(94 days)
The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.
NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.
The provided text describes a 510(k) premarket notification for a medical device called "NeoWire PTA/PTCA Guidewire." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a clinical study with acceptance criteria in the way one might for a diagnostic AI device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to the type of submission described in this document.
Here's an analysis based on the provided text, focusing on how the device meets the criteria for substantial equivalence rather than acceptance criteria for a novel clinical performance claim:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating that the NeoWire Guidewire is as safe and effective as its predicate devices. This is achieved by showing similar technological characteristics and performing a battery of non-clinical tests. The "performance" reported is that the device meets these specifications.
| Acceptance Criterion (Similarity to Predicate / Meeting Standards) | Reported Device Performance (NeoWire) |
|---|---|
| Same intended use | Meets: "The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature." (Matches predicate's intended use) |
| Same operating principle | Meets: Operating principle is the same. |
| Same shelf life and sterilization process | Meets: Same shelf life and sterilization process. |
| Similarities in Design, Material Types, and Technology | Meets: Nominal diameters: 0.014" and 0.018"Similar Lengths: 80, 180, 190, and 300cmNitinol alloy core wiresDistal radiopaque coilsFlexible, shapeable distal tip segmentsJoined by a combination of adhesive and weldsLubricious coatings |
| Adherence to Guidewire Dimensions (FDA Guidance Jan 1995) | Meets: Testing conducted on overall length, radiopaque tip length, and diameter. |
| Adherence to Torqueability and Torque Strength (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Adherence to Coating Adherence (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Adherence to Tip Flexibility (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Sterile Package Integrity (ASTM F 1929-98, ASTM F 88-09) | Meets: Testing conducted. |
| Reverse Bend (Fatigue Failure) (ISO 11070) | Meets: Testing conducted. |
| Tensile testing (ISO 11070) | Meets: Testing conducted. |
| Fracture Resistance (ISO 11070) | Meets: Testing conducted. |
| Corrosion Resistance (ISO 11070) | Meets: Testing conducted. |
| Tip Load (NeoMetrics' test method TM-3010) | Meets: Testing conducted. |
| Rail Support (NeoMetrics' test method TM-3002) | Meets: Testing conducted. |
| Biocompatibility (ISO 10993 series and ASTM F-756-00) | Meets: Specific tests (Partial Thromboplastin Time, Hemolysis, Cytotoxicity, Acute Systemic Injection, Intracutaneous Reactivity, Guinea Pig Maximization Sensitization, Complement Activation, In Vivo Thrombosis) were either tested on NeoWire components or leveraged from previously cleared NeoMetrics products. The table indicates "Tested on NeoWire" or "Leveraged" for each material and test, implying all necessary biocompatibility aspects were addressed. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a non-clinical performance testing study comparing the NeoWire Guidewire to predicate devices and assessing compliance with recognized standards. This is explicitly stated in "Section 5.6 Technological Characteristics" and "Section 5.7 Summary of Non-Clinical Testing."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for each test. It states "To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices" and "competetive devices were tested along with the proposed device in each test." This implies a comparative bench study using physical device samples.
- Data Provenance: The data is generated from bench testing conducted by NeoMetrics, Inc., following FDA Guidance and ISO standards. This is not patient-derived data, so "country of origin" or "retrospective/prospective" in a clinical sense are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is not a clinical study involving expert interpretation or ground truth establishment in that manner. The "ground truth" for these tests comes from established engineering principles, reference materials, and the defined performance characteristics of the predicate devices and relevant standards.
4. Adjudication Method for the Test Set
N/A. There is no adjudication method described as it's not a clinical or interpretive study. Performance is assessed against quantitative engineering specifications and comparison to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. No MRMC study was done, as this is a physical medical device (guidewire) and not an AI or diagnostic imaging system that would involve human readers.
6. Standalone Performance Study (Algorithm Only)
N/A. Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is derived from:
- Established engineering specifications and performance benchmarks defined by FDA guidance documents (e.g., "FDA Coronary and Cerebrovascular Guidewire Guidance January 1995").
- International ISO standards (e.g., ISO 11070, ISO 10993 series).
- ASTM standards (e.g., ASTM F 1929-98, ASTM F 88-09, ASTM Guideline F-756-00).
- NeoMetrics' internal test methods (e.g., TM-3010, TM-3002).
- The performance characteristics of the legally marketed predicate devices, against which the NeoWire is compared to demonstrate substantial equivalence.
8. Sample Size for the Training Set
N/A. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable.
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KCO1729
Section 5.0: 510(k) Summary
SEP 2 3 2010
5.1 Administrative Information
| Name: | NeoMetrics, Inc. |
|---|---|
| Address: | 2605 Fernbrook Lane North, SuitePlymouth, MN 55447 |
| Contact Person: | Gene Champeau |
| Title: | President |
| Phone: | (763)-559-4440 |
| Fax: | (763) 559-7676 |
| FDA Registration Number: | 2135342 |
| Date: | April 2, 2010 |
5.2 Device Information
| Name of Device: | NeoWire PTA/PTCA Guidewire |
|---|---|
| Common Name: | Guides, Guidewires, or spring Guidewires |
| Classification Name: | Catheter Guide Wire (870.1330) |
| Product Code: | DQX |
5.3 Predicate Device Information
The following commercially available guidewires are predicate devices for NeoWire.
| 510(k) Number | Trade or Model Name | Manufacturer |
|---|---|---|
| K070150 | VascuPuncture PICC Guidewire | NeoMetrics, Inc. |
| K983927 | Zinger Guidewire | Medtronic |
| K013024 | Selectiva | NeoMetrics, Inc. |
| K082304 | Roll-X | St. Jude Medical |
| K081337 | Approach CTO | Cook |
5.4 Device Description
NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.
