(103 days)
ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.
Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
This document describes the acceptance criteria and the study that proves the device (ComfortGuard Plus Surgical Gown, i500 and ComfortGuard Surgical Gown, i500) meets these criteria.
Acceptance Criteria and Device Performance
The acceptance criteria for the surgical gowns are based on their performance as protective apparel, specifically their liquid barrier performance (AAMI PB70 standard) and other physical and safety properties.
Table 1: Acceptance Criteria and Reported Device Performance
| Element of Comparison | Acceptance Criteria (per AAMI PB70, ISO 10993, ASTM, 16 CFR) | ComfortGuard Plus Surgical Gown, i500 (Reported Performance - Mean) | ComfortGuard Surgical Gown, i500 (Reported Performance - Mean) |
|---|---|---|---|
| General | |||
| AAMI PB 70 Classification | Level 3 | Level 3 | Level 3 |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Safety Properties | |||
| 16 CFR Part 1610 (2014) Flammability | Class 1 requirement | Met Class 1 requirement | Met Class 1 requirement |
| Biocompatibility (ISO 10993-5, 10993-10) | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating |
| Liquid Barrier Performance - Critical Zones | |||
| AATCC 127-2014 Hydrostatic Pressure (mmH2O) | A1: Base Material: ≥500mmH2O | ||
| A2: Tie Attachment: ≥500mmH2O | |||
| B1: Sleeve Seam: ≥500mmH2O | A1: Base Material: 657mmH2O | ||
| A2: Tie Attachment: 668mmH2O | |||
| B1: Sleeve Seam: 760mmH2O | A1: Base Material: 749mmH2O | ||
| A2: Tie Attachment: 637mmH2O | |||
| B1: Sleeve Seam: 689mmH2O | |||
| AATCC 42-2013 Impact Penetration (grams) | A1: Base Material: ≤1.0g | ||
| A2: Tie Attachment: ≤1.0g | |||
| B1: Sleeve Seam: ≤1.0g | A1: Base Material: 0.04g | ||
| A2: Tie Attachment: 0.02g | |||
| B1: Sleeve Seam: 0.04g | A1: Base Material: 0.07g | ||
| A2: Tie Attachment: 0.01g | |||
| B1: Sleeve Seam: 0.06g | |||
| Liquid Barrier Performance - Non-Critical Zones | |||
| AATCC 42-2013 Impact Penetration (grams) | C1: Base Material: ≤4.5g | ||
| C2: Sleeve Joint Sewn Seam: ≤4.5g | |||
| C3: Sleeve Seam: ≤4.5g | C1: Base Material: 0.02g | ||
| C2: Sleeve Joint Sewn Seam: 0.25g | |||
| C3: Sleeve Seam: 0.06g | C1: Base Material: 0.03g | ||
| C2: Sleeve Joint Sewn Seam: 0.29g | |||
| C3: Sleeve Seam: 0.03g | |||
| AATCC 42-2013 Impact Penetration (grams) | D1: Back- Base Material: ≤4.5g | ||
| D2: Back Joint Sewn Seam: ≤4.5g | |||
| D3: Back Tie Attachment: ≤4.5g | D1: Back- Base Material: 0.17g | ||
| D2: Back Joint Sewn Seam: 1.56g | |||
| D3: Back Tie Attachment: 0.86g | D1: Back- Base Material: 0.27g | ||
| D2: Back Joint Sewn Seam: 1.93g | |||
| D3: Back Tie Attachment: 0.65g | |||
| Physical Properties | |||
| ASTM D3776 (2009) Basis Weight (gsm) | Body/Sleeve Material: Mean=43gsm (-2, +6) | ||
| Back Material: Mean=33gsm (-2, +6) | Body/Sleeve Material: 46gsm | ||
| Back Material: 34gsm | Body/Sleeve Material: 50gsm | ||
| Back Material: 33gsm | |||
| ASTM D5034-09 (2013) Grab Tensile (Newton) | Body/Sleeve Material: Mean MD ≥50N, Mean CD ≥30N | ||
| Back Material: Mean MD ≥40N, Mean CD ≥20N | Body/Sleeve Material MD: 82.84N | ||
| Body/Sleeve Material CD: 58.54N | |||
| Back Material MD: 89.52N | |||
| Back Material CD: 56.32N | Body/Sleeve Material MD: 98.93N | ||
| Body/Sleeve Material CD: 61.34N | |||
| Back Material MD: 83.87N | |||
| Back Material CD: 56.16N | |||
| ASTM D5587 (2014) Trapezoid Tear (Newton) | Body/Sleeve Material: Mean MD ≥10N, Mean CD ≥20N | ||
| Back Material: Mean MD ≥10N, Mean CD ≥20N | Body/Sleeve Material: 19.01N | ||
| Body/Sleeve Material CD: 28.14N | |||
| Back Material MD: 21.19N | |||
| Back Material CD: 37.00N | Body/Sleeve Material MD: 15.69N | ||
| Body/Sleeve Material CD: 25.40N | |||
| Back Material MD: 20.74N | |||
| Back Material CD: 35.49N | |||
| ASTM D1683 (2007) Seam Strength (Newton) | Sleeve seam: Mean ≥15N | Sleeve Seam: 38.80N | Sleeve Seam: 49.01N |
