Cardinal Health Tiburon® surgical drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAM Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Device Description

The Cardinal Health Tiburon® surgical drapes described in this submission are single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of absorbent nonwoven fabric backed with a protective film that stops fluid strikethrough. The drapes are provided in various sizes and shapes to meet the surgical procedure. The sterile product will be sold as an individually ethylene oxide sterilized wrapped drape that is placed in a polyolefin - based vented pouch and heat sealed prior to sterilization and are intended for external use only.

These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film.

Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications.

This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology.

AI/ML Overview

The information provided describes the Cardinal Health Tiburon® surgical drape, a medical device, and its acceptance criteria as demonstrated through performance testing.

Here's an analysis based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Indication: Provide an absorbent sterile barrier during surgical procedures.	"Completion of the performance tests demonstrated that the surgical drape provides an adequate sterile barrier after sterilization."
Material Composition: Absorbent nonwoven fabric backed with a protective film that stops fluid strikethrough.	"These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film."
Sterility: Sterilized using ethylene oxide.	"The sterile product will be sold as an individually ethylene oxide sterilized wrapped drape..." and "The drape is sterilized using ethylene oxide..."
Barrier Performance (AAMI Standard PB70): Meet Level 4 liquid barrier classification.	"Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications." and "This drape is classified as Level 4 per AAMI Standard PB70 Liquid Barrier Performance..."
Biocompatibility: Safe for intended use.	"Cardinal Health Tiburon® surgical drapes were tested in compliance with the requirements of Level 4 liquid barrier performance of AAMI Standard PB70... In addition... these drapes were evaluated according to ISO 10993 and are considered toxicologically acceptable for its intended use." (Specifically, "Non-cytotoxic, Non-sensitizing, Non-irritating" as per Table #2).
Substantial Equivalence: Equivalent to predicate device (3M Health Care Steri-Drape™ Fabric Surgical Drape K031287).	The document explicitly states "The Cardinal Health Tiburon® surgical drapes are substantially equivalent to the predicate device." and details comparisons in Table #2 concluding "Substantially Equivalent" for most comparable aspects.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Extensive performance testing has been completed on the Cardinal Health Tiburon® surgical drape," and "This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology." However, it does not specify the exact number of drape samples tested for each performance criterion.
- Data Provenance: The data appears to be prospective as it involves performance testing conducted specifically for this submission. The country of origin is not explicitly stated for the testing, but the manufacturer is Cardinal Health 200, LLC, based in McGaw Park, IL, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a physical product (surgical drape), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or disease diagnosis does not directly apply here. The "ground truth" for this device's performance is objective measurements according to established industry standards (AAMI Standard PB70, ISO 10993).
Adjudication method for the test set:
- Not applicable as this is a physical product performance study, not a study involving human interpretation or clinical adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and its relevance is not applicable to a surgical drape's physical performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device submission, not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that the drape's physical properties are tested directly, without human interpretation as part of the core performance metric.
The type of ground truth used:
- The "ground truth" for the performance claims (e.g., Level 4 barrier, biocompatibility) is based on objective measurements and adherence to established industry standards (e.g., AAMI Standard PB70 for liquid barrier performance, ISO 10993 for biocompatibility). These standards define metrics and test methods.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of developing this surgical drape.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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K130404

5 2013 JUL

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge, resembling a bird in flight or an abstract representation of movement. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter of each word capitalized.

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

510(k) SUMMARY Surgical Drape

Manufacturer:

Cardinal Health 200, LLC 1430 Waukegan Road McGaw Park, IL 60085

Tiburon® surgical drape

Class II per 21 CFR § 878.4370

Lavenia Ford 1430 Waukegan Road McGaw Park, IL 60085

(847) 887-3323

April 17, 2013

Surgical Drape

Telephone Number:

Date summary Prepared:

Regulatory Affairs Contact:

Trade Name:

Classification:

Classification Name:

Common Name:

Product Code: KKX

Predicate Device:

KKK

3M Health Care Steri-Drape™ Fabric Surgical Drape K031287

Description:

These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film.

Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications.

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Extensive performance testing has been completed on the Cardinal Health Tiburon® surgical drape. The physical properties of surgical drape have been characterized after sterilization. Completion of the performance tests demonstrated that the surgical drape provides an adequate sterile barrier after sterilization.

Indications for Use:

This drape is classified as Level 4 per AAMI Standard PB70 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health-care Facilities.

	Indications for Use Catalog Number List	CatalogNumber	SF = spunbond/filmPE= Polyethylene
	Product Description		Drape Materials
No.		Sterile
1	Three-quarter Drape Sheet	9349	SF base panel
2	Laparotomy Drape	29410	SF base panel with SF reinforcement
3	General Endoscopy Drape	9458	SF base panel with SF reinforcement
4	Cardiovascular Split Drape II	9158	SF base panel with SF reinforcement
5	Arthroscopy Drape for Dropped LegProcedures	9414	SF base panel with SF reinforcement
6	Arthroscopy Hip Drape with Pouch	29439	SF base panel with SF reinforcement
7	Beach Chair Shoulder Drape	29369	SF base panel with PE pouch and elastomeric film
8	Pediatric Drape	29492	SF base panel with SF reinforcement
9	LAVH Drape	29474	SF base panel with SF reinforcement
10	Split Sheet Drape	29436	SF base panel with SF reinforcement

Table # 1 - Product Catalog numbers

Substantial Equivalence

The Cardinal Health Tiburon® surgical drapes are substantially equivalent to the predicate device. 3M Health Care Steri-Drape™ Fabric Surgical Drape. Both devices have the same intended use, similar material composition, similar film and nonwoven components, same sterilization modality (ethylene oxide) and compatibility with that modality, similar drape configurations/dimensions, similar labeling content, and comparable physical performance attributes (including strength, basis weight, flammability).

