(43 days)
The Sleek® OTW PTA Catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The subject device, the Sleek® OTW PTA Catheter LE, is a balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflation device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the whole length of the catheter using the distally open inner lumen. The outer shaft lumen and the balloon are made of Polyamide, enclosing the inner High Density Polyethylene (HDPE) / Plexar / PolyEther Block Amide shaft. A Polycarbonate hub is connected to the outer and inner shaft proximally together with a PolyEther Block Amide strain relief tube.
Acceptance Criteria and Study for Sleek® OTW PTA Catheters (K130786)
This submission describes the Sleek® OTW PTA Catheter LE, which is a balloon dilation catheter for angioplasty, substantially equivalent to the predicate device, the Sleek® OTW PTA Catheter (K102035).
A. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes that the device met all predetermined acceptance criteria but does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it states that the results demonstrated comparability to the predicate device. Therefore, the "Reported Device Performance" column reflects this general statement of comparability.
| Acceptance Criteria (Not explicitly stated, inferred as "comparable to predicate") | Reported Device Performance |
|---|---|
| Balloon Working Length (comparable to predicate) | Comparable to predicate |
| Marker Band Alignment (comparable to predicate) | Comparable to predicate |
| Burst Strength (Rated Burst Pressure) (comparable to predicate) | Comparable to predicate |
| Burst Mode (comparable to predicate) | Comparable to predicate |
| Proximal Tensile (comparable to predicate) | Comparable to predicate |
| Sheath Compatibility (comparable to predicate) | Comparable to predicate |
| Reinsertion (comparable to predicate) | Comparable to predicate |
| Inflation Time (comparable to predicate) | Comparable to predicate |
| Deflation Time (comparable to predicate) | Comparable to predicate |
| Fatigue (comparable to predicate) | Comparable to predicate |
| Balloon Outer Diameter (comparable to predicate) | Comparable to predicate |
| Compliance (comparable to predicate) | Comparable to predicate |
B. Sample sizes used for the test set and data provenance:
The document states that the evaluation involved "additional in vitro tests" using FDA Guidance Documents and internal Risk Assessment procedures. However, the specific sample sizes used for each of the listed in vitro tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective, but given they are "in vitro tests," they were likely conducted in a laboratory setting.
C. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not applicable as the evaluation involved in vitro non-clinical testing of device characteristics, not human clinical data requiring expert review for ground truth establishment.
D. Adjudication method for the test set:
This information is not applicable as the evaluation involved in vitro non-clinical testing of device characteristics, not human clinical data requiring adjudication.
E. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not performed. This submission pertains to the substantial equivalence of a medical device based on non-clinical performance data, not a study evaluating human reader performance.
F. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical device (catheter), not an algorithm or AI system.
G. The type of ground truth used:
The ground truth for the in vitro performance tests would be the physical and mechanical properties of the device as measured against established engineering specifications and design requirements, and critically, comparability to the predicate device's performance characteristics. This implicitly relies on the predicate device meeting acceptable standards.
H. The sample size for the training set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
I. How the ground truth for the training set was established:
This information is not applicable for the same reason as in H.
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K130786 p. 1 of 3
Sleek® OTW PTA Catheters
510(k) Summary
21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:
1. Submitter Information:
, محب
| Applicant: | ClearStream Technologies Ltd.Moyne Upper,Enniscorthy,Co. Wexford,Ireland. |
|---|---|
| Phone: | +353 53 9237111 |
| Fax: | + 353 53 9237100 |
| Contact: | Fiona Ní Mhulláin, Senior RA/QA Manager |
| Date: | 20 March 2013 |
2. Subject Device:
| Device Trade Name: | Sleek ® OTW PTA Catheters |
|---|---|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250, ProductCode LIT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
3. Predicate Device:
| Device Trade Name: | Sleek® OTW Percutaneous Transluminal Angioplasty(PTA) Catheter |
|---|---|
| Cleared 510(K) Number: | K102035 |
| Date of Cleared 510(K): | 01-Dec-10 |
4. Summary of Change:
The only difference between the predicate device, the Sleek® OTW PTA Catheter, and the subject device, the Sleek® OTW PTA Catheter LE, were the addition of balloon lengths.
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5. Device Description:
The subject device, the Sleek® OTW PTA Catheter LE, is a balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflation device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the whole length of the catheter using the distally open inner lumen.
The outer shaft lumen and the balloon are made of Polyamide, enclosing the inner High Density Polyethylene (HDPE) / Plexar / PolyEther Block Amide shaft. A Polycarbonate hub is connected to the outer and inner shaft proximally together with a PolyEther Block Amide strain relief tube.
6. Indications for Use of Device:
The Sleek® OTW PTA Catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device, the Sleek® OTW PTA Catheter LE, are equivalent to those of the predicate device (Sleek® OTW PTA Catheter. K102035), in terms of intended use, indications for use, materials, fundamental scientific technology, target population, operating principle, packaging, sterility assurance level, and method of sterilization.
8. Performance Data:
To demonstrate the substantial equivalence of the subject device, the Sleek® OTW PTA Catheter LE, to the predicate device, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on nonclinical testing of medical devices and internal Risk Assessment procedures, the following additional in vitro tests were performed:
- . Balloon Working Length
- Marker Band Alignment .
- . Burst Strength (Rated Burst Pressure)
- . Burst Mode
- . Proximal Tensile
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K130786 p. 3 of 3
- Sheath Compatibility .
- Reinsertion .
- Inflation Time .
- . Deflation Time
- . Fatigue
- Balloon Outer Diameter .
- Compliance .
The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Sleek® OTW PTA Catheter LE is comparable to the predicate device.
9. Conclusions:
The Sleek® OTW PTA Catheter LE met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols, and/or customer inputs. The Sleek® OTW PTA Catheter LE is substantially equivalent to the legally marketed predicate device, the Sleek® OTW PTA Catheter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
ClearStream Technologies, Ltd. c/o Ms. Fiona Ní Mhullain Senior RA/QA Manager Moyne Upper Enniscorthy County Wexford, Ireland
Re: K130786
Trade/Device Name: Sleek OTW PTA Catheters Line Extension Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: April 3, 2013 Received: April 5, 2013
Dear Ms. Fiona Ní Mhullain:
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
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Page 2 - Ms. Fiona Ní Mhullain
forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zookerman
Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K130786
Device Name: Sleek® OTW Percutaneous Transluminal Angioplasty Catheter
The Sleek® OTW PTA Catheters are intended for balloon Indications for Use: dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Prescription Use X (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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ream Technologies Ltd.
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§ 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).