The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart.

Device Description

The Achieve™ diagnostic mapping 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 catheter is a circular loop with eight evenly spaced electrodes to map electrical conduction within the atrium. The Achieve catheter should only be used with the corresponding electrical cable for Achieve. The Achieve catheter is available with two distal loop diameter sizes described in the following table:

Model	Loop Diameter
990063-015	15 mm
990063-020	20 mm

The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Medtronic Achieve™ Mapping Catheter:

Summary of Acceptance Criteria and Device Performance:

The document describes the Medtronic Achieve™ Mapping Catheter, a Class II device intended for electrophysiological mapping of cardiac structures. It achieves substantial equivalence to predicate devices (ProMap™ and Lasso™) through a series of performance, sterilization, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Measure	Reported Device Performance
Performance Testing	Torquer / Introducer: insertion testing	Performed as designed and suitable for intended use.
	Rotational motion	Performed as designed and suitable for intended use.
	Insertion and retraction with compatible delivery device	Performed as designed and suitable for intended use.
	Insertion/retraction cycling	Performed as designed and suitable for intended use.
	Loop rotation	Performed as designed and suitable for intended use.
	Rotational loading	Performed as designed and suitable for intended use.
	Electrode contact sufficient for mapping	Performed as designed and suitable for intended use.
	Atraumatic tip	Performed as designed and suitable for intended use.
	Stiffness / flexibility / buckling	Performed as designed and suitable for intended use.
	Flexion fatigue	Performed as designed and suitable for intended use.
	Torque to failure	Performed as designed and suitable for intended use.
	Simulated use testing	Performed as designed and suitable for intended use.
	Electrical testing and electrical safety testing (ISO 60601-1:2006)	Performed as designed and suitable for intended use.
	Tensile testing (ISO 10551-1:2009)	Performed as designed and suitable for intended use.
	Loop integrity	Performed as designed and suitable for intended use.
	Connector fatigue	Performed as designed and suitable for intended use.
	Corrosion resistance (ISO 10555-1:2009)	Performed as designed and suitable for intended use.
Biocompatibility Testing	Cytotoxicity (ISO 10993-5:2009)	Performed as designed and suitable for intended use.
	Sensitization (ISO 10993-10:2002, Amend 2006)	Performed as designed and suitable for intended use.
	Intracutaneous reactivity (ISO10993-10:2002, Amend 2006)	Performed as designed and suitable for intended use.
	Systemic toxicity (ISO 10993-11:2006)	Performed as designed and suitable for intended use.
	Pyrogenicity (ISO10993-11:2006)	Performed as designed and suitable for intended use.
	Hemolysis (ISO 10993-4:2002)	Performed as designed and suitable for intended use.
	Complement activation (ISO 10993-4:2002)	Performed as designed and suitable for intended use.
	Partial thromboplastin time (PPT) (ISO 10993-4:2002)	Performed as designed and suitable for intended use.
	Platelet and leukocyte count (ISO 10993-4:2002)	Performed as designed and suitable for intended use.
Electrical Cable Safety	BS EN 60601-1 (2006, Medical electrical equipment)	Considered safe and effective per applicable parts.
Overall Conclusion	Substantial Equivalence	The data "demonstrate that the Ablation Frontiers Achieve Mapping Catheter is substantially equivalent to the predicate devices identified in regards to device design, materials, and intended use."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size used for each individual test. It broadly mentions "in vitro bench testing and in vivo testing have been performed on the device materials and finished devices."
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device seeking substantial equivalence, it's highly likely that the in vivo testing would be prospective, and the in vitro bench testing would be conducted in a controlled laboratory environment (likely in the US or a country with comparable regulatory standards).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies listed are primarily engineering and biological performance tests, not clinical studies involving expert interpretation of results to establish a "ground truth" for diagnostic accuracy in a human population.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance and biocompatibility testing. Adjudication methods are typically relevant for clinical studies where multiple experts interpret data (e.g., medical images, patient outcomes) and their interpretations need to be reconciled.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes bench and in vivo performance tests and biocompatibility tests to demonstrate substantial equivalence to predicate devices, not a study comparing human reader performance with or without AI assistance.

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

This question is not applicable. The device is a physical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" would be established by engineering specifications, validated test methods (e.g., ISO standards), and pre-defined acceptance criteria for physical and electrical properties (e.g., acceptable range for torque, tensile strength, electrical resistance, stiffness, etc.).
For the biocompatibility testing, the "ground truth" is established by adherence to recognized ISO standards (e.g., ISO 10993 series) and the absence of adverse biological reactions (e.g., no cytotoxicity, no sensitization, no systemic toxicity).
For electrical safety testing, the "ground truth" is adherence to ISO and BS EN standards for medical electrical equipment.

Essentially, the ground truth is based on objective, measurable physical, electrical, and biological parameters as defined by international standards and engineering best practices.

8. The Sample Size for the Training Set

This question is not applicable/provided. The device is a physical catheter, not a machine learning model, so there is no concept of a "training set" in the context of AI development.

9. How the Ground Truth for the Training Set was Established

This question is not applicable. As there is no AI training set, there is no ground truth establishment for it.

