Achieve ST Mapping Catheter, Catheter Connecting Cable

K153139 · Medtronic, Inc. · DRF · May 6, 2016 · Cardiovascular

Device Facts

• Record ID: K153139
• Device Name: Achieve ST Mapping Catheter, Catheter Connecting Cable
• Applicant: Medtronic, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: May 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The intended use of the Achieve ST Mapping Catheter is to record intracardiac signals and provide cardiac stimulation during electrophysiology studies. The AchieveTM ST mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The AchieveTM ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Device Story

Achieve ST Mapping Catheter is an intra-cardiac electrophysiology diagnostic catheter; used for recording electrical signals and cardiac stimulation during electrophysiology studies. Device features a distal circular loop with 10 evenly spaced electrodes; 25mm loop diameter. Operated by physicians in clinical settings; inserted via delivery catheter to access atrial regions. Device captures intracardiac electrograms; output displayed on external electrophysiology recording systems for physician interpretation. Enables mapping of cardiac conduction; assists in diagnosis and management of cardiac arrhythmias. Benefits include precise atrial signal acquisition for improved procedural guidance.

Clinical Evidence

Bench testing only. Performance testing included radial loop compliance, distal stiffness, axial load, torque response, turns to failure, electrical continuity, kink resistance, joint strength, contrast media flow rate, and electrical safety (ISO 60601-1:2006). Biocompatibility testing conducted per ISO 10993 standards, including cytotoxicity, sensitization, intracutaneous injection, systemic toxicity, pyrogenicity, and hemocompatibility (ISO 10993-4, ASTM F756). No clinical human trial data presented.

Technological Characteristics

Catheter body: Pebax (distal), Stainless Steel/polyimide (proximal). Loop: Nitinol insulated with PET (Pebax covered). Diameter: 3.3F. Length: 146cm. 10 electrodes. Circular loop geometry. Connectivity: Connects to external recording systems via cable. Sterilization: Not specified. Electrical safety: ISO 60601-1:2006. Corrosion resistance: ISO 10555-1:2009.

Indications for Use

Indicated for patients requiring multiple electrode electrophysiological mapping of cardiac structures (recording or stimulation only) specifically within the atrial regions of the heart.

Regulatory Classification

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.

Predicate Devices

• Achieve Mapping Catheter (K102588)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

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

Re: K153139

Trade/Device Name: Achieve ST 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: April 5, 2016 Received: April 6, 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. Iisting 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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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) K153139

Device Name AchieveTM ST Mapping Catheter

#### Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| ☑ Export and/or Wildlife Trade |
|--------------------------------|
| ☐ Scientific Purposes |

X | 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

| Date Summary Prepared: | October 26, 2015 | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Applicant: | Medtronic Inc.<br>710 Medtronic Parkway<br>Minneapolis, MN 55432<br>Establishment Registration No.: 3001504994 | |
| Contact Person: | Heather Taylor<br>Principal Regulatory Affairs Specialist<br>Medtronic Inc.<br>Coral Sea Street<br>Mounds View, MN 55112<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Trade Name: | Achieve™ ST Mapping Catheter | |
| Common Name: | Catheter, electrode recording, or probe, electrode<br>recording | |
| Classification Name: | Electrode Recording Catheter | |
| Classification & Panel: | Class II, 21 CFR 870.1220 | |
| Product Code: | DRF | |
| Predicate Device(s): | Achieve™ Mapping Catheter K102588 | |
| Device Description: | The Achieve ST Mapping diagnostic catheter is an intra-cardiac<br>electrophysiology recording catheter and can be used for cardiac<br>stimulation during electrophysiology studies. The distal mapping<br>section of the Achieve ST Mapping Catheter is a circular loop with<br>evenly spaced electrodes to map electrical conduction within the<br>atrium. The Achieve ST Mapping Catheter is available in a 25mm<br>pre-shaped distal loop diameter. | |
| Intended Use of Device: | The intended use of the Achieve ST Mapping Catheter is to record | |

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intracardiac signals and provide cardiac stimulation during electrophysiology studies.

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

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

| | Achieve ST<br>Catheter (Subject<br>Device) K153139 | Achieve Catheter<br>(predicate device)<br>K102588 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Map intracardiac<br>structures of the<br>heart | Map intracardiac<br>structures of the heart |
| Indications for<br>Use | The Achieve ST is<br>indicated for<br>multiple electrode<br>electrophysiological<br>mapping of cardiac<br>structures (i.e.,<br>recording and<br>stimulation only).<br>The Achieve ST<br>Catheter is<br>designed to obtain<br>electrograms in the<br>atrial regions of the<br>heart. | The Achieve is<br>indicated<br>for multiple electrode<br>electrophysiological<br>mapping of cardiac<br>structures (i.e.,<br>recording and<br>stimulation only). The<br>Achieve Catheter is<br>designed to obtain<br>electrograms in the<br>atrial regions of the<br>heart. |
| Catheter Body<br>Tubing | Pebax (distal body)<br>Stainless Steel/<br>polyimide<br>(proximal) | Pebax (distal body)<br>Stainless Steel<br>(proximal) |
| Diameter | 3.3F | 3.3F |
| Effective Length | 146cm | 146cm |
| Number of<br>Electrodes | 10 | 8 |
| Distal End Shape | Circular Loop | Circular Loop |
| Loop Diameter | 25mm | 15mm and 20mm |
| Loop Material | Nitinol insulated | Nitinol insulated with |

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| | with PET (Pebax covered) | PET (Pebax covered) |
|---------------------------------------|--------------------------|---------------------|
| Delivered through a delivery catheter | Yes | Yes |

## Performance Data

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 ST Mapping Catheter performs as designed and is suitable for its intended use.

Performance testing included the following:

Radial Loop Compliance Distal Stiffness Axial Load Torque Response Turns to Failure Electrical Continuity Device Functionality Kink Resistance Joint Strength Contrast Media Flow Rate Stiffness Electrical Testing and Electrical Safety Testing (ISO 60601-1:2006) Corrosion Resistance (ISO 10555-1:2009)

Biocompatability testing included the following: Cytotoxicity (ISO 10993-5) Kligman Sensitization (ISO 10993-10) Intracutaneous Injection (ISO 10993-10) Systemic Injection, Acute (ISO 10993-11) Rabbit Pyrogen, Material Mediated (ISO 10993-11) Hemolysis (ASTM F756) Prothombin Time Assay (ISO 10993-4) Unactivated Partial Thromboplast in Time Assay (ISO 10993-4) Complement Activation Assay (ISO 10993-4) Thrombogenicity (ISO 10993-4)

The associated Connecting 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).

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## Conclusion

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