DCwire Micro-guidewire

K252122 · Shanghai Achieva Medical Suzhou Co., Ltd. · MOF · Mar 16, 2026 · Cardiovascular

Device Facts

• Record ID: K252122
• Device Name: DCwire Micro-guidewire
• Applicant: Shanghai Achieva Medical Suzhou Co., Ltd.
• Product Code: MOF · Cardiovascular
• Decision Date: Mar 16, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.

Device Story

Single-use micro-guidewire; shapeable tip; used to gain intravascular access; facilitates positioning/exchange of interventional devices in small-diameter, tortuous peripheral and neuro vasculature. Physician-operated in clinical settings. Device torqued manually to navigate vasculature. Provides mechanical guidance for catheters. Benefits patient by enabling precise navigation to target sites during diagnostic/interventional procedures.

Clinical Evidence

No clinical studies conducted. Substantial equivalence established via bench performance testing (dimensional verification, simulated use, tensile strength, torqueability, coating integrity/lubricity, kink resistance, radiopacity) and biocompatibility testing (ISO 10993 series, including canine thrombogenicity model).

Technological Characteristics

Core: 304 stainless steel; Tip: Nitinol; Coil: Platinum-tungsten alloy; Coating: Polyvinylpyrrolidone (top) and polyurethane (base). Dimensions: 0.010"/0.012" or 0.014" diameters; 215cm/300cm lengths. Sterilization: Ethylene Oxide (ISO 11135:2014). Accessories: Introducer, Torque Device.

Indications for Use

Indicated for patients undergoing endovascular treatment in neuro and peripheral vasculature requiring selective introduction and positioning of catheters and interventional devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Synchro SELECT™ Guidewire (K202522)
• PVS 1300 Synchro® 0.014” & PVS 1600 Synchro® 0.010” Guidewires (K032146)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

March 16, 2026

Shanghai Achieva Medical Suzhou Co., Ltd.
% Christine Zeng
Sr. RA Manager
SUZHOU MDCE Co., Ltd.
Room 03-1, Floor 20, Building 2, 10 Yueliangwan Road,
Suzhou Industrial Park, Suzhou, Jiangsu, 215123,
China

Re: K252122
Trade/Device Name: DCwire Micro-guidewire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: MOF, DQX
Dated: February 13, 2026
Received: February 13, 2026

Dear Christine Zeng:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K252122 - Christine Zeng
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

{2}

K252122 - Christine Zeng
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

NAIRA MURADYAN -S

Naira Muradyan, PhD
Assistant Director
DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252122 | |
| Device Name DCwire Micro-guidewire | |
| Indications for Use (Describe) The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. | |
| 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 [e-mail] | |
| "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." | |

{4}

Shanghai Achieva Medical Suzhou Co., Ltd.
Premarket Notification, Traditional
510(k)
DCwire™ Micro-guidewire

# 510(k) Summary K252122

## Submitter Name, Address and Contact

**Submitter:** Shanghai Achieva Medical Suzhou Co., Ltd.
Address 1: No.8 Zhongtian Alley, Suzhou Industrial Park, Suzhou Jiangsu, 215028, China
Address 2: No.133 Fangzhong Street, Suzhou Industrial Park, Suzhou, Jiangsu, 215028, China

**Sponsor Contact:** Jinwei Yi
Deputy Director of Regulatory Affairs Dept.
Email: [e-mail]
Phone: [phone]

**Correspondent:** Christine Zeng
SUZHOU MDCE Co., Ltd
Email: [e-mail]
Phone: [phone]

**Date Prepared:** Mar. 12, 2026

## Device Name and Classification

**Trade/Proprietary Name:** DCwire™ Micro-guidewire
**Common Name:** Micro-guidewire
**Classification Name:** Wire, Guide, Catheter, 21 CFR 870.1330 – Class II
**Product Code:** MOF, DQX

## Legally Marketed Predicate Devices

| Primary Predicate Device | |
| --- | --- |
| K202522 | Synchro SELECT™ Guidewire |
| Predicate Device | |
| K032146 | PVS 1300 Synchro® 0.014” & PVS 1600 Synchro® 0.010” Guidewires |

## Device Description

Page 1 of 9

{5}

Shanghai Achieva Medical Suzhou Co., Ltd.

