(171 days)
No
The device is a disposable isolation gown, and the description focuses on material properties and barrier performance, with no mention of AI or ML.
No.
The device is an isolation gown intended to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material, acting as a barrier rather than providing therapy.
No
Explanation: The device, a Cardinal Health™ Isolation Gown, is intended to protect against the transfer of microorganisms and body fluids. It is a protective apparel, not a device used to diagnose a medical condition.
No
The device description clearly states it is a "surgical isolation gown" constructed of "nonwoven material" and describes physical testing performed on the material. This indicates it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics of the gown (material, construction, barrier level) and its classification as a surgical isolation gown. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This gown does not perform any such function.
The device is clearly described as a medical device intended for barrier protection.
N/A
Intended Use / Indications for 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.
Product codes
FYC
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care patients and health care personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. The critical zone areas tested were the body and sleeve (same fabric), the sleeve seam, front belt or tie attachment, and the front seam arm attachment using multiple lots.
Under the conditions of each study, the Cardinal Health™ Isolation gown is non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.
All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
Key Metrics
Water Impact (g) AATCC-42 (performed with water per AATCC-42:2013)
Body/Sleeve: Mean = 0.08 Ind Min = 0.05 Ind Max = 0.13
Target Mean = 0.10 Max = 0.5 Ind Max = 1.0
Predicate Device(s)
Kool-Gard Procedure/Cover Gown, K952116
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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K160339
Device Name Cardinal Health™ Isolation Gown
Indications for Use (Describe)
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.
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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3
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, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|----------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli
1500 Waukegan Road
Waukegan, 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 |
4
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.
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.
5
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/Cover
Gown (K952116) | Proposed Device:
Cardinal Health™ Isolation Gown |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | The predicate Kool-Gard®
Procedure/Cover Gown is
intended for non-sterile use only,
and is not intended for use in the
operation room. It is intended for
use in areas where there is
potential for light fluid contact.
The predicate Kool-Gard®
Procedure/Cover Gown is a single
use, disposable medical device,
provided non-sterile. | 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 HealthTM
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 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. |
| Material Composition | Polypropylene SMS nonwoven | Polyolefin (Polypropylene) SMS
nonwoven |
| Design Features | Tape Neck Closure
Belt Tie
Elastic Cuffs | Medical Tape Neck Closure
White Belt Tie
Elastic Cuffs |
| Sterility | Non-Sterile | Non-Sterile |
| Use | Single Use; Disposable | Single Use; Disposable |
| Color | Blue, Yellow and White | Blue and Yellow |
6
| 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 Results | ||
| Specification | |||||
| 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 Cover | |||||
| Gown (K952116) |
| Proposed Device:
Cardinal Health™ Isolation Gown
Yellow | Proposed Device:
Cardinal Health™ Isolation Gown
Blue | | |
| | K952116 Test Results | Test Results
Mean (min/max) | Specification | Test Results
Mean (min/max) | Specification |
| Trap Tear CD, (lbs)*
ASTM D5587-15
Highest Peak | Performance values not available in predicate 510(k) submission | Mean = 9.24
Ind Min = 7.54
Ind Max = 12.98 | N/A | Mean = 7.99
Ind Min = 6.64
Ind Max = 11.11 | N/A |
| Flammability
CPSC, 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 = 69
Ind Min = 56
Ind Max = 84 | Target Mean = 67
Mean min = 55
Ind Min = 52 | Body/Sleeve:
Mean = 72
Ind Min = 53
Ind Max = 80 | Target Mean = 67
Mean min = 55
Ind 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 = 0.08
Ind Min = 0.05
Ind Max = 0.13 | Target Mean = 0.10
Max = 0.5
Ind Max = 1.0 | Body/Sleeve:
Mean = 0.08
Ind Min = 0.04
Ind Max = 0.13 | Target Mean = 0.10
Max = 0.5
Ind Max = 1.0 |
7
8
| Element of
Comparison | Predicate
Device:
Kool-Gard®
Procedure Cover
Gown (K952116) | Proposed Device:
Cardinal HealthTM Isolation Gown | Proposed Device:
Cardinal HealthTM Isolation Gown |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Yellow, Blue,
White | Yellow | Blue |
| | K952116
Test Results | Test Results
Mean (min/max) | Specification |
| Liquid Barrier
Performance
Classification
Properties | Predicate
Device:
PB70
Performance
standard not
available at time
of predicate
submission. | Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level
3 requirements for an isolation gown. The critical zone areas tested were the body
and sleeve (same fabric), the sleeve seam, front belt or tie attachment, and the
front seam arm attachment using multiple lots. | |
| Biocompatibility | Predicate
Device:
Biocompatibility
was accepted
based on a
material
equivalency
statement that is
included in the
predicate
submission. | Under the conditions of each study, the Cardinal HealthTM Isolation gown is non-
cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | |
| Sterilization
Modality | 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.
9
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.