Cardinal Health™ Isolation Gown 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 Cardinal Health™ Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Cardinal Health™ Gown is a single use, disposable medical device provided non-sterile.

Device Description

The Cardinal Health™ Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Cardinal Health™ Isolation Gown is a single use, disposable medical device provided non-sterile. The Cardinal Health™ Isolation Gown is offered in two color (blue and yellow) models and each model is offered in two sizes for a total of four models. Each model is constructed of a nonwoven material and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.

AI/ML Overview

The provided text is a 510(k) Summary for the Cardinal Health™ Isolation Gown. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it details performance testing for a medical garment.

Therefore, for aspects related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance), the information is not applicable (N/A) because this document is about a physical medical device (an isolation gown), not an AI/algorithm.

Here's the breakdown of the information that is available or N/A based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Cardinal Health™ Isolation Gown are based on physical and barrier properties, primarily meeting AAMI Level 3 requirements as per ANSI/AAMI PB70:2012.

Table of Acceptance Criteria and Reported Device Performance

Element of Comparison	Acceptance Criteria (Specification) - Proposed Device (Yellow/Blue)	Reported Device Performance - Yellow (Mean/Min/Max)	Reported Device Performance - Blue (Mean/Min/Max)
Basis Weight (oz/yd2)	Target Mean= 1.18, Mean min = 1.13, Mean max = 1.25	Mean = 1.21, Ind Min = 1.19, Ind Max = 1.23	Mean = 1.18, Ind Min = 1.15, Ind Max = 1.20
Grab Tensile MD (lb)	N/A (MD Grab tensile not specified as limiting)	Mean = 24.38, Ind Min = 21.94, Ind Max = 26.28	Mean = 22.23, Ind Min = 20.42, Ind Max = 24.03
Grab Tensile CD (lb)	Target Mean = 16.00, Mean min = 14.00	Mean = 14.54, Ind Min = 12.70, Ind Max = 16.45	Mean = 14.18, Ind Min = 12.40, Ind Max = 15.76
Trap Tear MD (lbs)	Target Mean = 5.40, Mean min = 3.60	Mean = 4.74, Ind Min = 3.67, Ind Max = 5.47	Mean = 4.40, Ind Min = 3.26, Ind Max = 5.54
Trap Tear CD (lbs)	N/A (CD Trap Tear not specified)	Mean = 9.24, Ind Min = 7.54, Ind Max = 12.98	Mean = 7.99, Ind Min = 6.64, Ind Max = 11.11
Flammability	Class I	Class I	Class I
Hydrostatic Head (cm)	Body/Sleeve: Target Mean = 67, Mean min = 55, Ind Min = 52	Body/Sleeve: Mean = 69, Ind Min = 56, Ind Max = 84	Body/Sleeve: Mean = 72, Ind Min = 53, Ind Max = 80
Water Impact (g) (AATCC-42)	Body/Sleeve: Target Mean = 0.10, Max = 0.5, Ind Max = 1.0 (mean values are the primary reference)	Body/Sleeve: Mean = 0.08, Ind Min = 0.05, Ind Max = 0.13	Body/Sleeve: Mean = 0.08, Ind Min = 0.04, Ind Max = 0.13
Liquid Barrier Performance Classification	Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012	Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012	Meets Level 3 requirements for an isolation gown per ANSI/AAMI PB70:2012
Biocompatibility	Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1	Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1	Non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1

Study Information (as requested, with N/A for AI/algorithm-specific points)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a single "test set" sample size. The performance data tables provide "Mean", "Ind Min" (Individual Minimum), and "Ind Max" (Individual Maximum) for various physical tests, indicating multiple units were tested per property. For example, for Hydrostatic Head, "Ind Min" and "Ind Max" values are given, implying multiple samples were tested for each measure. No overall "test set" number is provided.
- Data Provenance: N/A for geographic origin or retrospective/prospective nature in the AI/algorithm sense. The tests were performed on "multiple lots" of the gowns.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This refers to a physical product. "Ground truth" in this context is established by standardized physical and chemical testing methods (e.g., ASTM, AATCC, ISO standards), not expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for human-interpreted test results, not physical product performance testing.
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
- N/A. This is a physical medical device (an isolation gown), not an AI/algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device (an isolation gown), not an AI/algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Physical Testing Standards: For the isolation gown, the "ground truth" or reference for acceptance is established by recognized international and national standards for barrier performance and material properties, such as ANSI/AAMI PB70:2012 (Liquid Barrier Performance and Classification of Protective Apparel and Drapes), AATCC 127 (Hydrostatic Head), AATCC 42 (Water Impact), and various ASTM standards for material strength (e.g., ASTM D3776 for Basis Weight, ASTM D5034 for Grab Tensile, ASTM D5587-15 for Trapezoidal Tear). Biocompatibility is assessed against ISO 10993-1.
The sample size for the training set
- N/A. This is a physical medical device, not an AI/algorithm that requires a "training set."
How the ground truth for the training set was established
- N/A. This is a physical medical device, not an AI/algorithm. The concept of "training set ground truth" is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2016

