prepared: | July 1, 2013 |
|---|---|
| Submitter: | Klarity Medical Products, LLC80 Westgate DriveNewark, Ohio 43055Tel: 740.788.8107 |
| Est. Registration # | 1530561 |
| Contact Person: | Peter M LarsonPresidentKlarity Medical Products, LLCEmail: peter@klaritymedical.com |
| Trade Name: | Klarity Mold Cushion |
| Common Name: | Moldable Head and Neck cushions |
| Manufacturing Site: | Klarity Medical Products, LLC80 Westgate DriveNewark, Ohio 43055Tel: 740.788.8107 |
| Classification Name: | Medical charged-particle radiation therapy system |
Class 2 devices, 892.5050, IYE Classification:
- The MoldCare head and neck cushion marketed by Civco of Predicate Device: Orange City, Iowa. This device was classified as Class II by FDA and was given marketing clearance and assigned document control number K982624.
- The Klarity Mold Cushions are designed for the positioning and Intended Use: repositioning of patients receiving external-beam radiation therapy.
Claim of Substantial Equivalence:
This product is substantially equivalent to existing patient positioning cushions currently being marketed as accessories to radiation therapy systems.
One equivalent device is MoldCare head and neck cushion marketed by Civco (formerly Med-Tec) of Orange City, Iowa. This device was classified as Class II by FDA and was given marketing clearance and assigned document control number K982624. The
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device is currently marketed by Civco as the AccuForm™ head and neck cushion.
The Civco MoldCare cushion has an inner body of polystyrene spheres mixed with a water activated resin. This mixture is surrounded by a soft nylon fabric cover. Before use, and when sold, the cushions are packaged in an air-tight aluminum foil case, to prevent moisture from reaching the cushions.
To use the cushion, a therapist will remove the packaging and apply water to the fabric of the cushion. The cushion is then placed and shaped under the patient's head or other body part. The inner resin reacts with the water and hardens in about 10 minutes, creating a solid formed support, stabilizing the patient.
The Klarity Mold Cushions are similarly constructed but with a different method of becoming secure. The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The technology of this thermoplastic is commonly used in other radiation therapy devices, including our Klarity thermoplastic masks (510(k)#022708). The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.
To use the Klarity Mold cushion, a therapist must first place the cushion in an oven, or in a hot water bath to heat it to about 150° F. At this temperature the cushion becomes moldable by hand and will remain moldable for about 5 to 8 minutes as it cools to room temperature. The warm cushion is extremely comfortable.
Like the MoldCare cushion. the Klarity Mold cushion hardens to create a firm support cushion, conforming to and stabilizing the patient. The cushions also conform to the structure underneath the cushion, providing a means to specifically locate a patient on a treatment table or other support device.
Based on the similarity of design and construction of the Klarity Mold Cushions and the Civco Moldcare cushion, it is reasonable to expect that these devices will have similar properties and should function in a substantially equivalent fashion. Both devices are intended for use in positioning and re-positioning patients during radiation therapy procedures and are employed in clinically similar fashions. Therefore, it is reasonable to conclude that the Klarity Mold Cushion and the Civco Moldcare cushion, are substantially equivalent with respect to use, safety and effectiveness.
CONFIDENTIAL: Not to be reproduced outside of Klarity Medical Products. LLC without written permission
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Klarity Medical Products LLC % Mr. Peter Larson President 80 Westgate Drive NEWARK OH 43055
Re: K132124
Trade/Device Name: Klarity Vacuum Cushions and Klarity Mold Cushions Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 27, 2013 Received: October 4, 2013
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Larson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary Pastel
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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7/1/13
Indications for Use
510(k) Number: K132124
Device Names:
-
- Klarity Vacuum Cushions
- Klarity Mold Cushions
Indications for Use:
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors.
Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Pastel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K132124 510(k) Number
Page 1 of 1
§ 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.