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510(k) Data Aggregation
(443 days)
Barco Tekstil Sanayi ve Ticaret A.S.
The Sterile Level 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
The Sterile Level 3 Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Sterile Level 3 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Sterile Level 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use and EtO sterilized. The Sterile Level 3 Surgical Gowns are available in six sizes, including S, M, L, XXL and XXXL. The belt ties are integrated into the body. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification. The Sterile Level 3 Surgical Gown is provided as blue color. The Sterile Level 3 Surgical Gown is made of 50 Gsm PP (SMMS nonwoven polypropylene).
The provided text describes the acceptance criteria and study results for a Sterile Level 3 Surgical Gown. This is not an AI/ML powered medical device, but rather a textile product. As such, the requested information pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML) is not applicable or present in this engineering report.
The report details non-clinical performance testing for the physical properties and barrier performance of the surgical gown.
Here's a breakdown of the requested information based on the provided document for this medical device (a surgical gown):
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 16 CFR 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ASTM D5034-09(2017) | Tensile Strength | ≥7 lbf | Warp: 20.59 lbf, Weft: 30.48 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT ARMHOLE SEAM STRENGTH / SLIPPAGE: 8.1 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT ARMHOLE SEAM STRENGTH / SLIPPAGE: 9.8 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.1 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.7 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.0 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.1 lbf |
| ASTM D5587-15 (2019) | Tear Strength | ≥ 2.3 lbf | Warp: 5.817 lbf, Weft: 8.958 lbf |
| ISO 9073-10 | Evaluation of Particles Release | log10 ≤4 | Suitable according to ≤ 4 criteria |
| AATCC 127:2017 Option 2 | Water Resistance: Impact Penetration Test | ≥ 50 cm | 53.7 - 65.8 cm. LEVEL 3. |
| AATCC 42:2007 | Impact Penetration Test | no more than 1.0 grams (g) | Max 0.08. LEVEL 3 |
| ISO 10993-7 | EO Residue Test | 10µg/cm² | Not detected. |
| ISO 10993-5 | Cytotoxicity | Not Cytotoxic | Not Cytotoxic |
| ISO 10993-10 | Sensitization | Not Sensitive | Not Sensitive |
| ISO 10993-10 | Irritation | Not Irritant | Not Irritant |
| ASTM F88/F88M | Seal Strength of Flexible Barrier Materials | Package Seal integrity must be intact. | Passed |
| ASTM F1929:2015 | Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | No leakage observe | Passed |
| ASTM D3776 / D3776M - 20 | Mass Per Unit Area (Weight) of Fabric | - | 50 GSM |
Regarding AI/ML specific information (not applicable to this product):
- Sample sizes used for the test set and the data provenance: Not applicable. This is a physical product (surgical gown), not an AI/ML device. Tests were conducted on material samples of the gown. No information on the number of gowns or samples tested is provided beyond the aggregated results. The data provenance is implied to be from the manufacturer's testing, without specific country of origin mentioned for the raw test data. The tests are prospective in nature, as they are part of the premarket submission for a new device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized testing according to specified ASTM/ISO norms, not by expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for AI/ML device studies.
- 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 is a physical product, not an AI/ML system assisting human readers. The document explicitly states "Clinical Performance Testing is not applicable to the subject device."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective measurement based on established ASTM and ISO standards for material properties, fluid barrier performance, flammability, biocompatibility, and packaging integrity.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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