(234 days)
Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.
The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.
The provided document is a 510(k) summary for a guidewire device and specifically states that no clinical tests were performed (Section 8. Clinical Test: "It is not applicable"). Therefore, there is no study described that involves AI or human readers for diagnostic purposes. The acceptance criteria and testing detailed relate to the physical and biocompatibility performance of the guidewire itself.
Based on the provided text, here's a breakdown of the requested information, focusing on the non-clinical performance and a clear indication where information is not available or applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that for each performance test, "The predetermined acceptance criteria was met." Specific numerical thresholds for these criteria are not provided in this summary.
| Testing Item | Reference Standard | Reported Device Performance |
|---|---|---|
| Appearance | Section 4.3 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| O.D. (Outer Diameter) | Section 8.2 a) of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Length | Section 8.2 b) of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | The predetermined acceptance criteria was met |
| Fracture test | Section 8.4 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Flexing test | Section 8.5 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Peak tensile force | Section 8.6 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Torque strength | 3b of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995 | The predetermined acceptance criteria was met |
| Torqueability | 3c of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995 | The predetermined acceptance criteria was met |
| Tip flexibility | 3d of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995 | The predetermined acceptance criteria was met |
| Particulate test | In-house standard | The predetermined acceptance criteria was met |
| Coating Friction force | In-house standard | The predetermined acceptance criteria was met |
| Coating Integrity | In-house standard | The predetermined acceptance criteria was met |
| Radio-detectability | ASTM F640-12 | The predetermined acceptance criteria was met |
| EO residual | ISO 10993-7:2008/Cor1:2009. | The predetermined acceptance criteria was met |
| Sterility | ISO 11737-1 | The predetermined acceptance criteria was met |
| Bacterial Endotoxin (LAL test) | USP <85> | The predetermined acceptance criteria was met |
| Biocompatibility (various tests) | ISO 10993-1:2009 (e.g., In Vitro Hemolytic, Cytotoxicity, Sensitization, Pyrogen, etc.) | The biocompatibility was acceptable. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test in the acceptance criteria, nor does it detail the provenance of any data beyond indicating "in-house standard" for some tests. It mentions testing on "non-aged and aged to 3 years sample," implying samples were physical guidewire units. This is a medical device, not a diagnostic AI product, so "data provenance" as it relates to patient data is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument (guidewire) and not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of an AI study.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or adjudication described for the performance tests of the guidewire.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states "Clinical Test: It is not applicable." This is a guidewire, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a guidewire, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical and biological tests of the guidewire, the "ground truth" or reference points are defined by the standards themselves (e.g., ISO, ASTM, FDA guidance, USP) and "in-house" specifications. These standards provide the objective criteria against which the device performance is measured.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model requiring a training set or ground truth in that context.
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September 13, 2018
Jeffery Hui Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan yi Road Shanghai, CN 201803 Shanghai
Re: K180177
Trade/Device Name: Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 4, 2018 Received: August 13, 2018
Dear Jeffery Hui:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia S. Glaw -S 2018.09.13 15:51:20 -04'00'
Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180177
Device Name Guidewire
Indications for Use (Describe)
Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.
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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Section 3- 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.
510(k) Number: K180177
Date of Submission: Jan.22, 2018 1.
2. Submitter
Shanghai Kindly Medical Instruments Co., Ltd. No. 925. Jinyuan vi Road. Shanghai. 201803. China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Supervisor Tel.:+086-021-59140056 Fax: +086-021-59140056 Email: xujianhai@kdlchina.net
3. Proposed Device
Proposed Device Name: Guidewire Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1330. Regulation name: Catheter guide wire Regulation Class: Class II Product Code: DQX
Predicate device 4.
- 510(k) Number: K141295 a. Product Name: Merit Hydrophilic Guide Wire Manufacturer: Merit Medical Systems, Inc.
- 510(k) Number: K133230 b. Product Name: InQwire® Manufacturer: Merit Medical Systems, Inc.
5. Device description
The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the
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different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.
Intended Use Statement: 6.
Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.
Non-clinical Test Conclusion 7.
Testing were conducted to ensure the performance of the proposed device throughout the labeled shelf life, verify conformity to the applicable parts of standards and demonstrate substantial equivalence to the predicate device. The performance tests were performed on the non-aged and ages to 3 years sample. All sample tested met the standard applicable to each test, and no new issues of safety and effective were raised with the testing performed.
