(59 days)
No
The device description and performance studies focus on the electrical and physical properties of a connecting cable, with no mention of AI or ML.
No
This device is a connecting cable for a mapping catheter, designed to link the catheter to an ECG interface box. It facilitates the function of a therapeutic device (the mapping catheter) by ensuring electrical connection for monitoring, but it does not directly perform or contribute to a therapeutic action itself.
No
This device is a cable that connects a mapping catheter to an ECG interface box, facilitating the electrical connection, but it does not perform diagnostic functions itself. Its purpose is to transmit signals from a diagnostic catheter to a recording device.
No
The device is a physical cable designed to connect a catheter to an ECG interface box. The description and performance studies focus on hardware aspects like electrical continuity, dimensional verification, and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a connection between a mapping catheter and an ECG interface box for use with standard EP recording and pacing equipment. This is a device used in vivo (within the body) to facilitate the recording of electrical signals from the heart, not to perform tests on samples taken from the body.
- Device Description: The description reinforces its function as a conductor for electrical signals from a catheter used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely to connect equipment for in vivo procedures.
N/A
Intended Use / Indications for Use
The Reprocessed Achieve Catheter Connecting Cable is designed for use only with the Achieve family of mapping catheters. It is intended to provide connection of the catheter to a standard ECG interface box.
Product codes
NLH
Device Description
The Reprocessed Achieve Catheter Connecting Cable provides conduction from the proximal end of the mapping catheter to standard shielded ECG pins that connect standard EP recording and pacing equipment. The cable is designed for use with the Achieve family of mapping catheters.
Note: Only the Catheter Connecting Cable 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
Not Found
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Achieve Catheter Connecting Cable. This included the following:
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Verification
- Electrical Continuity Testing
- High Potential (HiPOT) Testing
- Packaging Validation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
January 24, 2020
Innovative Health, LLC. Amanda Babock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K193263
Trade/Device Name: Reprocessed Achieve Catheter Connecting Cable Regulatory Class: 21 CFR 870.1220 Product Code: NLH Dated: November 25, 2019 Received: November 26, 2019
Dear Amanda Babock:
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 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-reporting
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combination-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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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The item number in scope of this submission is as follows:
Item Number | Device Description | Length (Ft) | Number of Pins - Console Connector | Number of Pins - Catheter Connector |
---|---|---|---|---|
2ACHC | Achieve Catheter Connecting Cable | 6.4 | 10 | 14 |
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Indications for Use
510(k) Number (if known) K193263
Device Name
Reprocessed Achieve Catheter Connecting Cable
Indications for Use (Describe)
The Reprocessed Achieve Catheter Connecting Cable is designed for use only with the Achieve family of mapping catheters. It is intended to provide connection of the catheter to a standard ECG interface box.
X 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 Requlatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
November 25, 2019
Device Information:
Trade/Proprietary Name: Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Achieve Catheter Connecting Cable Diagnostic Electrophysiology Catheter Connecting Cable Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH
Predicate Device:
510(k) Number | 510(k) Device | Manufacturer |
---|---|---|
K153139 | Achieve Catheter Connecting Cable | Medtronic Inc. |
Reference Device:
510(k) Number | 510(k) Device | Manufacturer |
---|---|---|
K030279 | Reprocessed Electrophysiology | |
Catheters | Alliance Medical Corp. | |
K030187 | Reprocessed Electrophysiology | |
Catheters | Alliance Medical, Inc. |
Device Description:
The Reprocessed Achieve Catheter Connecting Cable provides conduction from the proximal end of the mapping catheter to standard shielded ECG pins that connect standard EP recording and pacing equipment. The cable is designed for use with the Achieve family of mapping catheters.
Note: Only the Catheter Connecting Cable is the subject of this submission. Any other related equipment is not included in the scope of this submission.
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Indications for Use:
The Reprocessed Achieve Catheter Connecting Cable is designed for use only with the Achieve family of mapping catheters. It is intended to provide connection of the catheter to a standard ECG interface box.
The item number in scope of this submission is as follows:
| Item Number | Device
Description | Length
(Ft) | Number of Pins -
Console Connector | Number of Pins -
Catheter Connector |
|-------------|--------------------------------------|----------------|---------------------------------------|----------------------------------------|
| 2ACHC | Achieve Catheter
Connecting Cable | 6.4 | 10 | 14 |
Table 5.1: Device Scope
Technoloqical Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Achieve Catheter Connecting Cable 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 Catheter Connecting Cable. This included the following:
- Cleaning Validation ●
- Sterilization Validation
- Functional Testing ●
- · Visual Inspection
- Dimensional Verification .
- Electrical Continuity Testing .
- High Potential (HiPOT) Testing
- Packaging Validation ●
The Reprocessed Achieve Catheter Connecting Cable 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 Catheter Connecting Cable is as safe and effective as the predicate device described herein.