Premarket Notification, Traditional
510(k)

DCwire™ Micro-guidewire

The DCwire™ Micro-guidewire is a single-use device with a shapeable tip, used to gain intravascular access and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The Micro-guidewire can be torqued to facilitate navigation through the vasculature.

DCwire™ Micro-guidewire comes in three stiffness profiles: Soft, Standard, and Support.

# Accessories

The DCwire™ Micro-guidewire is provided with two (2) accessories, an Introducer and a Torque Device.

# Indications for Use

The DCwire™ Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.

# Technological Characteristics and Product Feature Comparison

The DCwire™ Micro-guidewire is substantially equivalent to the Predicate devices, the Synchro SELECT™ Guidewire, cleared under K202522, and the PVS 1600 Synchro® 0.010” Guidewire, cleared under K032146, based on the following:

Same intended use
- Same fundamental materials, design and technology
- Same operating principles
Similar sterilization method and process for devices

A comparison of the Subject device with the Predicate devices is summarized in Table 1 below.

Table 1. Comparison of Subject Device to Predicate Devices

| Characteristic | Primary Predicate Device | Predicate Device | Subject Device |
| --- | --- | --- | --- |
| Device | Synchro SELECT™ Guidewire (K202522) | PVS 1300 Synchro 0.014” & PVS 1600 Synchro® 0.010” Guidewires (K032146) | DCwire™ Micro-guidewire (K252122) |
| Classification | Class II | Class II | Same |
| Product Code | MOF, DQX | DQX | MOF, DQX |
| Regulation Number | 21 CFR 870.1330 | 21 CFR 870.1330 | Same |
| Review Panel | Neurology, Cardiovascular | Cardiovascular | Neurology, Cardiovascular |

Page 2 of 9

{6}

Shanghai Achieva Medical Suzhou Co., Ltd.
Premarket Notification, Traditional 510(k)
DCwire™ Micro-guidewire

| Characteristic | Primary Predicate Device | Predicate Device | Subject Device |
| --- | --- | --- | --- |
| Indications for Use | The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. | The PVS 1300 Synchro® 0.014” & PVS 1600 Synchro® 0.010” Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. | DCwire™ Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. |
| Device Description/Principle of Operation | The Synchro SELECT Guidewire is a single-use device with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. | Same | Same |
| Patient Population | Patients undergoing endovascular treatment in neuro and peripheral vasculature. | Same | Same |
| Accessories | Guidewire Introducer, Torque Device | Guidewire Introducer, Torque Device | Same |
| Diameter | Distal: 0.014 inch
Proximal: 0.014 inch | PVS 1300 Synchro® 0.014” Guidewire:
Distal: 0.014 inch
Proximal: 0.014 inch

PVS 1600 Synchro® 0.010” Guidewire:
Distal: 0.010 inch
Proximal: 0.012 inch | 10 Series:
Distal: 0.010 inch
Proximal: 0.012 inch

14 Series:
Distal: 0.014 inch
Proximal: 0.014 inch |

Page 3 of 9

{7}

Shanghai Achieva Medical Suzhou Co., Ltd.

Premarket Notification, Traditional 510(k)

