(96 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard balloon catheter. There is no mention of AI, ML, or any computational analysis of data.
Yes
The device is described as a "PTA Catheter" intended for "balloon dilation of the illac, femoral, popliteal, and renal arteries," which directly describes a therapeutic medical intervention.
No
Explanation: The device is a Percutaneous Transluminal Angioplasty (PTA) catheter intended for balloon dilation, which is a therapeutic procedure, not a diagnostic one. While it uses fluoroscopy for visualization, this is for guidance during the intervention, not for diagnosis.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, inflation lumen, and radiopaque markers. The performance studies also focus on physical characteristics and biocompatibility of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "balloon dilation of the illac, femoral, popliteal, and renal arteries." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a catheter with a balloon designed for mechanical dilation within blood vessels. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and interventional.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.
Product codes
LIT
Device Description
The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.
The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.
The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal, and renal arteries
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
Non-Clinical Tests:
- . Dimensional verification
- Balloon preparation, pushability, trackability, deployment, withdrawal and balloon reinsertion .
- Balloon rated burst pressure (RBP) .
- Balloon fatigue (repeated balloon inflations)
- . Balloon Compliance at nominal and rated burst inflation pressure
- Balloon Inflation/Deflation Time ●
- Catheter Bond Strength (Tip to balloon, balloon to proximal shaft, shaft to manifold) ●
- . Flexibility and Kink test
- Torque Strength ●
- Radiopacity ●
- . Coating Integrity
- . Particulate evaluation
- Guide wire compatibility ●
- . Introducer sheath compatibility
Biocompatibility Tests:
- MTT Cytotoxicity Study ●
- ISO Maximization Sensitization Study .
- ISO Intracutaneous Study .
- ISO Systemic Toxicity Study ●
- ASTM Hemolysis .
- C3a Complement Activation Assay .
- SC5b-9 Complement Activation Assay ●
- ASTM Partial Thromboplastin Time ●
- In Vivo Thromboresistance Study - Jugular Vein
- . Pyrogenicity
Sterilization, Shelf life tests and Packaging validation:
- EO sterilzation validation by an adoption validation using a sub-lethal cycle approach; .
- EO/ECH residues of Pirouette 035 (K161427) were tested (largest surface area of Pirouette . family, therefore worst case);
- . Shelf life testing was leveraged from the data on the Pirouette 018;
- . Packaging validation was leveraged on the data of the Pirouette 018.
Key Results: The results showed that the Pirouette 014 met the pre-determined acceptance criteria. No new safety or effectiveness issues were raised during this testing. The results show that the Pirouette 014 is sterility is maintained by the packaging during the entire shelf life of the device. From the results it was also concluded that the device meets the criteria for Residual Testing, i.e. EO/ECH residues.
Clinical Performance Data: No clinical studies were performed for the purpose of obtaining safety and effectiveness data.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
ArraVasc Ltd. Ms. Aoife Donoghue Regulatory and Design Assurance Manager 2 Ballybrit Business Park Galway, Ireland
Re: K162316
Trade/Device Name: Pirouette 014 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 25, 2016 Received: October 31, 2016
Dear Ms. Donoghue:
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 devicerelated 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.
1
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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162316
Device Name Pirouette 014
Indications for Use (Describe)
The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
5.1 Submitter
| Submitter Address: | ArraVasc Limited
2 Ballybrit Business Park,
Galway
Ireland |
|--------------------|---------------------------------------------------------------------|
| Phone Number: | +353-91-758939 |
| Fax Number: | +353-91-758930 |
| Contact Person: | Aoife Donoghue Regulatory & Design Assurance Manager |
| Date Prepared: | 04 Aug 2016 |
5.2 Device
| Device Trade Name: | Pirouette 014 |
|---|---|
| Common Name: | OTW PTA catheter |
| Classification Name: | Peripheral Transluminal Angioplasty Catheter |
| Classification number: | 21 CFR 870.1250 |
| Product code: | LIT |
| Class: | II |
| Classification Panel: | Cardiovascular |
5.3 Predicate Device
| Predicate: | Pirouette 018 OTW PTA Catheter
ArraVasc Ltd.
510(K) number: K151153 |
|-------------------|---------------------------------------------------------------------------------|
| Reference Device: | Bantam α PTA Catheter
ClearStream Technologies Ltd
510(K) number: K093139 |
5.4 Device Description
Device Description:
The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.
The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.
The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.
