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510(k) Data Aggregation
(311 days)
The 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 Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
The proposed devices have a SMS design that provides a PB70:2012 level 3 Liquid Barrier Performance Barrier.
The proposed devices are single use, disposable medical devices and can be provided in nonsterile. These surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL.
This document is a 510(k) summary for a surgical gown, not an AI/ML device. Therefore, the requested information regarding AI/ML device performance criteria, study design, expert involvement, and ground truth establishment is not applicable.
The document describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Gown (Model: surgical gown-hp-3).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria (Predicate Device K202706 or Standard) | Reported Device Performance (surgical gown-hp-3) | Remark (for comparison to predicate) |
|---|---|---|---|---|
| Performance | ||||
| Water Resistance (Imp. Pen.) | AATCC TM42-2017e | ≤1.0g | ≤1.0g (Pass) | Same / Meet standard requirement |
| Water Resistance (Hydro. Res.) | AATCC 127 - 2017 (2018) | ≥50cm | ≥50m (Pass, Meet level 3 requirement) | Same / Meet standard requirement |
| Tensile Strength | ASTM D5034-09(2017) | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | Pass (≥10N(2.3 lbf)) | Meet standard requirement (See Note 2) |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Flammability | 16 CFR Part 1610 | Class 1 | Class 1 (Pass) | Same |
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5:2009 | No Cytotoxicity (under conditions of study) | Pass - Non-toxic | Same |
| Skin Sensitization | ISO 10993-10:2010 | No Irritation / Non-sensitizing (under conditions of study) | Pass - No Irritation / Non-sensitizing | Same |
| Skin Irritation | ISO 10993-10:2010 | No Sensitization / Non-irritating (under conditions of study) | Pass - No Sensitization / Non-irritating | Same |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to compliance with standards like ANSI/AAMI PB70:2012, ASTM F2407-20, ISO 10993-5, and ISO 10993-10, which would dictate the number of test samples required by those standards.
The data provenance is not explicitly stated as "country of origin," but the submitter (Weihai Dishang Medical Technology Co., Ltd) is located in Weihai, Shandong, China. The studies are non-clinical (laboratory tests), not patient-based data. These are prospective tests conducted on the device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (surgical gown), not an AI/ML diagnostic or predictive device requiring expert review for ground truth. The "ground truth" here is established by the specifications and measurement methodologies defined in the referenced standards (e.g., AATCC, ASTM, ISO).
4. Adjudication method for the test set
Not applicable. This refers to laboratory testing against defined standards, not clinical assessment requiring expert adjudication.
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 is for a physical medical device (surgical gown), not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML system.
7. The type of ground truth used
The "ground truth" is defined by the acceptance criteria specified in internationally recognized performance standards for surgical gowns. These include:
- ANSI/AAMI PB70:2012 (Liquid barrier performance and classification of protective apparel and drapes)
- ASTM F2407-20 (Standard Specification for Surgical Gowns)
- AATCC TM42-2017e (Water Resistance: Impact Penetration Test)
- AATCC 127 - 2017 (2018) (Water Resistance: Hydrostatic Pressure Test)
- ASTM D5034-09(2017) (Tensile Strength)
- ASTM D5733-1999 (Tearing Strength)
- ASTM D1683/D1683M-2011 (Seam Strength)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)
8. The sample size for the training set
Not applicable. This is not an AI/ML product that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML product.
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(258 days)
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The ear loop is made of Knited nylon and spandex. The nose clip contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Synthetic iron wire, PP and PE. The "Disposable Medical Surgical Mask" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided text describes a submission for a Disposable Medical Surgical Mask seeking FDA clearance (K210348) by demonstrating substantial equivalence to a predicate device (K202463).
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document includes two tables that effectively serve this purpose, one for general performance and another for biocompatibility.
