(115 days)
Not Found
No
The summary describes a mechanical stylet used for lead placement and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, a stylet, is intended to aid in the placement of an implantable venous lead, not to provide therapy itself.
No
This device is a stylet intended to aid in the placement of a venous lead. It is a tool for lead delivery and placement, not for diagnosing a medical condition.
No
The device description clearly states it is a physical stylet made of stainless steel wire with a polypropylene hub, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature." This describes a device used in vivo (within the body) for a surgical or interventional procedure.
- Device Description: The description details a physical tool (a stylet) made of stainless steel and polypropylene, designed to facilitate the delivery of a lead. This is consistent with a medical device used for insertion or guidance within the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or any diagnostic purpose.
Therefore, the EASYTRAK® 2 Stylet is a medical device used in vivo and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.
Product codes
DRB
Device Description
The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.
The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous vasculature
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)
Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK® 2 Stylet may be considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY 5.
| Owner: | Guidant Corporation | |
|---|---|---|
| Cardiac Rhythm Management (CRM) | ||
| 4100 Hamline Avenue North | ||
| St. Paul, Minnesota 55112-5798 | ||
| Contact: | Linda Kleinsasser, RAC | |
| Senior Regulatory Affairs Associate | ||
| Telephone: | (800) 227-3422, x24106 or direct (651) 582-4106 | |
| Fax: | (651) 582-5134 | |
| Email: | linda.Kleinsasser@guidant.com | |
| Date of Summary: | October 20, 2005 | |
| Common Name: | Stylet | |
| Trade Name: | EASYTRAK® 2 Stylet | |
| Classification Name: | Class II | |
| Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel | ||
| Predicate: | Stylet Accessory, Model 6602, K905674, cleared January 30, 1991 | |
| IRONMAN Guide Wire, Model 6725, K021285, | ||
| cleared May 2, 2002 |
DEVICE DESCRIPTION 5.1.
The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.
The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.
Gaetan Carpersona
way.guidant.com
1
5.2. INTENDED USE
The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant The EASYTRAK® 2 implantable venous lead in the coronary venous vasculature.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 5.3.
Comparisons of the EASYTRAK® 2 Stylet and the predicate devices show that the Comparisons of the Eristics such as Intended Use, material, packaging, shelf life and technological enaracteristion satin alles and and the currently marketed predicate devices.
5.4. TESTING
Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK® 2 Stylet may be considered substantially equivalent to the predicate devices.
5.5. CONCLUSION
The Guidant EASYTRAK® 2 Stylet are substantially equivalent to the currently marketed The Saccessory, Model 6602 (K905674, cleared 1/30/1991) and the IRONMAN Guide Wire, Model 6725 (K021285, cleared 5/2/2002).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
FEB 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guidant Corporation c/o Ms. Linda Kleinsasser, RAC Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K052965 Trade Name: EASYTRAK® 2 Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: January 9, 2006 Received: January 10, 2006
Dear Ms. Kleinsasser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of re(s) pe device is substantially equivalent (for the indications felerenced above and nave determined is a aveces marketed predicate devices marketed in interstate for use stated in the enerosale) to regary the Medical Device Amendments, or to Commerce prices that have been reclasion with the provisions of the Federal Food. Drug. de vices marchave been recuire approval of a premarket approval application (PMA). and Costinctle recry too, that do nover copied to the general controls provisions of the Act. The I ou may, dierelove, market 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), If your device is classified (566 acre) in the s. Existing major regulations affecting your device . FFA it may to subject to back as a segulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
3
Page 2 - Ms. Linda Kleinsasser, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a basevice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of any I ecolar statutes and regulations and limited to: registration and listing (21 Compry with an the Fee brequirements)01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) rogans (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro hereins (oveting your device as described in your Section 510(k) This letter will anow you to ogin maneting your antial equivalence of your device to a legally prematication. "The PDTP Intentig seriestion 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 If you ucate specific advice for Jour as not on a more as note the regulation written, Contact the Office of Comphalled as (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2011 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blymmman for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 4.
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K052965
Device Name: Stylet
Indication for Use:
- ﮪە ﻣ
The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
College of the country of the state of the same of the state and the comments of the comments with and
Bhumma
Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kos 1965 Company Controller Concession Comer Collection Comer College Comer College Comments of Concession Comers of Concession Comparis Comments of Concession Comers of Concession of
EASYTRAK® 2 Stylet Guidant Corporation Confidential October 20, 2005