(209 days)
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.
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.
This submission is for a medical device called the "Locator™ Steerable Stylet" (K972814). The provided documents are a 510(k) summary and the FDA's clearance letter.
Based on these documents, the device is an accessory to permanent pacemaker electrodes, specifically intended for use with Pacesetter Tendril® model 1188 T/K pacemaker leads.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantifiable acceptance criteria such as performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) or a table outlining them.
The device's intended use is:
- To facilitate advancement of the lead in the vasculature.
- To allow control of the shape of the lead without removing the stylet from the lead.
The summary states: "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." This implies that the device met the safety and effectiveness standards demonstrated by its predicate devices (Pacesetter ball-tipped stylets - straight and j-shaped) through these testing methods.
Without explicit criteria or detailed results of the preclinical and qualification testing, a "table of acceptance criteria and reported device performance" cannot be generated in the traditional sense of a clinical or algorithm performance study. The "performance" being reported is that it met the general requirements for substantial equivalence to its predicate for safety and effectiveness.
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary explicitly states: "No clinical testing was performed." This means there was no clinical test set involving human subjects to evaluate the device's performance in its intended use environment.
The testing mentioned ("preclinical and qualification testing") would likely involve bench testing, mechanical testing, and potentially animal studies (though not explicitly stated as such). Details on the sample size for these non-clinical tests are not provided in this summary. The data provenance would be from manufacturing and engineering tests, not patient data, given the absence of clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given that no clinical testing was performed, there was no test set requiring human expert-established ground truth related to clinical outcomes or diagnoses. The "ground truth" for preclinical and qualification testing would be established by engineering specifications, material standards, and perhaps expert assessment of mechanical functionality, though specific details or expert numbers are not provided.
4. Adjudication Method for the Test Set
Since no clinical testing was performed and no expert-read test set was described, no adjudication method (e.g., 2+1, 3+1) was used in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical testing was performed." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned, and human reader performance was not assessed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical instrument (a steerable stylet), not a software algorithm or an AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
For the preclinical and qualification testing that was performed, the "ground truth" would be based on:
- Engineering specifications and design requirements: Ensuring the device's physical and mechanical properties meet predefined standards.
- Performance against predicate devices: Demonstrating that the device functions comparably to existing, legally marketed predicate devices without raising new questions of safety or effectiveness. This would involve comparing material properties, dimensions, steerability, and compatibility with the specified leads.
8. The Sample Size for the Training Set
As this is a physical medical device and not an AI or machine learning model, the concept of a "training set" in the context of data-driven algorithm development is not applicable. The device's design, manufacturing, and testing process does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set as defined for algorithms, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and regulatory requirements.
Summary of the Study:
The "study" that proves the device meets the acceptance criteria is described as "preclinical and qualification testing." This type of testing typically includes:
- Bench Testing: Mechanical stress tests, fatigue tests, material compatibility, dimensional verification, and functional tests (e.g., steerability, ability to fit within pacemaker leads, ease of insertion/removal).
- Biocompatibility Testing: To ensure materials are safe for contact with body tissues.
- Sterilization Validation: To confirm the device can be effectively sterilized.
- Shelf-life Testing: To determine the stability of the device over its intended storage period.
The purpose of this testing, as stated in the 510(k) summary, was to demonstrate substantial equivalence to existing predicate devices (Pacesetter ball-tipped stylets). This means showing that the Locator™ Steerable Stylet is as safe and effective as the predicate devices, without raising new questions of safety or effectiveness, and that it performs its intended function (facilitating lead advancement and control) comparably. The FDA's clearance letter confirms their agreement that the device is substantially equivalent based on the provided non-clinical data.
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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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<10(k) Number: K972814 The Locator™ Steerable Styler Device Name: Indication 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.
(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ()N ANOTHER PAGE IF NEEDED)
Tan A-R Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 972811
510(k) Number
Prescription Use
(Per 21 C.FR 801.109)
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§ 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.