ULTIMUM EV HEMOSTASIS INTRODUCER

K140327 · St Jude Medical · DYB · Mar 11, 2014 · Cardiovascular

Device Facts

• Record ID: K140327
• Device Name: ULTIMUM EV HEMOSTASIS INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

Device Story

The Ultimum EV Hemostasis Introducer is a catheter introducer system consisting of a polyethylene introducer sheath and a tapered dilator. It features a hemostasis valve to minimize blood loss during catheter introduction or exchange over a guidewire. The proximal hub includes a sideport with a three-way stopcock for aspiration, fluid infusion, blood sampling, and pressure monitoring. A radiopaque marker band is located at the distal end for visualization. The device is used by clinicians in a clinical setting to facilitate vascular access. By maintaining hemostasis during procedures, the device reduces blood loss for the patient.

Clinical Evidence

Bench testing only. Performance testing included sheath configuration, OD/ID measurements, hemostasis maintenance, clot management, kink resistance, tip integrity, suture ring seal, and break force testing. Biocompatibility testing was conducted per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, and chemical characterization. All tests met pre-determined acceptance criteria.

Technological Characteristics

Polyethylene introducer and dilator; radiopaque marker band; hemostasis valve; three-way stopcock. Biocompatibility per ISO 10993-1. Sterilization method not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is required.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Ultimum EV Hemostasis Introducer (K023447)

Submission Summary (Full Text)

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St. Jude Medical

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| 510(k) Summary | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140327 |
| Submitter Information: | |
| Date Prepared: | March 6, 2014 |
| Submitter Name &<br>Address: | St. Jude Medical<br>5050 Nathan Lane<br>Plymouth, MN 55442 |
| Contact Person: | Loucinda Bjorklund<br>Principal Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Device Information: | |
| Trade Name: | Ultimum™ EV Hemostasis Introducer |
| Common Name: | Catheter Introducer |
| Class | II |
| Classification Name: | 870.1340 Catheter introducer |
| Predicate Device: | Ultimum EV Hemostasis Introducer (K023447) |
| Device Description: | The Ultimum™ EV Hemostasis Introducer consists of a polyethylene<br>introducer and dilator with a radiopaque marker band at the distal end. The<br>introducer is fitted with a hemostasis valve for use during catheter<br>introduction and/or exchange over a guidewire. The hub is located on the<br>proximal end of the introducer, where a sideport with a three-way<br>stopcock is provided for aspiration, fluid infusion, blood sampling, and<br>pressure monitoring. The dilator is tapered at the distal tip with an internal<br>lumen designed to accept guidewires that have a maximum diameter of<br>0.035" (0.889 mm). |
| Intended Use:<br>(Indications for Use) | Ultimum EV Hemostasis Introducers are designed for the introduction of<br>angiographic catheters, closed end catheters, balloon catheters and<br>electrodes into a vessel where minimizing blood loss is essential. |
| Comparison to Predicate<br>Devices | The modified Ultimum EV Hemostasis Introducer has the same intended<br>use and fundamental scientific technology as the predicate device. The<br>modified Ultimum EV has a redesigned hemostasis seal, minor<br>dimensional and polymer material changes on the introducer hub<br>assembly, and the use of an adhesive to bond the extension tube to the hub.<br>The dilator packaged with the modified Ultimum EV is yellow. In<br>addition, the modified Ultimum EV packaging is a PVC tray placed into a<br>pouch. The technological characteristics of the modified Ultimum EV<br>Hemostasis Introducer are substantially equivalent to the predicate device<br>including packaging, biocompatibility, sterilization, and labeling.<br>Biocompatibility and bench performance testing demonstrated that the |

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St. Jude Medical
K140327 – 510(k) Summary

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| Summary on Non-Clinical | Performance bench testing and biocompatibility testing were performed to verify the device modifications met the pre-determined acceptance criteria. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing | The following performance bench tests were performed: |
| | Sheath Configuration; Device Outer Diameter (OD) Effective Sheath Length Dilator Configuration; Dilator Sheath ID Hemostasis Maintenance; Introducer Assembly Clot Management; Flushing Assembly (Kink Resistance) Insertion (Kink Resistance) Functional Use During Procedure Tip Integrity Suture Ring Seal Performance; Device Exchange Device Integrity; Hemostasis Sheath Break Force Device Integrity; Dilator Sheath Break Force Device Integrity; Hemostasis Hub and Aspiration Tube Break Force Device Integrity; Hub and Cap Break Force Dilator Flushing Device Compatibility; Sheath Hub Device Compatibility; Dilator Hub ID |
| | Biocompatibility testing was performed in accordance with ISO 10993-1, |
| | the devices were tested for cytotoxicity, sensitization, intracutaneous |
| | reactivity, systemic toxicity (acute), pyrogencity, hemocompatibility and |
| | chemical characterization. The results of the non-clinical data |
| | demonstrates that the subject device has met the acceptance criteria for performance bench testing and biocompatibility. |
| Statement of Equivalence | The modified Ultimum EV Hemostasis Introducer has the same |
| | indications for use and technological characteristics as the predicate |
| | device. Based on this and the data provided in this pre-market notification, |
| | the subject device and predicate device has been shown to be substantially |
| | equivalent. |

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Public Health Service

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

March 11, 2014

St. Jude Medical Loucinda Bjorklund Sr. Regulatory Affairs Specialist 5050 Nathan Lane N Plymouth, MN 55442

Re: K140327

Trade/Device Name: 19F Ultimum EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 7, 2014 Received: February 10, 2014

Dear Ms. Bjorklund,

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. Iisting 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Loucinda Bjorklund

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

K140327 510(k) Number (if known): Device Name: Ultimum EV Hemostasis Introducer

Indications for Use:

Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

X ============================================================================================================================================================================ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Gilliam