(48 days)
Not Found
No
The description focuses on the mechanical components and function of a vascular introducer sheath and dilator, with no mention of AI or ML.
No.
The device is used to introduce other catheters and electrodes into a blood vessel, acting as an access and closure tool, rather than directly treating a condition.
No
Explanation: The device is an introducer sheath used to provide access to the vascular system for the introduction of other catheters and electrodes. Its stated "Intended Use" is for "The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes," which are interventional or delivery functions, not diagnostic ones. The "Device Description" also focuses on its function as an access tool, not on detecting or characterizing medical conditions.
No
The device description clearly outlines physical components such as sheaths, dilators, hubs, valves, side ports, tubing, and stopcocks, indicating it is a hardware medical 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 blood vessels for diagnostic and interventional procedures. This is a direct interaction with the patient's circulatory system, not the examination of specimens derived from the human body.
- Device Description: The device is a vascular introducer sheath and dilator. Its function is to provide access to blood vessels and minimize blood loss during procedures. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens like blood, urine, or tissue in vitro (outside the living body) to provide information about a physiological state, health, or disease.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
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)
DYB
Device Description
The modified Engage Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage Introducer is intended to provide easy access to the vascular system, while providing convenient temporary closure of the access port during catheter exchanges. The Engage Introducer sheaths range in effective length from a nominal 12cm to a nominal 25cm. The Engage Introducer sheaths included in the scope of this submission range in sizes from 4-9F ACT (Active Clotting Time). Guidewire compatibility ranges from 0.035" to 0.038".
The Engage device consists of two primary components: the Hemostasis sheath assembly and the dilator. The Hemostasis sheath assembly is the vessel access device and the dilator fits inside the sheath providing support. The dilator lumen is designed to provide a close fit to appropriately sized guidewire. At the proximal end of the Hemostasis sheath is a snap-lock hub which is equipped with a Hemostasis valve and side port with approximately 8 cm of tubing attached and ending with a 3-way stopcock. Some of the Engage devices are packaged with FDA cleared devices such as guidewires and needles.
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
Prescription Use
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)
The Engage Introducer product family is required to pass predetermined design performance criteria. The summary of Engage test performance data is provided in this 510k submission. Based on passing verification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage Introducer, no additional animal or clinical data was deemed necessary.
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
Section 7. 510(k) Summary
7.1 Applicant Information
OCT - 8 2009
| Submitted by: | St. Jude Medical
6500 Wedgwood Road
Maple Grove, MN 5531 |
|-----------------|----------------------------------------------------------------|
| Contact Person: | Linh Pham |
| Telephone: | 763-383-2586 |
| Fax: | 763-383-2559 |
| Date Prepared: | 14 August, 2009 |
Device Information 7.2
| Classification Name: | Introducer, Catheter |
|---|---|
| Common Name: | Hemostasis Introducer |
| Trade Name: | Engage Introducer |
| Classification: | Class II per 21 CFR 870.1340 |
| Product Code: | DYB |
7.3 Device Description
The modified Engage Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage Introducer is intended to provide easy access to the vascular system, while providing convenient temporary closure of the access port during catheter exchanges. The Engage Introducer sheaths range in effective length from a nominal 12cm to a nominal 25cm. The Engage Introducer sheaths included in the scope of this submission range in sizes from 4-9F ACT (Active Clotting Time). Guidewire compatibility ranges from 0.035" to 0.038".
The Engage device consists of two primary components: the Hemostasis sheath assembly and the dilator. The Hemostasis sheath assembly is the vessel access device and the dilator fits inside the sheath providing support. The dilator lumen is designed to provide a
1
close fit to appropriately sized guidewire. At the proximal end of the Hemostasis sheath is a snap-lock hub which is equipped with a Hemostasis valve and side port with approximately 8 cm of tubing attached and ending with a 3-way stopcock. Some of the Engage devices are packaged with FDA cleared devices such as guidewires and needles.
7.4 Intended Use
There is no change to the intended use of the modified Engage Introducer as it is identical to the predicate Engage/Engage TR Introducer, K091137-April 22, 2009. 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.
7.5 Predicate Device Comparison/Technological Characteristics
The modified Engage Introducer included in this Special 510(k) submission shares the same intended use as the predicate Engage/Engage TR Introducer (K091137. Avril. 22. 2009), which is indicated for 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. The modified Engage, covered by this submission, is substantially equivalent to the St. Jude Medical Engage/Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346. May 24, 2000), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991).
The modifications to the Engage device do not affect the intended use of the system and there is no alteration in the fundamental scientific technology of the device. The Engage Introducer covered by this Special 510(k) submission is similar in function and technological characteristics, mechanism of action and intended use as the market cleared predicated devices, Engage/Engage TR Introducer and Ultimum Hemostasis Introducer, and Fast-Cath Introducer (K091137, K001346, & K914090).
2
7.6 Test Summary
The Engage Introducer product family is required to pass predetermined design performance criteria. The summary of Engage test performance data is provided in this 510k submission. Based on passing verification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage Introducer, no additional animal or clinical data was deemed necessary.
7.7 Substantial Equivalence
The Engage Introducer covered by this submission is substantially equivalent to the previously cleared Engage/Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991), given equivalent intended use, principles of operation and similar technological characteristics.
7.8 Conclusion
In conclusion, the modified Engage Introducer is substantially equivalent to the market cleared Engage/Engage TR Introducer, Ultimum Hemostasis Introducers, and Fast Cath Hemostasis Introducer (K091137, K001346, K914090 respectively).
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313
OCT - 8 2009
Re: K092575
Engage™ Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 19, 2009 Received: September 23, 2009
11:12
Dear Mr. Job:
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.
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 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. 1
4
Page 2 - Mr. Mark Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
una R. vri Mner
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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Section 6. Indication For Use
510(k) Number: K092575 Device Name: Engage™ Introducer Indication 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 X
(Part 21 CFR 801 Subpart D)
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)
sima R. Lames
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K092575
St. Jude Medical Engage Introducer 510(k)