(30 days)
Not Found
No
The description focuses on the mechanical components and function of a vascular introducer, with no mention of AI or ML.
Yes
The device is an introducer sheath and dilator, which are used to facilitate the introduction of other catheters and electrodes into the blood vessel. It does not directly treat a disease or condition, but rather provides access for therapeutic or diagnostic devices.
No
The device is an introducer sheath designed to provide vascular access for other catheters and electrodes, facilitating procedures by minimizing blood loss during exchanges. It does not perform any diagnostic function.
No
The device description clearly details 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 in vitro (outside the body).
- Device Description: The device is a vascular introducer sheath and dilator, designed to facilitate access to blood vessels. This is a medical device used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural – providing access and minimizing blood loss during vascular interventions.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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
DYB
Device Description
The modified Engage TR Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage TR 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 TR Introducer range in effective length is from 7cm to 25cm. The Engage TR Introducer sheaths included in the scope of this submission range in sizes from 4-6F ACT (Active Clotting Time). In addition, the Engage TR Introducer has HPC coating on the sheath and it is compatible with 0.025" guidewires.
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
The Engage TR Introducer product family is required to pass predetermined design performance criteria. The summary of Engage TR test performance data is provided in this 510k submission. Based on passing verification specification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage TR Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage TR Introducer, no additional animal or clinical data was deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
K091137, K001346, K070166, K914090
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV - 4 2009
Section 4. 510(k) Summary
Applicant Information 4.1
Submitted by: St. Jude Medical 6500 Wedgwood Road Maple Grove, MN 55311
| Contact Person: | Linh Pham |
|---|---|
| Telephone: | 763-383-2586 |
| Fax: | 763-383-2559 |
| Date Prepared: | 1 October, 2009 |
Device Information 4.2
| Classification Name: | Introducer, Catheter |
|---|---|
| Common Name: | Hemostasis Introducer |
| Trade Name: | Engage TR Introducer |
| Classification: | Class II per 21 CFR 870.1340 |
| Product Code: | DYB |
4.3 Device Description
The modified Engage TR Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage TR 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 TR Introducer range in effective length is from 7cm to 25cm. The Engage TR Introducer sheaths included in the scope of this submission range in sizes from 4-6F ACT (Active Clotting Time). In addition, the
1
Engage TR Introducer has HPC coating on the sheath and it is compatible with 0.025" guidewires.
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.
4.4 Intended Use
There is no change to the intended use of the modified Engage TR Inroducer 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.
Predicate Device Comparison/Technological Characteristics 4.5
The modified Engage TR Introducer included in this Special 510(k) submission shares the same intended use as the predicate Engage/Engage TR Introducer (K091137, April, 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 TR Introducer, 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), Strada Carotid Guiding Sheath, (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991).
St. Jude Medical Engage TR Introducer Special 510k
2
The modifications to the Engage TR Introducer do not affect the intended use of the system and there is no alteration in the fundamental scientific technology of the device. The Engage TR 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 TR Introducer, Ultimum Hemostasis Introducer, Strada Carotid Guiding Sheath (K070166, April 06, 2007), and Fast-Cath Introducer (K091137, K001346, K070166 & K914090).
Test Summary 4.6
The Engage TR Introducer product family is required to pass predetermined design performance criteria. The summary of Engage TR test performance data is provided in this 510k submission. Based on passing verification specification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage TR Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage TR Introducer, no additional animal or clinical data was deemed necessary.
4.7 Substantial Equivalence
The Engage TR Introducer covered by this submission is substantially equivalent to the previously cleared Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), Strada Carotid Guiding Sheath (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991), given equivalent intended use, principles of operation and similar technological characteristics.
4.8 Conclusion
In conclusion, the modified Engage/Engage TR Introducer is substantially equivalent to the market cleared Engage/Engage TR Introducer, Ultimum Hemostasis Introducers, and Fast Cath Hemostasis Introducer (K091137, K001346, K070166 & K914090 respectively).
4-3
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol on the right, which is a common emblem associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Lynh Pham 6500 Wedgewood Road Maple Grove, MN 55311
NOV - 4 2009
Re: K093130
Engage™ TR Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 2, 2009 Received: October 5, 2009
Dear Ms. Pham:
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.
4
Page 2 -- Ms. Linh Pham
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
una R. v.dines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 3. Indication For Use
K09313D 510(k) Number:
Device Name: Engage™ TR 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)
MAMIE R. VASSAR
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko 931 3 C
St. Jude Medical Engage TR Introducer Special 510k 3-1