The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.

Device Description

The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.

AI/ML Overview

The provided text describes the regulatory clearance (K200674) for the AtriAmp device, which is an extension cable used with external pacemakers and ECG monitors. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance goal for an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
ANSI/AAMI EC53:2013 compliance	Compliance with applicable requirements of EC53:2013 for Cable and leadwire noise, performing the same as the predicate.	Pass: The AtriAmp complies with applicable requirements of EC53:2013 and performs the same as the predicate for Subclause 5.3.2 Cable and leadwire noise.
ANSI/AAMI ES 60601-1 and IEC 60601-2-31 compliance	Compliance with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011.	Pass: The AtriAmp with accessory external pacemaker interface cables complies with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011.
ES60601-1 Subclause 8.5.2.3 compliance (for 21 CFR Part 898)	Compliance with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables.	Pass: In support of 21 CFR Part 898 compliance, the AtriAmp complies with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables.
Sterility	Achieving a minimum Sterility Assurance Level (SAL) of $10^{-6}$ according to ISO 11137-1:2006(R)2015 & A1:2013 & A2:2018.	Pass: Sterilization of the subject device was validated according to ISO 11137-1:2006(R)2015 & A1:2013 & A2:2018, demonstrating the device is provided with a minimum sterility assumed level (SAL) of $10^{-6}$.
Sterile barrier integrity	The flexible pouch sterile barrier package must maintain integrity after terminal sterilization, simulated distribution, seal peel, and bubble emission testing.	Pass: The sterile barrier package is a flexible pouch. The methods applied to evaluate the sterile barrier package integrity included post terminal sterilization simulated distribution, seal peel and bubble emission testing.
Biocompatibility	Passing results for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2020), and Irritation (ISO 10993-10:2020).	Pass: The ISO 10993-5:2009 and ISO 10993-10:2020 test methods were applied, with passing results: for Cytotoxicity, Sensitization, Irritation.
Shelf life (two years)	Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096).	Pass: Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096).
Duration of use	Verification of use for up to 14 days.	Pass: Operation use was evaluated to verify use for up to 14 days.

2. Sample size used for the test set and the data provenance

The document describes non-clinical performance tests for the physical device (AtriAmp cable and accessories). These tests typically involve a sample of the manufactured device, but the specific number of units tested is not provided in this summary. The data provenance is not mentioned, but these are laboratory tests performed by the manufacturer to verify product specifications and regulatory standards. Given the nature of these tests, they are inherently prospective for the specific device being manufactured and tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests are for the physical and electrical characteristics, sterility, and biocompatibility of a medical device cable, not for an AI/ML algorithm requiring expert interpretation of medical images or data. The "ground truth" here is objective measurement against specified engineering and biological standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against established standards.

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 document is for a medical device (cable) and does not involve AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm.

7. The type of ground truth used

The ground truth for these tests is based on established engineering and biological standards and test methods (e.g., ANSI/AAMI EC53, IEC 60601-1, ISO 11137-1, ISO 10993 series, ASTM F88, ASTM F2096, ASTM 4169-16). These are objective criteria for physical, electrical, and biological safety and performance.

8. The sample size for the training set

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.

9. How the ground truth for the training set was established

Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.

Summary

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July 1, 2020

Atrility Medical, LLC % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K200674

Trade/Device Name: AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 15, 2020 Received: May 15, 2020

Dear Gary Syring:

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.

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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 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 (OS) 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.

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200674

Device Name AtriAmp

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)

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510(k) Summary

This 510(k) summary was prepared to provide an understanding of the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.

Submitters Name:	Atrility Medical, LLC313 Price Place, Suite #13Madison, WI 53705
Contact Person:	Matthew Knoespel, Regulatory EngineerAtrility Medical, LLC
Contact Phone:	Phone: 920-619-8737
Date Summary Prepared:	June 22, 2020
Device Trade Name:	AtriAmp
Common Name:	Passive interface cable to external pacemaker, epicardial pacing lead wire andcardiac monitor
Classification Name:	21 CFR 870.290 Patient transducer and electrode cable (including connector)Product Code: DSA, Class II
Predicate Devices:	K080621, Fastlock Pacing Wire Extension (Primary Predicate)K070926, Electrode/Extension Cables, Model series ATAR

Device Description

Intended Use of the Device

The AtriAmp is a single-use device that is intended to connect an electrode/lead from a patient to a Type CF, defibrillation-proof ECG Monitor and/or an external pacemaker.

