(178 days)
No
The device description and performance studies focus on the mechanical aspects of the balloon angioplasty system and embolic filter, with no mention of AI or ML.
Yes
The device is a peripheral balloon angioplasty system used for percutaneous transluminal angioplasty (PTA) and embolic material capture/removal, which is a therapeutic medical intervention.
No
The device is described as an angioplasty system with integrated embolic protection, used for percutaneous transluminal angioplasty (PTA) to treat blockages and capture embolic material. This is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines a physical catheter system with a balloon, filter, guidewire compatibility, radiopaque markers, and a pull-wire mechanism, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Vanguard IEP Peripheral Balloon Angioplasty System is a device used within the body (in vivo) to perform a medical procedure (angioplasty and embolic protection) on blood vessels. It does not analyze samples taken from the body.
The description clearly outlines a device used for a therapeutic intervention within the circulatory system, not for diagnostic testing of biological samples.
No
A PCCP authorized device would explicitly state its authorization under the Predetermined Change Control Plan within the clearance letter, often in sections related to the device's authorization or the scope of the clearance. The provided text does not contain any mention or indication that this device is authorized as a PCCP device.
Intended Use / Indications for Use
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, NTE
Device Description
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection platform is similar to a catheter with a typical angioplasty balloon, but between the distal end of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter component is composed of a nitinol filter frame with an overlying membrane perforated with a set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque markers, making the diameter of the filter visible when opened. The proximal end of the nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter frame to activate the filter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, popliteal and profunda arteries.
Indicated Patient Age Range
Mean age was 67.4 ± 10.3 years.
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)
Summary of Non- Clinical Data
In vitro bench testing of the Vanguard IEP System was conducted in accordance with Contego Medical's risk analysis and all applicable FDA guidance documents and international standards, including:
- ISO 10555-1 Sterile. Single Use Intravascular Catheters Part 1: General ● Requirements
- . ISO 10555-4 - Sterile, Single Use Intravascular Catheters - Part 4: Balloon Dilatation Catheters
- Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices ● - Premarket Notification [510(k)] Submissions, February 15, 2008
- . Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010.
Bench testing was conducted on sterilized, finished devices, unless otherwise specified. The following testing was completed:
- Dimensional Verification ●
- Simulated Use .
- Torque Response
- Stent Compatibility ●
- Balloon Rated Burst Pressure / Balloon Compliance
- Balloon Fatigue
- Balloon Inflation and Deflation .
- Filter flow characterization ●
- Embolic Capture Efficiency and Retrieval Ability ●
- Filter Capacity ●
- . Resistance to Filter Rupture during removal of a fully loaded filter
- Balloon Rated Burst Pressure (constrained and unconstrained) ●
- . Balloon Fatigue (constrained and unconstrained)
Packaging
Packaging validation was performed following environmental conditioning, per recognized standards, ASTM D4169, ASTM F2096-11 and ASTM F88/F88M.
Biocompatibility
Biocompatibility testing, per ISO 10993-1 included the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemolysis, Complement Activation, Thrombogenicity.
Sterilization
Sterilization validation has been performed per ISO 11135:2014 for products sterilized with Ethylene Oxide. EO residuals were tested per ISO 10993-7.
Animal Testing
Three GLP animal studies with acute and 28-day endpoints assessed the safety and performance of the Contego Medical catheter platform in the swine model. The ability to capture iniected thrombus and successfully retrieve the thrombus was demonstrated. Acute and 28-day histological analysis showed no local injury in the treated arteries and optimal local toleration. There was no evidence of embolization in the dependent tissues from either the Day 0 or Day 28 animal.
Clinical Study
A prospective, multicenter study to evaluate acute safety and clinical performance of the nine centers in Belgium and Germany. The conduct of this study is in compliance with ISO Study 14155:2011, Good Clinical Practices (GCP) and the Declaration of Helsinki.
