(189 days)
Not Found
No
The summary describes a physical mapping catheter and its performance testing, with no mention of AI, ML, or any software-based analysis of the collected electrograms.
No
The device is used for electrophysiological mapping (recording or stimulation) to obtain electrograms, which is a diagnostic function, not a therapeutic one.
Yes
The 'Device Description' section explicitly states, "The Achieve ST Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter," indicating its diagnostic purpose. Additionally, the 'Intended Use / Indications for Use' section mentions "mapping" and "recording," which are diagnostic activities.
No
The device description clearly states it is an "intra-cardiac electrophysiology recording catheter" with a "distal mapping section" and "electrodes," indicating it is a physical hardware device, not software only. The performance studies also detail testing on physical properties and materials.
Based on the provided information, the AchieveTM ST mapping catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This involves directly interacting with the patient's body to measure electrical activity within the heart.
- Device Description: The device is described as an "intra-cardiac electrophysiology recording catheter." This confirms its use within the body.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The AchieveTM ST mapping catheter is an in vivo device, meaning it is used within a living organism. It directly interacts with the patient's heart to record electrical signals, which is a diagnostic procedure performed on the patient, not on a specimen from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Achieve ST 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 ST Mapping Catheter is a circular loop with evenly spaced electrodes to map electrical conduction within the atrium. The Achieve ST Mapping Catheter is available in a 25mm pre-shaped distal loop diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures of the heart, atrial regions of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Achieve™ Mapping Catheter K102588
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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/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
2
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)
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared: | October 26, 2015 | |
|---|---|---|
| Applicant: | Medtronic Inc. | |
| 710 Medtronic Parkway | ||
| Minneapolis, MN 55432 | ||
| Establishment Registration No.: 3001504994 | ||
| Contact Person: | Heather Taylor | |
| Principal Regulatory Affairs Specialist | ||
| Medtronic Inc. | ||
| Coral Sea Street | ||
| Mounds View, MN 55112 | ||
| Telephone: 763.526.9066 | ||
| Fax: 763.367.9903 | ||
| Email: heather.m.taylor@medtronic.com | ||
| Trade Name: | Achieve™ ST Mapping Catheter | |
| Common Name: | Catheter, electrode recording, or probe, electrode | |
| 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 | |
| electrophysiology recording catheter and can be used for cardiac | ||
| stimulation during electrophysiology studies. The distal mapping | ||
| section of the Achieve ST Mapping Catheter is a circular loop with | ||
| evenly spaced electrodes to map electrical conduction within the | ||
| atrium. The Achieve ST Mapping Catheter is available in a 25mm | ||
| pre-shaped distal loop diameter. | ||
| Intended Use of Device: | The intended use of the Achieve ST Mapping Catheter is to record |
4
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
Catheter (Subject
Device) K153139 | Achieve Catheter
(predicate device)
K102588 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Map intracardiac
structures of the
heart | Map intracardiac
structures of the heart |
| Indications for
Use | The Achieve ST is
indicated for
multiple electrode
electrophysiological
mapping of cardiac
structures (i.e.,
recording and
stimulation only).
The Achieve ST
Catheter is
designed to obtain
electrograms in the
atrial regions of the
heart. | The Achieve is
indicated
for multiple electrode
electrophysiological
mapping of cardiac
structures (i.e.,
recording and
stimulation only). The
Achieve Catheter is
designed to obtain
electrograms in the
atrial regions of the
heart. |
| Catheter Body
Tubing | Pebax (distal body)
Stainless Steel/
polyimide
(proximal) | Pebax (distal body)
Stainless Steel
(proximal) |
| Diameter | 3.3F | 3.3F |
| Effective Length | 146cm | 146cm |
| Number of
Electrodes | 10 | 8 |
| Distal End Shape | Circular Loop | Circular Loop |
| Loop Diameter | 25mm | 15mm and 20mm |
| Loop Material | Nitinol insulated | Nitinol insulated with |
5
| 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).
6
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.