(79 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatius Potential and Tested for Use with Chemotherapy Drugs
This document is a 510(k) clearance letter from the FDA for Polychloroprene Powder Free Sterile Surgical Gloves and does not contain information about an AI/ML device. Therefore, it does not provide acceptance criteria or a study proving device performance as typically expected for AI/ML medical devices.
The document focuses on the regulatory clearance of a physical medical device (surgical gloves) and confirms its substantial equivalence to previously marketed devices. The "Indications for Use" section lists the device's intended purpose and data on the glove's permeation time for various chemotherapy drugs, which are essential for its specific indication as "Tested for Use with Chemotherapy Drugs."
To address your request, I will explain why your questions cannot be answered by the provided text.
Based on the provided document, the device in question is Polychloroprene Powder Free Sterile Surgical Gloves, which is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, do not apply to this document.
The document focuses on the FDA's 510(k) clearance for this type of medical glove, specifically highlighting its "Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs."
Here's an analysis based on the information provided, tailored to what can be extracted for a physical device:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for the chemotherapy drug permeation would be that the breakthrough detection time meets or exceeds certain standards for safe handling. The reported performance is directly presented in the table within the "Indications for Use" section.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Implied: High Breakthrough Time) | Reported Breakthrough Detection Time (Minutes) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | (Specific threshold not explicitly stated by FDA, but should allow reasonable handling time) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 min | >240 min |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 min | >240 min |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 min | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | (Specific threshold not explicitly stated by FDA, but should allow reasonable handling time) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min | >240 min |
Note: The implied acceptance criterion for most drugs is ">240 min", as the glove met this for the majority. For Carmustine and Thiotepa, the values are lower, and the document explicitly cautions about these drugs having "much lower permeation times." This suggests that even these lower times were deemed acceptable within the context of their use, with the caveat for users.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a physical device like gloves, the "test set" would refer to the number of gloves or samples tested for permeation. The document does not specify this, nor does it provide details on data provenance (e.g., retrospective or prospective) as that's more relevant to clinical studies for performance claims, rather than material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the ground truth for glove permeation is established through laboratory testing (e.g., using ASTM standards), not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not relevant to the chemical permeation testing of the surgical gloves.
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
This question is not applicable as the device is a physical surgical glove, not an AI-assisted diagnostic or predictive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical surgical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the glove's performance related to chemotherapy drug permeation would be established through laboratory testing using standardized methods, likely following ASTM guidelines (e.g., ASTM F739), which measure the breakthrough time of specific chemicals through a barrier material. This is a direct measurement, not subject to expert consensus or pathology in this context.
8. The sample size for the training set
This question is not applicable as the device is a physical product and does not involve AI/ML models that require a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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September 16, 2020
PT. Medisafe Technologies Punitha Samy Group Regulatory Affairs Manager J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan, North Sumatera 20362 Indonesia
Re: K201774
Trade/Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC Dated: June 2, 2020 Received: June 29, 2020
Dear Punitha Samy:
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 (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: CAPT Elizabeth 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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Indications for Use
510(k) Number (if known)
K201774
Device Name
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatius Potential and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
Test Chemotherapy Drug and Concentration
Breakthrough Detection Time (Minutes)
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
|---|---|
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml): 37.5 minutes ThioTEPA (10.0 mg/ml): 58.3 minutes CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHER APY DRUGS
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).