The study enrolled and treated 113 subjects, of which 112 were available for 30-day followup. All subjects presented with evidence of peripheral vascular disease. Mean age was 67.4 ± 10.3 years. The study population was predominantly male (63.7 %). Among the major risk factors, 28.3% of subjects had diabetes, 54% had hyperlipidemia, and 70.8% were hypertensive. 71.7% were either past or current smokers.
The vessels treated included superficial femoral arteries (75.2%), external iliac arteries (9.7%), common iliac arteries (8.9%), popliteal arteries (4.4%) and common femoral arteries (1.8%)
All enrolled subjects were successfully treated with the study device.
Both primary endpoints, assessing safety (Freedom from MAE, defined as death, amputation and target vessel revascularization at 30 days post-procedure) as well as effectiveness (Procedural Success is defined as
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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December 6, 2018
Contego Medical, LLC % Debra Cogan Regulatory Consultant ORAC. LLC 14906 Conway Avenue San Jose, California 95124
Re: K181529
Trade/Device Name: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, NTE Dated: November 6, 2018 Received: November 8, 2018
Dear Ms. Cogan:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Misti L. Malone -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181529
Device Name
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
Indications for Use (Describe)
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
| 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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3
510(k) Summary [per 21 CFR 807.92]
| Date
| Prepared: | November 05, 2018 |
|---|---|
| Applicant: | Contego Medical, LLC |
| 3921 Sunset Ridge Rd., Suite 102 | |
| Raleigh, NC 27607 | |
| Contact | |
| Person: | Debra Cogan |
| Regulatory Affairs Consultant to Contego Medical, LLC | |
| Phone: (408) 515-0820 | |
| Fax: (408) 273-6047 | |
| dcogan@contegomedical.com | |
| Proprietary | |
| Name: | Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
| Common | |
| Name: | Percutaneous Transluminal Angioplasty Balloon Catheter |
| Device | |
| Classification: | Class II (special controls) |
| Regulation | |
| Number: | 870.1250 |
| Classification | |
| Name: | Catheter, Percutaneous |
| Product Code: | LIT, NTE |
| Device | |
| Description: | The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
| platform is similar to a catheter with a typical angioplasty balloon, but between the distal end | |
| of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is | |
| over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes | |
| of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter | |
| component is composed of a nitinol filter frame with an overlying membrane perforated with a | |
| set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft | |
| placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to | |
| the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal | |
| tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque | |
| markers, making the diameter of the filter visible when opened. The proximal end of the | |
| nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter | |
| frame to activate the filter. | |
| Indications for | |
| Use: | The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
| is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of | |
| embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The | |
| System is not intended for use in the renal, cerebral, coronary or carotid vasculature. | |
| Predicate | |
| Device(s): | 1. Proteus ™ (AngioSlide) (K172494) - Primary Predicate |
- SpiderFX Embolic Protection Device (Medtronic) (K111010) |
4
Reference
-
- Sterling Monorail PTA Balloon Dilatation Catheter (K141150, Boston Scientific)
Predicates:
- Sterling Monorail PTA Balloon Dilatation Catheter (K141150, Boston Scientific)
-
- RX Accunet (K153086, Abbott Vascular)
Substantial Equivalency Table
- RX Accunet (K153086, Abbott Vascular)
| Parameters | Subject Device
Vanguard IEP® | Primary Predicate
Proteus ™ | Secondary Predicate
SpiderFX™ |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181529 | K172494 | K111010 |
| Manufacturer | Contego Medical | AngioSlide | Medtronic |
| Trade Name | Vanguard IEP®
Peripheral Balloon
Angioplasty System with
Integrated Embolic
Protection | Proteus PTA Catheter
with Embolic Capture
Feature | SpiderFX Embolic
Protection Device |
| Common name | Percutaneous
Transluminal Angioplasty
Balloon Catheter | Percutaneous
Transluminal Angioplasty
Balloon Catheter | Embolic Protection
Device |
| Classification | Class II (21 CFR
870.1250) | Class II (21 CFR
870.1250) | Class II (21 CFR
870.1250) |
| Classification
name | Catheter, Percutaneous | Catheter, Percutaneous | Percutaneous Catheter |
| Product code | LIT | LIT | NTE |
| Intended use /
Indications for
use | The Vanguard IEP®
Peripheral Balloon
Angioplasty System with
Integrated Embolic
Protection is indicated for
percutaneous
transluminal angioplasty
(PTA) and capture and
removal of embolic
material during
angioplasty, for the
femoral, iliac, popliteal
and profunda arteries. | The PROTEUS™
Percutaneous
Transluminal Angioplasty
(PTA) Balloon Catheter
with Embolic Capture
Feature is indicated for
peripheral transluminal
angioplasty and for
capture and removal of
embolic material (e.g.
