(181 days)
Not Found
No
The summary describes a material change in existing pacing leads and focuses on mechanical and electrical performance testing, with no mention of AI or ML.
Yes
The device, an endocardial lead, is designed to be used with implantable cardiac pacemakers. Pacemakers are therapeutic devices that regulate heart rhythm, and the lead is an essential component for delivering this therapy to the heart.
No
Explanation: The device is described as a "pacing lead" designed to provide a "permanent electrical pathway between a pacemaker and the ventricle/atrium." Its function is to facilitate pacing, not to diagnose a condition.
No
The device description explicitly states that the device is a silicone rubber, transvenous lead, which is a physical hardware component. The summary also details material changes and physical testing performed on the leads.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation in the ventricle" and "implantation in the atrium" to provide an electrical pathway between a pacemaker and the heart. This is a therapeutic and diagnostic device used in vivo (within the body), not in vitro (outside the body).
- Device Description: The description details a physical implantable device (leads) made of silicone rubber, designed to be placed inside the body.
- Performance Studies: The performance studies described are related to the physical and electrical properties of the leads and their biocompatibility when implanted in animals. These are not typical studies for an IVD, which would focus on analyzing samples like blood, urine, or tissue in vitro.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a medical implant used to treat or manage a cardiac condition by interacting directly with the heart.
N/A
Intended Use / Indications for Use
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle.
ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.
Product codes (comma separated list FDA assigned to the subject device)
DTB
Device Description
Stela™ Model BT45/46 and UT46 straight tined pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the ventricle.
Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium.
Stela™ Model UT 46 and UJ45 are silicone rubber, unipolar transvenous leads, similar in design and construction to bipolar models BT45/46 and BJ44/45, respectively.
The following silicone rubber material change was performed on Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads:
| Affected components | Current material | New material |
|---|---|---|
| Straight extruded tubing components (inner and outer lead isolation) | Dow Corning HP 77020 SP50 | Applied Silicone* HCRA HP 50E (part number 40094) |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricle, atrium
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 modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads: leak resistance, tensile strength, electrical continuity, leakage current, fatigue resistance, abrasion resistance.
In addition to raw material biocompatibility test results provided in Applied Silicone Corporation's Master file, the following biocompatibility tests were performed on products manufactured by ELA Medical using raw materials from Applied Silicone Corporation:
- · Implantation, according to ISO 10993-6: tissue analysis after 3-month endocardial implantation in sheep (4 animals at 3 months).
- · Histology, according to ISO 10993-6.
- · Blood-compatibility, according to ISO 10993-4: hemolysis test, coagulation time,
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
§ 870.3680 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.
0
APR 1 0 2000
Special 510(k): Device Modification, for Stela leads (silicone tubing change) ELA Medical, Inc.
2. Summary & Certification
2.1 Summary of safety and effectiveness information
2.1.1 General Information
Device Generic Name: Endocardial pacing lead.
Device Trade Name: Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 Pacing Leads
Applicant's Name and Address: ELA Medical, Inc., 2950 Xenium Lane North, Plymouth, MN 55441, Tel. (612) 519-9400
Date of Summary Preparation:
Contact Person: Catherine G. Goble
510(k) Number: K
Date of Judgment of Substantial Equivalence Sent to Applicant:
Predicate Devices:
| Device | 510(k) Number |
|---|---|
| ELA Medical Stela™ Model BT45/46 and UT46 | K904255 |
| ELA Medical Stela™ Model BJ44/BJ45 | K963698 |
| ELA Medical Stela™ Model UJ45 | K972574 |
2.1.2 Description of Conditions for Which the Devices are Indicated
The Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads are indicated for cardiac pacing and sensing, which is the same as other transvenous pacing leads.
2.1.3 Device Description
Stela™ Model BT45/46 and UT46 straight tined pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the ventricle.
Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium.
Stela™ Model UT 46 and UJ45 are silicone rubber, unipolar transvenous leads, similar in design and construction to bipolar models BT45/46 and BJ44/45, respectively.
The following silicone rubber material change was performed on Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads:
1
Special 510(k): Device Modification, for Stela leads (silicone tubing change) ELA Medical, Inc.
| Affected components | Current material | New material |
|---|---|---|
| Straight extruded tubing | ||
| components (inner and outer | ||
| lead isolation) | Dow Corning HP 77020 SP50 | Applied Silicone* HCRA HP |
| 50E (part number 40094) |
- Applied Silicone Corporation, 320 West Stanley Avenue, Ventura CA 93001
2.1.4 Alternatives
The alternatives for Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 leads are other commercially available transvenous pacing leads.
2.1.5 Marketing History
Commercial distribution of the modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 leads has not started anywhere yet.
2.1.6 Potential Adverse Effects
The potential adverse effects of Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads are the same as those for other implantable endocardial 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 modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads: leak resistance, tensile strength, electrical continuity, leakage current, fatigue resistance, abrasion resistance.
In addition to raw material biocompatibility test results provided in Applied Silicone Corporation's Master file, the following biocompatibility tests were performed on products manufactured by ELA Medical using raw materials from Applied Silicone Corporation:
- · Implantation, according to ISO 10993-6: tissue analysis after 3-month endocardial implantation in sheep (4 animals at 3 months).
- · Histology, according to ISO 10993-6.
- · Blood-compatibility, according to ISO 10993-4: hemolysis test, coagulation time,
2.1.8 Conclusion
The information presented in this submission provides reasonable assurance that the modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads will perform in a safe and effective manner.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
APR 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Catherine G. Goble Regulatory Affairs Manager ELA Medical, Inc. 2950 Xenium Lane North Plymouth, MN 55441
K993448 Re: Stela™ Models UT46, BT45/46, UJ45, and BJ44/45 Endocardial Pacing Leads Regulatory Class: III (three) Product Code: DTB Dated: February 7, 2000 February 10, 2000 Received:
Dear Ms. Goble:
We have reviewed your Section 510(k) notifications 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 legally marketed predicate 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submissions 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.
3
Page 2 - Ms. Catherine G. Goble
This letter will allow you to begin marketing your device as described in your 510(k) premarket notifications. 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 requlation (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 Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Chistopher
James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1.10 Indications for Use Statement
510 (k) Number: K
Device Name: Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 Pacing Leads.
Indication for Use:
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle.
ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993448 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |