(121 days)
No
The device description and performance studies focus on the mechanical and physical properties of a steerable introducer, with no mention of AI or ML capabilities.
No
This device is an introducer sheath, which is used to facilitate the insertion of other catheters. It does not provide any direct therapeutic benefit to the patient.
No
The device is an introducer used to facilitate the placement of cardiovascular catheters, not to diagnose a condition. Its function is to provide access and positioning for other medical instruments.
No
The device description clearly outlines physical components (sheath, dilator, guidewire, handle, valve, sideport) and performance studies focus on physical and mechanical testing, indicating it is a hardware 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 procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device used for accessing and navigating within the heart. It does not describe a test or assay performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are 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 is a surgical/interventional tool used for accessing and manipulating structures within the body.
N/A
Intended Use / Indications for Use
The Reprocessed Agilis NxT Steerable Introducing various cardiovascular cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.
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.
Product codes (comma separated list FDA assigned to the subject device)
PNE
Device Description
The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire 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 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 (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 Agilis NxT Steerable Introducer. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation ●
- Physical and Mechanical Testing ●
- Visual Inspection
- Dimensional Verification ●
- Tensile ●
- Deflection ●
- Simulated Use
- . Leak
- . Radiopacity
- Packaging Validation .
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.
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
§ 870.1340 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/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
Innovative Health, LLC. Ms. Amy Stoklas-Oakes Sr. Quality and Regulatory Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K170311
Trade/Device Name: Reprocessed Agilis NxT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Reprocessed Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: April 28, 2017 Received: May 1, 2017
Dear Ms. Amy Stoklas-Oakes,
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 of medical device
1
related adverse events) (21 CFR 803); 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.
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.
M.A. Hillemann
for
Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment
The following models are included in the clearance of K170311:
- 408309
- 408310
- o G408324
- . G408318
- G408319 ●
3
Indications for Use
510(k) Number (if known) K170311
Device Name
Reprocessed Agilis NxT Steerable Introducer
Indications for Use (Describe)
The Reprocessed Agilis NxT Steerable Introducing various cardiovascular 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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4
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:
Amy Stoklas-Oakes Innovative Health. LLC. Sr. Quality and Regulatory Manager (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com
Date prepared:
January 31, 2017
Device Information:
Trade/Proprietary Name: Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Aqilis NxT Steerable Introducer Steerable Introducer Reprocessed Catheter Introducer Class II, 21 CFR 870.1340 PNE
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K081645 | Agilis NxT Steerable Introducer | St. Jude Medical |
| K061363 | Agilis NxT Steerable Introducer | St. Jude Medical |
Device Description:
The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire 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 subject of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.
The item numbers included in the scope of this submission are as follows:
5
| DESCRIPTION | ITEM
NUMBER | FRENCH SIZE | | USEABLE
LENGTH
(cm) | CURVE TYPE | CURVE
REACH
(mm) |
|---------------------------------------|----------------|-------------|-------|---------------------------|---------------------------------------------|------------------------|
| AGILIS NxT
STEERABLE
INTRODUCER | 408309 | 8.5F | 11.5F | 71 | SMALL CURL
DUAL REACH
BI-DIRECTIONAL | 16.8 |
| AGILIS NxT
STEERABLE
INTRODUCER | 408310 | 8.5F | 11.5F | 71 | MEDIUM CURL
DUAL REACH
BI-DIRECTIONAL | 22.4 |
| AGILIS NxT
STEERABLE
INTRODUCER | G408324 | 8.5F | 11.5F | 71 | LARGE CURL
DUAL REACH
BI-DIRECTIONAL | 50.0 |
| AGILIS NxT
STEERABLE
INTRODUCER | G408318 | 8.5F | 11.5F | 61 | SMALL CURL
DUAL REACH
BI-DIRECTIONAL | 16.8 |
| AGILIS NxT
STEERABLE
INTRODUCER | G408319 | 8.5F | 11.5F | 61 | MEDIUM CURL
DUAL REACH
BI-DIRECTIONAL | 22.4 |
Table 5.1: Item Numbers
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 devices. 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 ●
- Physical and Mechanical Testing ●
- Visual Inspection
- Dimensional Verification ●
- Tensile ●
- Deflection ●
- Simulated Use
- . Leak
- . Radiopacity
- Packaging Validation .
6
The Reprocessed Agilis NxT Steerable Introducer are reprocessed no more than one (1) time. Each device is marked 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 Introducers are as safe and effective as the predicate devices described herein.