(168 days)
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSV/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
The Wildcat PE Surgical Isolation Gown Full Back is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided nonsterile. Wildcat PE Surgical Isolation Gown Full Back is offered in one color (blue) and one universal size. Each model is constructed of Linear Low- Density Polyethylene and has been 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.
This document is a 510(k) premarket notification for a medical device: Wildcat PE Surgical Isolation Gown Full Back (K202310). It is a submission to the FDA proving substantial equivalence to a predicate device, not an AI/ML medical device where the "device" is an algorithm. Therefore, the requested information regarding acceptance criteria and performance for an AI/ML device is not applicable to this document.
The document discusses the physical characteristics and performance of a surgical gown, specifically:
- Indications for Use: Protection of healthcare personnel from microorganisms, body fluids, and particulate material, meeting AAMI Level 3 barrier protection.
- Material Composition: Linear Low-Density Polyethylene (LLDPE).
- Performance Testing:
- Water Resistance Hydrostatic Pressure Test (AATCC 127:2017)
- Flammability of Clothing Textiles (16 CFR Part 1610)
- Tear Resistance (ASTM D1004) - Note: This and General Tensile Testing were NOT performed on the predicate device, only the proposed device, as their materials differ.
- General Tensile Testing (ASTM D882)
- Trap Tear (ASTM D5587-15)
- Grab Tensile CD (ASTM D5034)
- Water Resistance Impact Penetration Test (AATCC 42)
- Liquid Barrier Performance Classification (AAMI PB70:2012)
- Biocompatibility (ISO 10993-1)
- Acceptance Criteria and Performance: The document provides test results for the proposed device and, where available, compares them to the predicate device's performance or relevant standards (e.g., AAMI Level 3 requirements). For instance:
- Water Resistance Hydrostatic Pressure Test: Proposed device chest mean >151 cm (Min 155, Max >155 cm) vs. Predicate device body/sleeve mean 69 cm (Min 56, Max 80 cm). The proposed device's performance exceeds the predicate and likely meets AAMI Level 3 requirements for this test.
- Liquid Barrier Performance Classification: Both devices were tested per AAMI PB70:2012 and meet Level 3 requirements. This serves as a key acceptance criterion.
- Biocompatibility: Both passed ISO 10993-1.
Since the device is a physical product (a surgical gown) and not an AI/ML algorithm, the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC," "standalone performance," and "effect size of human readers" do not apply to this specific FDA submission.
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January 29, 2021
Wildcat PPE, LLC Matthew Mcfarlane General Counsel 301 S. Trade Center Pkwy Conroe, Texas 77385
Re: K202310
Trade/Device Name: Wildcat PE Surgical Isolation Gown Full Back Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: January 25, 2021 Received: January 27, 2021
Dear Matthew Mcfarlane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For: Elizabeth F. Claverie-Williams, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202320
Device Name Wildcat PE Surgical Isolation Gown Full Back
Indications for Use (Describe)
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSV/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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510(k) Summary (K202310) Wildcat PE Surgical Isolation Gown Full Back
Manufacturer:
Wildcat PPE, LLC 26980 Decker Prairie Rosehill Rd Magnolia, TX 77355
Regulatory Affairs Contact:
Matthew McFarlane 26980 Decker Prairie Rosehill Rd Magnolia, TX 77355 Telephone Number: (346) 367-4299
Date Summary Prepared: June 15, 2020
Trade Name: Wildcat PE Surgical Isolation Gown Full Back
Regulation Number: 21 CFR §878.4040
Device Class: Class II
Regulation Name: Surgical Apparel
Common Name: Surgical Isolation Gown
Product Code: FYC
Classification Name: Surgical Isolation Gown
Predicate Device: Cardinal Health Isolation Gown, K160339
Indications for Use:
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
Device Description:
The Wildcat PE Surgical Isolation Gown Full Back is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided nonsterile. Wildcat PE Surgical Isolation Gown Full Back is offered in one color (blue) and one universal size. Each model is constructed of Linear Low- Density Polyethylene and has been 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.
