(37 days)
Not Found
No
The description focuses on the mechanical function of a finishing wire and does not mention any AI or ML components or capabilities.
No
The device is described as an accessory (finishing wire) that aids in the placement and stabilization of another implantable device (coronary venous lead). It does not directly provide therapy.
No
The device is described as a finishing wire intended to aid in the placement and stabilization of an implantable coronary venous lead. Its purpose is to facilitate the positioning of another medical device, not to diagnose a condition or disease.
No
The device description clearly describes a physical wire with a mechanical stop and a formed loop, 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 clearly states that the device is "intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The description details a physical wire inserted into a lead to stabilize it during a medical procedure. This is a mechanical tool used in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a tool during a medical procedure.
N/A
Intended Use / Indications for Use
The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The SUPPORTRAK Finishing Wire is intended to facilitate the positioning of a Guidant over-the wire left ventricular coronary venous pace/sense lead. The finishing wire is inserted into the lumen of the implanted lead and serves to stabilize the lead as the guide catheter is removed. A mechanical stop engages with the terminal pin of the lead and controls the position of the wire relative to the lead.
Each finishing wire model is specific to a particular lead length and hence, the location of the mechanical stop along the core wire varies for each SUPPORTRAK model. Also, the proximal end of the wire is formed into a loop to prevent incorrect insertion of the finishing wire in the lumen 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 SUPPORTRAK Finishing Wire met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The SUPPORTRAK Finishing Wire may be considered substantially equivalent to the predicate devices.
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/DEL 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/DEL 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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
..............................................................................................................................................................................
AUG = 6 2004 510(K) SUMMARY
SPONSOR
Guidant Corporation Cardiac Rhythm Management (CRM) 4100 Hamline Avenue North St. Paul, Minnesota 55112-5498
CONTACT PERSON
Jennifer X. Tang, Phone: 800-CARDIAC or direct 651-582-6746 Fax: 651-582-5134 jennifer.tang(@guidant.com
DATE OF THE SUMMARY
June 28, 2004
PREDICATE DEVICE
- Stylet Accessory, K905674, cleared on 1/30/1991 .
- . HI TORQUE WHISPER Guide Wire, K023300, cleared on 10/28/2002
DEVICE TRADE NAME
Finishing Wire® SUPPORTRAK®
DEVICE COMMON NAME
Finishing Wire
1
DEVICE DESCRIPTION
The SUPPORTRAK Finishing Wire is intended to facilitate the positioning of a Guidant over-the wire left ventricular coronary venous pace/sense lead. The finishing wire is inserted into the lumen of the implanted lead and serves to stabilize the lead as the guide catheter is removed. A mechanical stop engages with the terminal pin of the lead and controls the position of the wire relative to the lead.
Each finishing wire model is specific to a particular lead length and hence, the location of the mechanical stop along the core wire varies for each SUPPORTRAK model. Also, the proximal end of the wire is formed into a loop to prevent incorrect insertion of the finishing wire in the lumen of the lead.
INTENDED USE
The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Comparisons of the SUPPORTRAK Finishing Wire and the predicate devices show that the technological characteristics such as Intended Use, Material, Assembly, Design, Package, and Sterilization are substantially equivalent to the currently marketed predicate devices.
TESTING DATA
Testing demonstrated that the SUPPORTRAK Finishing Wire met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The SUPPORTRAK Finishing Wire may be considered substantially equivalent to the predicate devices.
CONCLUSION
The Guidant SUPPORTRAK Finishing Wires are substantially equivalent to the currently marketed Stylet Accessory (K905674, cleared 1/30/1991) and HI TORQUE WHISPER Guide Wire (K023300, cleared 10/28/2002).
2
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Guidant Corporation c/o Ms. Jennifer X. Tang Senior Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K041762
K041702
Trade Name: SUPPORTRAK Finishing Wire, Models 6681-85 and 6667-69 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: June 29, 2004 Received: June 30, 2004
Dear Ms. Tang:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your Section > ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally maketed predicate devices marketed in interstate for use stated in the cherosule) to regars mannent date of the Medical Device Ameral Food. Drug commerce prior to May 28, 1976, the encontent and othe provisions of the Federal Food, Drug, devices that have occh recuise in assessmed in assessment of a premarket approval application (PMA). and Cosmelle Act (Act) that do not require approvince of the general controls provisions of the Act. The You may, therefore, market the device, basyer of the more of registration, listing of
general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classifica (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroling may of one 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi be found in the Oous ocements concerning your device in the Federal Register.
3
Page 2 -- Ms. Jennifer X. Tang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a succession of the requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decidination that Jour Correst by other Federal agencies. You must or any Federal statutes and regulations adminding, but not limited to: registration and listing (21 l
ess set comply with all the Act s requirements, merceive and acturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good manage (200); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (occions of 7 - evice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to location to local I his letter will anow you to begin mancellig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket nothication. The PDA midning of backannal reporterine 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
rs the results of the more and 1610 - 11 to the results to regulation entit if you desire specific advice for your ac novel as a look of the regulation entitled, white in the move obtain contact the Office of Complance at (301) of the Part 807.97). You may obtain " Misbranding by reference to premarket nouthean in the Act from the Division of Small other general information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number on any armanial Manufacturers, International and Ochschhttp://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil Rt. Ogle
Dr. D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K041762
Device Name:_Finishing Wire
Indications For Use:
The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Srogl
Division Sign-Off
307
ivision of Cardiovascular Devices
510(k) Number K041762
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