(86 days)
No
The device is a sterile cover for a tablet, and the summary focuses on its barrier properties and sterility, with no mention of AI/ML or related concepts.
No
The device is described as a sterile equipment cover to create a sterile barrier, serving to protect against contamination of a medical tablet, rather than directly treating or mitigating a disease or condition.
No.
The device is described as an equipment cover to maintain sterility and prevent contamination, not to diagnose or provide diagnostic information.
No
The device description clearly states it is a "single use sterile equipment cover" and a "terminally sterilized device intended to cover the ControlRad tablet," indicating it is a physical, sterile barrier, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover a tablet to create a sterile barrier during clinical procedures. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description reinforces its function as a sterile cover for a tablet in a sterile environment.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The device is a sterile equipment cover, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.
Product codes
KKX
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.
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
professionals in a sterile clinical setting
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
Non-clinical Testing:
Liquid Barrier - Purpose: Ensure cover protects against liquid penetration; Acceptance Criteria: No liquid penetration; Results: PASS
Viral Penetration via ASTM F1671 / F1671M-13 - Purpose: Ensure cover protects against viral penetration; Acceptance Criteria: No viral penetration; Results: PASS
Tensile Strength via ASTM D882 - Purpose: Characterization of tensile strength; Acceptance Criteria: Characterization testing; Results: PASS
Tear Resistance via ASTM D1004 - Purpose: Characterization of tear resistance; Acceptance Criteria: Characterization testing; Results: PASS
ISO 11135-1:2104: Sterilization of Health-Care Products - Ethylene Oxide - Purpose: Ensure sterility assurance level of 10-6; Acceptance Criteria: SAL 10-6; Results: PASS
ASTM F88/F88M-15 - Purpose: Seal Strength (TyVek pouch - primary sterile barrier); Acceptance Criteria: Seal Strength > 1lbf for all seals; Results: PASS
ASTM F1929-15 - Purpose: Dye Penetration; Acceptance Criteria: No dye penetration via visual inspection; Results: PASS
ISO 10993-5 Biological evaluation of medical devices: Part 5 Tests for in vitro Cytotoxicity - Purpose: Biocompatibility Testing; Acceptance Criteria: Cell culture treated with test sample exhibited no reactivity (Grade 0); Results: PASS Non-cytotoxic
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.
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)
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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).