(21 days)
No
The summary describes a physical medical device (a balloon catheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for percutaneous transluminal angioplasty (PTA) to treat lesions in peripheral arteries and obstructive lesions in arteriovenous dialysis fistulae, which is a therapeutic intervention.
No
Explanation: The device is a balloon dilatation catheter used for percutaneous transluminal angioplasty, which is a therapeutic procedure to open narrowed arteries, not to diagnose a condition.
No
The device description clearly describes a physical catheter with a balloon, and the performance studies focus on physical characteristics like dimensions, burst pressure, and fatigue. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is a device used inside the body (in vivo) to physically dilate blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries," which is a procedure performed directly on the patient's circulatory system.
The information provided describes a medical device used for a therapeutic procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are peripheral (rapid) exchange balloon dilatation catheters that are available with inflated balloon diameters of 2, 2.5, 3, and 4 millimeters and balloon lengths of 20, 40, 60, 80, 120, 160, 200 millimeters. The catheters are supplied sterile and are intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral; 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
The following tests were performed to demonstrate that the Advance® 14LP Low Profile PTA Balloon Dilatation Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Dimensional Verification - Testing showed that the catheter length was within acceptable tolerance limits. The acceptance criterion was met.
- . Balloon Burst Testing - Testing showed that statistically the balloons will burst at or above the minimum rated burst pressure. The acceptance criteria were met.
- . Balloon Fatigue Testing - Testing showed that the balloons can withstand ten inflation and deflation cycles to the rated burst pressure of 16 atm. The acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
February 13, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated Mr. Daniel J. Corbin Regulatory Affairs Specialist 750 Daniels Wav Bloomington, IN 47404
Re: K170193
Trade/Device Name: Advance 14LP Low Profile PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 20, 2017 Received: January 23, 2017
Dear Mr. Corbin:
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,
Fernando Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170193
Device Name
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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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510(k) SUMMARY
| Submitted By: | Daniel J. Corbin
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
Phone: (812) 335-3575 x104018
Fax: (812) 332-0281
Date Prepared: January 20, 2017 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | |
| Trade Name: | Advance® 14LP Low Profile PTA Balloon Dilatation
Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty Balloon Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal
LIT (21 CFR §870.1250) |
Indications for Use:
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Device:
The device, subject of this submission, is substantially equivalent to the predicate device, the Advance 14Rx Rapid Exchange Balloon Catheter, cleared under 510(k) number K090822. The reference device, K130293, the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter has been included in this submission to support the shorter device length.
Comparison to Predicate Device:
It has been demonstrated that the Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is comparable to the predicate device. The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate device. The predicate device, K090822, was only available with a catheter length of 165 centimeters and the proposed device, the Advance® 14LP Low Profile PTA Balloon Dilatation Catheter, is available with
4
catheter lengths of 110 and 165 centimeters. The rated burst pressure will increase from 12 atm to 16 atm.
Device Description:
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are peripheral (rapid) exchange balloon dilatation catheters that are available with inflated balloon diameters of 2, 2.5, 3, and 4 millimeters and balloon lengths of 20, 40, 60, 80, 120, 160, 200 millimeters. The catheters are supplied sterile and are intended for one-time use.
Test Data:
The following tests were performed to demonstrate that the Advance® 14LP Low Profile PTA Balloon Dilatation Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Dimensional Verification - Testing showed that the catheter length was within acceptable tolerance limits. The acceptance criterion was met.
- . Balloon Burst Testing - Testing showed that statistically the balloons will burst at or above the minimum rated burst pressure. The acceptance criteria were met.
- . Balloon Fatigue Testing - Testing showed that the balloons can withstand ten inflation and deflation cycles to the rated burst pressure of 16 atm. The acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.