(116 days)
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, infrapoplal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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.
The provided text describes the acceptance criteria and a study demonstrating that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compliance Testing | Under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. | "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 | Diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. | "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 | Balloons were free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation, in conformance with ISO 10555-4. | "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 | Balloons would burst at or above the minimum rated burst pressure, with all failure modes being linear tears. | "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 | Balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. | "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 | Catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. | "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 | Under proper clinical use of the device, the peak load values were in accordance with the applicable values of ISO 10555-1. | "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for each test. Instead, it uses phrases like "each balloon," "diameters for each catheter," and "the balloons," implying that multiple devices were tested to ensure consistency across their product line.
- Data Provenance: The data appears to be retrospective and internal to Cook Medical, generated from laboratory testing conducted on manufactured devices ("under simulated body temperature conditions"). There is no mention of data from external sources or clinical trials. The country of origin for the company is the U.S. (Bloomington, IN).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are engineering and performance-based (e.g., measuring diameter, resistance, burst pressure, fatigue cycles), which typically do not involve human expert consensus for 'ground truth' in the same way clinical diagnoses would. The "ground truth" for these tests is defined by pre-established engineering specifications and international standards (e.g., ISO 10555-4, ISO 10555-1).
4. Adjudication method for the test set:
This information is not applicable as the tests are objective, performance-based measurements against predefined engineering criteria, rather than subjective assessments requiring adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm. The "standalone performance" is demonstrated by the physical and mechanical tests outlined (e.g., compliance, burst, fatigue).
7. The type of ground truth used:
The ground truth used for these tests is based on engineering specifications, predetermined acceptance criteria, and compliance with international standards (ISO 10555-1, ISO 10555-4). For example, the "labeled diameter at the nominal pressure" and "minimum rated burst pressure" serve as the ground truth against which device performance is measured.
8. The sample size for the training set:
This is not applicable. The device undergoes physical and mechanical testing, not machine learning or AI model training. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above; there is no training set mentioned or implied as this is not an AI/ML device.
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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.
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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.
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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.
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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
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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
§ 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).