(116 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a "Balloon Dilatation Catheter" indicated for "percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries," which is a medical procedure designed to treat a disease condition, thus making it a therapeutic device.
No
Explanation: The device is indicated for percutaneous transluminal angioplasty (PTA), 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, which is a hardware component. The performance studies also focus on the physical properties and performance of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (percutaneous transluminal angioplasty) to treat lesions in arteries and fistulae. This is an in vivo procedure, not an in vitro diagnostic test which is performed on samples taken from the body.
- Device Description: The device is a balloon dilatation catheter, designed to be inserted into blood vessels. This is consistent with an in vivo therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated 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.
Product codes
LIT
Device Description
The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Compliance Testing - Testing showed that, under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. The predetermined acceptance criteria were met.
Balloon Profile Testing - Testing showed that diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The predetermined acceptance criteria were met.
Balloon Fatigue Testing - Testing showed that the balloons were from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. In conformance with the applicable sections of ISO 10555-4, the predetermined acceptance criteria were met.
Balloon Burst Testing - Testing showed that the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The predetermined acceptance criteria were met.
Sheath Compatibility Testing - Testing showed that the catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The predetermined acceptance criteria were met.
Tensile Strength Testing - Testing showed that under proper clinical use of the device, the peak load values shall be in accordance with the applicable values of ISO 10555-1. The predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and professional, and it is likely used on Cook Medical's products and marketing materials.
COOK INCORPORATEC
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE 812.339.2235 τOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
K132020 og. 1 of 2
510(k) SUMMARY
Submitted By:
Steven Lawrie, MS, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x 104518 Fax: (812) 332-0281 Date Prepared: October 22, 2013
OCT 2 5 2013
Device:
Trade Name:
Common Name: Classification Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter PTA Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal LIT (21 CFR §870.1250)
Indications for Use:
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated 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 Advance® 35LP Low Profile PTA Balloon Dilatation Catheters are identical in terms of intended use, principles of operation, materials of construction, and technological characteristics to the predicate device. Additional combinations of balloon diameter and length have been included. The device, subject of this submission, is substantially equivalent to the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters cleared under 510(k) number K091527.
Comparison to Predicate Device:
It has been demonstrated that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters are comparable to the predicate device. The predicate device and the device subject of this submission are indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, femoral and iliofemoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The predicate device and the proposed device are completely identical in terms of design, intended use, and materials.
1
Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, sans-serif font on the top line. Below that, the word "MEDICAL" is in a smaller, sans-serif font. The background is black, and the text is white.
COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
MONE 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
K132020 pg. 2 of 2
Device Description:
The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.
Test Data:
The following tests were performed to demonstrate that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Compliance Testing - Testing showed that, under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. The predetermined acceptance criteria were met.
- 미 Balloon Profile Testing - Testing showed that diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The predetermined acceptance criteria were met.
- 0 Balloon Fatigue Testing - Testing showed that the balloons were from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. In conformance with the applicable sections of ISO 10555-4, the predetermined acceptance criteria were met.
- . Balloon Burst Testing - Testing showed that the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
- 0 Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The predetermined acceptance criteria were met.
- l Sheath Compatibility Testing - Testing showed that the catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The predetermined acceptance criteria were met.
- D Tensile Strength Testing - Testing showed that under proper clinical use of the device, the peak load values shall be in accordance with the applicable values of ISO 10555-1. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2013 ·
Cook Inc. Mr. Steven Lawrie, MS, MA Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K132020
Trade/Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: September 26, 2013 Received: September 27, 2013
Dear Mr. Lawrie:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
3
Page 2 - Mr. Steven Lawrie, MS, MA
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Special 510(k): Device Modification PTA Balloon Catheter: Advance 351.P Low Profile PTA Balloon Dilatation Catheter Cook Incorporated June 28 2013
Indications for Use
510(k) Number (if known): K132020
Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter
Indications for Use for the Advance 35LP Low Profile PTA Balloon Dilatation Catheter:
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter has been designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including illiac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use XX (Part 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S