(128 days)
Not Found
No
The description focuses on the mechanical properties and materials of a steerable stylet, with no mention of AI or ML.
No
The device is a steerable stylet, intended for delivery of a lead in the coronary veins. It is an accessory to a therapeutic device (the lead), not a therapeutic device itself.
No
This device, a steerable stylet, is used for the delivery of a lead, which is an interventional procedure. The description and intended use do not indicate any diagnostic function, such as detecting, monitoring, or analyzing physiological states or conditions.
No
The device description clearly states it is a physical stylet made of stainless steel wire with a polypropylene knob/cap assembly, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a lead within the coronary veins. This is an in vivo procedure (within a living organism), not an in vitro procedure (testing samples outside the body).
- Device Description: The device is a physical stylet used to guide a lead. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic testing.
Therefore, the ACUITY Steerable Stylet is a medical device used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For use with compatible, transvenous, left ventricular, pace/sense leads
Product codes (comma separated list FDA assigned to the subject device)
DRB
Device Description
The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).
The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary veins
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 ACUITY Steerable Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The ACUITY Steerable Stylet 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/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
§ 870.1380 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
SFCTION 21: OTHER
MAR 3 2006
510(K) SUMMARY
| Submitter: | Guidant Corporation
Cardiac Rhythm Management (CRM)
4100 Hamline Avenue North
St. Paul, Minnesota 55112-5498 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer X. Tang
Senior Regulatory Affairs Associate
Telephone: (800) 227-3422 or direct (651) 582-6746
FAX: (612) 582-5134
Email: jennifer.tang@guidant.com |
| Date of Summary: | February 20, 2006 |
| Common Name: | Stylet |
| Trade Name: | ACUITY™ Steerable Stylet Accessory |
| Classification Name: | Class II
Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel |
| Predicate: | Firm Straight 0.016 Stylet, Model 6602, K905674, cleared January 30, 1991 Tapered 0.016 Stylet, Model 6583, K843060, cleared September 20, 1984 |
DEVICE DESCRIPTION 1.1.
The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).
The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.
1.2. INTENDED USE
For use with compatible, transvenous, left ventricular, pace/sense leads.
page 1 of 2
1
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 1.3.
Comparisons of the ACUITY Steerable Stylet and the predicate devices show that the technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life are substantially equivalent to the currently marketed predicate devices.
TESTING DATA 1.4.
Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The ACUITY Steerable Stylet may be considered substantially equivalent to the predicate devices.
CONCLUSION 1.5.
The Guidant ACUITY Steerable Stylets are substantially equivalent to the currently marketed Firm Straight 0.016 Stylet, Model 6602 (K905674, cleared 1/30/1991) and Tapered 0.016 Stylet, Model 6583 (K843060, cleared 9/20/1984).
2
Image /page/2/Picture/11 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 2006
Guidant Corporation c/o Ms. Jennifer X. Tang Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K053019
Trade Name: ACUITYTM Steerable Stylet Accessory Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: February 06, 2006 Received: February 07, 2006
Dear Ms. Tang:
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 interstatc 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 cl 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, MLA شھر publish further announcements 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Bffimmumator
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
| 510(k) Number (if known): | K053019 |
|---|---|
| Device Name: | ACUITY™ Steerable Stylet Accessory |
| Indications For Use: | For use with compatible, transvenous, left ventricular, pace/sense leads |
| Prescription Use: (Part 21 CFR 801 Subpart D) | X 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)
Bflimmmon
(Division Sign-Division of Caraiovascular Devices 510(k) Number k05 3019