(86 days)
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.
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.
The provided text describes the regulatory clearance for the "ControlRad Sterile Cover," a surgical drape accessory. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing results.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a "Sterile Cover," which is a physical device (a surgical drape accessory). It is not an AI/ML-driven device or a diagnostic device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML or diagnostic performance (like MRMC studies, expert ground truth establishment for diagnostic accuracy, standalone algorithm performance, training set details) are not applicable to this type of medical device. The "performance" here refers to the physical and functional integrity of the sterile cover.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 (Implies meeting a certain profile, though no specific numerical threshold is given in the table, "PASS" indicates compliance) | PASS |
| Tear Resistance via ASTM D1004 | Characterization of tear resistance | Characterization testing (Implies meeting a certain profile, though no specific numerical threshold is given in the table, "PASS" indicates compliance) | PASS |
| ISO 11135-1:2014: 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) |
Specifics Not Applicable or Not Provided for This Device Type:
Given that this is a physical medical device (sterile cover) and not an AI/ML diagnostic or treatment planning system, several items in the prompt are not applicable to the type of data and studies required for its clearance.
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2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each non-clinical test. These tests are typically conducted on a representative sample of the manufactured device.
- Data provenance is not specified in terms of country of origin or retrospective/prospective, as this applies more to clinical data or imaging datasets, which are not relevant here.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a sterile cover is established through objective physical, chemical, and biological testing as per international standards (e.g., ASTM, ISO). There are no human "experts" establishing diagnostic ground truth in this context.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image reads by radiologists), which is not part of the testing for this device.
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5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This type of study is for evaluating the impact of AI on human diagnostic performance, which is irrelevant for a sterile cover.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from the established and validated methodologies of the referenced ASTM and ISO standards for physical properties, barrier integrity, sterility, and biocompatibility.
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8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
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9. How the ground truth for the training set was established: Not applicable.
In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical laboratory tests performed according to recognized international and national standards (ASTM, ISO). The acceptance criteria are objective, quantifiable thresholds or observations (e.g., no penetration, specific strength values, sterility assurance level) that the device must meet to demonstrate its safety and effectiveness as a sterile barrier.
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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
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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
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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, Inc275 Scientific Drive NW #1100Norcross, GA 30092Phone: (800)-522-5148 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat Highway Suite 120Woodstock, GA 30188770-837-2681Regulatory@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 EquipmentSlicker(Predicate Device) | Whitney MedicalSolutions 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 |
| ProductClassification | Class II | Class II | Class II | Same |
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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 EquipmentSlicker(Predicate Device) | Whitney MedicalSolutions eShield(Reference Device) | Comparison | ||
|---|---|---|---|---|
| Trait | ControlRad Sterile Cover | |||
| Use | Prescription UsePart 21 CFR 801 Subpart D | Over-the-Counter UsePart 21 CFR 801 Subpart C | Over-the-Counter UsePart 21 CFR 801 Subpart C | Same |
| Mechanism ofAction | Create a plastic sterilebarrier around medicalequipment | Create a plastic sterilebarrier around medicalequipment | Create a plastic sterilebarrier around electronicequipment | Same |
| Composition | Polyethylene draping onABS frame | Not Disclosed | Polyethylene | Same |
| Single Use | Yes | Yes | Yes | Same |
| PhysicalSpecifications | 1100mm x 1200mm(43.3in x 47.2in) | Multiple Sizes | Width: 9 - 14 inchesHeight: 14 - 22 inchesAll Models | Different |
| PatientContacting | No | No | No | Same |
| Packaging | PET blister pack withTYVEK lid | Not Disclosed | Single barrier Tyvek/-LDPEfilm | 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 TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Liquid Barrier | Ensure cover protects against liquidpenetration | No liquid penetration | PASS |
| Viral Penetration via ASTMF1671 / F1671M-13 | Ensure cover protects against viralpenetration | No viral penetration | PASS |
| Tensile Strength via ASTMD882 | Characterizationof tensile strength | Characterization testing | PASS |
| Tear Resistance via ASTMD1004 | Characterizationof tear resistance | Characterization testing | PASS |
| ISO 11135-1:2104:Sterilization of Health-CareProducts - Ethylene Oxide | Ensure sterility assurance level of$10^{-6}$ | SAL $10^{-6}$ | PASS |
| ASTMF88/F88M-15 | Seal Strength(TyVek pouch - primary sterilebarrier) | Seal Strength > 1lbf for all seals | PASS |
| ASTMF1929-15 | Dye Penetration | No dye penetration via visualinspection | PASS |
| ISO 10993-5 Biologicalevaluation of medicaldevices: Part 5 Tests for invitro Cytotoxicity | Biocompatibility Testing | Cell culture treated with testsample exhibited no reactivity(Grade 0) | PASSNon-cytotoxic |
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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).
§ 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.