(98 days)
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Not Found
No
The device description and performance studies focus on the physical properties and functionality of a silicone sealing cap, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device description and summary of performance studies indicate it is an implantable component (sealing cap) that focuses on functionality, biocompatibility, and integrity rather than direct therapeutic action to treat or diagnose a disease.
No
The device description states that these are "single-component silicone devices" designed to be "chronically implantable." The performance studies mention testing for properties like ease of use, ability to withstand ligature application, and potential fluid leakage. There is no mention of acquiring or analyzing data or images to diagnose medical conditions.
No
The device description explicitly states it is a "single-component silicone device" and "chronically implantable," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description states the device is a "single-component silicone device, designed to be safe and effective through design functionality, simplicity and material biocompatibility." It is also described as "chronically implantable." This description aligns with an implantable medical device, not a device used to test biological samples.
- Lack of IVD-Specific Information: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics associated with IVDs.
The description points towards an implantable medical device, likely related to cardiovascular or neurological applications given the "IS-1 standards" mentioned in the performance studies (IS-1 is a standard for implantable cardiac leads).
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
BIOTRONIK BK Series Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility.
BK Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070, which has been extensively used by BIOTRONIK in cardiac pacing lead designs.
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
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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
BK Sealing Caps are tested for ease of use, ability to withstand ligature application, potential fluid leakage, and adherence to IS-1 standards. Packaging and transportation durability as well as sterilization validation have been performed to ensure the quality and sterility of the delivered product.
All production and biocompatibility test results were within specifications; therefore, when the currently proposed BK Sealing Caps are in use, the patient will be exposed to no risks in excess of those experienced by patients using comparable competitor sealing caps manufactured and distributed in the United States, or older model BIOTRONIK sealing caps.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”
0
,
APR 2 9 1997 K 9 70 20 4
1.2 Safety and Effectiveness Summary
BIOTRONIK BK Series Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility.
BK Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070, which has been extensively used by BIOTRONIK in cardiac pacing lead designs. FDA has reviewed and cleared this material in the following submissions:
Physios CTM 01 Pulse Generator and ELC XX-UP Epicardial Lead IDE #G960045 Approved August 22, 1996
TIR and TIJ Endocardial Leads 510(k) #K953044 Cleared September 27, 1996
Dromos DR and SR Pulse Generators PMA #P950037 Approved October 11, 1996.
Silopren LSR-4070 has been thoroughly tested for biocompatibility, and is commonly used in many market-released Class III products, including pacemaker and defibrillator leads and their accessories. Acute and chronic biocompatibility tests have been performed, as well as long-term implantation studies.
BK Sealing Caps are tested for ease of use, ability to withstand ligature application, potential fluid leakage, and adherence to IS-1 standards. Packaging and transportation durability as well as sterilization validation have been performed to ensure the quality and sterility of the delivered product.
All production and biocompatibility test results were within specifications; therefore, when the currently proposed BK Sealing Caps are in use, the patient will be exposed to no risks in excess of those experienced by patients using comparable competitor sealing caps manufactured and distributed in the United States, or older model BIOTRONIK sealing caps. Complications arising from usage may include body rejection phenomena, fibrosis, displacement, infection, and erosion. BIOTRONIK is not aware of any other adverse safety and effectiveness data on these accessories.
In accordance with the Safe Medical Device Act of 1990, a thorough literature search for adverse safety and effectiveness data on pacemaker lead sealing caps was performed. The search vielded no articles related to the safety of pacemaker lead sealing caps.