(182 days)
No
The device description details a purely mechanical system for introducing catheters and leads, with no mention of software, algorithms, or any components that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an introducer system for catheters/leads, which are therapeutic devices themselves. The introducer system merely facilitates the delivery of these therapeutic devices rather than providing a therapeutic function on its own.
No
The device description clearly states its purpose is for "introducing balloon catheters... or leads into vessels," which is an interventional or therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components made of materials like Teflon, silicone, stainless steel, and polyethylene, indicating it is a physical medical device, not software-only.
Based on the provided information, the SERPENTA™ Coronary Sinus Introducer System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for introducing catheters and leads into the coronary sinus and left heart vessels. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The components listed (sheaths, dilators, valves, guidewire, syringe, needle) are all instruments used for accessing and navigating within the body during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The SERPENTA™ system is a tool used during a medical procedure, not a device that performs a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The intended use of Cook Vascular SERPENTA™ Coronary Sinus Introducer System is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Product codes
DYB
Device Description
The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus, vessels of the left heart
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cook Introducer A176790, Attain LDS 6216 Left Heart Delivery System K012130, Attain Access 6218 Left Heart Delivery System K012083, SafeSheath MSP K003731
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
510 (k) Premarket Notification Cook Vascular SERPENTA™ Coronary Sinus Introducer System 8 of 9
510 (K) SUMMARY K.
Submitted By:
Thomas J. Kardos Vice President, Regulatory Affairs Cook Vascular Incorporated P.O. Box 529 Leechburg, PA 15656 Phone 724-845-8621 FAX 724-845-2848 November 14, 2002
Device: Trade Name:
Common/Usual Name:
Cook Vascular SERPENTA™ Coronary Sinus Introducer System
Percutaneous Catheter Introducer
Proposed Classification Name:
Introducer, Catheter 21 CFR Part 870.1340 (74-DYB)
Device Description:
The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.
Indications for Use:
The intended use of Cook Vascular SERPENTA™ Coronary Sinus Introducer System is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Vascular Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510 (k) substantial equivalency.
1
Predicate Devices:
The Cook Vascular SERPENTA™ Coronary Sinus Introducer System is substantially equivalent to devices currently marketed as identified with respect to intended use, material composition, and method of operation.
| Predicate Device | Manufacturer | 510(k) |
|---|---|---|
| Cook Introducer | Cook Incorporated | Pre-amendment |
A176790 |
| Attain LDS 6216 Left Heart
Delivery System | Medtronic | DC# K012130 |
| Attain Access 6218 Left Heart
Delivery System | Medtronic | DC# K012083 |
| SafeSheath MSP
(same as SafeSheath CSG) | Thomas Medical | DC# K003731 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
MAY 2 7 2003
.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Vascular Incorporated c/o Mr. Thomas J. Kardos Vice President, Regulatory Affairs P.O. Box 529, Rt. 66 River Road Leechburg, PA 1565-0529
Re: K023937
Trade Name: SERPENTA® Coronary Sinus Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: April 25, 2003 Received: April 28, 2003
Dear Mr. Kardos:
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 such 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
3
Page 2 – Mr. Thomas J. Kardos
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
V. OheT M
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K023937
Device Name: SERPENTA™ Coronary Sinus Introducer System
Indications For Use:
The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
510(k) Number K023937
Perscription Use
(Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
1.3