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510(k) Data Aggregation
(166 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with Chemotherapy Drugs
The BioClean Chemo Ultimate is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
This document is a 510(k) summary for the BioClean Chemo Ultimate patient examination glove. It details the device's characteristics, intended use, and substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the physical and chemical performance of the glove, not a software-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study for a software-based device are not applicable.
However, I can extract information related to the performance testing of the glove.
1. A table of acceptance criteria and the reported device performance
Based on the provided text and extracted table (Image /page/1/Picture/0), here is the information:
| Test/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6977-04 (specifications met) | Complies |
| Physical Properties | ASTM D 6977-04 (specifications met) | Complies |
| Freedom from Pinhole | ASTM D 6977-04 | AQL 2.5 |
| Powder Free | ASTM D 6977-04 | Max 2 mg/glove |
| Biocompatibility | ISO 10993 requirements met (cytotoxicity, irritation, sensitization) | Complies |
| Chemotherapy Drug Permeation (ASTM D 6978-05) | No breakthrough for at least 30 minutes (common industry standard for safe handling, though specific criteria are not explicitly stated for all drugs) | See table below |
Chemotherapy Drug Permeation Performance (from Image /page/1/Picture/0):
| Chemotherapy Agent | Concentration | Breakthrough Detection Time (minutes) |
|---|---|---|
| Carmustine (BiCNU) | 3.3 mg/mL | 9.8 |
| Cisplatinum | 1.0 mg/mL | > 480 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | > 480 |
| Dacarbazine (DTIC) | 10.0 mg/mL | > 480 |
| Doxorubicin HCl | 5.0 mg/mL | > 480 |
| Etoposide (Toposar) | 100.0 mg/mL | > 480 |
| 5-Fluorouracil | 50.0 mg/mL | > 480 |
| Ifosfamide (Ifex) | 50.0 mg/mL | > 480 |
| Methotrexate | 25.0 mg/mL | > 480 |
| Paclitaxel (Taxol) | 6.0 mg/mL | 18.2 |
| Thio-Tepa | 10.0 mg/mL | 47.7 |
| Vincristine | 1.0 mg/mL | > 480 |
| Cytarabine | 100.00 mg/mL | > 480 |
| Oxaliplatin | 5.00 mg/mL | > 480 |
| Gemcitabine HCl | 38.00 mg/mL | > 480 |
| Docetaxel | 10.00 mg/mL | 15.6 |
The remaining information requested is largely not applicable to this 510(k) submission for a non-software medical device like an examination glove. Here's why:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While samples were used for physical and chemical testing, the document does not specify exact sample sizes for each test in a clinical trials context. Data provenance refers to the origin of medical data (e.g., patient records), which is not relevant here.
- 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 pertains to expert review for diagnostic devices. For a glove, ground truth is established by standardized material testing following ASTM/ISO protocols, not expert consensus on medical images or diagnoses.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication is a process for resolving discrepancies in expert interpretations, again, not applicable to material testing of a glove.
- 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 relates to comparative studies of diagnostic performance, specifically with AI assistance. Completely irrelevant for a patient examination glove.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, ground truth for a glove's performance is based on standardized physical and chemical tests, not clinical "ground truth" like pathology or outcomes.
- 8. The sample size for the training set: Training sets are used for machine learning models. This is not applicable to a physical glove.
- 9. How the ground truth for the training set was established: Ground truth for a training set is established for machine learning models. Not applicable for this device.
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