(121 days)
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No
The summary describes a surgical gown and does not mention any AI or ML capabilities.
No.
The device is a surgical gown intended to protect personnel and patients from contamination, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly states it is a "Breathable Surgical Gown," which is a physical, disposable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description reinforces that they are single-use, disposable medical devices for protection.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This surgical gown does not perform such a function.
N/A
Intended Use / Indications for Use
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown 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. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
Product codes
FYA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel / operating room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2020
Cardinal Health 200, LLC Caroline Miceli Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K200824
Trade/Device Name: Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 10, 2020 Received: June 12, 2020
Dear Ms. 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. 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.
1
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 (QS) 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 Claverie 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) K200824
Device Name
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown
Indications for Use (Describe)
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown 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. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
SMARTGOWN™ Breathable Surgical Gowns | SMARTGOWN™ AIR Breathable Surgical Gowns | |||||
---|---|---|---|---|---|---|
Sterile | BNS | Case NS | Description | Sterile | BNS | Description |
89005 | 8900EN | N/A | Small/medium | 29005 | 29005N | Small/medium |
89015 | 89015NA | N/A | Large | 29015 | 29015N | Large |
89045 | 89045NA | K89045N | X-large | 29019 | 29019N | Large, X-long |
89075 | 89075NA | K89075NA | XX-large | 29045 | 29045N | X-large |
89085 | 89085N | N/A | XXX-large | 29049 | 29049N | X-large, X-long |
89095 | 89095N | N/A | XXXX-large | 29075 | 29075N | XX-large |
SMARTGOWN™ Breathable Surgical Gowns | 29079 | 29079N | XX-large, X-long | |||
with raglan sleeves | 29085 | 29085N | XXX-large | |||
Sterile | BNS | Case NS | Description | 29089 | 29089N | XXX-large, X-long |
39015 | 39015NA | K39015N | Large | 29095 | 29095N | XXXX-large |
39019 | 39019N | N/A | Large, X-long | 29099 | 29099N | XXXX-large, X-long |
39045 | 39045NA | N/A | X-large | Gowns | SMARTGOWN™ AIR Breathable Scrub Nurse | |
39049 | 39049NA | K39049N | X-large, X-long | Sterile | BNS | Description |
39075 | 39075NB | N/A | XX-large | N/A | 290015N | Large |
39079 | 39079NB | N/A | XX-large, X-long | N/A | 290045N | X-large |
39099 | 39099NA | N/A | XXX-large, X-long | |||
32474 | 32474NA | N/A | X-large, X-long, A-line | |||
C32474 | N/A | N/A | X-large, X-long, A-line | |||
SMARTGOWN™ Breathable Scrub Nurse Gowns | ||||||
Sterile | BNS | Case NS | Description | |||
N/A | 324740NA | N/A | X-large, X-long, A-line | |||
N/A | 890015NA | N/A | Large | |||
N/A | 890045NA | |||||
BNS = Bulk Non-Sterile | N/A | X-large |
Case NS = Case Non-Sterile
Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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