(51 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a thermoplastic mask for immobilization, with no mention of AI or ML.
No
The device is used for patient positioning and immobilization during radiation therapy, not for treating a disease or condition itself.
No
The device is described as a medical device used for patient positioning and immobilization during external beam radiation therapy procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "low-temperature thermoplastic mask" made of physical materials (polycaprolactone sheets and a polycarbonate frame) and describes a physical process of softening and hardening to create a physical immobilization device. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Aktina Thermoplastic Masks are used for patient positioning and immobilization during external beam radiation therapy procedures. They are applied externally to the patient's anatomy.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is purely mechanical – to create a custom-fit mask for immobilization.
Therefore, based on the provided information, the Aktina Thermoplastic Mask falls under the category of a medical device used for patient support and immobilization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for the duration of the treatment.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
This is a Traditional 510(k) for the Aktina Medical Thermoplastic Mask. The low-temperature thermoplastic mask is made of Aquaplast polycaprolactone sheets. When immersed in water heated to 70-75°C [160 to 170°F], the material softens, allowing the user to shape or stretch the mask over the contours of the patient's anatomy while cooling. When the material reaches room temperature, the mask hardens into the anatomical shape. The mask can then be placed over the patient treatment area to consistently immobilize the area from treatment to treatment. Predicate device manufacturers have used polycaprolactone materials for this intended use for over 25 years. The mask also has a polycarbonate frame with holes for mounting to the user's existing patient support hardware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Specification testing has been performed for this device to show that the verification, validation and safety requirements have been met regarding:
- All specified functional, performance, safety and labeling requirements, such as o biocompatibility, melting temperature, shrinkage, rigidity, and radiation attenuation.
- Assessment against ISO 14971 Risk Management requirements.
- Assessment against applicable sections of IEC Standard: 62366-1, Application of o usability engineering to medical devices.
The testing has demonstrated substantial equivalence or better when compared to the predicate device.
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.
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.
0
September 25, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aktina Medical Corporation % Mr. Tony Spaccarotella Director, Quality Assurance / Regulatory Affairs 360 North Route 9W CONGERS NY 10920
Re: K192102
Trade/Device Name: Thermoplastic Mask Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 30, 2019 Received: August 5, 2019
Dear Mr. Spaccarotella:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Section 4
Indications for Use
ng
No. of Pages Including Cover: 2
3
Expiration Date: 06/30/2020 See PRA Statement below.
Form Approved: 0MB No. 0910-0120
510(k) Number (if known)
Device Name Thermoplastic Mask
Indications for Use (Describe)
Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for the duration of the treatment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.●
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4
Section 5
510(k) Summary
360 North Route 9W Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700
ﻟﺘﻘﺪﻳ
:
5
510(k) Summary
In Compliance with 21 CFR Section 807.92(c)
1. General Provisions
| Device Trade Name: | Thermoplastic Mask |
|---|---|
| Common Name: | Moldable Thermoplastic |
| Owner Name | |
| and Address: | Aktina Medical Corporation |
| 360 North Route 9 W | |
| Congers, New York, 10920 | |
| Phone: 845-268-0101 | |
| Fax: 845-268-1700 | |
| Registration Number: 2436865 | |
| Contact Person: | Tony Spaccarotella, Director, QA/RA |
3. Date Prepared: July 1, 2019
4. Classification
This device is classified as a class II device according to 21 CFR 892.5050, "Medical chargedparticle radiation therapy system." The product code is IYE.
5. Predicate Device
Embrace Thermoplastic, 510(k) No. K120335, manufactured by Bionix Development Corporation, 5154 Enterprise Blvd, Toledo, OH 43612 USA.
6. Description
This is a Traditional 510(k) for the Aktina Medical Thermoplastic Mask. The low-temperature thermoplastic mask is made of Aquaplast polycaprolactone sheets. When immersed in water heated to 70-75°C [160 to 170°F], the material softens, allowing the user to shape or stretch the mask over the contours of the patient's anatomy while cooling. When the material reaches room temperature, the mask hardens into the anatomical shape. The mask can then be placed over the patient treatment area to consistently immobilize the area from treatment to treatment. Predicate device manufacturers have used polycaprolactone materials for this intended use for over 25 years. The mask also has a polycarbonate frame with holes for mounting to the user's existing patient support hardware.
