(58 days)
No
The device description and performance studies focus on the physical properties and barrier performance of a surgical gown and hood, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgical gown and hood designed for protection during procedures, not for treating or diagnosing a medical condition.
No
The device is a surgical gown intended for protection during surgical procedures, not for diagnosis.
No
The device description clearly indicates it is a physical gown and hood made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide the wearer with protection from blood and other body fluids during surgical procedures. This is a protective barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a gown or hood made of fabric. It is designed to be worn by a person.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies focus on the physical properties of the fabric and its barrier capabilities (hydrostatic head, bacterial filtration, synthetic blood/viral resistance), which are relevant to its protective function, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a protective garment.
N/A
Intended Use / Indications for Use
The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.
Product codes
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Device Description
The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown. The surgical gown and hood are similar in design and composition to the Kappler Pro/Vent Surgical Gown identified in premarket notification #K932694. The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown. The gown and hood may be used with air supplied cooling systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The technological characteristics of the Kappler Pro/Vent Surgical Gown and the Pro/Vent TE Gown or Hood are identical. The non-clinical performance data is summarized below. (Table provided with the following characteristics for both PRO/VENT GOWN and PRO/VENT TE):
Material Composition: 100% Polypropylene
Fabric Configuration: Trilaminate
Barrier Layer: Microporous Film
Composite Weight: 2.1 oz/square yard
Hydrostatic Head: 43 inches
Bacterial Filtration: 99.9%
Moisture Vapor Transmission Rate: 1385 g/sqm/24hr
Flammability: Class 1
Synthetic Blood/Viral Resistance: Pass
Sterility: The sterilization method is Ethylene Oxide (ETO). The method used to validate the sterilization cycle is overkill. The sterility assurance level (SAL) for the device will be 10*. The packaging for the sterile device is the same type as the predicate device. The maximum levels of residues of ethylene oxide were less than 25 ppm, for ethylene chlorohydrin were less than 50 ppm and for ethylene glycol were less than 250 ppm from the sterilization process and are below allowable FDA limits.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 20 1996
510(k) Summary (K963809)
Submitter: Kappler USA, 70 Grimes Drive, Guntersville, AL 35976
Prepared: September 20, 1996
Contact: Philip C. Mann
Device Name: Totally Encapsulated (TE) Surgical Gown/Hood Proprietary Name: COOL-ZONE Classification Name: Gown, Surgical
The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown.
Gown and Hood
The surgical gown and hood are similar in design and composition to the Kappler Pro/Vent Surgical Gown identified in premarket notification #K932694.
The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown.
The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.
The technological characteristics of the Kappler Pro/Vent Surgical Gown and the Pro/Vent TE Gown or Hood are identical. The non-clinical performance data is summarized below.
The gown and hood may be used with air supplied cooling systems.
1
| CHARACTERISTIC | PRO/VENT GOWN | PRO/VENT TE |
|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Fabric Configuration | Trilaminate | Trilaminate |
| Barrier Layer | Microporous Film | Microporous Film |
| Composite Weight | 2.1 oz/square yard | 2.1 oz/square yard |
| Hydrostatic Head | 43 inches | 43 inches |
| Bacterial Filtration | 99.9% | 99.9% |
| Moisture Vapor | ||
| Transmission Rate | 1385 g/sqm/24hr | 1385 g/sqm/24hr |
| Flammability | Class 1 | Class 1 |
| Synthetic Blood/ | ||
| Viral Resistance | Pass | Pass |
Sterility
The sterilization method is Ethylene Oxide (ETO). The method used to validate the sterilization cycle is overkill. The sterility assurance level (SAL) for the device will be 10 *. The packaging for the sterile device is the same type as the predicate device.
The maximum levels of residues of ethylene oxide were less than 25 ppm, for ethylene chlorohydrin were less than 50 ppm and for ethylene glycol were less than 250 ppm from the sterilization process and are below allowable FDA limits.