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Table #2 - Overall Comparison of Predicate and Proposed Device

. . . .

・

11 - 11 - 11

Element ofComparison	PREDICATE3M Steri-Drape™ Surgical Drape(K031287)	PROPOSEDCardinal Health Tiburon® surgicaldrape	Comparisonto Predicate
Indications forUse	3M Steri-Drape™ Surgical Fabric Drapesare used to create a sterile field for asurgical procedure. They are providedsterile using ethylene oxide or gammaradiation and intended for external useonly.3M Steri-Drape™ non-sterile fabricdrapes are provided to othermanufacturers for further processingusing ethylene oxide. 3M providesinformation on compatibility with ethyleneoxide processing.	Cardinal Health Tiburon® surgical drapesare devices made of natural or syntheticmaterials intended to be used as aprotective patient covering to isolate a siteof surgical incision from microbial andother contamination. The drape is sterileusing ethylene oxide and is intended forsingle external use only.These drapes are classified as Level 4per AAMI Standard PB70 liquid barrierperformance and classification ofprotective apparel and drapes intendedfor use in health-care facilities.	SubstantiallyEquivalent
MaterialComposition	Drape fabric, with a blue absorbentnonwoven on top and a blue film on theunderside.	Drape fabric, with a blue absorbentnonwoven on top and a blue film on theunderside.	SubstantiallyEquivalent
Lamination	Unknown	Adhesive	Unknown
SterilizationModality	Ethylene Oxide or Gamma Irradiation	Ethylene Oxide	SubstantiallyEquivalent
Configurations/Dimensions	Various sizes and shapes	Various sizes and shapes	SubstantiallyEquivalent
MaterialCompatibilitywith EthyleneOxide	Compatible	Compatible	SubstantiallyEquivalent
Biocompatibility	Unknown	Non-cytotoxicNon-sensitizingNon-irritating	Unknown
Labeling	Label content:Catalog number drape description visibleDrape Dimensions and drawing on labelLot number visibleNo barrier AAMI level listedSite of manufacturing listedLabeled as sterileLabeled as single use only	Label content:Catalog number drape description visibleDrape Dimensions and drawing on labelLot number visibleAAMI level listedCompany address listedLabeled as sterileLabeled as single use onlyAAMI PB70 Barrier Level 4	SubstantiallyEquivalent
BarrierProperties	Unknown	AAMI PB70 Barrier Level 4	Unknown

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Summary of Testing

Cardinal Health Tiburon® surgical drapes performance has been tested in accordance with the applicable requirements recommended in the FDA's Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, Infection Control Devices Branch Division of General and Restorative Devices, August, 1993 in this submission. In addition to performance testing in accordance with industry recognized standards; these drapes were evaluated according to ISO 10993 and are considered toxicologically acceptable for its intended use. Cardinal Health Tiburon® surgical drapes were tested in compliance with the requirements of Level 4 liquid barrier performance of AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Conclusions:

Based on the results of the biocompatibility and physical performance testing, Cardinal Health Tiburon® surgical drape is safe for its intended use. The Cardinal Health Tiburon® surgical drape is substantially equivalent to the predicate device, 3M Health Care Steri-Drape ™ Fabric Drape, in terms of general intended use, physical performance testing, material composition modality and compatibility, drape configurations/dimensions, and labeling, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 5, 2013

Cardinal Health 200, LLC Ms. Lavenia Ford Regulatory Affairs Manager 1430 Waukegan Road MCGAW PARK, IL 60085-6786

Re: K130404

Trade/Device Name: Cardinal Health Tiburon® Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape Regulatory Class: II Product Code: KKX Dated: April 8, 2013 Received: April 10, 2013

Dear Ms. Ford:

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, 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.

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

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Page 2 - Ms. Ford

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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/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 Small Manufacturers, International and Consumer Assistance 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.

Image /page/5/Picture/7 description: The image shows a document with the text "Sincerely yours" at the top. Below this, there is a signature and the name "Tejashri Purohit Sheth, M.D." followed by the title "Clinical Deputy Director". The acronym "DAGRID" is also present, along with the word "FOR" at the bottom right.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K130404

Device Name: Cardinal Health Tiburon® surgical drape

This drape is classified as Level 4 per AAM Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Elizabeth The Glax Millence of CDRH, Office of Devices Evaluation (ODE)
2013.06.28 2222888993-04'00'

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) K130404

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Table 1 - Product Catalog numbers

and the comments of the comments of the comments of

and the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the

	Indications for Use Catalog Number List		SF = spunbond/filmPE= Polyethylene
	Product Description	CatalogNumber	Drape Materials
No.		Sterile
1	Three-quarter Drape Sheet	9349	SF base panel
2	Laparotomy Drape	29410	SF base panel with SF reinforcement
3	General Endoscopy Drape	9458	SF base panel with SF reinforcement
4	Cardiovascular Split Drape II	9158	SF base panel with SF reinforcement
5	Arthroscopy Drape for Dropped LegProcedures	9414	SF base panel with SF reinforcement
6	Arthroscopy Hip Drape with Pouch	29439	SF base panel with SF reinforcement
7	Beach Chair Shoulder Drape	29369	SF base panel with PE pouch and elastomeric film
8	Pediatric Drape	29492	SF base panel with SF reinforcement
9	LAVH Drape	29474	SF base panel with SF reinforcement
10	Split Sheet Drape	29436	SF base panel with SF reinforcement

the submit and the subject of the states of the states

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.