(209 days)
Not Found
K/DEN number: Not Found
No
The description focuses on mechanical manipulation for steering and does not mention any computational or learning-based components.
No
The device is described as a stylet used for implanting pacemaker leads, which are therapeutic devices. However, the stylet itself is an accessory tool used during the implantation procedure to manipulate the lead's curvature; it does not directly provide therapy or interact with the body in a therapeutic manner.
No
The device is described as a steerable stylet used for implanting pacemaker leads, allowing for different curvatures. Its intended use and description focus on aiding the physical placement of leads, not on diagnosing medical conditions or diseases.
No
The device description clearly outlines physical components (curved wire, thin-walled tube, handle) and their mechanical interaction, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the Locator™ Steerable Stylet is used during the implantation of pacemaker leads within the patient's body. It's a tool used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is to assist in the placement of pacemaker leads for cardiac pacing, which is an in-vivo (within the living organism) procedure.
Therefore, based on the provided information, the Locator™ Steerable Stylet is a medical device used in an in-vivo procedure, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Locator"™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiuc pacing.
Product codes
DTB
Device Description
The Locator™ steerable stylet consists of a curved wire that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Nonclinical Testing: Both preclinical and qualification testing of the Locator™ indicate that this device is substantially equivalent with regard to safety and effectiveness to a marketed device.
Clinical Testing: No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pacesetter ball-tipped stylets - straight and j-shaped
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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St. Jude MEDICAL
CARDIAC RHYTHM MANAGEMENT DIVISION
15900 Valley View Court Sylmar, CA 91342 818 362-6822 800 777-2237 www.sjm.com
FEB 23 1998
510(K) SUMMARY
Name of Sponsor:
Sponsor Address:
Pacesetter, Inc., A St. Jude Medical Company
15900 Valley View Court PO Box 9221 Sylmar, CA 91392-2991 (818) 362-6822
(516) 562-6622
Ana Wood
December 3, 1997
Proprietary - The Locator™
Common Name - steerable stylet
74DTB - accessory to permanent pacemaker electrode
Class III - Division of Cardiovascular, Respiratory and
Pacesetter ball-tipped stylets - straight and j-shaped
The Locator™ steerable stylet consists of a curved wire
that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be
· To facilitate advancement of the lead in the vasculature
· To allow control the shape of the lead without removing
Both preclinical and qualification testing of the Locator™
Neurological Devices
Ana Wood
12/5/97
Date
Date of Summary Preparation:
Name of Device:
Contact:
Classification:
Predicate Devices:
Device Description:
Intended Use:
Nonclinical Testing:
Clinical Testing:
indicate that this device is substantially equivalent with regard to safety and effectiveness to a marketed device.
the stylet from the lead
No clinical testing was performed.
obtained.
000033
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1998
Ms. Ana Wood St. Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91392-9221
Re: K972814 Locator™ Steerable Stylet, Model 4036 III (three) Regulatory Class: Product Code: DTB December 5, 1997 Dated: Received: December 8, 1997
Dear Ms. Wood: ... . .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: this concerning your device in the Federal Register. response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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