debris, thrombus) during
angioplasty, for the
femoral, iliac, ilio-
femoral, popliteal, tibial,
peroneal, and profunda
arteries.
The PROTEUS™ PTA
Balloon Catheter with
Embolic Capture Feature
is not intended for use in
the renal, cerebral,
coronary or carotid
vasculature. | The SpiderFX™ Embolic
Protection Device is
indicated for use as a
guidewire and embolic
protection system to
contain and remove
embolic material in
conjunction with the
TurboHawk™ Peripheral
Plaque Excision System,
either during standalone
procedures or together
with PTA and/or stenting,
in the treatment of
severely calcified lesions
in arteries of the lower
extremities. The vessel
diameter at the filter
basket placement site
should be between 3.0
mm and 6.0 mm. |
| Principles of
Operation | Combines balloon
angioplasty and distal
embolic particle capture
and removal.
During balloon dilation,
embolic debris is
captured by the filter.
Upon completion of the
intervention the filter is
allowed to collapse and
the entire system is
withdrawn through the
introducer sheath or
guide catheter. | Combines balloon
angioplasty and proximal
embolic particle capture
and removal.
During balloon dilation,
negative pressure
creates suction to
capture embolic debris.
Upon completion of the
intervention the balloon
is collapsed and the
entire system is
withdrawn through the
introducer sheath or
guide catheter. | The device serves as
both guidewire for
interventional devices
and a distal embolic
capture and removal
filter. The filter is
removed following
angioplasty through a
custom removal catheter
that is also used to
deliver the filter at the
onset of the procedure
(dual-ended SpiderFX
Catheter). |
| Sterilization | EO gas | EO gas | EO gas |
| Sterility
Assurance
Level (SAL) | 10-6 | 10-6 | 10-6 |
| Single use | Yes | Yes | Yes |
| Shelf life | 1 year | 3 years | 2 years |
| Packaging
system | Packaged in a PET/G
thermoformed tray with
lid, sealed in a sterile
pouch and single unit
box. | Information is not
available. | Packaged in a protective
hoop, tray, sterile pouch
and in a single unit box. |
| Catheter
Platform | OTW | OTW | OTW, converts to RX |
| Radiopaque
Markers | Two markers distal and
proximal to both filter and
balloon.
Five gold circumferential
markers on the proximal
perimeter of the filter
frame are visible when
filter is open. | Two balloon markers
distal and proximal to
balloon. | Two marker bands distal
and proximal to the filter.
A gold radiopaque
Proximal Mouth Indicator
is visible when filter is
open. |
| Angioplasty
Balloon
Characteristics | Nylon, semi-compliant
PTA balloon | Semi-compliant PTA
balloon | N/A |
| Usable Catheter
Length | 135 cm | 135 cm | 140 cm |
| Guidewire
compatibility | 0.018" | 0.014" and 0.035" | 0.014" and 0.018" |
| Introducer
sheath
compatibility | All sizes 6F except for
8 mm diameter balloon
sizes are 7F | various: 5F, 6F and 7F | 6 F |
| Embolic
Capture
Mechanism | Distal embolic protection.
Adjustable nitinol filter
frame covered with a
porous polyurethane
membrane captures
embolic debris during
PTA procedure. | Proximal occlusion.
Negative pressure
creates suction to
capture embolic debris in
the inverted balloon. | Distal embolic protection.
