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510(k) Data Aggregation
(361 days)
The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The SEIONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.
The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. Below Table provides model number of the Sejong Surgical Gown Soft. The chest and sleeve critical zones, as well as the overall body, are constructed from a blue polyolefin/polypropylene SMMMS (Spunbound, meltblown, meltblown, spunbound). Sejong Surgical Gown Soft has been tested according to ANSI/AAMI PB70:2012 and meets and AAMI Level 3 barrier level protection for a surgical gown. Sejong Surgical Gown Soft is nonreinforced, single use, disposable medical device that will be provided in both a sterile packaging configuration and a variety of sizes.
This document describes the premarket notification (510(k)) for the SEJONG Surgical Gown Soft, manufactured by Sejong Healthcare Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Medline Level 3 Surgical Gown (Sirus Non-Reinforced) (K190950).
As this is a 510(k) submission for a surgical gown, the "device" in question is not an AI/software medical device, but rather a physical apparel. Therefore, many of the typical acceptance criteria and study components associated with AI/software performance (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and human-in-the-loop performance) are not applicable here. The "performance" of this device is assessed through non-clinical laboratory testing to ensure it meets established safety and performance standards for surgical apparel.
Here's the breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are presented in a table under Section VII. "Non-Clinical Test Conclusion."
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 42 | Assess resistance to water impact penetration | Level 3, ≤1.0g | Pass |
| AATCC 127 | Assess hydrostatic resistance | Level 3, ≥50cm | Pass |
| ASTM D5034 | Assess adequate tensile strength | Length ≥ 30NWidth ≥ 30N | Pass |
| ASTM D5587ASTM D5733 | Assess adequate tear resistance | Length ≥ 10NWidth ≥ 10N | Pass |
| ASTM D1683 | Assess adequate seam strength | Sleeve Seam: ≥ 30NArmhole Seam: ≥ 30NShoulder Seam: ≥ 30N | Pass |
| Bursting StrengthASTM D3787ISO 13938-1 | Assess adequate bursting resistance | ≥ 5.80 psi | Pass |
| ISO 9073-10 | Assess acceptable lint and other particles generation in the dry state | Log10 < 4 | Pass |
| 16 CFR Part 1610 | Flammability testing | Class 1 | Pass |
| ISO 11737-2 | Sterility assurance | 10-6 | Pass |
| ISO 10993-5 | Biocompatibility - cytotoxicity | Non-cytotoxic | Pass |
| ISO 10993-10 | Biocompatibility - irritation | Non-irritating | Pass |
| ISO 10993-10 | Biocompatibility - sensitization | Non-sensitizing | Pass |
| ISO 10993-7 | Verify acceptable sterilant residuals | EO residual ≤ 4 mg/deviceECH residual ≤ 9 mg/device | Pass |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical tests were conducted. The sample size for these tests is not explicitly stated in the provided text. However, for physical product testing like surgical gowns, "samples" refer to individual gowns or material swatches taken from gowns, and these tests are typically conducted in a laboratory setting.
- Data Provenance: The manufacturing company, Sejong Healthcare Co., Ltd., is located in Republic of Korea. The non-clinical tests would have been performed in a laboratory, likely in Korea or by a certified testing facility adhering to international standards (e.g., ISO, ASTM, AATCC). These are prospective tests conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For physical product performance tests (like barrier properties, strength, flammability, biocompatibility), "ground truth" is established by adherence to established, quantitative international and national standards (e.g., ANSI/AAMI PB70:2012, ISO standards, ASTM standards, CFR regulations). There is no "expert" interpretation or consensus involved in determining the outcome of these objective laboratory tests. The tests themselves provide the "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3. Testing is objective and quantitative, not qualitative, so no adjudication is required.
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 section pertains to AI/software performance studies. The device is a surgical gown.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This section pertains to AI/software performance studies. The device is a surgical gown.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for the performance of the surgical gown is based on objective measurements and quantitative results from validated laboratory tests, adhering to established industry and regulatory standards (e.g., AATCC, ASTM, ISO, 16 CFR Part 1610, ANSI/AAMI PB70:2012). For example, barrier performance is "ground-truthed" by measuring the amount of water impact penetration (in grams) or hydrostatic pressure (in cmH2O), and these numerical results are compared against the specific pass/fail criteria defined by the standards. Biocompatibility is "ground-truthed" by established biological assays that yield results like "Non-cytotoxic," "Non-irritating," or "Non-sensitizing."
8. The sample size for the training set
Not applicable. This concept relates to machine learning models. The specified "device" is a physical surgical gown, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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