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510(k) Data Aggregation
(393 days)
Disposable Ultra Reinforced Surgical Gown
The Disposable Ultra Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile
The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The provided document describes the K173847 Disposable Ultra Reinforced Surgical Gown, for which a 510(k) premarket notification was submitted. The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison to a predicate device and non-clinical performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by being "same or better performance to the predicate device" (K170762 Cardinal Health Surgical Gown) and meeting specific industry standards.
| Characteristic | Acceptance Criteria (Predicate Device K170762) | Reported Device Performance (Proposed Device) | Comparison |
|---|---|---|---|
| Intended Use | Protection for surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material; AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012; single use, disposable; provided sterile. | Protection for surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material; AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012; single use, disposable; provided sterile. | Same |
| Material | SMS polypropylene nonwoven | SMS polypropylene nonwoven | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Sterility | Sterile (and non-sterile) | Sterile | Same |
| Color | Blue | Blue | Same |
| Weight per square (g) | 31g/m² (1.32 oz/yd²) | 44 g/m² | Similar (Better) |
| Tensile | MD Mean 21.57 lbs; CD Mean 13.6 lbs | MD Mean ≥30 lbs; CD Mean≥25 lbs | Similar (Better) |
| Tear | MD Mean 3.47 lbs; CD Mean 5.63 lbs | MD Mean ≥9 lbs; CD Mean≥18 lbs | Similar (Better) |
| Flammability (sec.) CPSC, Part 1610 | Class I | Class I | Same |
| Hydrostatic Pressure (cm) AATCC-127 | >50 cm | >50 cm | Same |
| Water Impact (g) AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| Resistance to blood and liquid penetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Biocompatibility (Cytotoxicity) | Not cytotoxic | Not cytotoxic | Same |
| Biocompatibility (Irritation) | No data for predicate (assumed acceptable previous clearance) | Not an irritant | Consistent |
| Biocompatibility (Sensitization) | No data for predicate (assumed acceptable previous clearance) | Not a sensitizer | Consistent |
| Sterilization Method & SAL | Ethylene Oxide (EO), SAL=10⁻⁶; EO/ECH residues meet ISO 10993-7 | Ethylene Oxide (EO), SAL=10⁻⁶; EO/ECH residues meet ISO 10993-7 | Same |
| Size | M-S, M, L, XL, XXL | S, M, L, XL | Similar (Covers key sizes) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gowns tested for tensile strength, hydrostatic pressure, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests conducted by the manufacturer, Xiantao Rayxin Medical Products Co., Ltd., and a third party, and is prospective as these tests were conducted on the proposed device to support its submission.
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 as the evaluation of the surgical gown is based on objective, standardized physical and biological performance tests (e.g., tensile strength, fluid resistance, biocompatibility) rather than subjective expert interpretation or ground truth establishment typically associated with diagnostic or image-based devices. The "ground truth" for these tests is defined by the specific parameters and limits set by the referenced international and national standards (e.g., AAMI PB70:2012, ASTM, ISO).
4. Adjudication method for the test set
This information is not applicable. As stated above, the evaluation relies on objective measurements against defined standards, not on subjective assessments requiring adjudication among experts.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a surgical gown, which is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the surgical gown is based on objective measurements against established national and international standards for material properties, barrier protection, and biocompatibility. These include:
- AAMI/ANSI PB70:2012: Liquid Barrier Performance and Classification of Protective Apparel and Drapes
- ISO 10993 Series: Biological Evaluation of Medical Devices (Part 5: Cytotoxicity, Part 10: Irritation and Skin Sensitization, Part 7: Ethylene oxide sterilization residuals)
- ASTM F2407-06: Standard Specification For Surgical Gowns
- CPSC 16 CFR Part 1610: Standard for the Flammability of clothing textiles
- AATCC 127-2014: Water Resistance: Hydrostatic Pressure Test
- AATCC 42-2013: Water Penetration Resistance: Impact Penetration Test
- ASTM D5034-09: Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-15: Tearing Strength of Fabrics by Trapezoid Procedure
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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