(175 days)
No
The device description and performance studies focus on the mechanical and physical properties of a reprocessed medical device, with no mention of AI or ML capabilities.
No
The device is an introducer, which facilitates access for other catheters. It does not provide any therapeutic effect on its own.
No
Explanation: The device description indicates that the Reprocessed Agilis NxT Introducer is used for introducing various cardiovascular catheters into the heart. Its components and functions (like a steerable sheath, dilator, hemostasis valve, and sideport for fluid management) are designed to facilitate catheter placement for interventional procedures, not to diagnose a condition.
No
The device description clearly outlines physical components (steerable sheath, dilator, guidewire, handle, valves, sideport, stopcock, tip marker, vent holes) and the performance studies focus on physical and mechanical testing, biocompatibility, cleaning, sterilization, and packaging validation, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the heart. This is a procedural device used in vivo (within the body) for a medical intervention.
- Device Description: The description details a physical device (sheath, dilator, guidewire) designed for mechanical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits used to detect or measure substances in these specimens.
Therefore, the Reprocessed Agilis NxT Introducer is a medical device used for a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.
Product codes
PNE
Device Description
The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
Note: Only the steerable sheath and dilator are the subject of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart including the left side of the heart through the interatrial septum.
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 Agilis NxT Steerable Introducer. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Physical and Mechanical Testing
- Visual Inspection
- Dimensional Verification
- Tensile Testing
- Deflection Testing
- Simulated Use Testing
- Leak Testing
- Radiopacity Testing
- Packaging Validation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
August 7, 2023
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257
Re: K230376
Trade/Device Name: Reprocessed Agilis NxT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: July 14, 2023 Received: July 17, 2023
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.
1
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-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 mediation-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.
Rachel E. Neubrander -S
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Agilis NxT Steerable Introducer
Indications for Use (Describe)
The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.
Type of Use (Select one or both, as applicable)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 Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
2/10/2023
Device Information:
| Trade/Proprietary Name: | Reprocessed Agilis NxT Steerable Introducer |
|---|---|
| Common Name: | Steerable Introducer |
| Classification Name: | Reprocessed Catheter Introducer |
| Classification Number: | Class II, 21 CFR 870.1340 |
| Product Code: | PNE |
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K081645 | Agilis NxT Steerable Introducer | Abbott (formerly St. |
| Jude Medical) |
Reference Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K170311 | Reprocessed Agilis NxT Steerable | |
| Introducer | Innovative Health, LLC |
Device Description:
The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
Note: Only the steerable sheath and dilator are the subject of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.
4
The item numbers included in the scope of this submission are as follows:
| DESCRIPTION | ITEM
NUMBER | FRENCH SIZE | | USEABLE
LENGTH
(cm) | CURVE TYPE | CURVE
REACH
(mm) |
|------------------------------------------------------|----------------|-------------|-------|---------------------------|---------------------------------------------|------------------------|
| Reprocessed
Agilis Nxt
Steerable
Introducer | 408309 | 8.5F | 11.5F | 71 | Small Curl
Dual Reach
Bi-Directional | 16.8 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | 408310 | 8.5F | 11.5F | 71 | Medium Curl
Dual Reach
Bi-Directional | 22.4 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | G408324 | 8.5F | 11.5F | 71 | Large Curl
Dual Reach
Bi-Directional | 50.0 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | G408318 | 8.5F | 11.5F | 61 | Small Curl
Dual Reach
Bi-Directional | 16.8 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | G408319 | 8.5F | 11.5F | 61 | Medium Curl
Dual Reach
Bi-Directional | 22.4 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | G408320 | 8.5F | 11.5F | 71 | Small Curl
Dual Reach
Bi-Directional | 16.8 |
| Reprocessed
Agilis Nxt
Steerable
Introducer | G408321 | 8.5F | 11.5F | 71 | Medium Curl
Dual Reach
Bi-Directional | 22.4 |
Table 5.1: Device Scope
Indications for Use:
The Reprocessed Agilis NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Steerable Introducer are 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 these devices 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 Agilis NxT Steerable Introducer. This included the following:
- Biocompatibility ●
- Cleaning Validation
- Sterilization Validation ●
5
- Physical and Mechanical Testing
- Visual Inspection
- 트 Dimensional Verification
- . Tensile Testing
- . Deflection Testing
- . Simulated Use Testing
- . Leak Testing
- . Radiopacity Testing
- Packaging Validation
The Reprocessed Agilis NxT Steerable Introducer is reprocessed no more than one (1) time. 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 Agilis NxT Steerable Introducer, is as safe and effective as the predicate device described herein.