360 North Route 9W Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700
6
7. Intended Use
Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for single patient use for the duration of the treatment.
Technological Characteristics 8.
The Table below compares the technological characteristics of the Aktina Thermoplastic Mask to the Predicate Device:
| Item | Predicate Device, K120035
Embrace Thermoplastic
Bionix Development Corporation,
5154 Enterprise Blvd, Toledo, OH 43612
USA | This 510(k) Submission
Thermoplastic Mask
Aktina Medical Corp.,
360 N. Route 9W, Congers, NY 10920
USA | Equivalent or
Better for
Intended Use? |
|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 1. | Intended Use:
Immobilize patients receiving external beam
radiation therapy. | Intended Use:
Same as predicate. | Equivalent |
| 2. | Design:
Moldable plastic sheet used for patient
immobilization. Heat is applied to the sheet
to soften it and mold it to the shape of the
patient anatomy. The mask is used for
multiple treatments on a single patient. The
sheet is pre-mounted to a non-patient
contacting frame to interface with the user's
existing support hardware. | Design:
Same as predicate. | Equivalent |
| 3. | Components:
Low temperature thermoplastic sheet with
non-low temperature plastic mounting
frame. | Components:
Same as predicate. | Equivalent |
| 4. | Technology:
-
Perforated plastic sheets that soften for
molding when exposed to heat. -
Fastened to patient support equipment. | Technology:
-
Same as predicate.
-
Same as predicate. | Equivalent |
360 North Route 9W Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700
7
| 5. | Materials:
a. Plastic sheet:
Polycaprolactone | Materials:
a. Plastic sheet:
Same as predicate. | a. Equivalent |
|-----|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| | b. Frame:
"Non-low temperature thermoplastic" | b. Frame:
Polycarbonate | b. Equivalent |
| 6. | Biocompatibility:
Plastic sheet is biocompatible for skin
contact up to 24 hours. | Biocompatibility:
Same as predicate. | Equivalent |
| 7. | Sterility:
Non-sterile. | Sterility:
Same as predicate. | Equivalent |
| 8. | Melting Temperature:
160°F | Melting Temperature:
Same as predicate. | Equivalent |
| 9. | Rigidity:
Pressure (psi)
Deflection (inches)
@ 5.08 psi
0.011
@ 10.4 psi
0.052 | Rigidity:
Pressure (psi)
Deflection (inches)
@ 5.08 psi
0.011
@ 10.4 psi
0.019 | Equivalent
at 5.08 psi
Submitted device
has less deflection
at 10.4 psi |
| 10. | Shrinkage:
0.3% | Shrinkage:
0.3% | Equivalent |
| 11. | Sheet Thickness:
2.4mm | Sheet Thickness:
Same as predicate. | Equivalent |
| 12. | Sheet Type:
Perforated sheets. | Sheet Type:
Same as predicate. | Equivalent |
| 13. | Radiation Attenuation (X-ray):
Less than 2% | Radiation Attenuation (X-ray):
Same as predicate device. | Equivalent |
Performance Standards, Non-Clinical Testing, and Data 9.
The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product
Specification testing has been performed for this device to show that the verification, validation and safety requirements have been met regarding:
- All specified functional, performance, safety and labeling requirements, such as ● biocompatibility, melting temperature, shrinkage, rigidity, and radiation attenuation.
Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700 360 North Route 9W
8
- o Assessment against ISO 14971 Risk Management requirements.
- Assessment against applicable sections of IEC Standard: 62366-1, Application of 0 usability engineering to medical devices.
This device does not contain software.
The testing has demonstrated substantial equivalence or better when compared to the predicate device.
10. Clinical Testing
No clinical testing was performed in support of this pre-market submission.
11. Biocompatibility
The patient contact component for this device is the low-temperature thermoplastic mask material, which contacts the skin surface for less than 24 hours. This material has been shown to be biocompatible for the intended use when tested against the requirements of ISO 10993-1, -5 and -10 for cytotoxicity, irritation, and sensitization.
12. Conclusion Regarding of Substantial Equivalence
This device is similar in design, intended use, technological, physical and performance characteristics to the predicate device. No new issues of safety or effectiveness are introduced by using this device. Therefore, Aktina Medical Corp. believes that the Thermoplastic Mask is substantially equivalent to the predicate device.