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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Sterilizable Internal Defibrillation Paddles. It's important to clarify that this document is for a medical device (hardware), not an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training/test set sizes) are not directly applicable in the same way.

Instead, the acceptance criteria for such a device typically revolve around demonstrating substantial equivalence to a predicate device, as well as meeting established safety and performance standards through design verification and validation.

However, I will extract the information that is comparable or relevant to your questions, and specify where the requested information is not applicable for this type of device.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting design specifications related to safety and performance.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Intended Use Equivalence	The device's intended use (internally detect ECG rhythm, defibrillation/synchronized cardioversion directly to surgically exposed heart in a sterile environment) must be equivalent to the predicate device.	The "Indications for Use" and "Intended Use" are stated to be equivalent to the predicate device. The device is used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery.
Functional Equivalence	Features and functional characteristics must be equivalent to the predicate device, despite material/design changes (integrated handle-electrode assembly, improved durability/resistance to cleaning/sterilization).	The "features, and functional characteristics of the proposed Sterilizable Internal Defibrillation Paddles are equivalent to the predicate device." The changes (integrated assembly, material for durability/sterilization) "have not raised any new issues when compared to the existing predicate devices."
Design Verification	All established design specifications (including those related to electrical performance, mechanical integrity, material properties, and sterilization efficacy) must be met.	"Design Verification Testing" was completed to "demonstrate that the proposed Sterilizable Internal Defibrillation Paddles meet the safety and performance requirements established in the design specifications."
Biocompatibility	The materials in contact with human tissue must be biocompatible. --------------------	"Biocompatibility Testing" was completed to demonstrate safety.
Electrical Safety & EMC	The device must meet electrical safety standards and electromagnetic compatibility requirements. --------------------	"Electrical Safety and Electromagnetic Compatibility Testing" was completed.
Design Validation	The device must perform effectively and safely under simulated use conditions and, where applicable, in animal models, consistent with its intended clinical application. --------------------	"Design Validation Testing" was completed, described as including "Animal Testing" and "Simulated Use Testing."
No New Safety/Efficacy Issues	There must be no new questions of safety or effectiveness raised by the device compared to the predicate. --------------------	The submission concludes that the information "demonstrates that the Sterilizable Internal Defibrillation Paddles are substantially equivalent to the predicate Internal Defibrillation Handles and Electrodes with respect to performance," implying no new safety or efficacy issues.

Non-Applicable / General Information for Hardware Devices

The following questions are primarily relevant to AI/ML software performance studies and are not directly applicable to this hardware device's 510(k) submission as described.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device in the context of AI/ML test sets. Performance testing for hardware involves laboratory, animal, and simulated use testing, not "test sets" of data in the AI/ML sense. Data sources for such tests are internal (e.g., test benches, animal studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML test set is not a concept used for this type of hardware device's testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hardware device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory to a defibrillator and requires a highly-trained medical professional for use. It is a human-operated device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a hardware device means meeting its engineering and safety specifications, and performing its intended function.
8. The sample size for the training set: Not applicable for hardware.
9. How the ground truth for the training set was established: Not applicable for hardware.

Summary of Device-Specific Study Information (Performance Data)

The submission highlights that no human clinical studies were submitted as part of this 510(k) Premarket Notification. This is typical for devices seeking substantial equivalence where predicate device experience or non-clinical data is deemed sufficient.

The performance data that supports the acceptance criteria for this hardware device includes:

Design Verification Testing: To ensure the device meets established design specifications.
Biocompatibility Testing: To ensure materials are safe for biological contact.
Electrical Safety and Electromagnetic Compatibility Testing: To ensure the device operates safely within electrical and electromagnetic parameters.
Design Validation Testing: Which encompassed:
- Animal Testing: To evaluate performance in a living biological system.
- Simulated Use Testing: To assess performance under conditions mimicking clinical use.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182503

Device Name Sterilizable Internal Defibrillation Paddles

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 andCFR 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 PaddleHandles with DischargeControl	K895379 / cleared in 1990

{4}------------------------------------------------

Device Description:

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:

Intended Use:

Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic 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.

{5}------------------------------------------------

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.

Regulation Number and Section

§ 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.