ControlRad Sterile Cover

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April 26, 2020 ControlRad, Inc % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K200238 Trade/Device Name: ControlRad Sterile Cover Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: January 30, 2020 Received: January 31, 2020 Dear Linda Braddon: 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 {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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, CAPT Elizabeth F. Claverie M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Food and Drug Administration # Indications for Use 510(k) Number (if known) K200238 #### Device Name ControlRad Sterile Cover Indications for Use (Describe) ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures. Type of Use (Select one or both, as applicable) □ Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Service s(301)443-6740 EF Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, sans-serif font and is colored in a dark teal. To the right of the word "CONTROL" is the word "RAD", which is also in a bold, sans-serif font. The word "RAD" is inside of a green circle that is made up of two different shades of green. # 510(k) Summary K200238 In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for ControlRad Sterile Cover is provided below. | Date | April 21, 2020 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by | ControlRad, Inc<br>275 Scientific Drive NW #1100<br>Norcross, GA 30092<br>Phone: (800)-522-5148 | | 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>Regulatory@SecureBME.com | | Trade Name | ControlRad Sterile Cover | | Common Name | Sterile Cover | | Code -Classification | KKX: Class II | | Predicate | K101350, RadScan Equipment Slicker | | Reference Device | K141438, Whitney Medical Solutions eShield | #### Device Description The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment. ### Indications for Use ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover a ControlRad Tablet and create a sterile barrier between the tablet and the rest of the sterile field to prevent contamination during various procedures. ### Technological Characteristics The subject device has similar technological characteristics as the predicates in terms of principles of operation, intended use, material, performance, and biocompatibility. ### Technological Characteristics Comparison Table The ControlRad Sterile Cover is similar in function and intended use to the predicate and/or reference device. A comparison of the subject device to the predicate devices is shown in the following table. | Trait | ControlRad Sterile Cover | RadScan Equipment<br>Slicker<br>(Predicate Device) | Whitney Medical<br>Solutions eShield<br>(Reference Device) | Comparison | |---------------------------|--------------------------|----------------------------------------------------|------------------------------------------------------------|------------| | 510(k) number | K200238 | K101350 | K141438 | N/A | | FDA Regulation | 878.4370 | 878.4370 | 878.4370 | Same | | Product Code | KKX | KKX | KKX | Same | | Product<br>Classification | Class II | Class II | Class II | Same | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green and is inside of a green circle. The circle is made up of two different shades of green. | | | RadScan Equipment<br>Slicker<br>(Predicate Device) | Whitney Medical<br>Solutions eShield<br>(Reference Device) | Comparison | |----------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|------------| | Trait | ControlRad Sterile Cover | | | | | Use | Prescription Use<br>Part 21 CFR 801 Subpart D | Over-the-Counter Use<br>Part 21 CFR 801 Subpart C | Over-the-Counter Use<br>Part 21 CFR 801 Subpart C | Same | | Mechanism of<br>Action | Create a plastic sterile<br>barrier around medical<br>equipment | Create a plastic sterile<br>barrier around medical<br>equipment | Create a plastic sterile<br>barrier around electronic<br>equipment | Same | | Composition | Polyethylene draping on<br>ABS frame | Not Disclosed | Polyethylene | Same | | Single Use | Yes | Yes | Yes | Same | | Physical<br>Specifications | 1100mm x 1200mm<br>(43.3in x 47.2in) | Multiple Sizes | Width: 9 - 14 inches<br>Height: 14 - 22 inches<br>All Models | Different | | Patient<br>Contacting | No | No | No | Same | | Packaging | PET blister pack with<br>TYVEK lid | Not Disclosed | Single barrier Tyvek/-LDPE<br>film | Same | | Sterilization | EO | Sterile<br>(Not Disclosed) | Gamma | Different | # Biocompatibility The subject device is categorized as a non-patient contacting device was found. Cytotoxicity testing was performed to evaluate the safety of the device. #### Non-clinical Testing The subject device has equivalent performance characteristics in regard to liquid barrier and blood-born pathogen penetration as assessed by ASTM F1671. Additional characterization of mechanical performance including tensile strength and tear resistance via ASTM D882 and ASTM D1004, respectively, was performed. #### Summary of Non-clinical Testing | Name of Test<br>Method | Purpose | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------| | Liquid Barrier | Ensure cover protects against liquid<br>penetration | No liquid penetration | PASS | | Viral Penetration via ASTM<br>F1671 / F1671M-13 | Ensure cover protects against viral<br>penetration | No viral penetration | PASS | | Tensile Strength via ASTM<br>D882 | Characterization<br>of tensile strength | Characterization testing | PASS | | Tear Resistance via ASTM<br>D1004 | Characterization<br>of tear resistance | Characterization testing | PASS | | ISO 11135-1:2104:<br>Sterilization of Health-Care<br>Products - Ethylene Oxide | Ensure sterility assurance level of<br>$10^{-6}$ | SAL $10^{-6}$ | PASS | | ASTM<br>F88/F88M-15 | Seal Strength<br>(TyVek pouch - primary sterile<br>barrier) | Seal Strength > 1lbf for all seals | PASS | | ASTM<br>F1929-15 | Dye Penetration | No dye penetration via visual<br>inspection | PASS | | ISO 10993-5 Biological<br>evaluation of medical<br>devices: Part 5 Tests for in<br>vitro Cytotoxicity | Biocompatibility Testing | Cell culture treated with test<br>sample exhibited no reactivity<br>(Grade 0) | PASS<br>Non-cytotoxic | {5}------------------------------------------------ K200238: ControlRad, Inc 275 Scientific Drive NW#1100 Norcross, GA 30092 Image /page/5/Picture/1 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark green sans-serif font, followed by the word "RAD" in the same font but with a green circle around it. The circle is two-toned, with the top half being a lighter green and the bottom half being a darker green. # Conclusions The conclusions drawn from the nonclinical tests demonstrate that the ControlRad sterile cover is as safe, as effective, and performs as well as or better than the legally marketed device RadScan Equipment Slicker (K101350).