(118 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is used for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
Explanation: The device is a Coronary Dilatation Catheter used for therapeutic purposes (balloon dilatation of stenotic portions or occlusions). It is not described as assessing, monitoring, or detecting physiological parameters or conditions for diagnostic purposes.
No
The device description clearly outlines physical components such as a catheter, balloon, lumens, guide wire, coatings, radiopaque markers, and a Luer-lock fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NC TREK NEO™ Coronary Dilatation Catheter is a medical device used directly within the body (in vivo) to physically dilate narrowed or blocked coronary arteries or bypass grafts. It is a mechanical intervention, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedure performed on a patient's coronary arteries, not a diagnostic test on a biological sample.
- Device Description: The description details the physical components of a catheter designed for insertion into the body, including a balloon, guide wire lumen, and inflation lumen. These are characteristic of an interventional device, not an IVD.
Therefore, the NC TREK NEO™ Coronary Dilatation Catheter falls under the category of an interventional cardiovascular device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
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)
The NC TREK NEO™ Coronary Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence.
The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new questions of safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate device.
The following biocompatibility and chemical characterization tests were completed on the NC TREK NEO™ Coronary Dilatation Catheter:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic & Pyrogenicity
- Hemocompatibility
The following dimensional and in-vitro performance tests were completed and support the NC TREK NEOTM Coronary Dilatation Catheter
- Tip dimensions
- Crossing Profile
- Guidewire Lumen
- Shaft Dimensions
- Proximal Shaft Marker Location
- Catheter Length
- Catheter Preparation
- Balloon Inflation/Deflation Time
- Balloon Rated Burst Pressure (RBP)
- Maximum Compliance Label
- Balloon Compliance
- Balloon RBP (In-Stent)
- Proximal Seal Tensile Strength
- Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile Strength)
- Proximal Adaption Tensile Strength
- Catheter Tip Tensile Strength
- Inner Member Lumen Collapse
- Balloon Fatigue Resistance
- Balloon Fatigue Resistance (In-Stent)
- Hydrophilic Coating- Dry Adhesion of Coating
- Hydrophilic Coating- Coefficient of Friction
- Kink/Flex
- Torque
- Particulates
- Finished Good Sheath Removal
- Balloon Preparation, Deployment and Retraction
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.
P810046/S226, P810046/S232, K103153, K141236
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
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 30, 2022
Abbott Vascular Nishi Singh Regulatory Affairs Project Manager 3200 Lakeside Drive Santa Clara, California 95054
Re: K220634
Trade/Device Name: NC TREK NEO Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: March 3, 2022 Received: March 4, 2022
Dear Nishi Singh:
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
1
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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220634
Device Name NC TREK NEO™ Coronary Dilatation Catheter
Indications for Use (Describe)
The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, sans-serif letter 'a' in a light blue color. Below the symbol, the company name "Abbott" is written in a bold, black, sans-serif font.
ABBOTT VASCULAR
3200 Lakeside Drive Santa Clara, CA 95054
T: 408 845 3000 F: 408 845 3743
510(k) SUMMARY - K220634
The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. SUBMITTER'S NAME | Abbott Vascular (with Business Trade Name as
Abbott Medical) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. SUBMITTER'S ADDRESS | 3200 Lakeside Drive, Santa Clara, CA 95054 |
| 3. TELEPHONE | (408) 845-3000 |
| 4. FAX | (408) 845-3743 |
| 5. CONTACT PERSON | Nishi Singh |
| 6. DATE PREPARED | May 31, 2022 |
| 7. DEVICE TRADE NAME | NC TREK NEO™ Coronary Dilatation Catheter |
| 8. DEVICE COMMON NAME | Coronary Dilatation Catheter Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| 9. DEVICE CLASSIFICATION NAME | PTCA Catheter, LOX, Class II |
| 10. PREDICATE DEVICE NAME | NC TREK™ RX Coronary Dilatation Catheter
(K180040) |
| 11. REFERENCE DEVICE NAME | Voyager NC (P810046/S226, approved August 21
2008, P810046/S232, approved Feb 4, 2010, and
downgraded to Class II- K103153, cleared
December 30, 2010) and |
NC Emerge Monorail (K141236)
4
11. DEVICE DESCRIPTION
NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.
12. INDICATIONS FOR USE
The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
- a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
- b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST segment elevation myocardial infarction.
