(260 days)
Not Found
No
The 510(k) summary describes a mechanical angioplasty balloon catheter and its physical characteristics and performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic intervention aimed at restoring blood flow.
No
The device is an angioplasty balloon catheter used for treatment (PTA), not for diagnosing conditions.
No
The device description clearly describes a physical angioplasty balloon catheter with hardware components like a retractable sheath, balloon, shaft, and marker bands. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body to treat blockages in blood vessels.
- Device Description: The device is a physical catheter with an inflatable balloon designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.
Product codes
LIT
Device Description
The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon catheter with a retractable sheath allowing a variable length inflatable balloon; up to 250mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with radiopaque marker bands denoting 0mm, 100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a 6Fr catheter system with a shaft working length of 150cm. The device uses a semi-compliant balloon with a rated burst pressure of 15atm and an indicated clinical use range of 4atm - 12atm. The balloon expands to a nominal diameter of 5.0 to 5.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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)
To verify that the device design meets its functional and performance requirements, representative samples of the device underwent performance bench testing and pre-clinical animal testing. As a result of verification and validation activities and risk assessment, testing ensures the device design meets its functional and performance requirements. The following tests were performed:
• Balloon compliance
• Balloon nominal diameter
• Balloon length
• Balloon Fatigue
• Marker band visibility
• Inflation and deflation time
• Device tracking, delivery, and retrieval
• Torque strength
• Kink resistance
• Joint strength testing
• Rated burst pressure
• Simulated use
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
§ 870.1250 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2020
Infinity Angioplasty Balloon Company, LLC Ms. Tiffini Wittwer Regulatory Affairs 6865 N. Reynolds Rd Suite 200 Toledo, Ohio 43615
Re: K192399
Trade/Device Name: Infinity Angioplasty Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 13, 2020 Received: April 15, 2020
Dear Ms. Wittwer:
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 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,
For 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) K192399
Device Name INFINITY Angioplasty Balloon Catheter
Indications for Use (Describe)
The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.
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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3
| Submitter: | INFINITY Angioplasty Balloon Company, LLC | | INFINITY Angioplasty
Balloon Catheter
(Subject Device) | Boston Scientific
Corporation
Sterling™ Over-the-
Wire PTA Balloon
Dilation Catheter
(Predicate Device) | Comment |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Wittwer
Regulatory Affairs | 510(k) Number | K192399 | K141112 | |
| | Phone: 707.799.6732
E-mail: twittwer@mededge.io | Manufacturer | INFINITY Angioplasty
Balloon Co., LLC | Boston Scientific
Corporation | |
| Trade Name: | INFINITY Angioplasty Balloon Catheter | Classification | Class II | Class II | Same |
| Common Name: | Percutaneous catheter | Product Code | LIT | LIT | Same |
| Classification: | Class II | Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Product Code: | LIT | Indications for Use | The INFINITY
Angioplasty Balloon
Catheter is indicated for
Percutaneous
Transluminal Angioplasty
(PTA) in the peripheral
vasculature, including
iliac, femoral,
popliteal, infra-popliteal
arteries, and for the
treatment of obstructive
lesions of native or
synthetic arteriovenous
dialysis fistulae. This
catheter is not for use in
coronary or
cerebrovascular arteries. | The Sterling OTW PTA
Balloon Dilatation
Catheter is indicated for
Percutaneous
Transluminal Angioplasty
(PTA) in the peripheral
vasculature, including
iliac, femoral,
popliteal, infra-popliteal.
and renal arteries, and for
the treatment of
obstructive lesions of
native or synthetic
arteriovenous dialysis
fistulae. This device is
also indicated for post-
dilatation
of balloon expandable and
self-expanding stents in
the peripheral vasculature. | Subject device has
narrower indication for
use than the predicate.