Cardinal Health 200, LLC Caroline Miceli Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K160339

Trade/Device Name: Cardinal Health Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYC Dated: June 30, 2016 Received: July 1, 2016

Dear Caroline Miceli:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Runno, DDS, MA

Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160339

Device Name Cardinal Health™ Isolation Gown

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is composed of several curved lines that intersect, resembling a stylized bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" and "Health" connected as one word.

1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com

510(k) SUMMARY Cardinal Health™ Isolation Gown

Manufacturer:	Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085
Regulatory Affairs Contact:	Caroline Miceli1500 Waukegan RoadWaukegan, IL 60085
Telephone Number:	(847) 887-6864
Fax Number:	(847) 785-2461
Date Summary Prepared:	July 25, 2016
Trade Name:	Cardinal Health™ Isolation Gown
Regulation Number:	21 CFR §878.4040
Device Class:	Class II
Regulation Name:	Surgical Apparel
Common Name:	Isolation Gown
Product Code:	FYC
Classification Name:	Surgical Isolation Gown
Predicate Device:	Kool-Gard Procedure/Cover Gown, K952116

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Description

Indications for Use/Intended Use

Cardinal Health™ Isolation Gown 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 Cardinal Health™ Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid BarrierPerformance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Cardinal Health™ Isolation Gown is a single use, disposable medical device provided non-sterile.

Device and Predicate Device Technical Characteristics

The proposed Cardinal Health™ Isolation Gown is substantially equivalent to the predicate Kool-Gard Procedure/Cover gown with regards to claims, design, technology, and intended use. Refer to the Side by Side Comparison Table below.

The proposed Cardinal Health™ Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material. The Cardinal Health™ Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings and has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.

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Side by Side Comparison Table Predicate Device, Kool-Gard Procedure/Cover Gown (K952116) and Proposed Device, Cardinal Health™ Isolation Gown

Element of Comparison	Predicate Device:Kool-Gard® Procedure/CoverGown (K952116)	Proposed Device:Cardinal Health™ Isolation Gown
Intended Use/Indications for Use	The predicate Kool-Gard®Procedure/Cover Gown isintended for non-sterile use only,and is not intended for use in theoperation room. It is intended foruse in areas where there ispotential for light fluid contact.The predicate Kool-Gard®Procedure/Cover Gown is a singleuse, disposable medical device,provided non-sterile.	Cardinal Health™ Isolation Gownis intended to protect health carepatients and health care personnelfrom the transfer ofmicroorganisms, body fluids andparticulate material. Not intendedfor use in the operating room. Inaddition, The Cardinal HealthTMIsolation Gown meets therequirements of an AAMI Level 3barrier protection for an isolationgown per ANSI/AAMI PB70:2012Liquid Barrier Performance andClassification of ProtectiveApparel and Drapes Intended forUse in Health Care Facilities(ANSI/AAMI PB70).TheCardinal Health™ Isolation Gownis a single use, disposable medicaldevice provided non-sterile.
Material Composition	Polypropylene SMS nonwoven	Polyolefin (Polypropylene) SMSnonwoven
Design Features	Tape Neck ClosureBelt TieElastic Cuffs	Medical Tape Neck ClosureWhite Belt TieElastic Cuffs
Sterility	Non-Sterile	Non-Sterile
Use	Single Use; Disposable	Single Use; Disposable
Color	Blue, Yellow and White	Blue and Yellow

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Element of	Predicate	Proposed Device:		Proposed Device:
		Cardinal Health™ Isolation Gown		Cardinal Health™ Isolation Gown
Comparison	Device:
	Kool-Gard®
	Procedure Cover
	Gown (K952116)

	Yellow, Blue,	Yellow		Blue
	White

	K952116	Test Results	Specification	Test ResultsSpecification
	Test Results	Mean (min/max)		Mean (min/max)


Basis weight
(oz/yd2)
ASTM	1 - 1.2 oz/yd2***	N/A	N/A	N/A	N/A
D1910-75**
		Mean = 1.21	Target Mean=	Mean = 1.18	Target Mean =
ASTM D3776		Ind Min = 1.19	1.18	Ind Min = 1.15	1.18
		Ind Max = 1.23	Mean min = 1.13	Ind Max = 1.20	Mean min = 1.13
			Mean max = 1.25		Mean max = 1.25



Grab tensile
MD* (lb)