Summary

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MAR 1 8 2011

02588

510(K) SUMMARY

Date Prepared:	March 7, 2011
Trade Name of Device:Common Name:	Achieve™ Mapping CatheterCatheter, electrode recording, or probe, electroderecording
Classification:	Class II, 21 CFR 870.1220, Electrode RecordingCatheter
Applicant:	Medtronic Ablation Frontiers2210 Faraday Avenue, Suite 100Carlsbad, CA 92008 USATel: 760-827-0007Fax: 760-827-0020
Contact Person:	Brenda ClayRegulatory Affairs
Predicate Devices:	ProMap™, ProRhythmLasso™, Biosense Webster

Device Description:

Model	Loop Diameter
990063-015	15 mm
990063-020	20 mm

Indications for Use:

Contraindications:

The catheter is contraindicated as follows:

For use as an ablation device .
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For use with transeptal sheaths featuring side holes larger than 1.00 mm in diameter
Retrograde approach .

Electrophysiology studies are contraindicated when the patient's underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions:

An active systemic infection ●
Left atrial thrombus .
Pulmonary vein stents .
Prosthetic heart valve (tissue or mechanical) .
Myxoma ◆
Interatrial baffle or patch ●
Conditions where the manipulation of the catheter within the heart would be unsafe �
Acute myocardial infarction .

Technological Characteristics of the Device Compared to the Predicate Device:

The Achieve Mapping Catheter uses similar technology, has similar intended use, functions, materials and method of operation as the following predicate device(s):

Device	Achieve Catheter(Subject Device)	ProMap Catheter	Lasso Catheter
Intended Use	Map intracardiacstructures of the heart	Map intracardiacstructures of the heart	Map intracardiacstructures of the heart
Indications for Use	The Achieve is indicatedfor multiple electrodeelectrophysiologicalmapping of cardiacstructures (i.e., recordingand stimulation only). TheAchieve Catheter isdesigned to obtainelectrograms in the atrialregions of the heart.	The ProRhythm ProMap isto be used for theevaluation of cardiacarrhythmias fromendocardial andintravascular sites. TheProMap coaxial mappingCatheter is typically usedin Electrophysiologyclinical procedures.	The LASSO Catheter isindicated for multipleelectrodeelectrophysiologicalmapping of cardiacstructures (i.e., recordingand stimulation only). TheLASSO Catheter isdesigned to obtainelectrograms in the atrialregions of the heart.
Catheter Body Tubing	Pebax (distal body)Stainless Steel (proximal)	Unknown	Pebax
Diameter	3.3F	3F	3F
Effective Length	146cm	60 - 125cm	143cm
Number of Electrodes	8	6	10 or 20
Distal End Shape	Circular Loop	Circular Loop	Circular Loop
Loop Diameter	15 and 20mm	15 to 25mm	15 to 25mm
Loop Material	Nitinol insulated with PET(Pebax covered)	Nitinol	Unknown
Delivered through adelivery catheter	Yes	Yes	Yes

Table 5-1: Characteristic Comparison

Note: Materials in the predicate devices are not known with certainty. Material equivalence is demonstrated by in vivo performance tests and biocompatibility tests to FDA recognized standards.

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Summary of Studies:

In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Achieve Mapping Catheter performs as designed and is suitable for its intended use.

Performance testing included the following:

Torquer / Introducer: insertion testing
Rotational motion �
. Insertion and retraction with compatible delivery device
. Insertion/retraction cycling
. Loop rotation
Rotational loading
Electrode contact sufficient for mapping
Atraumatic tip
. Stiffness / flexibility / buckling
. Flexion fatigue
. Torque to failure
. Simulated use testing
Electrical testing and electrical safety testing (ISO 60601-1:2006) .
. Tensile testing (ISO 10551-1:2009)
Loop integrity ●
. Connector fatigue
Corrosion resistance (ISO 10555-1:2009) .

Biocompatibility testing included the following:

Cytotoxicity (ISO 10993-5:2009) .
. Sensitization (ISO 10993-10:2002, Amend 2006)
Intracutaneous reactivity (ISO10993-10:2002, Amend 2006)) .
Systemic toxicity (ISO 10993-11:2006) .
. Pyrogenicity (ISO10993-11:2006)
. Hemolysis (ISO 10993-4:2002)
Complement activation (ISO 10993-4:2002) .
Partial thromboplastin time (PPT) (ISO 10993-4:2002) .
. Platelet and leukocyte count (ISO 10993-4:2002)

The Cable has been tested and is considered safe and effective per applicable parts of BS EN 60601-1 (2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).

Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Medtronic Ablation Frontiers c/o Ms. Brenda Clay Regulatory Affairs Specialist 2210 Faraday Avenue, Suite 100 Carlsbad, CA 92008

MAR 1 8 2011

Re: K102588

Trade Name: Achieve Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 11, 2011 Received: March 14, 2011

Dear Ms. Clay:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 – Ms. Brenda Clay

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D.

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 STATEMENT 4.

510(K) Number (if known):

Device Name: Medtronic Achieve™ Mapping Catheter

Indications for Use:

The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Mapper Catheter is designed to obtain electrograms in the atrial regions of the heart.

Prescription Use	X
(21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
of Cardiovascular Devices
510(K) Number	K102588

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).

510(K) SUMMARY

Device Description:

Indications for Use:

Contraindications:

Technological Characteristics of the Device Compared to the Predicate Device:

Table 5-1: Characteristic Comparison

Summary of Studies:

. Platelet and leukocyte count (ISO 10993-4:2002)

Conclusion:

DEPARTMENT OF HEALTH & HUMAN SERVICES

INDICATIONS FOR USE STATEMENT 4.

§ 870.1220 Electrode recording catheter or electrode recording probe.