(264 days)
Not Found
No
The summary describes a physical accessory (paddles) for a defibrillator that detects ECG rhythm and delivers therapy. There is no mention of AI/ML in the device description, intended use, or performance studies. The device's function is based on direct electrical interaction and signal detection, not algorithmic learning or inference.
Yes
The device is used to provide defibrillation and synchronized cardioversion, which are therapies to treat specific arrhythmias.
Yes
The device is intended to "internally detect ECG rhythm," which is a diagnostic function.
No
The device description explicitly states it consists of metal paddle electrodes and molded plastic handles, which are physical hardware components.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Sterilizable Internal Defibrillation Paddles are used directly on the surgically exposed heart to detect electrical rhythm and deliver electrical therapy. They do not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states it's for detecting ECG rhythm and providing defibrillation or synchronized cardioversion directly to the heart. This is a therapeutic and diagnostic function performed in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
Therefore, this device falls under the category of a therapeutic and diagnostic medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
Product codes
LDD
Device Description
The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.
The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
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Intended User / Care Setting
highly-trained medical professionals / open heart cardiac surgery
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
Performance testing has been completed to demonstrate that the proposed Sterilizable Internal Defibrillation Paddles meet the safety and performance requirements established in the design specifications. Comprehensive testing included the following:
- Design Verification Testing
- Biocompatibility Testing
- Electrical Safety and Electromagnetic Compatibility Testing
- Design Validation Testing
- Animal Testing, and Simulated Use Testing
No human clinical studies were submitted as part of this 510(k) Premarket Notification.
The information in this 510(k) notification demonstrates that the Sterilizable Internal Defibrillation Paddles are substantially equivalent to the predicate Internal Deffbrillation Handles and Electrodes with respect to performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Physio-Control, Inc. Chelsea Cullen Sr. Regulatory Affairs Specialist 11811 Willow Road NE Redmond, Washington 98052
Re: K182503
Trade/Device Name: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (Including Paddles) Regulatory Class: Class II Product Code: LDD Dated: April 30, 2019 Received: May 1, 2019
Dear Chelsea Cullen:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
For Matthew Hillebrenner Deputy Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182503
Device Name Sterilizable Internal Defibrillation Paddles
Indications for Use (Describe)
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5: 510(k) SUMMARY
Submitter:
Physio-Control, Inc. 11811 Willows Road Northeast Redmond, Washington 98073-9706 Registration Number: 3015876, 3006703820
Contact:
Chelsea Cullen Staff Regulatory Affairs Specialist 425 867 4138 (o) (425) 867-4154 (f) chelsea.cullen(@stryker.com
April 23, 2019 Date of Preparation:
Device Trade/Proprietary Name:
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK® defibrillators/monitors
Device Common Name:
Internal Defibrillation Paddles
Device Classification:
| Device Classification and
| CFR Reference | Classification Panel | Product Code |
|---|---|---|
| Low Energy DC-Defibrillator | ||
| (Including Paddles), Class II | ||
| (21CFR 870.5300) | Cardiovascular Devices | LDD |
Predicate Devices:
The features and functions of the proposed Sterilizable Internal Defibrillation Paddles accessory are equivalent to the following previously cleared Internal Paddles:
| Predicate Device | 510(k) Number(s)/ Clearance Date |
|---|---|
| Internal Paddles and Paddle | |
| Handles with Discharge | |
| Control | K895379 / cleared in 1990 |
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Device Description:
The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.
The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.
Indications for Use:
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.
Intended Use:
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
Contraindications:
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.
Synchronized cardioversion is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular or ventricular escape rhythms, asystole, and ventricular fibrillation.
Summary of Technological Characteristics:
The intended use, features, and functional characteristics of the proposed Sterilizable Internal Defibrillation Paddles are equivalent to the predicate device. The main differences between the previously cleared predicate Internal paddle handles with discharge control and the proposed Sterilizable Internal Defibrillation Paddles are 1) an integrated handle-electrode assembly which is available in two (2) connector configurations, and 2) material change to the device to increase durability and resistance of the paddles to better withstand the harshness of cleaning and repeated sterilization methods.
The proposed changes have not raised any new issues when compared to the existing predicate devices.
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Performance Data:
Performance testing has been completed to demonstrate that the proposed Sterilizable Internal Defibrillation Paddles meet the safety and performance requirements established in the design specifications. Comprehensive testing included the following:
- o Design Verification Testing
- Biocompatibility Testing
- Electrical Safety and Electromagnetic Compatibility Testing o
- o Design Validation Testing
- O Animal Testing, and Simulated Use Testing
No human clinical studies were submitted as part of this 510(k) Premarket Notification.
Conclusion:
The information in this 510(k) notification demonstrates that the Sterilizable Internal Defibrillation Paddles are substantially equivalent to the predicate Internal Deffbrillation Handles and Electrodes with respect to performance.