(2 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is a standard introducer sheath with a hemostasis valve.
No.
The device is an introducer sheath and dilator, used for introducing other devices into blood vessels, which is a procedural or access device, not a therapeutic one.
No
This device is described as an introducer sheath for the insertion of other catheters and electrodes into blood vessels, and its stated purpose is to minimize blood loss. There is no mention of it being used to detect, monitor, or diagnose a medical condition. While it allows for blood sampling and pressure monitoring, these are functions of the sideport on the sheath and are not the primary diagnostic function of the sheath itself.
No
The device description explicitly lists physical components such as an introducer sheath, hemostasis valve, sideport, hub, dilator, and guidewire, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the introduction of catheters and electrodes into a blood vessel for procedures like angiography. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device components (introducer sheath, dilator, guidewire) are designed for accessing and navigating within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body internally for procedural purposes. This device is a medical device used for interventional procedures within the circulatory system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DBY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessel (including but not limited to femoral, radial, and brachial access)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY
K09113)
APR ११२ २००९
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 | |
| Introducer (St. Jude | |
| Medical) | K001346 (cleared 05/24/2000) |
| GlideSheath (Terumo | |
| 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.
3
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
4
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 | ||
| (Part 21 CFR 801 Subpart D) | X AND/OR | Over-The-Counter Use |
| (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 | |
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