(143 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a guidewire intended to facilitate the placement of other medical devices, not to provide therapy itself.
No
Explanation: The device is a guidewire intended to facilitate the placement of other intravascular devices for therapeutic procedures (angioplasty), not to diagnose a condition.
No
The device description clearly details a physical guidewire constructed from stainless steel with specific dimensions, coatings, and a radiopaque coil. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PW Guidewires are used to "facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA)." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly manipulate structures within the body during a procedure.
N/A
Intended Use / Indications for Use
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.
Product codes
DQX
Device Description
The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and peripheral vasculature. Not cerebral vasculature.
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 laboratory testing was performed on the Tatara Vascular, LLC PW Guidewires t demonstrate the device would perform as intended. The following tests and assessments were performed:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Tip Load
- Coating Adhesion
- Simulated Use ●
- Resistance to Wire Fracture
- Dimensional Verification
- Catheter Compatibility ●
- Radiopacity Testing ●
The in vitro bench tests demonstrated that the Tatara Vascular, LLC PW Guidewires met the required acceptance criteria and performed in a similar manner to the predicate devices. Performance data demonstrate that the device will function as intended and has an equivalent performance profile as the predicate devices.
Biocompatibility tests were also conducted to demonstrate the materials of the Tatara Vascular, LLC PW Guidewires were suitable for human use. The materials necessary to construct the PW Guidewires are similar to the predicate devices and were evaluated in accordance with ISO 10993-1. The results of the biocompatibility evaluations demonstrated the materials of the PW Guidewires are suitable for their intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Tatara Vascular, LLC % Jill Munsinger Regulatory Consultant JMCS. LLC 11470 Kenyon Ct. NE Blaine, Minnesota 55449
Re: K152497
Trade/Device Name: PW Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 15, 2015 Received: December 18, 2015
Dear Jill Munsinger:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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
Enclosure
2
510(k) Number: K152497
Device Name: PW Guidewires
Indications For Use:
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K152497
Applicant Information:
| Date Prepared: | January 20, 2016 |
|---|---|
| 510(k) Owner: | Tatara Vascular, LLC |
| Address: | 10000 Cedar Ave. GCIC-10 |
| Cleveland, OH 44106 | |
| Facsimile Number: | (216) 445-6514 |
| Regulatory Correspondent: | Jill Munsinger |
| Phone Number: | 651-270-0572 |
| E-mail: | jill.munsinger@outlook.com |
Device Information:
| Classification: | Class II Percutaneous Guidewire |
|---|---|
| Trade Name: | PW Guidewires |
| Common Name: | Percutaneous Guidewire |
| Classification Name: | Percutaneous Guidewire |
Predicate Devices:
The Tatara Vascular, LLC PW Guidewire is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices:
K041531 - Asahi Confianza Pro Guidewire K052339 - Asahi MiracleBros Guidewire
Device Description:
The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).
Intended Use:
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.
4
Comparison to Predicate Device(s):
Comparison of the Tatara Vascular, LLC PW Guidewires and predicate devices show that the technological characteristics (indications, components, design, materials, sterilization method, and operating principles) of the PW Guidewires are identical or similar to the currently marketed predicate devices. The following table outlines the comparison of the PW Guidewires to the predicate devices.
| Characteristic | PW Guidewires | Asahi Confianza Pro | Asahi MiracleBros |
|---|---|---|---|
| 510(k) Number | TBD | K041531 | K052339 |
| Indications for Use | ...to facilitate | ||
| placement of balloon | |||
| dilatation catheters or | |||
| other intravascular | |||
| devices during | |||
| percutaneous | |||
| transluminal coronary | |||
| angioplasty (PTCA) | |||
| and percutaneous | |||
| transluminal | |||
| angioplasty (PTA). | |||
| The PW Guidewires | |||
| are not to be used in | |||
| cerebral blood | |||
| vessels. | Same | Same | |
| Sterilization | Ethylene Oxide to | ||
| SAL 10-6 | Same | Same | |
| Target Body Location | Coronary and | ||
| peripheral | |||
| vasculature. Not | |||
| cerebral vasculature. | Same | Same | |
| Core Wire Material | Stainless steel | Same | Same |
| Nominal Outer | |||
| Diameter | 0.014" (0.36mm) | Same | Same |
| Overall length | 180 cm | 180 cm and 300 cm | 180 cm and 300 cm |
| Proximal Coating | PTFE | Same | Same |
| Distal Coating | Hydrophilic | Same | Hydrophobic |
| Tip Load | 5g, 12g | 9.3g, 12.4g | 3.9g, 4.4g, 8.8g, 13g |
| Tip Radiopacity | 2.5cm | 20cm | 11cm |
| Tip Outer Diameter | 0.26mm | 0.23mm | 0.36mm |
5
Non-clinical laboratory testing was performed on the Tascular, LLC Pwditional S10(k)
Non-clinical laboratory testing was performed on the Tatara Vascular, LLC PW Guidewires t demonstrate the device would perform as intended. The following tests and assessments were performed:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Tip Load
- Coating Adhesion
- Simulated Use ●
- Resistance to Wire Fracture
- Dimensional Verification
- Catheter Compatibility ●
- Radiopacity Testing ●
The in vitro bench tests demonstrated that the Tatara Vascular, LLC PW Guidewires met the required acceptance criteria and performed in a similar manner to the predicate devices. Performance data demonstrate that the device will function as intended and has an equivalent performance profile as the predicate devices.
Biocompatibility tests were also conducted to demonstrate the materials of the Tatara Vascular, LLC PW Guidewires were suitable for human use. The materials necessary to construct the PW Guidewires are similar to the predicate devices and were evaluated in accordance with ISO 10993-1. The results of the biocompatibility evaluations demonstrated the materials of the PW Guidewires are suitable for their intended use.
Summary:
Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the Tatara Vascular, LLC PW Guidewires have been shown to be substantially equivalent to currently marketed predicate devices.