Note on Reported Performance: The reported device performance values are the "Mean" results obtained from three lots, as provided in the tables within the document. The values in parenthesis (Min, Max) represent the range of results obtained. The document states that both devices "meet the predetermined specifications" for these physical properties.
Study Proving Device Meets Acceptance Criteria
The provided document is a 510(k) Pre-market Notification for surgical gowns, demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the comprehensive testing conducted to prove that the new devices meet established performance standards (acceptance criteria) and are as safe and effective as a legally marketed predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
(See Table 1 above)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the AATCC and ASTM tests (Hydrostatic Pressure, Impact Penetration, Grab Tensile, Trapezoid Tear, Seam Strength), the acceptance criteria specify a sample size of n=32 (Acc=3; Rej=4) for the AQL/RQL statistical sampling plan. The test results reported were "obtained from Three Lots".
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed. The applicant, GRI Medical & Electrical Technology Co., Ltd., is located in China, suggesting the data may originate from testing facilities in China or a contracted lab. The data is retrospective, as it represents results from tests already performed to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of submission for surgical apparel does not involve clinical studies with human "experts" establishing ground truth in the way a diagnostic AI device would. The "ground truth" for the performance of these surgical gowns is established by adherence to recognized industry standards (AAMI PB70, ASTM, 16 CFR, ISO) and laboratory testing methodologies described within those standards. The expertise lies in the certified labs and technicians performing these specific material and barrier tests. There is no mention of "experts" in the context of clinical interpretation or adjudication.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Performance is measured against objective, quantitative physical and barrier properties according to established industry standards, not subjective expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, where human readers interpret medical images. Surgical gowns are physical barrier devices, and their effectiveness is determined by laboratory performance testing, not human reading of cases. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical gown), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" is defined by the objective, quantitative performance requirements of the referenced industry standards:
- AAMI PB70: Liquid barrier performance and classification for protective apparel.
- 16 CFR Part 1610: Flammability standards.
- ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation & Sensitization): Biocompatibility standards.
- ASTM D3776, D5034-09, D5587, D1683: Physical property testing standards (basis weight, tensile strength, tear resistance, seam strength).
- AATCC 127-2014 & AATCC 42-2013: Hydrostatic pressure and impact penetration for liquid barrier.
These standards provide the pre-defined, objectively measurable criteria for performance.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this device would refer to the manufacturing processes and quality control to consistently produce gowns meeting the specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI. For the manufacturing process, the "ground truth" (or target specifications) for quality control and process validation would be established by the engineering and quality teams based on material properties, design requirements, and the performance criteria outlined in the regulatory standards (e.g., AAMI PB70 Level 3).
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are 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. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.