(240 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No.
The device is a guide wire, which is an accessory used to direct a catheter, not to provide therapy itself.
No
Explanation: The device is a guide wire used to direct catheters for diagnostic or interventional procedures, not to perform diagnosis itself. Its "intended use" section clearly states it is "designed to direct a catheter".
No
The device description clearly outlines physical components (core wire, polymer jacket, coating) and performance studies related to material properties and mechanical performance, indicating it is a physical medical 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 device is designed to "direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures." This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details the physical components of a guide wire used for navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Hydrophilic Coating Guide Wire is a medical device used in vivo for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.
Product codes
DQX
Device Description
The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and coronary 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-I: Evaluation and testing within a risk management process." The wire is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24h). The following biocompatibility tests were completed and the biocompatibility was acceptable:
- Cytotoxicity
- Sensitization (Kligman Maximization)
- Irritation / Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogen
- Hemolysis test(extract method)
- Thrombosis test
- Partial Thromboplastin Time (PTT) test
- Prothrombin time (PT) test
Non-Clinical Performance Testing:
Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995; Coronary, Peripheral, and Neurovascular Guidewire-Performance Tests and Recommended Labeling, Draft Guidance for Industry and Food and Drug Administration Staff, June 15, 2018; ISO 11070:2014, Sterile Single-use Intravascular Introducers, Dilators And Guidewires. The tests included the following:
- Size and Surface
- Tensile Strength
- Torque Strength
- Torqueability
- Coating Integrity
- Particulate Evaluation
- Lubricity
- Kink Resistance
- Tip Flexibility
- Radiopacity
- Fracture test
- Flexing test
- EO and ECH residual
- Sterile Bacterial endotoxin
- Visual Inspection of the inner pouch
- Dye leakage test of the inner pouch
- Sealing-strength of the inner pouch
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
August 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
Suzhou Hengrui Disheng Medical Co., Ltd. Ling Li Regulatory Affairs Manager No. 11 Building, No.8 Jinfeng Road Suzhou 215163, China
Re: K193653
Trade/Device Name: Hydrophilic Coating Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 20, 2020 Received: July 27, 2020
Dear Ling Li:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Hydrophilic Coating Guide Wire
Indications for Use (Describe)
The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd |
|---|---|
| No. 11 Building No. 8 Jinfeng Road, Suzhou, China | |
| Phone: +86- 512-6805-0607 | |
| Fax: +86- 512-6680-6133 | |
| Contact Person: | Ling Li |
| Regulatory Affairs Manager | |
| Phone: +86- 512-6805-0607 | |
| Fax: +86- 512-6680-6133 | |
| Email: liling02@hrmedical.com.cn | |
| Date prepared: | August 4, 2020 |
| Trade Name: | Hydrophilic Coating Guide Wire |
| Common Name: | Guide wire |
| Classification Name: | Wire, Guide, Catheter |
| Classification Panel: | Cardiovascular Devices |
| Regulation Number: | 21CFR Part 870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
| Predicate device: | Acme Monaco Slidewire® (K113162) |
| Reference Device: | Terumo Radifocus Guide Wire (K863138) |
Device Description:
The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.
4
Intended Use:
The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.
Substantial Equivalence Comparison:
The Hydrophilic Coating Guide Wire was found to be substantially equivalent to the predicate device Acme Monaco Slidewire® (K113162) and reference device Terumo Radifocus Guide Wire (K863138). A comparison of the technological characteristics is summarized on the table below:
| Description | Subject Device:
Hydrophilic Coating
Guide Wire Guide Wire | Predicate Device:
Acme Monaco
Slidewire | Reference Device:
Radifocus Guide Wire | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 510(k)
Number | K193653 | K113162 | K863138 | N/A |
| Manufacturer | Suzhou Hengrui Disheng
Medical Co., Ltd | Acme Monaco
Corporation | Terumo Medical
Corporation | N/A |
| Classification | II | II | II | Same |
| Product Code | DQX | DQX | DQX | Same |
| Regulation | 21 CFR Part 870.1330 | 21 CFR Part 870.1330 | 21 CFR Part 870.1330 | Same |
| Indications
for use | Designed to direct a
catheter to the desired
anatomical location in
the peripheral and
coronary vasculature
during diagnostic or
interventional
procedures.
This device is not
intended for
neurovascular
interventions. | Intended for use in
diagnostic or
interventional
procedures to assist in
directing a catheter to
the desired anatomical
location in the
coronary or peripheral
vasculature. | Designed to direct a
catheter to the desired
anatomical location
during diagnostic or
interventional
procedures. | Same with
predicate
device |
| Operation
Principle | Manual | Manual | Manual | Same |
| Core wire | Nickel Titanium | Nickel Titanium | Nickel Titanium | Same |
| Jacket | Polyurethane | Polyurethane | Polyurethane | Same |
| Radiopaque | Tungsten | Tungsten | Tungsten | Same |
Table 1 Summary of Comparative Information
5
| Description | Subject Device:
Hydrophilic Coating
Guide Wire Guide Wire | Predicate Device:
Acme Monaco
Slidewire | Reference Device:
Radifocus Guide Wire | Remark |
|---------------|-------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|
| Coating | Hydrophilic Caoting | Hydrophilic Caoting | Hydrophilic Caoting | Same |
| Specification | Diameter:
0.032",0.035",0.038"
Length:
150cm, 180cm, 260cm | Diameter:
0.014"- 0.052"
Length:
30cm - 300cm | Diameter:
0.018"- 0.052"
Length:
30cm - 300cm | Within the
range of
predicted
device
specification |
| | Usability | Single use | Single use | Single use |
Biocompatibility Testing:
Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-I: Evaluation and testing within a risk management process." The wire is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24h). The following biocompatibility tests were completed and the biocompatibility was acceptable:
- Cytotoxicity ●
- Sensitization (Kligman Maximization) ●
- Irritation / Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Pyrogen ●
- Hemolysis test(extract method) ●
- Thrombosis test ●
- Partial Thromboplastin Time (PTT) test ●
- Prothrombin time (PT) test ●
Non-Clinical Performance Testing:
Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995; Coronary, Peripheral, and Neurovascular Guidewire-Performance Tests and Recommended Labeling, Draft Guidance for Industry and Food and Drug Administration Staff, June 15, 2018; ISO 11070:2014, Sterile Single-use Intravascular Introducers, Dilators And Guidewires. The tests included the following:
6
- Size and Surface
- Tensile Strength ●
- Torque Strength ●
- Torqueability ●
- Coating Integrity ●
- Particulate Evaluation ●
- Lubricity ●
- Kink Resistance ●
- Tip Flexibility ●
- Radiopacity ●
- Fracture test ●
- Flexing test ●
- EO and ECH residual ●
- Sterile Bacterial endotoxin ●
- Visual Inspection of the inner pouch ●
- Dye leakage test of the inner pouch ●
- Sealing-strength of the inner pouch ●
Conclusion:
The Hydrophilic Coating Guide Wire was found to be substantially equivalent in its design, intended use, technology, principal of operation, and performance to the predicate device. There are not significant differences between the Hydrophilic Coating Guide Wire and the predicate device that raise new issues of safety and effectiveness.