(182 days)
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. J-shaped leads are intended for permanent pacing and sensing of the atrium.
The Stela™ Model UJ45 is a silicone rubber, tined, J-shaped, unipolar transvenous lead that provides a permanent electrical pathway between a pacemaker and the atrium. It is similar in design and construction to other such leads in commercial distribution.
The provided document is a 510(k) submission for a medical device (Stela™ Model UJ45 Pacing Lead) and its associated FDA clearance letter from 1998. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for safety and effectiveness.
Therefore, the document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/diagnostic devices. Specifically, it does not include:
- A table of acceptance criteria and reported device performance metrics in the way you've requested (e.g., sensitivity, specificity, AUROC).
- Details about a test set (sample size, data provenance), ground truth establishment, or expert adjudication for performance evaluation.
- Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details.
Instead, the document states:
- "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." (Section 2.1.7)
- The device's safety and effectiveness are supported by its substantial equivalence to predicate devices (ELA Medical Focus® Model J43F and Stela™ Model BJ45), which have a history of successful use.
- The primary "studies" mentioned are in-vitro functional testing to ensure the new model met basic engineering specifications, consistent with existing lead products.
Here's a breakdown of the available information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/In-Vitro) | Reported Device Performance (Implied "Meets") |
|---|---|
| Stylet insertion/removal | Passed (Functional) |
| Stylet bottoming | Passed (Functional) |
| Electrical resistance | Passed (Functional) |
| IS-1 connector conformity | Passed (Functional) |
| Leak resistance | Passed (Functional) |
| Insulation integrity | Passed (Functional) |
| Tensile strength test | Passed (Functional) |
Note: The document implicitly states that these tests were "performed" and contributed to the conclusion that the device would "perform in a safe and effective manner," suggesting that it met internal specifications for these functional tests. Specific quantitative performance values or defined acceptance thresholds are not provided in this public summary.
2. Sample size used for the test set and the data provenance
- No specific "test set" in the diagnostic/AI sense was used. The evaluation relied on in-vitro functional testing of the device itself and comparison to predicate devices, not on a dataset of clinical cases for diagnostic performance.
- The in-vitro tests were conducted on the Stela™ Model UJ45 leads. The sample size for these specific in-vitro tests is not specified in the document.
- Data provenance: Not applicable in the context of clinical data for performance evaluation. The data is from in-vitro engineering tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there was no clinical "test set" requiring ground truth established by experts for performance evaluation. The functional tests likely had engineering specifications as their "ground truth" and were evaluated by engineers/technicians.
4. Adjudication method for the test set
- This is not applicable as there was no clinical "test set" requiring expert adjudication for performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No such study was performed. This device is a pacing lead, not an AI-assisted diagnostic tool or an imaging analysis system. The concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (a pacing lead), not an algorithm or AI system.
7. The type of ground truth used
- For the in-vitro functional testing, the "ground truth" would be established engineering specifications and performance standards for each test (e.g., a certain electrical resistance range, a minimum tensile strength).
8. The sample size for the training set
- Not applicable. This device is a pacing lead, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary Rationale from the Document:
The FDA 510(k) clearance for the Stela™ Model UJ45 Pacing Lead was based on demonstrating "substantial equivalence" to legally marketed predicate devices, not on new clinical trials or performance studies as would be required for novel diagnostic algorithms. The manufacturer explicitly states: "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." The in-vitro functional tests were performed to confirm that the new model met established engineering standards consistent with its predicate devices.
{0}------------------------------------------------
19172574
JAN - 8 1998
510(k) Notification for Stela lead, Model UJ45
Page 8/43
2. Summary & Certification
2.1 Summary of safety and effectiveness information
2.1.1 General Information
Device Generic Name: Atrial tined pacing lead.
Device Trade Name: Stela™ Model UJ45 Pacing Lead
Applicant's Name and Address: ELA Medical, Inc., 2950 Xenium Lane North, Plymouth, MN 55441, Tel. (612) 519-9400
Date of Summary Preparation: June 27, 1997
Contact Person: Catherine G. Goble
510(k) Number:
Date of Judgment of Substantial Equivalence Sent to Applicant:
Predicate Devices: ELA Medical Focus® Model J43F unipolar tined silicone rubber pacing lead (Document Control Number K896742) and Stela™ Model BJ45 bipolar tined silicone rubber pacing lead(Document Control Number K963698).
2.1.2 Description of Conditions for Which the Devices are Indicated
The Stela™ Model UJ45 lead is indicated for cardiac pacing and sensing, which is the same as other transvenous tined leads.
2.1.3 Device Description
The Stela™ Model UJ45 is a silicone rubber, tined, J-shaped, unipolar transvenous lead that provides a permanent electrical pathway between a pacemaker and the atrium. It is similar in design and construction to other such leads in commercial distribution.
2.1.4 Alternatives
The alternatives for the Stela™ Model UJ45 lead are other commercially available transvenous pacing leads.
{1}------------------------------------------------
2.1.5 Marketing History
The Stela™ Model UJ45 lead is not in commercial distribution in the U.S. It was recently introduced into commercial distribution outside the U.S. No unanticipated adverse device effects have been reported for these leads.
2.1.6 Potential Adverse Effects
The potential adverse effects of Stela™ Model UJ45 leads are the same as those for tined, J-shaped, transvenous leads in commercial distribution. Lead-related complications are described in the ELA Medical generic lead manual.
2.1.7 Summary of Studies
The following in-vitro functional testing was performed on the Stela™ Model UJ45 leads:
- · stylet insertion/removal
- · stylet bottoming
- · electrical resistance
- · IS-1 connector conformity
- · leak resistance
- · insulation integrity
- · tensile strength test.
Biocompatiblity testing was not performed, due to the successful history with the same materials in other lead products. No new sterilization testing or mechanical / environmental packaging validation were performed, because the lead package design and sterilization method did not change from the Stela™ Model BJ45.
No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature.
2.1.8 Conclusion
The information presented in this submission provides reasonable assurance that the Stela™ Model UJ45 lead will perform in a safe and effective manner.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling a bird or a human figure in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
JAN - 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Catherine G. Goble Regulatory Affairs Manager ELA Medical Inc. 2950 Xenium Lane North Plymouth, Minnesota 55441
Re: K972574 Stela™ Model UJ45 Pacing Lead Regulatory Class: III (three) Product Code: 74 DTB Dated: June 27, 1997 Received: July 10, 1997
Dear Ms. Goble:
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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.
{3}------------------------------------------------
Page 2 - Ms. Catherine G. Goble
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investiqator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general quidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(1)(C) of the Act (21 U.S.C. 331 (q)(1)(C). Further, under section 502(t)(3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
{4}------------------------------------------------
Page 3 - Ms. Catherine G. Goble
In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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. O'Keefe
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
1.10 Indications for Use Statement
510 (k) Number:
Device Name: Stela™ Model UJ45 pacing lead.
Indication for Use:
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
J-shaped leads are intended for permanent pacing and sensing of the atrium.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ru. A-Ph.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1972574 510(k) Number _
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
§ 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.