(460 days)
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.
This document describes the non-clinical testing performed on the Paneffort AAMI Level 3 Isolation Gown to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| S.No. | Test Performed | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| 1. | Bursting Strength | ≥ 40 kPa (≥5.80 psi) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 2. | Basis Weight | ≥35 g/m² | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 3. | Linting Test | Co-coefficient of Linting ≤4.2 | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 4. | Air Permeability | ≥15 ft³/min/ft² | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 5. | Water Resistance: Hydrostatic Pressure | ≥ 50cm H₂O (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012) | Lot 1: 3 out of 32 samples failed. Lot 2: 3 out of 32 samples failed. Lot 3: 2 out of 32 samples failed. Despite these failures, the overall conclusion states: "The test meets the Acceptance Criteria." | The test meets the Acceptance Criteria |
| 6. | Water Resistance: Impact Penetration | ≤1.0g (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 7. | Tensile Strength/Breaking Strength | ≥30N (≥7 lbf) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 8. | Tearing Strength | ≥10N (≥2.3 lbf) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 9. | Seam Strength | ≥30N (≥7 lbf) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 10. | Flammability | Class I. Textile exhibiting normal flammability. | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| 11. | Water Vapour resistance | 0,0-1,0 kPa.m²/W (This appears to be a range, but typically there would be a specific limit or target for water vapor resistance for PPE) | The test meets the Acceptance Criteria | The test meets the Acceptance Criteria |
| Biocompatibility: In Vitro Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | The test meets the Acceptance Criteria | |
| Biocompatibility: Skin Irritation | Not an irritant | Under the conditions of the study, not an irritant. | The test meets the Acceptance Criteria | |
| Biocompatibility: Skin Sensitization | Not a sensitizer | Under the conditions of the study, not a sensitizer. | The test meets the Acceptance Criteria |
Note on Water Resistance (Hydrostatic Pressure): The reported performance shows individual sample failures within each lot (3 out of 32 in Lot 1, 3 out of 32 in Lot 2, and 2 out of 32 in Lot 3). However, the "Conclusion" column for this test still states "The test meets the Acceptance Criteria." This implies that the passing condition is based on an Allowable Quality Level (AQL) or a specific sampling plan where a certain number of defects are permitted within the sample size while still meeting the overall acceptance criteria (Ac: 3, Re: 4; AQL: 4%).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Sizes:
- Bursting Strength, Basis Weight, Linting Test, Air Permeability, Tensile Strength/Breaking Strength, Tearing Strength, Seam Strength, Flammability, Water Vapour resistance: 32 samples each from 3 different lots (total 96 samples per test).
- Water Resistance: Hydrostatic Pressure and Impact Penetration: Lot 1: 74 pieces; Lot 2: 72 pieces; Lot 3: 72 pieces (total 218 pieces across 3 lots for each test).
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is Paneffort (Cambodia) Garment Co. Ltd., and the specification developer is Paneffort, LLC (USA). The testing standards are international (ASTM, AATCC, ISO, CFR), suggesting tests were conducted in reputable labs, but the specific location of the test facilities is not provided. The data is retrospective, as it was collected to support a 510(k) submission for a device that has already been manufactured and tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This study is a non-clinical performance testing of a physical medical device (isolation gown) against established engineering and material science standards. It does not involve human interpretation of data or diagnostic tasks where expert ground truth would be required. The "ground truth" here is objective measurement against specified criteria.
4. Adjudication Method for the Test Set:
- Not Applicable. As no expert review or human interpretation for diagnosis is involved, there is no adjudication method in the traditional sense. The pass/fail criteria are defined by the testing standards and AQLs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical medical device (isolation gown) and does not involve human readers or diagnostic cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI/algorithm-based device. It is a physical product. The performance reported is that of the gown itself, as tested in a lab environment.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on established industry and regulatory standards for protective apparel. This includes:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (specifically Level 3).
- Various ASTM, AATCC, ISO, and CFR standards for material properties and flammability.
- ISO 10993 for biocompatibility.
- The tests generate objective, measurable data that is compared directly to the numerical acceptance criteria defined in these standards.
8. The Sample Size for the Training Set:
- Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The performance is inherent to its physical design and materials, verified through non-clinical testing.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.