(88 days)
Not Found
No
The document describes a standard cardiac pacing lead and does not mention any AI/ML components or capabilities.
Yes
The device is used for permanent pacing and sensing, which are therapeutic interventions for cardiac rhythm management.
No
The device is described as a "pacing lead" for "permanent pacing and sensing," and it is used "in conjunction with implantable pulse generators." This indicates its role in regulating heart rhythm rather than diagnosing a condition.
No
The device description clearly outlines physical components like wires, insulation, electrodes, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "permanent pacing and sensing" and describes the device as a "pacing lead" used with "implantable pulse generators." This indicates a device that is implanted in the body to regulate heart rhythm.
- Device Description: The description details the physical components of a pacing lead, such as the conductor, insulation, electrodes, and connector. These are all components of 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.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an active implantable medical device used for therapeutic and monitoring purposes within the body.
N/A
Intended Use / Indications for Use
BIOTRONIK's YP xx/15-BP 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. The leads may be used with single or dual chamber pacing systems.
The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.
Product codes (comma separated list FDA assigned to the subject device)
DTB
Device Description
BIOTRONIK's YP xx/15-BP leads are transvenous, bipolar, active fixation, endocardial pacing leads. The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with silicone tubing, and electrodes surfaces with a fractal iridium surface treatment. The leads are available in 45, 53, and 60 cm lenaths and have IS-1 connectors.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's right atrium or right ventricle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K990483, K841451/A, K910608, K873888
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.
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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).
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§ 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
YP xx/15-BP Active Fixation Endocardial Lead 510(k) Premarket Notification
1. 510(K) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number: 1028232
Device Name:
Proprietary Names: YP 45/15-BP, YP 53/15-BP, and YP 60/15-BP Classification: Class III (21 CFR 870.3680(b)) Classification Name: Cardiovascular permanent pacemaker electrode
Date Prepared: September 17, 1999
General Description and Predicate Devices:
BIOTRONIK's YP xx/15-BP leads are transvenous, bipolar, active fixation, endocardial pacing leads. The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with silicone tubing, and electrodes surfaces with a fractal iridium surface treatment. The leads are available in 45, 53, and 60 cm lenaths and have IS-1 connectors. The predicate devices upon which BIOTRONIK is basing its claim of substantial equivalence are the following:
- BIOTRONIK's Retrox family of bipolar, active fixation, endocardial leads with Elgiloy® (#K990483, . cleared 06/03/99).
- BIOTRONIK's DY unipolar, active fixation, endocardial lead (#K841451/A, cleared 02/07/85). .
- BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91). .
- Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial lead (#K873888, . cleared 05/17/88)
Indications for Use:
BIOTRONIK's YP xx/15-BP 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. The leads may be used with single or dual chamber pacing systems.
The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co.(reg. no. 7010992) Woermannkehre 1, Berlin, Germany 011-49-30-689-05-304
Sponsor Contact Person and Phone Number:
Jon Brumbaugh, Director of Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC | 7 1999
Mr. Jon Brumbaugh Director of Requlatory Affairs BIOTRONIK, Inc. 6024 Jean Road 97035 Lake Oswego, OR
Re : K993139 Active-Fixation Endocardial Pacing Lead Model Trade Name: YP 45/15-BP, YP 53/15-BP and YP 60/15-BP Requlatory Class: III Product Code: DTB Dated: September 17, 1999 Received: September 20, 1999
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 You may, therefore, market the device, subject to the Act (Act). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Mr. Jon Brumbaugh
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.
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) 594-4586. 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 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,
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Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
BIOTRONIK's YP xx/15-BP 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. The leads may be used with single or dual chamber pacing systems.
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The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.
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