(234 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 AI or ML capabilities.
No
The device, a guidewire, is intended to introduce and position catheters for diagnostic or interventional procedures, not directly treat a condition. While it is used in interventional procedures, its function is facilitative rather than therapeutic.
No
The guidewire is used to introduce and position catheters during diagnostic or interventional procedures, but it does not perform any diagnostic function itself. It's an accessory to diagnostic procedures, not a diagnostic device.
No
The device description clearly details physical components (stainless steel, nickel titanium alloys, coatings, etc.) and physical characteristics (diameter, length, tip configuration), indicating it is a hardware device, not software-only.
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 guidewire is used to "introduce and position catheters to desired anatomical location during diagnostic or interventional procedures." This describes a physical tool used within the body for procedural guidance, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details the physical construction and materials of the guidewire, which is consistent with a medical device used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, this guidewire is a medical device used for interventional and diagnostic procedures within the vascular system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vascular system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 :
- Appearance - Reference Standard: Section 4.3 of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- O.D. - Reference Standard: Section 8.2 a) of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Length - Reference Standard: Section 8.2 b) of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Corrosion resistance - Reference Standard: Section 4.4 ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Fracture test - Reference Standard: Section 8.4 of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Flexing test - Reference Standard: Section 8.5 of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Peak tensile force - Reference Standard: Section 8.6 of ISO 11070:2014, Conclusions: The predetermined acceptance criteria was met
- Toque strength - Reference Standard: 3b of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995, Conclusions: The predetermined acceptance criteria was met
- Torqueability - Reference Standard: 3c of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995, Conclusions: The predetermined acceptance criteria was met
- Tip flexibility - Reference Standard: 3d of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995, Conclusions: The predetermined acceptance criteria was met
- Particulate test - Reference Standard: In-house standard, Conclusions: The predetermined acceptance criteria was met
- Coating Friction force - Reference Standard: In-house standard, Conclusions: The predetermined acceptance criteria was met
- Coating Integrity - Reference Standard: In-house standard, Conclusions: The predetermined acceptance criteria was met
- Radio-dectectability - Reference Standard: ASTM F640-12, Conclusions: The predetermined acceptance criteria was met
- EO residual - Reference Standard: ISO 10993-7:2008/Cor1:2009., Conclusions: The predetermined acceptance criteria was met
- Sterility - Reference Standard: ISO 11737-1, Conclusions: The predetermined acceptance criteria was met
- Bacterial Endotoxin (LAL test) - Reference Standard: USP , Conclusions: The predetermined acceptance 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
Clinical Test: It is not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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
4
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 Coronary | |
| and Cerebrovascular Guidewire | The predetermined acceptance criteria was met |
5
| Guidance 1995 | ||
|---|---|---|
| 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-dectectability | 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 | The predetermined |
| acceptance 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.
6
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 |
| Regulation | ||||
| No. | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 | Same |
| Class | II | II | II | Same |
| Intended Use | 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 Merit Hydrophilic | |||
| Guide Wire is | ||||
| intended to be used in | ||||
| the peripheral vascular | ||||
| system to facilitate the | ||||
| placement of devices | ||||
| during diagnostic and | ||||
| interventional | ||||
| procedure. | The Merit Guide | |||
| Wire are used to | ||||
| facilitate the | ||||
| placement of | ||||
| devices during | ||||
| diagnostic and | ||||
| interventional | ||||
| procedure. | Same | |||
| Principle of | ||||
| Operation | The guidewire is | |||
| manually inserted into | ||||
| a vessel and advance to | ||||
| the target region | The guidewire is | |||
| manually inserted into | ||||
| a vessel and advance | ||||
| to the target region | The guidewire is | |||
| manually inserted | ||||
| into a vessel and | ||||
| advance to the | ||||
| target region | Same | |||
| Package | ||||
| contents | Guiewire, straighter, | |||
| hoop dispenser | Guiewire, straighter, | |||
| hoop dispenser | Guiewire, | |||
| straighter, hoop | ||||
| dispenser | Same | |||
| Design | ||||
| Description | The PTFE coating | |||
| guide wire consist of a | ||||
| PTFE coated a coil | ||||
| wire, with an inside | ||||
| core wire and safety | ||||
| wire. The core wire | ||||
| extends the full length | ||||
| of the coil wire. | ||||
| The hydrophilic | ||||
| coating wire consist of | ||||
| a jacketed core wire | The Merit Hydrophilic | |||
| Guide wire is jacketed | ||||
| core wire with a | ||||
| hydrophilic coating | ||||
| applied to the jacket. | The guidewire | |||
| have a continuous | ||||
| PTFE coated coil, | ||||
| inside core wire | ||||
| and a safety wire. | ||||
| The core wire is | ||||
| fixed at the | ||||
| proximal end only | ||||
| and extends to a | ||||
| specified distance | ||||
| from the distal | Same | |||
| with hydrophilic | ||||
| coating. The core wire | ||||
| is made of Ninickel | ||||
| titanium alloys. | end. | |||
| Outer | ||||
| diameter | 0.025", 0.028", 0.032", | |||
| 0.035", 0.038" | 0.018", 0.025", | |||
| 0.035", 0.038" | 0.035", 0.038" | Device | ||
| size more | ||||
| than | ||||
| predicate | ||||
| device | ||||
| Hydrophilic | ||||
| coating | Hydrophilic coating | |||
| and PTFE coating | Hydrophilic coating | PTFE coating | Same | |
| Tip | ||||
| configuration | Straight, J-tip and | |||
| angel. | Straight, angled, | |||
| standard and stiff | Straight or J-tip | Similar | ||
| Material | Stainless steel, Ninickel | |||
| titanium alloys | Ninickel titanium | |||
| alloys | Stainless steel | Same | ||
| Jacket | ||||
| material | TPU with tungsten | |||
| powder | unknown | unknown | The | |
| material | ||||
| have no | ||||
| risk for | ||||
| intended | ||||
| clinical | ||||
| use | ||||
| Sterilization | ||||
| Method | EO | EO | EO | Same |
| Sterility | ||||
| Assurance | ||||
| Level | 10-6 | 10-6 | 10-6 | Same |
7
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.