Self-expanding nitinol
filter captures embolic
debris during
interventional
procedures. |
| Filter Size
(diameter) | Adjustable up to 8 mm
diameter | N/A | 5.0 mm, 6.0 mm, 7.0 mm |
| Filter Length | 16 mm | N/A | 23 mm, 24 mm (7.0
diameter)1 |
| Reference
Vessel
Diameters | up to 8 mm | 3 mm -6 mm | 3 mm -6 mm |
| Pore Size
Filter Materials | 150 micron
nitinol, polyurethane | N/A
N/A | 1 Per SpiderFX IFU, these diameters when delivered at maximum vessel size.
2 Nii, K., et al., Comparison of Flow Impairment during Carotid Artery Stenting Using Two Types of Eccentric Filter Embolic Protection Devices. Neurol Med Chir (Tokyo), 2016. 56(12): p. 759-765.
6
Summary of Non- Clinical Data
In vitro bench testing of the Vanguard IEP System was conducted in accordance with Contego Medical's risk analysis and all applicable FDA guidance documents and international standards, including:
- ISO 10555-1 Sterile. Single Use Intravascular Catheters Part 1: General ● Requirements
- . ISO 10555-4 - Sterile, Single Use Intravascular Catheters - Part 4: Balloon Dilatation Catheters
- Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices ● - Premarket Notification [510(k)] Submissions, February 15, 2008
- . Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010.
Bench testing was conducted on sterilized, finished devices, unless otherwise specified. The following testing was completed:
- Dimensional Verification ●
- Simulated Use .
- Torque Response
- Stent Compatibility ●
- Balloon Rated Burst Pressure / Balloon Compliance
- Balloon Fatigue
- Balloon Inflation and Deflation .
- Filter flow characterization ●
- Embolic Capture Efficiency and Retrieval Ability ●
- Filter Capacity ●
- . Resistance to Filter Rupture during removal of a fully loaded filter
- Balloon Rated Burst Pressure (constrained and unconstrained) ●
- . Balloon Fatigue (constrained and unconstrained)
Packaging
Packaging validation was performed following environmental conditioning, per recognized standards, ASTM D4169, ASTM F2096-11 and ASTM F88/F88M.
Biocompatibility
Biocompatibility testing, per ISO 10993-1 included the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemolysis, Complement Activation, Thrombogenicity.
Sterilization
Sterilization validation has been performed per ISO 11135:2014 for products sterilized with Ethylene Oxide. EO residuals were tested per ISO 10993-7.
Animal Testing
Three GLP animal studies with acute and 28-day endpoints assessed the safety and performance of the Contego Medical catheter platform in the swine model. The ability to capture iniected thrombus and successfully retrieve the thrombus was demonstrated. Acute and 28-day histological analysis showed no local injury in the treated arteries and optimal local toleration. There was no evidence of embolization in the dependent tissues from either the Day 0 or Day 28 animal.
7
Clinical Study A prospective, multicenter study to evaluate acute safety and clinical performance of the nine centers in Belgium and Germany. The conduct of this study is in compliance with ISO Study 14155:2011, Good Clinical Practices (GCP) and the Declaration of Helsinki.
The study enrolled and treated 113 subjects, of which 112 were available for 30-day followup. All subjects presented with evidence of peripheral vascular disease. Mean age was 67.4 ± 10.3 years. The study population was predominantly male (63.7 %). Among the major risk factors, 28.3% of subjects had diabetes, 54% had hyperlipidemia, and 70.8% were hypertensive. 71.7% were either past or current smokers.
The vessels treated included superficial femoral arteries (75.2%), external iliac arteries (9.7%), common iliac arteries (8.9%), popliteal arteries (4.4%) and common femoral arteries (1.8%)
All enrolled subjects were successfully treated with the study device.
Both primary endpoints, assessing safety (Freedom from MAE, defined as death, amputation and target vessel revascularization at 30 days post-procedure) as well as effectiveness (Procedural Success is defined as