(248 days)
K904255, K.896742
Not Found
No
The summary describes a standard cardiac pacing lead and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is a pacing lead, which provides a permanent electrical pathway between a pacemaker and the atrium, and is used to deliver therapy (pacing) to the heart.
No
The device is described as an endocardial lead that provides an electrical pathway between a pacemaker and the atrium, and its performance studies focus on pacing and sensing characteristics, not diagnosing conditions.
No
The device description clearly states it is a physical lead made of silicone rubber and other materials, designed to be implanted. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a permanent electrical pathway between a pacemaker and the atrium. This is a therapeutic and diagnostic function performed in vivo (within the body), not in vitro (outside the body).
- Device Description: The description details a physical implantable lead, not a reagent, instrument, or system used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing information about a person's health status through laboratory testing.
Therefore, this device falls under the category of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Stela™ Model BJ44 and BJ45 leads are indicated for cardiac pacing and sensing, which is the same as other transvenous tined leads.
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.
Product codes (comma separated list FDA assigned to the subject device)
DTB
Device Description
Stela™ BJ44 and BJ45 models are silicone rubber, tined, J-shaped, bipolar transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. They are similar in design and construction to other such leads in commercial distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial implantation
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)
The following in-vitro functional testing was performed on the Stela™ Model BJ44 and/or BJ45 leads: stylet insertion/removal, stylet bottoming, electrical resistance, IS-1 connector conformity, leak resistance, distal tip electrode/conductor coil tensile strength, insulation integrity, conductor coil fatigue, and tip flexibility. Biocompatiblity testing was not performed, due to the successful history with the same materials in other lead products. Sterilization testing and mechanical / environmental packaging validation were performed, because the lead package design and sterilization method changed. All test results demonstrated that the established pass / fail criterion was met in all cases.
A limited clinical study demonstrated that the Model BJ45 lead exhibits appropriate pacing and sensing characteristics. No complications were observed in this study.
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.
ELA Medical Focus® Model T44F bipolar tined silicone rubber pacing lead (Document Control Number K904255) and Focus® Model J83F tined silicone rubber pacing lead (Document Control Number K.896742).
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
§ 870.3680 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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Image /page/0/Figure/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '6', '3', '7', '2', and '8'. The digits are written in a slightly irregular style, with some variations in thickness and spacing. The overall impression is that of a quickly written or somewhat stylized numerical code.
510(k) Notification for Stela leads, Models BJ44/BJ45
2. Summary & Certification
MAY 23 1997
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 BJ44 and BJ45 Pacing Leads
Applicant's Name and Address: ELA Medical, Inc., 15245 Minnetonka Boulevard, Minnetonka, MN 55345, Tel. (612) 935-2033
Date of Summary Preparation: September 16th 1996
Contact Person: Cathy G. Goble
510(k) Number: K963698
Date of Judgment of Substantial Equivalence Sent to Applicant:
Predicate Devices: ELA Medical Focus® Model T44F bipolar tined silicone rubber pacing lead (Document Control Number K904255) and Focus® Model J83F tined silicone rubber pacing lead (Document Control Number K.896742).
2.1.2 Description of Conditions for Which the Devices are Indicated
The Stela™ Model BJ44 and BJ45 leads are indicated for cardiac pacing and sensing, which is the same as other transvenous tined leads.
2.1.3 Device Description
Stela™ BJ44 and BJ45 models are silicone rubber, tined, J-shaped, bipolar transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. They are similar in design and construction to other such leads in commercial distribution.
2.1.4 Alternatives
The alternatives for Stela™ Model BJ44 and BJ45 leads are other commercially available transvenous pacing leads.
ELA Medical Incorporated
Confidential and proprietary
1
2.1.5 Marketing History
Stela™ Model BJ44 and BJ45 leads are not in commercial distribution in the U.S. They were 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 BJ44 and BJ45 leads are the same as those for tined, J-shape, 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 BJ44 and/or BJ45 leads: stylet insertion/removal, stylet bottoming, electrical resistance, IS-1 connector conformity, leak resistance, distal tip electrode/conductor coil tensile strength, insulation integrity, conductor coil fatigue, and tip flexibility. Biocompatiblity testing was not performed, due to the successful history with the same materials in other lead products. Sterilization testing and mechanical / environmental packaging validation were performed, because the lead package design and sterilization method changed. All test results demonstrated that the established pass / fail criterion was met in all cases.
A limited clinical study demonstrated that the Model BJ45 lead exhibits appropriate pacing and sensing characteristics. No complications were observed in this study.
2.1.8 Conclusion
The information presented in this submission provides reasonable assurance that the Stela™ Model BJ44 and/or BJ45 leads will perform in a safe and effective manner.
ELA Medical Incorporated
Confidential and proprietary
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 1997
Ms. Catherine G. Goble Regulatory Affairs Manager ELA Medical, Inc. 2950 Xenium Lane North Plymouth, Minnesota 55441
Re: K963738 Stela Models BJ44 and BJ45 Pacing Leads Regulatory Class: III (three) Product Code: DTB Dated: February 21, 1997 Received: February 25, 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 reqistration, 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 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Fevices: General (GMP) regulation (21 CFR Part 620) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 requlation.
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Page 2 - Ms. Catherine G. Goble
新闻网 - 1
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 investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance 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 requlations (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 probibited 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 requlatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
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Page 3 - Ms. Catherine G. Goble
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1996, 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 trackinq that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the requlation 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 diaqnostic 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) 594-4639. 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,
Wolf Saporta mo
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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1.10 Indications for Use Statement
| 510 (k) Number: | K963738 |
|---|---|
| Device Name: | Stela™ Model BJ44 and BJ45 pacing leads. |
Indication for Use:
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K963735
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
ELA Medical Incorporated
Confidential and proprietary