(119 days)
No
The summary describes a standard pacing lead with no mention of AI or ML capabilities. The device description focuses on the physical components and materials.
Yes
The device is a pacing lead, which is used for "permanent pacing and sensing" in conjunction with an implantable pulse generator to treat heart rhythm disorders, thus providing therapy.
No
The device is described as an "endocardial pacing lead" indicated for "permanent pacing and sensing," designed for use with "implantable pulse generators." This functionality is therapeutic (pacing) and for monitoring (sensing), not for making a medical diagnosis.
No
The device description clearly details physical components such as leads, fixation helix, sleeves, conductors, and a connector, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that the ELOX lead is a transvenous, active fixation endocardial lead. This means it is a device that is implanted inside the body (in vivo) to help regulate heart rhythm.
- Intended Use: The intended use is for "permanent pacing and sensing," which is a therapeutic and diagnostic function performed directly on the heart within the body.
The device is an implantable medical device, specifically a cardiac pacing lead.
N/A
Intended Use / Indications for Use
BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.
The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.
Product codes
DTB
Device Description
Elox (EX xx-BP) is a straight, bipolar endocardial pacing lead utilizing an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal Iridium coating. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The lead contains two conductors composed of quadrifilar MP35N wire in coaxial configurations and is insulated with silicone tubing. A 3.2 mm IS-1 bipolar connector attaches the lead to the pulse generator. The Elox lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium or right ventricle.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981083, K843707, K910608, K980869
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.
0
APR 1 3 2000
Elox Active Fixation Endocardial Lead 510(k) Notification
1. 510(K) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
Device Name:
1028232 Proprietary Names: Elox Leads
Class III (21 CFR 870.3680(b)) Classification: Classification Name: Cardiovascular Permanent Pacemaker Electrode Product Code: DTB
Date Prepared:
December 15, 1999
General Description and Predicate Devices:
Elox (EX xx-BP) is a straight, bipolar endocardial pacing lead utilizing an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal Iridium coating. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The lead contains two conductors composed of quadrifilar MP35N wire in coaxial configurations and is insulated with silicone tubing. A 3.2 mm IS-1 bipolar connector attaches the lead to the pulse generator. The Elox lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.
BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate devices for the Elox lead:
- BIOTRONIK's Retrox bipolar, active fixation, endocardial lead (#K981083, cleared 07/22/98) .
- Medtronic's Model 6957 J-58 unipolar, active fixation, endocardial lead (#K843707, cleared 01/08/85) .
- BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91) .
- BIOTRONIK's Synox bipolar, passive fixation, endocardial lead (#K980869, cleared 09/10/98) .
Indications for Use:
BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.
The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co. (reg. no. 7010992) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
1
Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of three horizontal lines curving upwards, resembling a bird in flight. The seal appears to be a logo or emblem representing the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2000
Mr. Jon Brumbaugh Biotronik, Inc. 6024 Jean Road Lake Oswego, OR 97035
Re: K994240 Elox Active-Fixation Endocardial Pacing Lead, Model EX 45-BP, EX 53-BP, and EX 60-BP Regulatory Class: III (three) Product Code: DTB March 22, 2000 Dated: Received: March 23, 2000
Dear Mr. Brumbaugh:
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 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 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 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Jon Brumbaugh
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) 594-4639. Also, please note the regulation entitled, "Misbranding by referenće 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/dsma/dsmamain.html".
Sincerely yours,
Sincerely yours,
Clint M. Ahfor
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. INDICATIONS FOR USE
BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.
The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.
Chito lyn. Ah for Dillard.
(Division Sign-Off) Division of Carelovascular, Respiratory, and Neurological Devices 510(k) Namber