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Technological Characteristics Comparison Tables:
| Element of Comparison | Predicate Device:Cardinal HealthIsolation Gown(K160339) | Proposed Device: WildcatPE Surgical Isolation GownFull Back (K202310) | Comparison Analysis |
|---|---|---|---|
| Indications for Use | Cardinal Health Isolation Gownis intended to protect healthcare patients and health carepersonnel from the transfer ofmicroorganisms, body fluidsand particulate material. Notintended for use in theoperating room. In addition,The Cardinal Health IsolationGown meets the requirementsof an AAMI Level 3 barrierprotection for an isolation gownper ANSI/AAMI PB70:2012Liquid Barrier and PerformanceClassification of ProtectiveApparel and Surgical DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70).The Cardinal Health IsolationGown is a singleuse, disposable medical deviceprovided non-sterile. | Wildcat PE Surgical IsolationGown Full Backis intended toprotect health care patients andhealth care personnel from thetransfer of microorganisms,body fluids and particulatematerial.Not intended for use in theoperating room. In addition, TheWildcat PE Surgical IsolationGown Full Back meets therequirements of an AAMI Level3 barrier protection for anisolation gown per ANSI/AAMIPB70:2012Liquid Barrier and PerformanceClassification of ProtectiveApparel and Surgical DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70).The Surgical Isolation Gown isa single use, disposable medicaldevice provided non- sterile | Similar |
| Element of Comparison | Predicate Device:Cardinal HealthIsolation Gown(K160339) | Proposed Device: WildcatPE Surgical Isolation GownFull Back (K202310) | Comparison Analysis |
| Material Composition | Polyolefin (Polypropylene) SMSnonwoven | Linear Low-DensityPolyethylene (LLDPE) | Different |
| Design Features | Medical Tape Neck ClosureWhite Belt TieElastic Cuffs | Tabs Tie in the Middle of BackThumbhole at Cuff | Different |
| Sterility | Non-sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue and Yellow | Blue | Similar |
| Test ResultsMean (min/max) | Test ResultsMean (min/max) | ||
| Specifications | Specifications | ||
| Water Resistance HydrostaticPressure Test - AATCC127:2017 (cm) | Body/Sleeve:Mean = 69Ind Min = 56Ind Max = 80 | Chest:Mean = >151Min = 155Max = >155Sleeve Seam:Mean =>165Min = 171Max = >173 | Target Mean = 67Mean Min = 55Ind Min = 52 |
| Flammability of ClothingTextiles - 16 CFR Part 1610 (a) | Class I | Class I | Same |
| Tear Resistance - ASTM D1004* | NA | Max Load (lbf):Mean = 1.04Min = .95Max = 1.17Max Extension(in):Mean = 1.01Min = .91Max = 1.10 | NA |
| General Tensile Testing - ASTMD882* | NA | Breaking Factor(lbf/in):Mean = 6.66Min = 4.87Max = 9.20Tensile (Max)(MPa):Mean = 24.8Min = 19.7Max = 33.4Tensile (Break)(MPa):Mean = 21.5Min = 15.9Max = 33.4Elongation (%):Mean = 1061Min = 945Max = 1327Modulus (MPa):Mean = 91.1Min = 2.58Max = 117 | NA |
| Trap Tear ASTM D5587-15 | Mean = 4.74Ind Min = 3.67Ind Max = 5.47 | Mean = 5.10Ind Min = 3.2Ind Max = 7.0 | Similar |
| Grab Tensile CD ASTM D5034 | Mean = 14.54Ind Min = 12.70Ind Max = 16.45 | Mean = 21.95Ind Min = 20.60Ind Max = 23.30 | Similar |
| Water Resistance ImpactPenetration Test - AATCC 42 | Body/Sleeve:Mean = .07Ind Min = .05 | Chest:Mean = < 0.1Min = < 0.1 | Similar |
| Target Mean = .1Max = .5Ind Max = 1.0 | Target Mean = .1Max = .5Ind. Max = 1.0 |
Side by Side Comparison Table: Predicate Device, Cardinal Health Isolation Gown and Proposed Device, Wildcat PPE Disposable PE Isolation Gown.
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| Ind Max = .10 | Max = .5Sleeve Seam:Mean = <0.1Min = <0.1Max = <0.1 | ||||
|---|---|---|---|---|---|
| Liquid Barrier PerformanceClassification Properties | Device was tested in accordancewith AAMI PB70:2012 andmeets Level 3 requirements for asurgical gown | Device was tested in accordancewith AAMI PB70:2012 andmeets Level 3 requirements for asurgical gown | |||
| Biocompatibility | Pass: ISO 10993-1 | Pass: ISO 10993-1 | Same | ||
| Sterilization Modality | None (Non-Sterile) | None (Non-Sterile) | Same |
- These tests are specifically for tear and tensite sheeting. As Wildcat's PPEs Surgical Isolation Govens are made entrely of LLDPE, the tests sphied o Cardinal Health's Isolation Gowns associated with tear and tensile properties are not applicable.
The Wildcat PE Surgical Isolation Gowns Full Back are similar to the predicate device, in terms of intended use, performance testing, material composition, and configuration/dimensions. The Wildcat PE Surgical Isolation Gowns passed biocompatibility studies per ISO-10993 and have met the requirements of AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed 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.