Who is the manufacturer of ControlRad Sterile Cover?

Controlrad, Inc. filed the 510(k) submission for ControlRad Sterile Cover (K200238).

What is the FDA product code for ControlRad Sterile Cover?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ControlRad Sterile Cover?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ControlRad Sterile Cover?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ControlRad Sterile Cover

K200238 · Controlrad, Inc. · KKX · Apr 26, 2020 · General, Plastic Surgery

Device Facts

Record ID	K200238
Device Name	ControlRad Sterile Cover
Applicant	Controlrad, Inc.
Product Code	KKX · General, Plastic Surgery
Decision Date	Apr 26, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Intended 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.

Device Story

ControlRad Sterile Cover is a single-use, sterile, non-patient contacting equipment cover; designed to enclose the ControlRad Tablet for use within sterile clinical environments. The device functions as a physical barrier to prevent contamination of the sterile field by the tablet. It consists of polyethylene draping on an ABS frame. The cover is deployed by clinical professionals during procedures. It provides a protective barrier against liquids and viral penetration, ensuring the tablet does not compromise the sterility of the surgical or clinical environment.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via liquid barrier testing, viral penetration (ASTM F1671), tensile strength (ASTM D882), tear resistance (ASTM D1004), seal strength (ASTM F88), and dye penetration (ASTM F1929). Biocompatibility confirmed via ISO 10993-5 (non-cytotoxic). Sterility assurance level of 10^-6 validated per ISO 11135-1.

Technological Characteristics

Materials: Polyethylene draping, ABS frame. Dimensions: 1100mm x 1200mm. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ASTM F1671 (viral penetration), ASTM D882 (tensile strength), ASTM D1004 (tear resistance), ASTM F88 (seal strength), ASTM F1929 (dye penetration), ISO 10993-5 (cytotoxicity), ISO 11135-1 (sterilization). Non-patient contacting.

Indications for Use

Indicated 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.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

RadScan Equipment Slicker (K101350)

Reference Devices

Whitney Medical Solutions eShield (K141438)

Related Devices

K101350 — RADSCAN EQUIPMENT SLICKER · Radscan Medical Equipment, Inc. · Jan 4, 2011
K052395 — STERILE EQUIPMENT COVERS · Volcano Corporation · Dec 1, 2005
K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN · Mtp Medical Technical Promotion GmbH · Jul 31, 2009
K973067 — DRTS REMOTE CONTROL DRAPE · Minrad, Inc. · Oct 16, 1997
K121436 — DAS MEDICAL EQUIPMENT DRAPES · Das Medical, LLC · Jun 6, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." 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 275 Scientific Drive NW #1100 Norcross, GA 30092 Phone: (800)-522-5148 | | 510(k) Contact | Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 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 Slicker (Predicate Device) | Whitney Medical Solutions eShield (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 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 Slicker (Predicate Device) | Whitney Medical Solutions eShield (Reference Device) | Comparison | |----------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|------------| | Trait | ControlRad Sterile Cover | | | | | Use | Prescription Use Part 21 CFR 801 Subpart D | Over-the-Counter Use Part 21 CFR 801 Subpart C | Over-the-Counter Use Part 21 CFR 801 Subpart C | Same | | Mechanism of Action | Create a plastic sterile barrier around medical equipment | Create a plastic sterile barrier around medical equipment | Create a plastic sterile barrier around electronic equipment | Same | | Composition | Polyethylene draping on ABS frame | Not Disclosed | Polyethylene | Same | | Single Use | Yes | Yes | Yes | Same | | Physical Specifications | 1100mm x 1200mm (43.3in x 47.2in) | Multiple Sizes | Width: 9 - 14 inches Height: 14 - 22 inches All Models | Different | | Patient Contacting | No | No | No | Same | | Packaging | PET blister pack with TYVEK lid | Not Disclosed | Single barrier Tyvek/-LDPE film | Same | | Sterilization | EO | Sterile (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 Method | Purpose | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------| | Liquid Barrier | Ensure cover protects against liquid penetration | No liquid penetration | PASS | | Viral Penetration via ASTM F1671 / F1671M-13 | Ensure cover protects against viral penetration | No viral penetration | PASS | | Tensile Strength via ASTM D882 | Characterization of tensile strength | Characterization testing | PASS | | Tear Resistance via ASTM D1004 | Characterization of tear resistance | Characterization testing | PASS | | ISO 11135-1:2104: Sterilization of Health-Care Products - Ethylene Oxide | Ensure sterility assurance level of $10^{-6}$ | SAL $10^{-6}$ | PASS | | ASTM F88/F88M-15 | Seal Strength (TyVek pouch - primary sterile barrier) | Seal Strength > 1lbf for all seals | PASS | | ASTM F1929-15 | Dye Penetration | No dye penetration via visual inspection | PASS | | ISO 10993-5 Biological evaluation of medical devices: Part 5 Tests for in vitro Cytotoxicity | Biocompatibility Testing | Cell culture treated with test sample exhibited no reactivity (Grade 0) | PASS 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).