Summary of Technological Characteristics

The following table provides a side-by-side comparison of the predicate devices applied to support this pre-market notification.

Technical Characteristics Comparison
Feature	AtriAmp andAccessoriesUnder Review	Fastlock PacingWire ExtensionCable(Primary Predicate:K080621)	Electrode/ExtensionCables, Model seriesATARPredicate: K070926	EquivalenceComments
Product Code,Classification	DSA,21 CFR 870.2900,Class II	DSA,21 CFR 870.2900,Class II	IKD,21 CFR 890.1175Class II	Identical to primarypredicate.

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Technical Characteristics Comparison
Feature	AtriAmp andAccessoriesUnder Review	Fastlock PacingWire ExtensionCable(Primary Predicate:K080621)	Electrode/ExtensionCables, Model seriesATARPredicate: K070926	EquivalenceComments
Indications forUse	The AtriAmp supportspacing by acting as anextension cable betweenan external pacemakerand cardiac pacingleads. The AtriAmp alsosupports monitoring ofintra-cardiac signals bytransmitting signals toone of the unipolarprecordial chest leads(leads V1-V6) of a TypeCF, defibrillation-proof ECG monitor.	Fastlock pacing wireextension cable withconnectors is indicatedfor use as an electricalextension cable used totransmit signal from, orpower or excitationsignal to patient-connected electrodes.	Electrode/extensioncable is intended toconnect anelectrode/lead from apatient or anothercable to a diagnosticmachine or anexternal pacemaker.	EquivalentThe same as thepredicate devices, theAtriAmp interfacesbetween an externalpacemaker and patientapplied intra-cardiacpacing lead wires.Equivalent to thesecondary predicate, theAtriAmp interfaces thesignal from theepicardial lead wires toa, defibrillation-proofECG Monitor, one ofthe leads (V1 to V6) ofan ECG monitor.
Duration ofuse	Anticipated to be lessthan 14 days	< 7 Days	< 7 Days	Similar
Single use,disposable	Yes	Yes	Yes	Same
Provided sterile	Yes	Yes	Yes	Same
Sterilizationmethod	e-beam	ethylene oxide	ethylene oxide	Similar
SterilityAssurance Level(SAL)	$ ≤ 10^{-6} $	Unknown	Unknown	Acceptable for theintended use
Sterile barrierpackage	Flexible Double Pouch	Tyvek Flexible Barrier	Tyvek Flexible Barrier	Similar
Biocompatibilityevaluation	Cytotoxicity, Irritation,Sensitization	Unknown	Unknown	Similar

Non-clinical Performance Tests

To establish the technical equivalency of the AtriAmp with accessories, evaluations were conducted to confirm
compliance with performance requirements, including:

Test	Test Method Summary	Result
ANSI/AAMIEC53:2013compliance	The AtriAmp complies with applicable requirements of EC53:2013and performs the same as the predicate for Subclause 5.3.2 Cableand leadwire noise.	Pass
ANSI/AAMI ES60601-1 and IEC60601-2-31compliance	The AtriAmp with accessory external pacemaker interface cablescomplies with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011.	Pass

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Test	Test Method Summary	Result
ES60601-1Subclause 8.5.2.3	In support of 21 CFR Part 898 compliance, the AtriAmp complieswith ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables.	Pass
Sterility	Sterilization of the subject device was validated according to ISO11137-1:2006(R)2015 & A1:2013 & A2:2018, demonstrating thedevice is provided with a minimum sterility assumed level (SAL) of$10^{-6}$ .	Pass
Sterile barrierintegrity	The sterile barrier package is a flexible pouch. The methods appliedto evaluate the sterile barrier package integrity included postterminal sterilization simulated distribution, seal peel and bubbleemission testing.	Pass
Biocompatibility	The ISO 10993-5:2009 and ISO 10993-10:2020 test methods wereapplied, with passing results: for Cytotoxicity, Sensitization,Irritation.	Pass
Shelf lifetwo (2) years	Confirmation of device functional performance and sterile barrierpouch integrity (seal peel per ASTM F88 and bubble leak per ASTMF2096) with accelerated aging and simulated distribution per ASTM4169-16 and bubble leak (ASTM F2096).	Pass
Duration of use	Operation use was evaluated to verify use for up to 14 days.	Pass

Clinical data are not needed.

Conclusion

The AtriAmp with accessories meet performance requirements equivalent to the predicate device. The intended use and technology of the AtriAmp with accessories is the same as the predicate device.

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).