(69 days)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Not Found
The document provided is a 510(k) clearance letter from the FDA for a surgical glove, specifically the SensiCare PI Evolution Surgical Glove, which has been tested for use with chemotherapy drugs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for the "use with chemotherapy drugs" indication is based on the breakthrough detection time of various chemotherapy drugs when permeating the glove. The device's performance is measured by how long it can withstand permeation by these drugs according to ASTM D6978.
Table of Acceptance Criteria and Reported Device Performance:
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Implied / Regulatory Standard) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|
| Bleomycin (15mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Busulfan (6 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Carboplatin (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | 24.3 minutes (average of 24.3, 24.6, 25.5 minutes) |
| Cisplatin (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Fludarabine (25.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Idarubicin (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Ifosfamide (50.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mechlorethamine HCl (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Melphalan (5 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Paraplatin (10 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Rituximab (10 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | 32.6 minutes (average of 32.6, 34.7, 45.4 minutes) |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
Note on Acceptance Criteria: The document implies that "approved for use with chemotherapy drugs" is the acceptance. The specific quantitative acceptance criteria for each drug (e.g., minimum breakthrough time required for "safe" use) are not explicitly stated in this FDA letter. However, the data provided indicates the device's performance against a standard test method (ASTM D6978), and the FDA's clearance implies that this performance is deemed acceptable for the stated indications. The warnings for Carmustine and Thiotepa suggest that lower breakthrough times lead to specific usage precautions or contraindications, effectively defining the de facto acceptance threshold for these chemicals where performance below a certain time necessitates a warning.
Study Details from the Provided Content:
The information provided in the FDA letter and particularly the "Indications for Use" section focuses on the results of the testing. It does not contain specific details about the study design, sample sizes, expert involvement, or adjudication methods typically associated with clinical trials or AI/ML model performance studies. The study mentioned is a laboratory test:
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Sample size for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in the document. The breakthrough times for Carmustine and Thiotepa show three individual readings (e.g., (24.3, 24.6, 25.5) for Carmustine), suggesting at least three samples were tested for these specific drugs. The general "gt;240 minutes" for others does not detail the number of tests.
- Data Provenance: The testing was done "in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This indicates a laboratory-based, prospective testing method. The country of origin of the data is not specified, but it would presumably be from a testing lab associated with Medline Industries, Inc. or a contracted facility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study described is a laboratory performance test against chemical permeation, not a clinical study involving experts to establish ground truth for diagnostics or outcomes. The "ground truth" here is the physical breakthrough of the chemotherapy drugs, measured by scientific instruments.
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Adjudication method for the test set:
- Not applicable for a laboratory material permeation test. The measurements are objective physical data.
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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 a surgical glove, a medical product, not an AI/ML-driven diagnostic or treatment assistance tool. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm or AI device. The "standalone" performance refers to the intrinsic barrier properties of the glove material.
-
The type of ground truth used:
- The ground truth is based on objective physical measurement of chemical permeation through the glove material according to a standardized analytical method (ASTM D6978).
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The sample size for the training set:
- Not applicable. This is a manufactured product (glove) whose performance is characterized, not an AI/ML model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model. The glove's performance characteristics are inherent to its manufacturing and material composition.
In summary, the provided document details the results of laboratory testing demonstrating the surgical glove's resistance to various chemotherapy drugs, which forms the basis for its intended use with these agents. It does not involve AI or human expert assessments in the way requested in some of the questions, as it is a physical product rather than a diagnostic or AI-enabled tool.
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September 9, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60030
Re: K201829
Trade/Device Name: SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, KGO Dated: June 29, 2020 Received: July 2, 2020
Dear Jennifer Mason:
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.
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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 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 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.
Elizabeth F. Claverie-Williams, MS 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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Indications for Use
510(k) Number (if known)
Device Name
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Bleomycin (15mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.3 mg/ml) 24.3 minutes (24.3, 24.6, 25.5) Cisplatin (1.0 mg/ml) >240 minutes Cyclohosphamide (Cytoxan) (20 mg/ml) >240 minutes Dacarbazine (DTIC) (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Epirubicin (Ellence) (2 mg/ml) >240 minutes Etoposide (Toposar) (20.0 mg/ml) >240 minutes Fludarabine (25.0 mg/ml) >240 minutes Fluorouracil (50.0 mg/ml)>240 minutes Idarubicin (1.0 mg/ml) >240 minutes Ifosfamide (50.0 mg/ml) >240 minutes Mechlorethamine HCI (1.0 mg/ml) >240 minutes Melphalan (5 mg/ml) >240 minutes WARNING: DO NOT USE WITH CARMUSTINE. Methotrexate (25 mg/ml) >240 minutes CAUTION: Testing showed a minimum Mitomycin C (0.5 mg/ml) >240 minutes breakthrough time of 32.6 minutes for Thiotepa Mitoxantrone (2.0 mg/ml) >240 minutes Paclitaxel (Taxol) (6.0 mg/ml) >240 minutes Paraplatin (10 mg/ml) >240 minutes Rituximab (10 mg/ml)>240 minutes Thiotepa (10.0 mg/ml) 32.6 minutes (32.6, 34.7, 45.4) Vincristine Sulfate (1.0 mg/ml) >240 minutes
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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§ 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).