(471 days)
Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
powder-free surgeon's gloves that are disposable devices made of synthetic rubber
The provided text describes the 510(k) clearance for "Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves". This document primarily focuses on the regulatory clearance for a physical medical device (surgical gloves) and its resistance to chemotherapy drug permeation. It does NOT describe an AI/ML-driven medical device, an algorithm's performance, or any associated clinical study involving human readers or expert ground truth establishment for such an algorithm.
Therefore, I cannot fulfill your request for information related to acceptance criteria and studies for an AI device. The questions you've asked are specifically tailored for AI/ML device evaluations (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance).
Based on the provided document, the "acceptance criteria" and "study" are related to the physical properties of the surgical gloves as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria and reported performance for these surgical gloves, as detailed in the "Indications for Use" section, relate to their resistance to permeation by various chemotherapy drugs. This is assessed by reporting the minimum breakthrough detection time.
| Chemotherapy Drug | Acceptance Criteria (Conceptual) | Reported Device Performance (min. breakthrough detection time in minutes, 0.01 µg/cm²/min) |
|---|---|---|
| Carmustine (3.3 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 18.5 |
| Cisplatin (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Cyclophosphamide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Doxorubicin HCl (2 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Etoposide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| 5-Fluorouracil (50 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Methotrexate (25 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Mitomycin C (0.5 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Paclitaxel (6 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Thiotepa (10 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 24.4 |
| Vincristine Sulfate (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
Explanation of the Study:
The study proving the device meets its performance claims is referenced as testing "per ASTM D6978, 'Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.'" This is a standardized laboratory test protocol aimed at evaluating the barrier properties of medical gloves against hazardous drugs.
I cannot answer the following questions because the document pertains to a physical medical device (gloves) and not an AI/ML-driven device:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a physical glove's chemical resistance test in the context of AI.
- 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 gloves is defined by the chemical testing method.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is established through standardized chemical permeation testing, not expert consensus or medical outcomes.
- 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document clearly indicates a regulatory submission for surgical gloves, with performance claims related to their chemical resistance. It does not contain any information about an AI/ML device or its associated clinical and technical studies related to AI model evaluation.
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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2021
Cardinal Health 200, LLC Padmini Sahoo Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K201592
Trade/Device Name: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: August 25, 2021 Received: August 26, 2021
Dear Padmini Sahoo:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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 Clarence W. Murray, III, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201592 Device Name
Cardinal HealthTM ProtexisTM PI Blue with Neu-TheraTM Surgical Gloves
Indications for Use (Describe)
Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 µg/cm²/min):
| Carmustine | (3.3 mg/mL) 18.5 |
|---|---|
| Cisplatin | (1 mg/mL) >240 |
| Cyclophosphamide | (20 mg/mL) >240 |
| Doxorubicin Hydrochloride | (2 mg/mL) >240 |
| Etoposide | (20 mg/mL) >240 |
| 5-Fluorouracil | (50 mg/mL) >240 |
| Methotrexate | (25 mg/mL) >240 |
| Mitomycin C | (0.5 mg/mL) >240 |
| Paclitaxel | (6 mg/mL) >240 |
| Thiotepa | (10 mg/mL) 24.4 |
| Vincristine Sulfate | (1 mg/mL) >240 |
Please note that the gloves showed extremely low permeation times of 18.5 and 24.4 minutes respectively with Carmustine (BCNU) (3.3 mg/mL) and Thiotepa (10 mg/mL). When chemotherapy drugs are present, gloves selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety for the chemicals being used to determine an adequate level of protection.
| 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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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).