This difference limits use
of the device compared to
the predicate and does not
raise new questions of
safety or effectiveness. |
| Regulation | 21 CFR 870.1250 | Principle of operation | Inflation of semi-
compliant balloon for
dilation | Inflation of semi-
compliant balloon for
dilation | Same |
| Predicate Device(s): | The subject device is substantially equivalent to the following device:
● Boston Scientific Corporation Sterling Over-the-Wire PTA
Balloon Catheter (K141112) | Balloon Diameter (mm) | 5.0 | 2.0, 2.5, 3.0, 3.5, 4.0, 5.0,
6.0, 7.0, 8.0, 9.0, 10.0 | Same as one predicate
device size |
| Device Description: | The INFINITY Angioplasty Balloon Catheter is a intravascular
angioplasty balloon catheter with a retractable sheath allowing a
variable length inflatable balloon; up to 250mm. The over the wire
(OTW) catheter has a retractable sheath allowing the balloon to be
inflated at various lengths as determined by the physician. The balloon
lengths are graduated with radiopaque marker bands denoting 0mm,
100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a
6Fr catheter system with a shaft working length of 150cm.
The device uses a semi-compliant balloon with a rated burst pressure
of 15atm and an indicated clinical use range of 4atm - 12atm. The
balloon expands to a nominal diameter of 5.0 to 5.5mm. | Balloon Length (mm) | Variable
Marker bands located at
100mm, 200mm, and
250mm on balloon length | 20, 30, 40, 60, 80, 100,
200, 220 | Dimensional testing,
simulated use, rated burst
pressure, and in vivo
testing demonstrates the
difference does not create
additional risk to safety
and effectiveness of the
subject device |
| Indication for Use: | The INFINITY Angioplasty Balloon Catheter is indicated for
Percutaneous Transluminal Angioplasty (PTA) in the peripheral
vasculature, including iliac, femoral, popliteal, infra-popliteal arteries,
and for the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This catheter is not for use in coronary
or cerebrovascular arteries. | Balloon Length Variability | Yes | No 1 fixed balloon length
per device size | Simulated use and in vivo
testing demonstrate the |
INFINITY Angioplasty Balloon Company, LLC
Page 1 of 4
Premarket Notification for the INFINITY Angioplasty Balloon Catheter™
4
INFINITY Angioplasty Balloon Company, LLC
Page 2 of 4
5
| | Balloon length controlled
by outer sheath placement
relative distal tip of the
balloon. | | difference does not create
additional risk to safety
and effectiveness of the
subject device |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Outer Sheath | Yes | Yes | Same |
| Number of radiopaque
markerbands | 5
Proximal and distal ends
of balloon, 100mm and
200mm balloon length,
and distal tip of outer
sheath | 2
Proximal and distal ends
of balloon | Visibility, marker band to
balloon alignment, and in
vivo testing demonstrate
the difference does not
create additional risk to
safety and effectiveness
of the subject device |
| Location markers | Yes Markers designate
location of the sheath
relative to the catheter
shaft | Markers designate
locations on catheter tip to
the guiding catheter | Marker band to balloon
alignment, and simulated
use demonstrate the
difference does not create
additional risk to safety
and effectiveness of the
subject device |
| Catheter Shaft Lengths
(cm) | 150 | 40, 90, 135, 150 | Same |
| Guidewire compatibility | 0.018" | 0.014", 0.018" | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
6
| Functional Testing: | To verify that the device design meets its functional and
performance requirements, representative samples of the
device underwent performance bench testing and pre-clinical
animal testing. As a result of verification and validation
activities and risk assessment, testing ensures the device
design meets its functional and performance requirements. The
following tests were performed:
• Balloon compliance
• Balloon nominal diameter
• Balloon length
• Balloon Fatigue
• Marker band visibility
• Inflation and deflation time
• Device tracking, delivery, and retrieval
• Torque strength
• Kink resistance
• Joint strength testing
• Rated burst pressure
• Simulated use
The following standards were used in testing:
• ISO 11135:2018, Sterilization of health-care products - Ethylene
oxide - Requirements for the development, validation and routine
control of a sterilization process for medical devices
• ISO 10993-1:2018, Biological evaluation of medical devices
• ISO 10555:2018, Intravascular catheters – Sterile and single use
intravascular catheters. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The INFINITY Angioplasty Balloon Catheter™ intended use, indication
for use, materials, and fundamental scientific technology is similar to the
predicate device. Performance bench testing and pre-clinical testing
demonstrate that the differences between the subject device and the
predicate device do not raise new risks of safety and effectiveness. |
INFINITY Angioplasty Balloon Company, LLC
Page 4 of 4
Premarket Notification for the INFINITY Angioplasty Balloon Catheter™