(149 days)
Not Found
No
The description focuses on the physical characteristics and function of a reprocessed electrophysiology catheter for recording and stimulation, with no mention of AI or ML for data analysis or interpretation.
No
The device is used for electrophysiological mapping (recording of electrical activity) and stimulation only, which are diagnostic procedures, not therapeutic interventions.
Yes
The device is explicitly named "Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter" and its intended use is for "electrophysiological mapping of the cardiac structures of the heart," which is a diagnostic activity.
No
The device description explicitly states it is a "Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter," which is a physical, intra-cardiac catheter with electrodes. The submission focuses on the reprocessing of this hardware device.
Based on the provided text, 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 involves directly interacting with the patient's heart to record electrical signals or provide stimulation.
- Device Description: The device is described as an "intra-cardiac electrophysiology (EP) recording catheter." This confirms its use within the body.
- 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. This device does not perform tests on samples taken from the body; it interacts directly with the body.
The device is a medical device used for diagnostic purposes within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
Product codes
NLH
Device Description
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is an intra-cardiac electrophysiology (EP) recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the mapping catheter is a circular loop with eight or ten evenly spaced electrodes to map electrical conduction between the left atrium and the pulmonary veins.
The reprocessed mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Refer to the applicable Medtronic Arctic Front Technical Manual for additional instructions for use.
The reprocessed mapping catheter should only be used with the Medtronic catheter connecting cable (Model 2ACHC), which interfaces with standard electrophysiology recording equipment. For cable instructions, see the Medtronic 2ACHC catheter connecting cable instructions for use.
Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.
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, left atrium, pulmonary veins
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Achieve Advance Mapping Diagnostic EP Catheter. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Verification
- Electrical Continuity and Resistance
- Simulated Use
- Mechanical Characteristics
- Electrical Safety Testing
- Dielectric and Current Leakage
- Packaging Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2019
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K191880
Trade/Device Name: Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: November 12, 2019 Received: November 13, 2019
Dear Amanda Babcock:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
Page
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Nicole Gillette Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| Item Number | Device Description | Electrodes | Loop
Diameter
(mm) | Spacing
(mm) | French
Size | Total
Length
(cm) | Usable
Length
(cm) |
|-------------|------------------------------------------------------|------------|--------------------------|-----------------|----------------|-------------------------|--------------------------|
| 2ACH15 | Achieve Advance
Mapping Diagnostic
EP Catheter | 8 | 15 | 4 | 3.3F | 165 | 146 |
| 2ACH20 | Achieve Advance
Mapping Diagnostic
EP Catheter | 8 | 20 | 6 | 3.3F | 165 | 146 |
| 2ACH25 | Achieve Advance
Mapping Diagnostic
EP Catheter | 10 | 25 | 6 | 3.3F | 165 | 146 |
The following device models are included in the scope of this 510(k) submission:
3
Indications for Use
510(k) Number (if known) K191880
Device Name
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The 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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SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
July 12, 2019
Device Information:
| Trade/Proprietary Name: | Reprocessed Achieve Advance Mapping Diagnostic
Electrophysiology Catheter | | | |
|-------------------------|------------------------------------------------------------------------------|--|--|--|
| Common Name: | Diagnostic Electrophysiology Catheter | | | |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed | | | |
| Classification Number: | Class II, 21 CFR 870.1220 | | | |
| Product Code: | NLH | | | |
Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K162892 | Achieve Advance Mapping | |
| Electrophysiology Catheter | Medtronic |
Device Description:
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is an intra-cardiac electrophysiology (EP) recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the mapping catheter is a circular loop with eight or ten evenly spaced electrodes to map electrical conduction between the left atrium and the pulmonary veins.
The reprocessed mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Refer to the applicable Medtronic Arctic Front Technical Manual for additional instructions for use.
5
The reprocessed mapping catheter should only be used with the Medtronic catheter connecting cable (Model 2ACHC), which interfaces with standard electrophysiology recording equipment. For cable instructions, see the Medtronic 2ACHC catheter connecting cable instructions for use.
Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.
Indications for Use:
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
| Item Number | Device Description | Electrodes | Loop
Diameter
(mm) | Spacing
(mm) | French
Size | Total
Length
(cm) | Usable
Length
(cm) |
|-------------|------------------------------------------------------|------------|--------------------------|-----------------|----------------|-------------------------|--------------------------|
| 2ACH15 | Achieve Advance
Mapping Diagnostic
EP Catheter | 8 | 15 | 4 | 3.3F | 165 | 146 |
| 2ACH20 | Achieve Advance
Mapping Diagnostic
EP Catheter | 8 | 20 | 6 | 3.3F | 165 | 146 |
| 2ACH25 | Achieve Advance
Mapping Diagnostic
EP Catheter | 10 | 25 | 6 | 3.3F | 165 | 146 |
The item numbers in scope of this submission are as follows:
Table 5.1: Device Scope
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology (EP) Catheter is identical to the predicate device. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of this device includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Achieve Advance Mapping Diagnostic EP Catheter. This included the following:
- Biocompatibility
- Cleaning Validation ●
- Sterilization Validation
Innovative Health Reprocessed Diagnostic EP Catheters
Page 2 of 3 Traditional 510(k) K191880
6
- . Functional Testing
- Visual Inspection .
- . Dimensional Verification
- Electrical Continuity and Resistance .
- Simulated Use .
- . Mechanical Characteristics
- Electrical Safety Testing ●
- Dielectric and Current Leakage .
- . Packaging Validation
The Reprocessed Achieve Advance Mapping Diagnostic EP Catheter is reprocessed no more than two (2) times. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Achieve Advance Mapping Diagnostic EP Catheter is as safe and effective as the predicate device described herein.