(75 days)
Y - Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
The Y-Wire 2 is an orthopedic guidewire with a distinctive distal split tip that is designed to prevent inadvertent advancement of the wire in tissue. Upon exiting a cannula, the distal tips will deploy to stop further advancement past the desired location. By design the distal tip is splayed 300 decrees for a distance of 11mm. The guidwire is made of Nitinol. The Y-Wire 2 is manufactured in five (5) diameters: 1.10mm, 1.40mm, 1.45mm and 1.50mm all have the same length of 560mm.
The provided text describes a medical device, the Y-Wire 2 Orthopedic Wire Passer, but it does not contain acceptance criteria or a study that proves the device meets specific performance criteria beyond basic biocompatibility and packaging validations.
The "Performance Data" section lists three items:
- Biocompatibility: States a study was accomplished to ensure interaction between material and body tissues. This is a general statement and doesn't provide specific acceptance criteria or results.
- Packaging: States that appropriate IQ, OQ, and PQ validations were performed at an ISO 13485 facility, determining the packaging method. Again, no specific acceptance criteria or performance numbers are given.
- Performance - Bench Testing: States that "Static push through force testing demonstrated that the force required to push the Y-wire through a bone test fixture was greater than that for the predicate devices, thus reducing the risk of inadvertent advancement." This is the closest to a performance claim, but it lacks:
- Specific acceptance criteria: What is an acceptable "force required"? How much greater?
- Quantified reported device performance: What was the actual force? What were the forces for the predicate devices?
- Study design details: No information on sample size, how the test fixture simulates bone, or the methodology.
Therefore, I cannot populate the requested table and sections with the information provided because the document does not include detailed acceptance criteria or a comprehensive study report with quantitative performance data.
Here's how I would answer the prompt based on the lack of this information in the text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Y-Wire 2 Orthopedic Wire Passer does not explicitly state detailed acceptance criteria with quantitative thresholds nor does it provide a comprehensive study report with specific performance metrics against such criteria.
The "Performance Data" section broadly outlines three areas: Biocompatibility, Packaging, and Bench Testing. However, it lacks the specific quantitative performance data and the defined acceptance criteria against which the device's performance was measured.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility: Ensure interaction between material and patient body tissues and other related body systems (per FDA Guidance / ISO 10993). | "Biocompatibility study was accomplished to ensure the interaction between the material of the Y-Wire 2 device and patient body tissues and other related body systems to determine the outcome when the device is in use." | No specific quantitative criteria or results provided. The text only states that a study was "accomplished" to "ensure" interaction. |
| Packaging: Validated according to ISO 13485 to determine the method of packaging. | "Safewire, LLC utilized an ISO 13485 packaging facility that accomplished the appropriate IQ (Installation Qualification), OQ (Operating Qualification) and PQ (Process Qualification) packaging validations. These processes when successfully completed through protocol development and final report outcomes determined the method in which the Y-Wire 2 is to be packaged." | No specific quantitative criteria or results provided. The text confirms validation processes were completed but not the performance outcomes relative to any defined acceptance limits (e.g., package integrity, sterile barrier maintenance over time). |
| Static Push-Through Force: Force required to push the Y-Wire through a bone test fixture. | "Static push through force testing demonstrated that the force required to push the Y -wire through a bone test fixture was greater than that for the predicate devices, thus reducing the risk of inadvertent advancement." | Acceptance criteria are implied but not quantified. The criterion seems to be "greater than predicate devices," but no specific force values (N or lbf) are provided for either the Y-Wire 2 or the predicate devices. The magnitude of "greater" is undefined. |
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the document. For the "Static Push-Through Force" bench testing, the sample size of Y-Wires or predicate devices tested is not mentioned, nor is the type or origin of the "bone test fixture."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided as the performance data described relates to physical bench testing, not clinical evaluation requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the performance data described relates to physical bench testing, not image or clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not conducted/not described. The performance data is based on bench testing of the device's physical properties.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical orthopedic guidewire, not a software algorithm.
7. Type of Ground Truth Used
For the static push-through force testing, the "ground truth" would implicitly be the physical measurement of force using appropriate instruments (e.g., a force gauge) in a controlled bench test setting. This is a direct measurement, not a consensus, pathology, or outcomes-based ground truth.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical product, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
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510(k) Summary 5.0
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Y - Wire 2 device is provided below.
