ULTIMUM/ENGAGE/ENGAGE TR

K091137 · St Jude Medical · DYB · Apr 22, 2009 · Cardiovascular

Device Facts

• Record ID: K091137
• Device Name: ULTIMUM/ENGAGE/ENGAGE TR
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

Device Story

The Engage Hemostasis Introducer is a vascular access device consisting of an introducer sheath, hemostasis valve, sideport with 3-way stopcock, hub, dilator, and guidewire. It is used by physicians in clinical settings to facilitate the introduction of catheters and electrodes into blood vessels. The hemostasis valve minimizes blood loss during the procedure, while the sideport allows for air aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator features a tapered distal tip to ensure a close fit with guidewires. The device functions as a mechanical conduit for interventional procedures, providing a stable access point while maintaining vessel integrity.

Clinical Evidence

No clinical data. This submission is for indication clarification only; no device changes were made, and no additional bench or clinical testing was required.

Technological Characteristics

The device consists of an introducer sheath with a hemostasis valve, sideport with 3-way stopcock, hub, dilator, and guidewire. It is a mechanical, non-powered device. Materials and specifications are identical to the previously cleared Ultimum Hemostasis Introducer (K001346).

Indications for Use

Indicated for patients requiring vascular access for angiographic, closed end, or balloon catheters and electrodes, including femoral, radial, and brachial approaches, where hemostasis is required to minimize blood loss.

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 Hemostasis Introducer (K001346)
• GlideSheath (K082644)

Submission Summary (Full Text)

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# 510(K) SUMMARY

K09113)

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## 5.1. APPLICANT INFORMATION

Submitted by:

St. Jude Medical 6500 Wedgwood Rd. N. Maple Grove, MN 55311

| Contact Person: | Linh Pham |
|-----------------|----------------|
| Telephone: | 763-383-2586 |
| Fax: | 763-383-2559 |
| Date Prepared: | 10 April, 2009 |

#### 5.2. DEVICE INFORMATION

| Classification Name: | Introducer, Catheter |
|----------------------|------------------------------|
| Common Name: | Hemostasis Introducer |
| Trade Name: | Ultimum/Engage/Engage TR |
| Classification: | Class II per 21 CFR 870.1340 |
| Product Code: | DBY |

Ultimum and Engage are the same devices (intended use, function and specifications, and device materials). SJM reserves the right to modify the trade name of the Ultimum/Engage device in the future; as a result, the name, Engage Introducer (Engage), will be referred to for the remainder of this submission.

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#### 5.3. DEVICE DESCRIPTION

The Engage device consists of an introducer sheath with hemostasis valve and sideport for 3-way stopcock, hub, dilator, and guidewire. At the end of the sheath is a snap fit hub that is equipped with a hemostasis valve and sideport containing tubing ending with a 3way stopcock valve. The 3-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. The dilator lumen is designed to provide close fit to appropriately sized guidewires by incorporating a tapered distal tip.

To further assist physicians on the application of the Ultimum/Engage device, SJM is providing physicians with more clarity in the device's indications for use.

## 5.4. INTENDED USE

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

## 5.5. TEST SUMMARY

This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required.

## 5.6. PREDICATE DEVICE

The predicate devices are provided below:

| Product Name | 510k # |
|--------------------------------------------------------|------------------------------|
| Ultimum Hemostasis<br>Introducer (St. Jude<br>Medical) | K001346 (cleared 05/24/2000) |
| GlideSheath (Terumo<br>Corporation) | K082644 (cleared 09/18/2008) |

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#### 5.7. SUBSTANTIAL EQUIVALENCE

The Engage Introducer covered by this submission is substantially equivalent to the previously cleared St. Jude Medical's Ultimum Hemostasis Introducer-K001346-05/24/2000 and Terumo's GlideSheath-K082644-09/18/2008. Differences between devices do not raise any issues of safety or effectiveness.

#### 5.8. CONCLUSION

The Engage Introducer in this submission has the same intended use, principles of operation, and technological characteristics as the Ultimum Hemostasis Introducer (K001346), and it has similar sub-indications for use and principles of operations as the Terumo GlideSheath (K082644). The Engage is submitted to provide further clarification to the physicians regarding the indications for use of Ultimum in procedures requiring vessel access, including but not limited to femoral, radial, and brachial approach.

As a result, the differences between this device and its predicate device do not raise new questions of safety or efficacy. Therefore, the Engage Introducer is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2009

St. Jude Medical c/o Mark Job, Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313

Re: K091137

Trade/Device Name: Ultimum/Engage/Engage TR Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 17, 2009 Received: April 20, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of April 22, 2009.

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 (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.

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

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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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

K

A 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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| Ultimum/Engage Introducer Premarket Notification 510(k) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------|
| 4. INDICATIONS FOR USE STATEMENT | | |
| Device Name: | Ultimum/Engage/Engage TR | |
| Indications for Use: | | |
| The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential. | | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
| (Division Sign-Off) | | |
| Division of Cardiovascular Devices | | |
| 510(k) Number | K69137 | |
| 4 | | |