The following performance tests have completed per the ISO standards, in house standard and/or FDA guidance :
| Testing item | Reference Standard | Conclusions |
|---|---|---|
| Appearance | Section 4.3 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| O.D. | Section 8.2 a) of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Length | Section 8.2 b) of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | The predetermined acceptance criteria was met |
| Fracture test | Section 8.4 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Flexing test | Section 8.5 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Peak tensile force | Section 8.6 of ISO 11070:2014 | The predetermined acceptance criteria was met |
| Toque strength | 3b of FDA Guidance for Coronaryand Cerebrovascular Guidewire | The predetermined acceptance criteria was met |
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| Guidance 1995 | ||
|---|---|---|
| Torqueability | 3c of FDA Guidance for Coronaryand Cerebrovascular GuidewireGuidance 1995 | The predeterminedacceptance criteria was met |
| Tip flexibility | 3d of FDA Guidance for Coronaryand Cerebrovascular GuidewireGuidance 1995 | The predeterminedacceptance criteria was met |
| Particulate test | In-house standard | The predeterminedacceptance criteria was met |
| Coating Friction force | In-house standard | The predeterminedacceptance criteria was met |
| Coating Integrity | In-house standard | The predeterminedacceptance criteria was met |
| Radio-dectectability | ASTM F640-12 | The predeterminedacceptance criteria was met |
| EO residual | ISO 10993-7:2008/Cor1:2009. | The predeterminedacceptance criteria was met |
| Sterility | ISO 11737-1 | The predeterminedacceptance criteria was met |
| Bacterial Endotoxin(LAL test) | USP <85> | The predeterminedacceptance criteria was met |
Per ISO 10993-1:2009,the proposed device is classified as external communication devices in contact with circulating blood for a limited (≤24 hours) duration. The following biocompatibility test were completed and the biocompatibility was acceptable:
- . In Vitro Hemolytic
- In Vitro Cytotoxicity .
- Intracutaneous Reactivity .
- Skin Sensitization •
- Acute Systemic Toxicity .
- Pyrogen .
- In Vivo Thrombogenicity .
- Complement Activation .
8. Clinical Test
It is not applicable
Summary Comparing the Technological Characteristics 9.
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In accordance with the recognized consensus ISO standard and FDA guidance document, performance test was conducted to ensure the performance characteristic of the proposed device. Comparisons of the proposed and predicate devices show that the intended use , classification, principle of operation, main materials, performance characteristics, sterilization method, sterility level and packaging are identical or substantially equivalent to the currently marked predicate devices. Please refer to the table.
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| K141295 | K133230 | |||
| Product Code | DQX | DQX | DQX | Same |
| RegulationNo. | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 | Same |
| Class | II | II | II | Same |
| Intended Use | Guidewire is intendedto be used in thecoronary and/orperipheral vascularsystem to introduce andposition catheters todesired anatomicallocation duringdiagnostic orinterventionalprocedures. | The Merit HydrophilicGuide Wire isintended to be used inthe peripheral vascularsystem to facilitate theplacement of devicesduring diagnostic andinterventionalprocedure. | The Merit GuideWire are used tofacilitate theplacement ofdevices duringdiagnostic andinterventionalprocedure. | Same |
| Principle ofOperation | The guidewire ismanually inserted intoa vessel and advance tothe target region | The guidewire ismanually inserted intoa vessel and advanceto the target region | The guidewire ismanually insertedinto a vessel andadvance to thetarget region | Same |
| Packagecontents | Guiewire, straighter,hoop dispenser | Guiewire, straighter,hoop dispenser | Guiewire,straighter, hoopdispenser | Same |
| DesignDescription | The PTFE coatingguide wire consist of aPTFE coated a coilwire, with an insidecore wire and safetywire. The core wireextends the full lengthof the coil wire.The hydrophiliccoating wire consist ofa jacketed core wire | The Merit HydrophilicGuide wire is jacketedcore wire with ahydrophilic coatingapplied to the jacket. | The guidewirehave a continuousPTFE coated coil,inside core wireand a safety wire.The core wire isfixed at theproximal end onlyand extends to aspecified distancefrom the distal | Same |
| with hydrophiliccoating. The core wireis made of Ninickeltitanium alloys. | end. | |||
| Outerdiameter | 0.025", 0.028", 0.032",0.035", 0.038" | 0.018", 0.025",0.035", 0.038" | 0.035", 0.038" | Devicesize morethanpredicatedevice |
| Hydrophiliccoating | Hydrophilic coatingand PTFE coating | Hydrophilic coating | PTFE coating | Same |
| Tipconfiguration | Straight, J-tip andangel. | Straight, angled,standard and stiff | Straight or J-tip | Similar |
| Material | Stainless steel, Ninickeltitanium alloys | Ninickel titaniumalloys | Stainless steel | Same |
| Jacketmaterial | TPU with tungstenpowder | unknown | unknown | Thematerialhave norisk forintendedclinicaluse |
| SterilizationMethod | EO | EO | EO | Same |
| SterilityAssuranceLevel | 10-6 | 10-6 | 10-6 | Same |
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10. Conclusion
In summary, a battery testing was conducted in accordance with protocols based on requirements outline in guidance's and standards and these were shown to meet the acceptance criteria that were determined to demonstrated substantial equivalence. There are no significant difference that raise any new issues of safety and effectiveness.
§ 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.