Device Common Name: Orthopedic Wire Passer
Device Proprietary Name: Y-Wire 2
- Submitter: Wyatt Geist - CEO Safewire, LLC 8963 Stirling Rd Suite 7 Cooper City, FLA 33328
- Contact: Stephen Inglese Consultant to Safewire, LLC Quality Solutions and Support, LLC Phone: 561-251-0876 Email: swiqss1@gmail.com
Date Prepared: 05/14/2014
Classification 21 CFR 888.4540 - Orthopedic manual surgical instrument Regulation:
Panel: Orthopedics
Product Code: HXI
Legally Marketed Predicates - K2M - K Wire and Nuvasive - K Wire
Indication for Use: Y-Wire 2 is intended for use by surgeons to assist with the proper introduction and placements of orthopedic instruments and implants.
MAY 2 0 2014
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Device Description:
The Y-Wire 2 is an orthopedic guidewire with a distinctive distal split tip that is designed to prevent inadvertent advancement of the wire in tissue. Upon exiting a cannula, the distal tips will deploy to stop further advancement past the desired location. By design the distal tip is splayed 300 decrees for a distance of 11mm. The guidwire is made of Nitinol. The Y-Wire 2 is manufactured in five (5) diameters: 1.10mm, 1.40mm, 1.45mm and 1.50mm all have the same length of 560mm.
Performance Data:
1) Biocompatibility - FDA Guidance / ISO 10993
Biocompatibility study was accomplished to ensure the interaction between the material of the Y-Wire 2 device and patient body tissues and other related body systems to determine the outcome when the device is in use.
2) Packaging
Safewire, LLC utilized an ISO 13485 packaging facility that accomplished the appropriate IQ (Installation Qualification), OQ (Operating Qualification) and PQ (Process Qualification) packaging validations. These processes when successfully completed through protocol development and final report outcomes determined the method in which the Y-Wire 2 is to be packaged.
3) Performance - Bench Testing
Static push through force testing demonstrated that the force required to push the Y -wire through a bone test fixture was greater than that for the predicate devices, thus reducing the risk of inadvertent advancement.
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Substantial Equivalence:
The Y-Wire 2 is substantially equivalent to the predicate devices based on similar intended use and technological characteristics.
The intended use of the Y-Wire 2 is the same as the predicate device in that it is designed for minimally invasive surgery as a guidewire used by surgeons to assist with proper introduction and placement of surgical instruments and implants.
The technological characteristics are compared in the Device Comparison Table below. The Y -Wire 2 is available in similar diameters and lengths to that of the predicate. The difference in technological characteristics is the design of the tip. The Y-Wire 2 has a "Y" shaped tipped whereas the predicate device tip is straight and pointed. Additionally, the Y-Wire 2 is made of Nitinol whereas the predicate device is made of stainless steel. .
Summary of Substantial Equivalence:
The differences in technological characteristics do not raise new types of safety and effectiveness questions. Specifically, the "Y" shaped tip raises the same types of safety questions as a straight tipped guidewire. The material used for the Y-Wire 2 is Nitinol. The Nitinol material is recognized for its superelasticity and shape memory which exceeds that of the predicate devices which are manufactured with Stainless Steel. The Y-Wire 2 device length of 560mm exceeds the length of the predicates to provide the surgeon with the additional wire length to support the surgical procedure. The splayed tip of the Y-Wire 2 is designed to avoid advancement of the guidewire through bone whereas the predicates contain a straight and pointed tip. The Y-Wire 2 is provided sterile versus the predicates which are provided non-sterile. This provides the surgical staff with a device ready for use. The performance data provided in this 510(k) show equivalence to the predicate and therefore the Y-Wire 2 can be found substantially equivalent to the predicate device.
Sterilization Information:
The Y-Wire 2 will be provided sterile with a shelf life of five (5) years. The sterilized method used is E-Beam in accordance with ANSI/AAMI/ ISO 11137-1&2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized wing shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gix Silver Spring, MD 20993-0002
May 20, 2014
Safewire, LLC % Mr. Stephen W. Inglese Founder and CEO Quality Solutions and Support, LLC 520 Butternut Drive #8 PMB #256 Holland, Michigan 49424
Re: K140576
Trade/Device Name: Y-Wire 2 Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: Class I Product Code: HXI Dated: March 25, 2014 Received: March 26, 2014
Dear Mr. Inglese:
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 10 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 cither 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 that + Dr has Internations and regulations administered by other Federal agencies. You must or any i 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 - Mr. Stephen W. Inglese
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 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" (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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140576
Device Name
Y-Wire 2
Indications for Use (Describe)
Y - Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
1 4.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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