Search Results
Found 1 results
510(k) Data Aggregation
(112 days)
The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.
| Test Parameter / Acceptance Criteria (per ASTM F2100-11) | Subject Device Performance (San-M Surgical Masks) | Predicate Device Performance (K160269) | Comparison |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | |||
| Level 1: Pass at 80 mmHg | Pass at 80 mmHg | Pass at 80 mmHg | Equivalent |
| Level 2: Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Equivalent |
| Level 3: Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Equivalent |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | |||
| $\ge 98%$ | Pass at 99.6% (all levels) | Pass at 99.6% (all levels) | Equivalent |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | |||
| $\ge 98%$ (Level 1, 2) | Pass at >98% (Level 1, 2) | Pass at >98% (Level 1, 2) | Equivalent |
| $\ge 99%$ (Level 3) | Pass at >99.9% (Level 3) | Pass at >99% (Level 3) | Equivalent |
| Differential Pressure ($\Delta$P) (MIL-M-36945C) | |||
| <5.0 mm H2O/cm$^2$ | Pass at 2.0 mm H2O/cm$^2$ (Level 1) | Pass at 2.0 mm H2O/cm$^2$ (Level 1) | Equivalent |
| Pass at 1.6 mm H2O/cm$^2$ (Level 2) | Pass at 1.6 mm H2O/cm$^2$ (Level 2) | Equivalent | |
| Pass at 2.5 mm H2O/cm$^2$ (Level 3) | Pass at 2.5 mm H2O/cm$^2$ (Level 3) | Equivalent | |
| Flammability (16 CFR 1610) | |||
| Class 1 | Class 1 (all levels inferred) | Class 1 (all levels inferred) | Equivalent |
| Biocompatibility (ISO 10993) | |||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Equivalent |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating | Equivalent |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Equivalent |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance and biocompatibility testing program, as detailed in Table 3 of the submission. The key objective was to demonstrate that the subject device performs "as well as or better than the identified predicate device" (K160269) across all specified test parameters, and specifically that the change in nose clamp material (from polyethylene coated steel wire to just polyethylene) does not negatively impact performance, and allows for MR safety.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of masks tested) for each of the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). However, it implies that the tests were conducted according to the relevant ASTM and ISO standards, which typically specify sample sizes for such evaluations.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer (SAN-M PACKAGE CO., LTD.) being located in Japan. The type of study is prospective non-clinical performance and biocompatibility testing conducted on the newly manufactured subject device and, for comparison, on the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in this context. The "ground truth" for a medical mask's performance is established by adherence to recognized performance standards (e.g., ASTM F2100-11, ISO 10993) and measured through objective laboratory tests. There is no concept of expert consensus or interpretation for these physical and biological performance characteristics.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where human reviewers make subjective assessments that might require a consensus. Performance tests for surgical masks are objective, standardized laboratory measurements that yield quantitative results (e.g., filtration efficiency percentages, pressure differentials, pass/fail for chemical tests).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging devices where multiple readers interpret cases to assess the effectiveness of an AI system, with and without AI assistance. The device in question is a surgical face mask, which does not involve human interpretation or AI assistance in its function or evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This concept applies to AI/ML software as a medical device (SaMD). The device under review is a physical medical device (surgical face mask), not an algorithm or software. Its performance is evaluated through direct physical and biological testing.
7. Type of Ground Truth Used
The "ground truth" for the performance of the surgical face masks is established through objective, standardized laboratory measurements against predefined thresholds and criteria outlined in recognized national and international standards (e.g., ASTM F2100-11 for mask performance, ISO 10993 for biocompatibility, 16 CFR 1610 for flammability, MIL-M-36945C for differential pressure). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather on physical and chemical properties and biological response.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1