(211 days)
No
The summary describes a passive medical device (a pacing lead) with no mention of computational processing, algorithms, or learning capabilities.
Yes
The device, an endocardial lead, is indicated for permanent pacing and sensing, which are therapeutic interventions for heart rhythm disorders. It is designed to work with implantable pulse generators as part of a pacing system to treat physiological conditions.
No
This device, a cardiac lead, is indicated for permanent pacing and sensing, which are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly details physical components such as leads, conductors, insulation, and a connector, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent pacing and sensing" within the human body (right atrium or right ventricle). This is an in vivo application, meaning it interacts directly with the living organism.
- Device Description: The description details an implantable lead with conductors, insulation, and a connector for a pulse generator. This is consistent with an implantable medical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic and diagnostic tool used within the body to regulate heart rhythm.
N/A
Intended Use / Indications for Use
BIOTRONIK's ELOX P 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 P lead models are intended for placement in either the right atrium or right ventricle.
Product codes
DTB
Device Description
Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.
The proposed Elox P leads in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Eloxieads (K994240, cleared 04-13-00 and K001413, cleared 06-02-00). The modification to the Elox P lead involves the addition of a Parylene C coating to the proximal portion of the fixation helix in order to decrease the electrically active surface of the helix and therefore increase the electrical impedance of the lead.
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)
K994240, K001416, K980869, K911122
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 2 4 2003
BIOTRONIK, Inc., Elox P Active-Fixation Endocardial Lead, Special 510(k)
September 24, 2002
Elox P Active Fixation Endocardial Lead Special 510(k) Notification
1028232
1. 510(K) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
Elox P Leads Class III (21 CFR 870.3680(b)) Cardiovascular Permanent Pacemaker Electrode DTB
Date Prepared:
September 24, 2002
General Description:
Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.
Device Modification:
The proposed Elox P leads in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Eloxieads (K994240, cleared 04-13-00 and K001413, cleared 06-02-00). The modification to the Elox P lead involves the addition of a Parylene C coating to the proximal portion of the fixation helix in order to decrease the electrically active surface of the helix and therefore increase the electrical impedance of the lead.
Predicate Devices:
BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate devices for the Elox P leads:
- BIOTRONIK's Elox bipolar, active fixation, endocardial leads (#K994240, cleared 04-13-00) ●
- BIOTRONIK's Elox 45-BP bipolar, active fixation, endocardial leads (#K001416, cleared 06-02-00) .
- . BIOTRONIK's Synox bipolar, passive fixation endocardial leads with 31 mm spacing (#K980869, cleared 09-10-98)
- Intermedics's Quantum implantable pulse generator (#K911122, cleared 05-16-91) ●
Indications for Use:
BIOTRONIK's ELOX P 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 P lead models are intended for placement in either the right atrium or right ventricle.
1
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:
Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
Name and Address of Contract Manufacturing Site: BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169 ·
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Biotronik, Inc. c/o Mr. Jon Brumbaugh Director of Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035
Re: K023205 Trade Name: Elox P Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: III (three) Product Code: DTB Dated: January 24, 2003 Received: January 27, 2003
Dear Mr. Brumbaugh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
3
Page 2 - Mr. Jon Brumbaugh
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer 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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of 1
K023205 510(k) Number (if known):_
Device Name: Elox P Active-Fixation, Bipolar Pacemaker Lead
Indications For Use:
BIOTRONIK's ELOX P 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 P lead models are intended for placement in either the right atrium or right ventricle.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Optional Format 3-10-98)
V. Della
510(k) Number K033205