(190 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and function of a mapping catheter for recording and stimulating cardiac electrical activity. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a diagnostic mapping catheter used for recording and stimulation, not for treating a condition.
Yes
The 'Device Description' specifically states: "The Achieve™ diagnostic mapping catheter is an intra-cardiac electrophysiology recording catheter..." indicating its diagnostic purpose.
No
The device description clearly details a physical catheter with electrodes and an electrical cable, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This describes a procedure performed within the body to measure electrical activity.
- Device Description: The device is an "intra-cardiac electrophysiology recording catheter." This confirms it is used invasively inside the heart.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
This device is a medical device used for a diagnostic procedure performed in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / 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 Achieve 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™ 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.
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 Mapping Catheter performs as designed and is suitable for its intended use. Performance testing included: 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: 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).
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.
ProMap™, Lasso™
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/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol appears to depict a stylized human figure within a circle.
MAR 1 8 2011
02588
510(K) SUMMARY
| Date Prepared: | March 7, 2011 |
|---|---|
| Trade Name of Device: | |
| Common Name: | Achieve™ Mapping Catheter |
| Catheter, electrode recording, or probe, electrode | |
| recording | |
| Classification: | Class II, 21 CFR 870.1220, Electrode Recording |
| Catheter | |
| Applicant: | Medtronic Ablation Frontiers |
| 2210 Faraday Avenue, Suite 100 | |
| Carlsbad, CA 92008 USA | |
| Tel: 760-827-0007 | |
| Fax: 760-827-0020 | |
| Contact Person: | Brenda Clay |
| Regulatory Affairs | |
| Predicate Devices: | ProMap™, ProRhythm |
| Lasso™, Biosense Webster |
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.
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 Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart.
Contraindications:
The catheter is contraindicated as follows:
- For use as an ablation device .
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1
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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 intracardiac
structures of the heart | Map intracardiac
structures of the heart | Map intracardiac
structures of the heart |
| Indications for Use | 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. | The ProRhythm ProMap is
to be used for the
evaluation of cardiac
arrhythmias from
endocardial and
intravascular sites. The
ProMap coaxial mapping
Catheter is typically used
in Electrophysiology
clinical procedures. | The LASSO Catheter is
indicated for multiple
electrode
electrophysiological
mapping of cardiac
structures (i.e., recording
and stimulation only). The
LASSO Catheter is
designed to obtain
electrograms in the atrial
regions 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 a
delivery 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.
2
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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.
3
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.
4
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 |