4
Percutaneous Transluminal Angioplasty Catheter (PTA Catheter). Physical Description:
5.5 Indication for use
The Pirouette 014 PTA Catheter is intended for balloon dilation of the iliac, Indications for Use femoral, popliteal, infra-popliteal, and renal arteries. Statement:
5.6 Comparison with the predicate device
The Pirouette 014 is substantially equivalent to the predicate device in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. The following table provides a summary of general and technical characteristics as compared to the primary predicate device and predicate device.
| Parameter | Characteristics |
|---|---|
| Classification | Class II, 21 CFR 870.1250 |
| Same Classification as predicate devices. | |
| Intended Use | Same intended use: balloon dilatation of the iliac, femoral, popliteal |
| and infra-popliteal arteries and renal arteries. | |
| Balloon material | Same material |
| Balloon diameter | Comparable range of balloon diameters: 1.25 mm - 4.0 mm versus |
| 2.0 mm - 9.0 mm for the predicate device | |
| Balloon length | Comparable range of balloon lengths: 15 mm - 300 mm versus 20 |
| mm - 300 mm for the predicate device | |
| Nominal pressure (atm) | Same nominal pressure: 8 atm. |
| Rated burst pressure | |
| (atm) | Same rated burst pressure: 16 atm |
| Radioopaque | |
| markerbands | Two Markerbands, one at distal and one at proximal side of the |
| balloon, with the same function | |
| Outer shaft | Same material |
| Catheter shaft | |
| outer diameter | Comparable catheter diameter: 2-7-3.6 Fr versus: 3.6 – 4.2 Fr for the |
| Predicate | |
| Catheter Usable | |
| lengths (cm) | Comparable range of usable lengths: 90 cm - 150 cm versus 45 cm - |
| 150cm for the Predicate device | |
| Recomended | |
| Introducer Sheath Size | |
| compatibility | Comparable size: 4 Fr versus 4 - 5 Fr for the Predicate device |
| Recommended | |
| Guidewire diameter | Maximum 0.014" versus; maximum 0.018" |
| Catheter strain relief & | |
| manifold material | Same material, with the same function |
| Catheter manifold | |
| design | Same design, dual lumen Y design, with the same function |
| Catheter coating | Same coating |
| Sterilization Method | Same method; Ethylene Oxide |
| Single Use / Reusable | Single Use |
Table 1 Comparison of Pirouette 014 to Pirouette 018 (Predicate)
5
5.7 Performance Data
As per ArraVasc Risk Analysis procedures, the Pirouette 014 was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications and to support a determination of substantial equivalence. The bench testing plan was developed with the recommendations outlined in the applicable FDA guidance documents, tests recommended in ISO 10555-1, Intravascular catheters-Sterile and single-use catheters - Part 1: General Requirements, and 10555-4, Intravascular catheters-Sterile and single-use catheters - Part 4: Balloon dilatation catheters. Testing performed on Pirouette included the following:
Non-Clinical Tests:
- . Dimensional verification
- Balloon preparation, pushability, trackability, deployment, withdrawal and balloon reinsertion .
- Balloon rated burst pressure (RBP) .
- Balloon fatigue (repeated balloon inflations)
- . Balloon Compliance at nominal and rated burst inflation pressure
- Balloon Inflation/Deflation Time ●
- Catheter Bond Strength (Tip to balloon, balloon to proximal shaft, shaft to manifold) ●
- . Flexibility and Kink test
- Torque Strength ●
- Radiopacity ●
- . Coating Integrity
- . Particulate evaluation
- Guide wire compatibility ●
- . Introducer sheath compatibility
The results showed that the Pirouette 014 met the pre-determined acceptance criteria. No new safety or effectiveness issues were raised during this testing.
Biocompatibility Tests:
Per ISO10993-1:2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Pirouette 014 is classified as an externally communicating device, which contacts circulating blood during a limited contact duration (≤24hours). For reason that the Pirouette 014 has the same indication, general design, materials, and packaging, the Biocompatibility tests with the Pirouette 018 were considered valid for the Pirouette 014. Biocompatibility testing with the Pirouette 018 was conducted per ISO 10993-1:2009 were completed and passed:
- MTT Cytotoxicity Study ●
- ISO Maximization Sensitization Study .
- ISO Intracutaneous Study .
- ISO Systemic Toxicity Study ●
- ASTM Hemolysis .
- C3a Complement Activation Assay .
- SC5b-9 Complement Activation Assay ●
- ASTM Partial Thromboplastin Time ●
- In Vivo Thromboresistance Study - Jugular Vein
- . Pyrogenicity
6
Sterilization, Shelf life tests and Packaging validation:
- EO sterilzation validation by an adoption validation using a sub-lethal cycle approach; .
- EO/ECH residues of Pirouette 035 (K161427) were tested (largest surface area of Pirouette . family, therefore worst case);
- . Shelf life testing was leveraged from the data on the Pirouette 018;
- . Packaging validation was leveraged on the data of the Pirouette 018.
The results show that the Pirouette 014 is sterility is maintained by the packaging during the entire shelf life of the device. From the results it was also concluded that the device meets the criteria for Residual Testing, i.e. EO/ECH residues.
Clinical Performance Data:
- . No clinical studies were performed for the purpose of obtaining safety and effectiveness data.
- . The Pirouette 014 is approved for marketing in the European Union (CE certified).
5.8 Conclusions
Based upon the intended use, fundamental scientific technology, performance characteristics, non-clinical performance testing, and comparison to legally marketed devices, it is concluded that the Pirouette 014 is appropriate for its intended use, and is substantially equivalent to the predicate device.