5.5 Intended Use
The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.
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5.6 Technological Characteristics
A comparison of the characteristics of the proposed device to the predicate devices show the proposed device to have the following same or similar technological characteristics to the devices which have received 510(k) clearance:
- . Same intended use;
- . Same operating principle;
- . Same shelf life and sterilization process;
- Similarities in Design, Material Types, and Technology include: .
- Nominal diameters: 0.014" and 0.018" o
- Similar Lengths: 80, 180 190, and 300cm o
- Nitinol alloy core wires o
- Distal radiopaque coils o
- 0 Flexible, shapeable distal tip segments
- o Joined by a combination of adhesive and welds
- o Lubricious coatings
To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices:
- . Guidewire Dimensions (overall length, radiopaque tip length, and diameter) per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
- . Torqueability and Torque Strength per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
- . Coating Adherence per FDA Coronary and Cerebrovascular Guidewire Guidance January 1 ਰੇਰੇਟ
- Tip Flexibility per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995 .
- . Sterile Package Integrity per ASTM F 1929-98
- Sterile Package Integrity per ASTM F 88-09 .
- Reverse Bend (Fatigue Failure) per ISO 11070 .
- Tensile testing per ISO 11070
- . Fracture Resistance per ISO 11070
- Corrosion Resistance per ISO 11070 .
- . Tip Load per NeoMetrics' test method TM-3010
- . Rail Support per NeoMetrics' test method TM-3002
Due to the destructive nature of the tests and the availability of predicate devices not all testing was conducted on each predicate device, however competitive devices were tested along with the proposed device in each test.
5.7 Summary of Non-Clinical Testing
Non-clinical testing of the NeoWire Guidewire includes bench testing, biocompatibility testing, shelflife and packaging testing and sterilization evaluation. Bench testing, shelf-life testing, and sterilization testing were conducted on NeoWire. Biocompatibility testing was conducted on NeoWire and leveraged from other previously cleared NeoMetrics products. A summary table of the test data source is shown:
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| Tested and Leveraged Biocomaptibility Data | ||||||||
|---|---|---|---|---|---|---|---|---|
| Test GuidanceDocument | ISO 10993-4 | ISO 10993-4(ASTMGuidelineF-756-00) | ISO 10993-5 | ISO 10993-11 | ISO-10993-10 | ISO 10993-10 | ||
| Material | PartialThromboplastinTime (PTT) | ASTMHemolysis AssayDirect ContactMethod | MEM ElutionAssay with L-929 MouseFibroblast Cells(Cytotoxicity) | Acute SystemicInjection Test | IntracutaneousReactivity Test | Guinea PigMaximizationSensitizationTest | ComplementActivation | In VivoThrombosis(Thrombo-genicity) |
| Core Wire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire |
| HydrophilicCoating | Leveraged | Leveraged | Leveraged | Leveraged | Leveraged | Leveraged | Tested onNeoWire | Tested onNeoWire |
| SiliconeCoating | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Leveraged | Leveraged |
| Proximal Coll(dual colldesigns) | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Leveraged | Leveraged |
| RadiopaqueDistal Coll(Option 1) | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire |
| RadiopaqueDistal Coll(Option 2) | LeveragedTested onNeoWire | LeveragedTested onNeoWire | LeveragedTested onNeoWire | LeveragedTested onNeoWire | LeveragedTested onNeoWire | LeveragedTested onNeoWire | Leveraged | Leveraged |
| Adhesive | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Leveraged | Leveraged |
| PTFE Coating | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire | Tested onNeoWire |
Results of this testing demonstrate that the guidewire design meets the product specifications and intended uses.
5.8 Substantial Equivalence Conclusion
The NeoWire Guidewire described in this 510(k) is substantially equivalent to the devices listed in section 5.3. The intended use, design, material types, technology, and performance of the NeoWire Guidewire are equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.
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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NeoMetrics, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW Buffalo, MN 55313
SEP 2 3 2010
Re: K101729
Trade/Device Name: NeoWire PTA/PTCA Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 7, 2010 Received: September 8, 2010
Dear Mr. Job:
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.
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.
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Page 2 - Mr. Mark Job
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
.z
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
SEP 2 3 2010
Indications for Use
510(k) Number (if known): unavailable
Device Name: NeoWire PTA/PTCA Guidewire
Indications for Use:
The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (S 9g) are intended for peripheral or coronary use. The guldewire is not intended for use in the cerebral vasculature.
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)
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ivision Sign-Off) Division of Cardiovascular Devices
510(k) Number: K101729
§ 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.