TIBURON SURGICAL DRAPE
Device Facts
| Record ID | K130404 |
|---|---|
| Device Name | TIBURON SURGICAL DRAPE |
| Applicant | Cardinal Health200, LLC |
| Product Code | KKX · General, Plastic Surgery |
| Decision Date | Jul 5, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
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 Story
Tiburon® surgical drapes are single-use, disposable sterile barriers; designed to cover patients during surgical procedures. Constructed from blue absorbent polyolefin spun-melt nonwoven fabric adhesively bonded to a blue polyolefin film; provides a protective barrier against fluid strikethrough. Available in various configurations (e.g., laparotomy, endoscopy, cardiovascular, arthroscopy, pediatric, split sheets) to accommodate specific surgical needs. Used in clinical settings; operated by surgical staff. Drapes are ethylene oxide sterilized; provided in heat-sealed polyolefin-based vented pouches. Function as a physical barrier to prevent microbial contamination of the surgical site; benefits patient by reducing risk of surgical site infection.
Clinical Evidence
Bench testing only. No clinical data. Performance evaluated per FDA Guidance for Surgical Gowns and Surgical Drapes (1993) and AAMI PB70 (Level 4 liquid barrier performance). Biocompatibility testing conducted per ISO 10993; device confirmed non-cytotoxic, non-sensitizing, and non-irritating.
Technological Characteristics
Materials: Polyolefin spun-melt nonwoven fabric adhesively bonded to polyolefin film. Barrier Performance: AAMI PB70 Level 4. Sterilization: Ethylene oxide. Form factor: Various sizes/shapes for specific surgical procedures. Connectivity: None.
Indications for Use
Indicated for use as a protective patient covering to isolate a surgical incision site from microbial and other contamination during surgical procedures. Intended for single external use.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- 3M Health Care Steri-Drape™ Fabric Surgical Drape (K031287)
Submission Summary (Full Text)
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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
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:
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.
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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.
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:
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 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 | Catalog<br>Number | SF = spunbond/film<br>PE= 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 Leg<br>Procedures | 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 | |
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| Element of<br>Comparison | PREDICATE<br>3M Steri-Drape™ Surgical Drape<br>(K031287) | PROPOSED<br>Cardinal Health Tiburon® surgical<br>drape | Comparison<br>to Predicate |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for<br>Use | 3M Steri-Drape™ Surgical Fabric Drapes<br>are used to create a sterile field for a<br>surgical procedure. They are provided<br>sterile using ethylene oxide or gamma<br>radiation and intended for external use<br>only.<br><br>3M Steri-Drape™ non-sterile fabric<br>drapes are provided to other<br>manufacturers for further processing<br>using ethylene oxide. 3M provides<br>information on compatibility with ethylene<br>oxide processing. | Cardinal Health Tiburon® surgical drapes<br>are devices made of natural or synthetic<br>materials intended to be used as a<br>protective patient covering to isolate a site<br>of surgical incision from microbial and<br>other contamination. The drape is sterile<br>using ethylene oxide and is intended for<br>single external use only.<br><br>These drapes are classified as Level 4<br>per AAMI Standard PB70 liquid barrier<br>performance and classification of<br>protective apparel and drapes intended<br>for use in health-care facilities. | Substantially<br>Equivalent |
| Material<br>Composition | Drape fabric, with a blue absorbent<br>nonwoven on top and a blue film on the<br>underside. | Drape fabric, with a blue absorbent<br>nonwoven on top and a blue film on the<br>underside. | Substantially<br>Equivalent |
| Lamination | Unknown | Adhesive | Unknown |
| Sterilization<br>Modality | Ethylene Oxide or Gamma Irradiation | Ethylene Oxide | Substantially<br>Equivalent |
| Configurations/<br>Dimensions | Various sizes and shapes | Various sizes and shapes | Substantially<br>Equivalent |
| Material<br>Compatibility<br>with Ethylene<br>Oxide | Compatible | Compatible | Substantially<br>Equivalent |
| Biocompatibility | Unknown | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Unknown |
| Labeling | Label content:<br>Catalog number drape description visible<br>Drape Dimensions and drawing on label<br>Lot number visible<br>No barrier AAMI level listed<br>Site of manufacturing listed<br>Labeled as sterile<br>Labeled as single use only | Label content:<br>Catalog number drape description visible<br>Drape Dimensions and drawing on label<br>Lot number visible<br>AAMI level listed<br>Company address listed<br>Labeled as sterile<br>Labeled as single use only<br>AAMI PB70 Barrier Level 4 | Substantially<br>Equivalent |
| Barrier<br>Properties | 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
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
#### 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.
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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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Image /page/6/Picture/0 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 at a point, resembling a stylized bird in flight or a medical symbol. The text "CardinalHealth" is written in a bold, sans-serif font, with the two words joined together.
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### Indications for Use
510(k) Number (if known): K130404
Device Name: Cardinal Health Tiburon® surgical drape
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.
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
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| | Indications for Use Catalog Number List | | SF = spunbond/film<br>PE= Polyethylene | |
|-----|-------------------------------------------------|-------------------|--------------------------------------------------|--|
| | Product Description | Catalog<br>Number | 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 Leg<br>Procedures | 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 | |
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