Search Results
Found 2 results
510(k) Data Aggregation
(106 days)
The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.
The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.
The provided document is a 510(k) premarket notification for a medical device, specifically a "Surgical Isolation Cover Gown." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or diagnostic accuracy for an AI/ML powered device.
Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable to this document. This document details the physical and biological performance characteristics of a protective garment.
However, I can extract the acceptance criteria and reported device performance from the provided tables, as well as information about the testing methodology for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | Meets Class 1 requirements | Class 1 |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | >50 cm H2O | Mean = 70.63 cm H2O (Max = 72.33 cm H2O, Min = 68.88 cm H2O) |
| Water Impact | Determine the water impact of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | ≤1.0 g | Mean = 0.58 g (Max = 0.69 g, Min = 0.49 g) |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). | >20 N | MD: Mean = 74.82 N (Max = 79.64 N, Min = 70.43 N) |
| CD: Mean = 49.35 N (Max = 55.18 N, Min = 40.96 N) | |||
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. | >20 N | MD: Mean = 62.92 N (Max = 69.72 N, Min = 62.01 N) |
| CD: Mean = 32.57 N (Max = 34.99 N, Min = 30.05 N) | |||
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State. | Log10(particle count) 50 N | Mean = 102.92 N (Max = 109.98 N, Min = 95.37 N) |
| Air Permeability | Evaluate the air permeability of the test sample in accordance with ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² |
| Cytotoxicity | Evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5:2009. | Viability $\ge$ 70% of the blank. 50% extract should have $\ge$ 100% extract viability. | Viability $\ge$ 70% of the blank. 50% extract had higher viability than 100% extract. Non-cytotoxic. |
| Sensitization | Evaluate the sensitization of the test sample in accordance with ISO 10993-10:2010. | Non-sensitizing | Non-sensitizing. |
| Irritation | Evaluate the irritation of the test sample in accordance with ISO 10993-10:2010. | Non-irritating | Non-irritating. |
| Barrier Protection Level | - | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted according to recognized international and national standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the number of individual garments or test specimens used for each particular test (e.g., how many samples were used to calculate the mean Hydrostatic Pressure). However, standard testing protocols for these types of materials and products typically involve multiple specimens to ensure representative results.
- Data Provenance: The device manufacturer is "Wuhan Dymex Healthcare Co., Ltd." in Wuhan, China. The tests are reported to have been performed in accordance with international (ISO, AATCC) and national (ASTM, 16 CFR) standards. The nature of these tests (material properties) suggests they are prospective tests performed on manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical and biological performance testing of a medical device (a gown), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling (e.g., for images or clinical data). The "ground truth" for these tests comes from the physical/chemical measurements themselves against defined standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there's no need for expert adjudication in these types of performance tests. The results are quantitative measurements against predefined physical/chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML or diagnostic imaging device. MRMC studies are used to evaluate the impact of a new technology (e.g., AI assistance) on human reader performance, which is not relevant for a surgical isolation gown.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. The "standalone" performance here refers to the gown's inherent physical and biological barrier properties, which were measured directly through the non-clinical tests.
7. The Type of Ground Truth Used:
- For physical properties (e.g., hydrostatic pressure, breaking strength, linting), the "ground truth" is established by direct measurement of the material and product characteristics against the specifications outlined in the referenced standards (e.g., ANSI/AAMI PB70, ASTM, AATCC, ISO).
- For biocompatibility (cytotoxicity, sensitization, irritation), the "ground truth" is established through laboratory testing against the criteria specified in ISO 10993 (e.g., cell viability percentages, absence of specific reactions).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/ML device that requires machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8, there is no training set for this type of medical device submission.
Ask a specific question about this device
(175 days)
The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).
The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 requirement.
The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria (Requirement) | Reported Device Performance (Average, 32 samples/lot) |
|---|---|---|
| Flammability (16 CFR Part 1610-2008) | Class I | Lot1: Class I, Lot2: Class I, Lot3: Class I |
| Hydrostatic Pressure (AATCC 127) | Level 3: >50 cmH2O | Lot1: Front: 151.6, Back: 142.8, Sleeve: 148.5, Sleeve seam: 149.8, Shoulder seam: 155.3, Waistband seam: 99.5 |
| Lot2: Front: 165.4, Back: 158.4, Sleeve: 153.4, Sleeve seam: 133.5, Shoulder seam: 141.2, Waistband seam: 59.1 | ||
| Lot3: Front: 163.7, Back: 154.4, Sleeve: 153.9, Sleeve seam: 130.7, Shoulder seam: 143.2, Waistband seam: 58.3 | ||
| Impact Penetration (AATCC 42) | Level 3: 1.00 kPa·m²/W | Lot1: >1.0 kPa·m²/W, Lot2: >1.0 kPa·m²/W, Lot3: >1.0 kPa·m²/W |
| Cytotoxicity (EN ISO10993-5) | Non-Cytotoxic | PASS (non-Cytotoxic) |
| Irritation (EN ISO 10993-10) | Non-Irritating | PASS (non-Irritating) |
| Sensitization (EN ISO 10993-10) | Non-Sensitizing | PASS (non-Sensitizing) |
2. Sample size used for the test set and the data provenance
The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).
4. Adjudication method for the test set
Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.
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 document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.
6. 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.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:
- Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
- Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).
8. The sample size for the training set
Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1