(29 days)
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No
The document describes a standard electrophysiology mapping catheter and its performance testing, with no mention of AI or ML capabilities.
No
The device is described as a "mapping catheter" and "diagnostic catheter" used to "record" and "stimulate" electrical activity in the heart to obtain electrograms. Its purpose is diagnosis and monitoring, not direct treatment.
Yes
The device description explicitly states, "The Achieve Advance Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter," and its intended use is for "multiple electrophysiological mapping of the cardiac structures of the heart" to obtain "electrograms," which are used for diagnosis.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Achieve Advance mapping catheter is an intra-cardiac electrophysiology recording catheter. It is inserted directly into the heart to record electrical signals and potentially stimulate the heart. This is an in vivo procedure (performed within the living body), not an in vitro procedure (performed outside the living body).
- Intended Use: The intended use clearly states "multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This describes a procedure performed directly on the patient's heart.
Therefore, the Achieve Advance mapping catheter is a medical device used for a diagnostic procedure performed within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
DRF
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cardiac structures of the heart, atrial regions of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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™ ST Mapping Catheter (K153139)
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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures in profile.
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
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/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
2
Indications for Use
510(k) Number (if known) K162892
Device Name Achieve Advance Mapping Catheter
Indications for Use (Describe)
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.
| 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 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 Advance™ 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™ ST Mapping Catheter (K153139) | |||
| 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. |
4
| Intended Use of Device: | The intended use of the Achieve Advance Mapping Catheter is to
record intracardiac signals and provide cardiac stimulation during
electrophysiology studies. |
| ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 Advance
Catheter - Line
Extension (Subject
Device) | Achieve ST Catheter
(predicate device, now
named Achieve
Advance Catheter)
K153139 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Map intracardiac
structures of the
heart | Map intracardiac
structures of the heart |
| Indications for
Use | The Achieve
Advance is
indicated for
multiple electrode
electrophysiological
mapping of cardiac
structures (i.e.,
recording and
stimulation only).
The Achieve
Advance Catheter
is designed to
obtain
electrograms in the
atrial regions of the
heart. | 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. |
| Catheter Body
Tubing | Nitinol/Pebax
(distal body)
Stainless Steel/
polyimide
(proximal) | Nitinol/Pebax (distal
body)
Stainless Steel/
polyimide (proximal) |
| Diameter | 3.3F | 3.3F |
5
| Effective Length | 146cm | 146cm |
|---|---|---|
| Number of | ||
| Electrodes | 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.