ASTM	20-22 lb	N/A	N/A	N/A	N/A
D882-83**

ASTM D5034		Mean = 24.38	N/A	Mean = 22.23	N/A
		Ind Min = 21.94		Ind Min = 20.42
		Ind Max = 26.28		Ind Max = 24.03

Grab tensile

CD* (lb)

ASTM	10.5 - 13 lb	N/A	N/A	N/A	N/A
D882-83**

ASTM D5034		Mean = 14.54	Target Mean =	Mean = 14.18	Target Mean=
		Ind Min = 12.70	16.00	Ind Min = 12.40	16.00
		Ind Max = 16.45	Mean min = 14.00	Ind Max = 15.76	Mean min = 14.00

Trap Tear MD,
(lbs)*
ASTM D5587-15	Performance	Mean = 4.74	Target Mean =	Mean = 4.40	Target Mean =

Highest Peak	values not	Ind Min = 3.67	5.40	Ind Min = 3.26	5.40
	available in	Ind Max = 5.47	Mean min = 3.60	Ind Max = 5.54	Mean min = 3.60
	predicate 510(k)
	submission







Element of Comparison	Predicate Device:Kool-Gard® Procedure CoverGown (K952116)	Proposed Device:Cardinal Health™ Isolation GownYellow	Proposed Device:Cardinal Health™ Isolation GownBlue
	K952116 Test Results	Test ResultsMean (min/max)	Specification	Test ResultsMean (min/max)	Specification
Trap Tear CD, (lbs)*ASTM D5587-15Highest Peak	Performance values not available in predicate 510(k) submission	Mean = 9.24Ind Min = 7.54Ind Max = 12.98	N/A	Mean = 7.99Ind Min = 6.64Ind Max = 11.11	N/A
FlammabilityCPSC, Part 1610	Performance values not available in predicate 510(k) submission	Class I	Class I	Class I	Class I
Hydrostatic Head (cm)AATCC 127	Performance values not available in predicate 510(k) submission	Body/Sleeve:Mean = 69Ind Min = 56Ind Max = 84	Target Mean = 67Mean min = 55Ind Min = 52	Body/Sleeve:Mean = 72Ind Min = 53Ind Max = 80	Target Mean = 67Mean min = 55Ind Min = 52
Water Impact (g)AATCC-42 (performed with simulated blood)	4.4 g	N/A	N/A	N/A	N/A
AATCC-42 (performed with water per AATCC-42:2013)		Body/Sleeve:Mean = 0.08Ind Min = 0.05Ind Max = 0.13	Target Mean = 0.10Max = 0.5Ind Max = 1.0	Body/Sleeve:Mean = 0.08Ind Min = 0.04Ind Max = 0.13	Target Mean = 0.10Max = 0.5Ind Max = 1.0

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Element ofComparison	PredicateDevice:Kool-Gard®Procedure CoverGown (K952116)	Proposed Device:Cardinal HealthTM Isolation Gown	Proposed Device:Cardinal HealthTM Isolation Gown
	Yellow, Blue,White	Yellow	Blue
	K952116Test Results	Test ResultsMean (min/max)	Specification
Liquid BarrierPerformanceClassificationProperties	PredicateDevice:PB70Performancestandard notavailable at timeof predicatesubmission.	Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level3 requirements for an isolation gown. The critical zone areas tested were the bodyand sleeve (same fabric), the sleeve seam, front belt or tie attachment, and thefront seam arm attachment using multiple lots.
Biocompatibility	PredicateDevice:Biocompatibilitywas acceptedbased on amaterialequivalencystatement that isincluded in thepredicatesubmission.	Under the conditions of each study, the Cardinal HealthTM Isolation gown is non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.
SterilizationModality	None(Non-Sterile)	None(Non-Sterile)

Note - Individual Maximum (Ind. Max.): specification allows only one value at this level. Individual minimum (Ind. Min.): specification allows only one value at this level. The mean performance of the proposed device was compared to the mean specification values.

- MD Grab tensile not specified, CD Grab tensile is limiting specification value; CD Trap Tear is not specified; MD Trap Tear is the limiting specification value as it is the weaker direction.
** Predicate test methods for basis weight and grab tensile strength were accepted test methods at the time; proposed device was tested on current standards.
*** The basis weight for the predicate device was reported as 1 - 1.2 oz/yd2 which converts to 34 - 41 gsm.

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The Cardinal Health™ Isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration/dimensions. Under the conditions of each study, the Cardinal Health™ Isolation gown is non-cytotoxic, nonirritating, and non-sensitizing per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown. Therefore, the subject device is determined as safe and effective for it's intended use as the predicate device.

Conclusion:

The Cardinal Health™ Isolation Gowns are as safe, as effective and performs as well as the legally marketed device identified in this submission.

Regulation Number and Section

§ 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.