(26 days)
Convertors® Surgical gowns are made from natural and synthetic materials 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 the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.
SMS polyolefin, the standard, fabric and poly-reinforced gowns are comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.
The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.
The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.
The provided text describes the Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, and O.R. Surgical Gowns. This document is a 510(k) summary for these surgical gowns, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for the device itself.
Therefore, much of the requested information regarding detailed performance studies, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, as typically found for AI/ML medical devices, is not present in this document because it pertains to traditional medical device clearance based on substantial equivalence.
However, I can extract the available information, particularly regarding the acceptance criteria as defined by the "performance attributes" being the same as the predicate devices, and the general testing conducted.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of explicit numerical acceptance criteria and corresponding device performance values. Instead, the primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing predicate devices. This means that the new devices are considered safe and effective if their performance attributes are "the same" as the legally marketed predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: | |
| To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | |
| Single use, disposable, intended for repackaging and sterilization before use. | The Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns, and O. R. Surgical Gowns have the same intended use as the current SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns, and O. R. Surgical Gowns (predicate devices). |
| Performance Attributes: | |
| Expected to perform equivalently to predicate devices in protection against microorganisms, body fluids, and particulate material. | The performance attributes are the same as the predicate devices. Testing was conducted: |
- Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices": Cytotoxicity, sensitization, and primary skin irritation were performed and found acceptable.
- Industry recognized test methods: Materials were tested and found acceptable for the intended use. (Specific tests/results are not detailed). |
| Sterilization:
Ability to withstand specified sterilization methods (Industrial Moist Heat Sterilization and Ethylene Oxide). | The single-use product is designed to be repackaged and sterilized prior to use. It may be sterilized using Industrial Moist Heat Sterilization (under ANSI/AAMI/ISO 11134) and Ethylene Oxide (under ANSI/AAMI/ISO 11135).
However, the SMS polyolefin reinforced gown cannot undergo steam sterilization as it may damage the impervious reinforcement; Ethylene Oxide is the only method for this specific gown. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the performance testing. The document states "All materials used in the fabrication of this Convertors® SMS Polyolefin Gowns... were evaluated through biological qualification safety tests" and "These materials also were tested in accordance with industry recognized test methods." The exact number of gowns or material samples tested is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily lab-based (biological and material performance tests). The country of origin of the data is not specified beyond being generated by Cardinal Health Inc.
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/not provided. The "ground truth" for this type of device clearance is generally established through adherence to recognized consensus standards for material properties and biological safety (e.g., ISO 10993) and comparison to predicate devices, rather than through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typical in diagnostic studies where multiple readers interpret images. This document describes material and biocompatibility testing.
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/not provided. MRMC studies are relevant for diagnostic devices that involve human interpretation assisted by AI. This document is for surgical gowns.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Consensus Standards: Adherence to established standards such as ISO 10993 Part-1 for biological evaluation of medical devices.
- Industry Recognized Test Methods: Performance against established material and barrier property tests.
- Predicate Device Equivalence: The performance of the new gowns is considered "acceptable" because their intended use and performance attributes are "the same" as legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
§ 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.