The Achieve Advance mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Advance mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Device Description

The Achieve Advance Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve Advance Mapping Catheter is a circular loop with evenly spaced electrodes to map electrical conduction within the atrium. The Achieve Advance Mapping Catheter is available in a 15mm, 20mm, or 25mm pre-shaped distal loop diameter.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is primarily a 510(k) summary for a medical device (Achieve Advance Mapping Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It lists design features and the types of performance testing conducted (bench testing), but does not detail acceptance criteria or specific study results in the manner requested for an AI/ML device. There is no mention of an algorithm or AI component, human reader studies, ground truth establishment, or training/test set sizes.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

Medtronic, Inc. Heather Taylor Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View, Minnesota 55112

Re: K162892

Trade/Device Name: Achieve Advance Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: October 14, 2016 Received: October 17, 2016

Dear Heather Taylor:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely

Minda Jellison
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162892

Device Name Achieve Advance Mapping Catheter

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 OF SAFETY AND EFFECTIVENESS

510(k) Summary per 21 CFR §807.92
Date Summary Prepared:	26 Sep 2016
Applicant:	Medtronic Inc.710 Medtronic ParkwayMinneapolis, MN 55432Establishment Registration No.: 3001504994

Contact Person:	Heather TaylorPrincipal Regulatory Affairs SpecialistMedtronic Inc.Coral Sea StreetMounds View, MN 55112Telephone: 763.526.9066Fax: 763.367.9903Email: heather.m.taylor@medtronic.com
Trade Name:	Achieve Advance™ Mapping Catheter
Common Name:	Catheter, electrode recording, or probe, electroderecording
Classification Name:	Electrode Recording Catheter
Classification & Panel:	Class II, 21 CFR 870.1220
Product Code:	DRF
Predicate Device(s):	Achieve™ ST Mapping Catheter (K153139)
Device Description:	The Achieve Advance Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter and can be used forcardiac stimulation during electrophysiology studies. The distalmapping section of the Achieve Advance Mapping Catheter is acircular loop with evenly spaced electrodes to map electricalconduction within the atrium. The Achieve Advance MappingCatheter is available in a 15mm, 20mm, or 25mm pre-shaped distalloop diameter.

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Intended Use of Device:	The intended use of the Achieve Advance Mapping Catheter is torecord intracardiac signals and provide cardiac stimulation duringelectrophysiology studies.
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The Achieve Advance mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Advance mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Comparison of Technological The Achieve Advance Mapping Catheter uses the same technology, Characteristics and has the same intended use, functions, materials and method of operation as the following predicated device:

	Achieve AdvanceCatheter - LineExtension (SubjectDevice)	Achieve ST Catheter(predicate device, nownamed AchieveAdvance Catheter)K153139
Intended Use	Map intracardiacstructures of theheart	Map intracardiacstructures of the heart
Indications forUse	The AchieveAdvance isindicated formultiple electrodeelectrophysiologicalmapping of cardiacstructures (i.e.,recording andstimulation only).The AchieveAdvance Catheteris designed toobtainelectrograms in theatrial regions of theheart.	The Achieve ST isindicated for multipleelectrodeelectrophysiologicalmapping of cardiacstructures (i.e.,recording andstimulation only). TheAchieve ST Catheter isdesigned to obtainelectrograms in theatrial regions of theheart.
Catheter BodyTubing	Nitinol/Pebax(distal body)Stainless Steel/polyimide(proximal)	Nitinol/Pebax (distalbody)Stainless Steel/polyimide (proximal)
Diameter	3.3F	3.3F

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Effective Length	146cm	146cm
Number ofElectrodes	8 (15mm & 20mm)	10 (25mm)
Electrode Spacing	5.8mm (20mm)4.1mm (15mm)	5.8mm (25mm)
Distal End Shape	Circular Loop	Circular Loop
Loop Diameter	15mm and 20mm	25mm
Loop Material	Nitinol insulated with PET (Pebax covered)	Nitinol insulated with PET (Pebax covered)
Delivered through a delivery catheter	Yes	Yes

Performance Data In vitro bench testing was completed to support the line extension of the Achieve Advance Mapping Catheter. Performance testing verified that the 15mm and 20mm Achieve Advance Mapping Catheter performs as designed and is suitable for its intended use.

Performance testing included the following: Thermal Conditioning & Packaging Distribution TT0224 (per ASTM 4332 and D4169) Radial Loop Compliance Distal Stiffness Axial Load Torque Response Turns to Failure Electrical Continuity Device Functionality Kink Resistance Joint Strength (per 10555-1) Stiffness Radiopacity (per ASTM F640) Life Testing

Conclusion

The data presented in this submission demonstrate that the Achieve Advance Mapping Catheter is substantially equivalent to the predicate device identified in regards to device design, materials, and intended use.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).