- c) balloon dilatation of a stent after implantation (balloon models 2.00mm 5.00mm only)
13. SUBSTANTIAL EQUIVALENCE
The NC TREK NEOTM Coronary Dilatation Catheter incorporates substantially equivalent device materials and design, packaging materials and design, manufacturing processes, sterilization process, and the same indications for use and principles of operation as in the Abbott Vascular predicate device:
NC TREKTM RX Coronary Dilatation Catheter (K180040)
5
| Comparison
Items | Subject Device – NC TREK
NEO™ Coronary Dilatation
Catheter | Predicate Device – NC
TREKTM RX Coronary
Dilatation Catheter | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Indications
for Use | balloon dilatation of
a)
the stenotic portion of
a coronary artery or
bypass graft stenosis,
for the purpose of
improving
myocardial perfusion.
balloon dilatation of a
b)
coronary artery
occlusion, for the
purpose of restoring
coronary flow in
patients with ST-
segment elevation
myocardial
infarction.
balloon dilatation of a
c)
stent after
implantation (balloon
models 2.00 mm -
5.00 mm only) | a) balloon dilatation of
the stenotic portion of
a coronary artery or
bypass graft stenosis,
for the purpose of
improving myocardial
perfusion.
b) balloon dilatation of a
coronary artery
occlusion, for the
purpose of restoring
coronary flow in
patients with ST-
segment elevation
myocardial infarction.
c) balloon dilatation of a
stent after
implantation (balloon
models 2.00 mm -
5.00 mm only) | Identical |
| Classification
Name | Percutaneous Transluminal
Coronary Angioplasty
(PTCA) Catheter 21 CFR
870.5100 (class II, special
control) | Percutaneous
Transluminal Coronary
Angioplasty (PTCA)
Catheter 21 CFR
870.5100 (class II,
special control) | Identical |
| Product Code | LOX | LOX | Identical |
| Sterilization
method | Sterilization Method:
Ethylene Oxide | Sterilization Method:
Ethylene Oxide | Identical |
| Shelf Life | 36-month (3 years) | 36-month (3 years) | Identical |
| System Type | Rapid Exchange (RX) | Rapid Exchange (RX) | Identical |
| Balloon
Diameter
(mm) | 1.5-6.0mm | 1.5-5.0mm | Equivalent |
| Balloon
Length (mm) | 6-25mm | 6-25mm | Identical |
| Comparison
Items | Subject Device – NC TREK
NEOTM Coronary Dilatation
Catheter | Predicate Device - NC
TREKTM RX Coronary
Dilatation Catheter | Comparison |
| Balloon
Material
1.50 - 5.0 mm
Size | Polyether block amide | Polyether block amide | Identical |
| Balloon
Material
5.50 - 6.00
mm Size | Polyamide | N/A | 5.50 - 6.00 mm Sizes are
not in the NC TREK RX
Size Matrix. |
| Catheter
Coating | Hydrophilic Coating | Hydrophilic Coating | Identical |
| Balloon
Compliance | Non-Compliant | Non-Compliant | Identical |
| Balloon Rated
Burst Pressure
(RBP) | 18 atm (Minimum) | 18 atm (Minimum) | Identical |
| Guidewire
Size (inch) | 0.014" | 0.014" | Identical |
| Total Catheter
Length | 145 cm | 143 cm | Equivalent |
6
14. PERFORMANCE DATA
The NC TREK NEO™ Coronary Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence.
The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new questions of safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate device.
The following biocompatibility and chemical characterization tests were completed on the NC TREK NEO™ Coronary Dilatation Catheter:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic & Pyrogenicity ●
- Hemocompatibility ●
7
The following dimensional and in-vitro performance tests were completed and support the NC TREK NEOTM Coronary Dilatation Catheter
- Tip dimensions ●
- Crossing Profile ●
- Guidewire Lumen ●
- Shaft Dimensions ●
- Proximal Shaft Marker Location ●
- Catheter Length ●
- Catheter Preparation
- . Balloon Inflation/Deflation Time
- Balloon Rated Burst Pressure (RBP) ●
- Maximum Compliance Label
- Balloon Compliance ●
- Balloon RBP (In-Stent) ●
- Proximal Seal Tensile Strength ●
- Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile ● Strength)
- Proximal Adaption Tensile Strength
- Catheter Tip Tensile Strength
- Inner Member Lumen Collapse ●
- Balloon Fatigue Resistance ●
- Balloon Fatigue Resistance (In-Stent)
- Hydrophilic Coating- Dry Adhesion of Coating
- Hydrophilic Coating- Coefficient of Friction ●
- Kink/Flex
- Torque ●
- Particulates ●
- Finished Good Sheath Removal
- Balloon Preparation, Deployment and Retraction
CONCLUSIONS 15.
Given that the indications for use and the technological characteristics of the NC TREK NEO™ Coronary Dilatation Catheter are the same to the predicate device, and the results of the performance testing demonstrate no new questions of safety and effectiveness of the subject device when compared to the predicate device. Abbott concludes that the NC TREK NEO™ Coronary Dilatation Catheter is substantially equivalent to the Abbott predicate device - NC TREK RX Coronary Dilatation Catheter.