(270 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the temporary myocardial electrodes, with no mention of AI or ML for signal processing, pacing algorithms, or any other function.
Yes.
The device is intended for temporary cardiac pacing and sensing of cardiac chambers to prevent postoperative bradycardia and conduction disorders, which are therapeutic interventions for heart conditions.
No
The device is primarily used for temporary cardiac pacing and sensing to prevent postoperative bradycardia and conduction disorders. While it senses cardiac signals, its main purpose is therapeutic (pacing) rather than diagnosis.
No
The device description clearly outlines physical components such as flexible insulated electrical conductors, wires, needles, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The OSYPKA TME Temporary Myocardial Electrodes are designed to be implanted into the heart to directly pace the heart or sense its electrical activity. This is an in vivo (within the living body) function, not an in vitro (in glass, or outside the body) diagnostic test.
- Intended Use: The intended use is for temporary cardiac pacing and sensing after cardiac surgery to prevent postoperative issues. This is a therapeutic and monitoring function, not a diagnostic test performed on a sample.
The device description clearly outlines its use in direct contact with the heart tissue for electrical stimulation and sensing, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external 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.
The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of.
OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac chambers, heart, myocardium
Indicated Patient Age Range
pediatrics, children, and adult patients.
Intended User / Care Setting
physician in a healthcare facility.
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 TME Temporary Myocardial Electrodes been thoroughly tested through verification of product specifications, user requirements, and device compatibility to ensure equivalency to the predicate device. The following quality assurance and performance testing includes:
- Bending Strength
- Dielectric Strength
- Cannulas
- Surfaces, Edges, and Corners
- Lead Resistance
- Tensile Strength
- Corrosion Resistance
- Retention Force
- Withdrawal Force
- Patient Connection Line
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
April 26, 2024
Osypka AG Nicola Osypka CEO Earl-H.-Wood Str. 1 Rheinfelden, Baden 79618 Germany
Re: K232261
Trade/Device Name: TME Temporary Myocardial Electrode Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: March 26, 2024 Received: March 27, 2024
Dear Nicola Osypka:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/8 description: The image shows a digital signature of Sara M. Royce. The signature includes the name "Sara M. Royce" on the left side of the image. On the right side of the image, it states that the signature was digitally signed by Sara M. Royce. The date of the signature is 2024.04.26, and the time is 14:32:30 -04'00'.
Sara Royce Assistant Director Division of Cardiac Electrophysiology, Diagnostics
2
and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name TME Temporary Myocardial Electrodes
Indications for Use (Describe)
OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Premarket Notification 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for OSYPKA. The logo consists of a red icon on the left and the word "OSYPKA" in black letters on the right. The icon is a stylized letter "E" with a heartbeat symbol inside.
510(k) Summary
| General Information:
Submitter: | OSYPKA AG
Earl-H.-Wood-Str. 1
D-79618 Rheinfelden-Herten
Germany |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Number: | 3003923762 |
| Contact: | Dr. Nicola Osypka
Chief Executive Officer
email: n.osypka@osypka.de |
| Date Prepared: | |
| Trade Name: | TME Temporary Myocardial Electrodes |
| Common Name: | temporary pacemaker electrode |
| Product Code: | LDF |
| Regulation Number: | 21 CFR §870.3680 |
| Regulation Name: | temporary pacemaker electrode |
| Class: | Cardiovascular |
| Predicate Devices: | |
510(k) Number K850622
Description Oscor Inc. Model TME 64S Bipolar Temporary Heart Wire
Device Description:
OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external 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.
The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of.
5
Image /page/5/Picture/0 description: The image shows the logo for OSYPKA. The logo consists of a red symbol on the left and the word "OSYPKA" in black letters on the right. The red symbol appears to be a stylized letter "G" with a waveform inside it.
Premarket Notification 510(k) Summary
OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.
Indications for Use:
OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.
Comparison to Predicate and reference Devices:
The OSYPKA TME Temporary Myocardial Electrodes are substantially equivalent to the predicate and reference devices in terms of design, materials, and performance. The predicate and subject device have similar indications and identical construction.
Differences in Indications for Use:
The Indications for Use are very similar to the predicate device. They are intended for the same use and compatible with the same pacing devices.
Packaging:
Each TME Temporary Myocardial Electrode is packaged in: double pouch consisting of Tyvek®/Poly pouches. The double pouched sterile TME devices are packed in a cardboard box in quantities of 1,5 or 25 per box.
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Image /page/6/Picture/1 description: The image shows the logo for OSYPKA. The logo consists of a red symbol on the left, followed by the word "OSYPKA" in black, bold letters. The red symbol appears to be a stylized letter "E" with a heartbeat waveform inside.
Non-Clinical Performance testing:
The TME Temporary Myocardial Electrodes been thoroughly tested through verification of product specifications, user requirements, and device compatibility to ensure equivalency to the predicate device. The following quality assurance and performance testing includes:
- Bending Strength ●
- Dielectric Strength ●
- Cannulas ●
- Surfaces, Edges, and Corners ●
- Lead Resistance ●
- Tensile Strength ●
- Corrosion Resistance ●
- Retention Force ●
- Withdrawal Force ●
- Patient Connection Line .
Sterilization
The TME Temporary Myocardial Electrodes are sterilized using the same Ethylene Oxide (ETO) Sterilization process and equipment as the predicate electrodes.
Biocompatibility
Biocompatibility testing was completed on finished packaged devices that had gone through controlled manufacturing processes and ETO sterilization prior to physical and chemical analysis, and biocompatibility testing. TME Temporary Myocardial Electrodes were found to be biocompatible with the following ISO 10993-1 tests based on the use type and duration of contact:
- Chemical analysis and characterization
- Cytotoxicity ●
- Sensitization ●
- irritation
- Toxicity
- Implantation ●
- Genotoxicity ●
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Premarket Notification 510(k) Summary
Image /page/7/Picture/1 description: The image shows the logo for OSYPKA. The logo consists of a red symbol on the left and the word "OSYPKA" in black letters on the right. The red symbol appears to be a stylized letter "E" with a heartbeat line running through it.
Comparison to Predicate and reference devices:
The TME Temporary Myccardial Electrodes is substantially equivalent to the predicate based on the following technological elements:
Technology and construction: The construction of the subject device and predicate device are identical. Osypka AG manufactures the complete line of Unipolar, Bipolar & Quadripolar Temporary Myocardial Heartwires for Oscor. There are no material, construction, specification, manufacturing process, or sterilization process differences.
Environment of Use: The use environments are the same. The TME are provided sterile. The TME are temporarily implanted into the myocardium of the heart and connected to an external pacemaker. The subject and predicate devices must be used by a physician in a healthcare facility.
Patient Population: The patient populations are the same as the predicate and reference devices, namely, pediatrics, children, and adult patients.
The following technological differences exist between the subject and predicate devices:
There are no technological differences between the subject and predicate devices. The construction of the subject device and the predicates are the same.