Performance Test Results:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| BFE (Bacterial Filtration Efficiency) | ASTM F2101-19 | ≥98% | Accepted (≥98%) |
| PFE (Particulate Filtration Efficiency) | ASTM F2299-03(2017) | ≥98% | Accepted (≥98%) |
| Differential Pressure | EN 14683:2019+AC (2019)(E), Annex C | <6.0 | Accepted (<6.0) |
| Synthetic Blood Penetration Resistance | ASTM F1862M-17 | 120mmHg | Accepted (120mmHg) |
| Flammability | 16 CFR Part 1610 (As Amendment In 2008) | (A) There are no burn times; or (B) There is only one burn time and it is equal to or greater than 3.5 seconds; or (C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. | Class 1 |
Biocompatibility Test Results:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-5:2009 In Vitro Cytotoxicity | To test the potential cytotoxicity of the test article on mammalian L-929 cells. Cells were exposed to extracts of the mask, and morphology, cell lysis, and cytotoxicity were observed and determined by MTT assay. | The 50% extract of the test article should have at least the same or a higher viability than the 100% extract. Otherwise, the test should be repeated. If viability is reduced to <70% of the blank, it has a cytotoxic potential. The Viab.% of the 100% extract of the test article is the final result. | Under the condition of the test, the test article was found to be cytotoxic. |
| Skin Sensitization ISO 10993-10:2010 | To observe skin sensitization in guinea pigs after intradermal and topical induction with extracts of the test article. Challenge phase observed for erythema and edema, and scored according to Magnusson and Kligman scales. | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | Under the conditions of the test, the test article was found to be non-sensitizing. |
| Skin Irritation test ISO 10993-10:2010 | To observe skin irritation in New Zealand white Rabbits after exposure to extracts of the test article. Extracts were applied to skin, bandages were removed after 4 hours, and skin reactions (erythema and edema) were scored at 1h, 24h, 48h, and 72h. The primary irritation score was calculated. | Use only (24±2) h, (48±2) h and (72±2) h observations for calculation. The primary irritation score for an animal was calculated by dividing the sum of all the scores by 6. To obtain the primary irritation index for the test article, add all the primary irritation scores of the individual animals and divide by the number of animals. Subtract control scores if applicable. | Under the conditions of the test, the test article was found to be non-irritating. |
| Acute systemic toxicity ISO 10993-11:2017 | To evaluate acute systemic toxicity in mice through intraperitoneal injection of a single dose of the test article extract. Mice were observed for adverse clinical reactions, systemic reactions, and weighed daily for three days. Gross necropsy for animals found dead or showing abnormal signs. | (1) If none of the mice treated with the test article extract exhibited a significantly greater biological reactivity than control mice, the test article met the requirements. If two or more animals died, or abnormal behavior occurs in two or more animals, or body weight loss >10% occurs in three or more animals, the test article did not meet the requirements. (2) If slight signs are observed, and no more than one animal showed gross symptoms or died, repeat with ten animals. If all ten animals show no meaningful biological reactivity, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. |
2. Sample size used for the test set and the data provenance
- Sample Size: For performance testing (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability), the testing was performed using 3 nonconsecutive lots of 32 samples per lot.
- Data Provenance: Not explicitly stated regarding country of origin or specific lab accreditation, but the tests were "conducted below testing" for the proposed device, suggesting the tests were specifically performed for this submission. The lack of further detail on provenance beyond "Proposed Device" suggests these are new tests conducted for the submission. The classification and purpose indicate these are likely laboratory tests rather than human clinical data. The submission is from Weihai Dishang Medical Technology Co., Ltd in Weihai, Shandong, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for surgical masks is established by objective measurements based on specified ASTM and ISO standards (e.g., filtration efficiency, differential pressure). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for medical images. The acceptance criteria themselves serve as the ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, primarily in imaging studies where multiple readers interpret cases and disagreements need to be resolved. For objective laboratory tests like those performed on a surgical mask, there is no subjective interpretation requiring an adjudication process.
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 information is not applicable. This is a submission for a physical medical device (surgical mask), not an AI-powered diagnostic tool, therefore no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established objective laboratory test results that meet internationally recognized standards (ASTM, EN, ISO) for performance and biocompatibility. These standards define the acceptable range for parameters like filtration efficiency, pressure differential, and biological reactions.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of testing a physical medical device like a surgical mask. These are direct performance and safety evaluations.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
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