DCwire™ Micro-guidewire

| Characteristic | Primary Predicate Device | Predicate Device | Subject Device |
| --- | --- | --- | --- |
| Core Wire | 304 Stainless Steel, PTFE Coated on the proximal section | 304 Stainless Steel, PTFE Coated on the proximal section | Same |
| Core Wire Length | 215cm Access Length
300cm Exchange Length | 180 – 300cm | 215cm and 300cm Effective Lengths |
| Guidewire Tip | Nickel-Titanium, Micro-Machined Nitinol | Nickel-Titanium, Micro-Machined Nitinol | Same |
| Radiopaque Coil | Platinum | Platinum | Platinum-Tungsten Alloy |
| Adhesive | UV Curable Adhesive | Limited information | Epoxy Glue
UV Curable Glue |
| Primer | Parylene Dimer | Limited information | None |
| Hydrophilic Top Coating | Proprietary Hydrophilic Top Coating | Hydrophilic Polymer | Polyvinylpyrrolidone |
| Hydrophilic Base Coating | Proprietary Hydrophilic Base Coating | Hydrophilic Polymer | Polyurethane |
| Dispenser Hoop | High Density Polyethylene | Limited information | High Density Polyethylene |
| Accessory Card | Clay Coated Solid Bleached Sulfate (CCSBS) | Limited information | PVC |
| Sterile Pouch | Tyvek-Polyethylene | Limited information | Tyvek-Polyethylene/Polyethylene terephthalate |
| Shipping Carton | Solid Bleached Sulphate (SBS) | Limited information | 5-ply AB flute corrugated cardboard |
| Sterilization Method | Ethylene Oxide (EO) gas | Irradiation | EO gas |
| How Supplied | Single Use/Sterile | Single Use/Sterile | Same |

The differences between the devices do not raise new questions of safety and effectiveness.

## Bench Performance Testing

The results of the bench testing conducted on the subject device demonstrate that it performs as intended and meets design specifications. Bench performance testing included the following:

Table 2. Bench Testing Summary

{8}

Shanghai Achieva Medical Suzhou Co., Ltd.
Premarket Notification, Traditional 510(k)
DCwire™ Micro-guidewire

| Test name | Test Method Summary | Conclusions |
| --- | --- | --- |
| Dimensional Verification | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Verified key dimensions of the guidewire. | Acceptance criteria were met. |
| Visual Inspection | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Ensure devices are free of defects that could cause trauma to vessels during use. | Acceptance criteria were met. |
| Simulated Use | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Guidewires were tested for use with a microcatheter, the guidewire introducer, and torque device while navigating to target locations in a tortuous simulated use model. | Acceptance criteria were met. |
| Tensile Strength | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Measured the force required to break at bond. | Acceptance criteria were met. |
| Tip Pull | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Evaluated the tensile force required to separate the distal tip from the guidewire for guidewires with joints at the tip. | Acceptance criteria were met. |
| Torque Strength | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). | Acceptance criteria were met. |

Page 5 of 9

{9}

Shanghai Achieva Medical Suzhou Co., Ltd.

Premarket Notification, Traditional 510(k)

DCwire™ Micro-guidewire

| | Record the angle the proximal end of the wire can be rotated until it exceeds its maximum rotations and fails. | |
| --- | --- | --- |
| Torqueability | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Measured starting angle and rotation efficiency when proximal end is rotated. | Acceptance criteria were met. |
| Coating Integrity | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires –Performance Tests and Recommended Labeling" (2019).Visually inspect and compare hydrophilic coating before and after tracking through a tortuous simulated use model. Additionally, visually inspect device coating after staining the devices. | Acceptance criteria were met. |
| Particulate Evaluation | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Counted particulates of various size ranges after tracking through a tortuous simulated use model. | Acceptance criteria were met. Comparable to the predicate. |
| Coating Lubricity | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Hydrophilic coating lubricity was assessed after multiple pull cycles through silicone pads. | Acceptance criteria were met. |
| Corrosion Resistance | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). The metal part of the Micro-guidewire should show no signs of corrosion on its surface after the corrosion resistance test | Acceptance criteria were met. |
| Kink Resistance | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). | Acceptance criteria were met. |

Page 6 of 9

{10}

Shanghai Achieva Medical Suzhou Co., Ltd.
Premarket Notification, Traditional 510(k)
DCwire™ Micro-guidewire

| | Demonstrate the device's resistance to kinking when bent around anatomically relevant radii. | |
| --- | --- | --- |
| Tip Flexibility | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Measured the force required to deflect the guidewire tip when held at specific gauge lengths. | Acceptance criteria were met. |
| Radiopacity | Testing completed per FDA guidance document “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019). Ensure radiopaque markers or portions are visible using clinical imaging techniques. | Acceptance criteria were met. |
| Coating Durability | Coating durability was assessed after repeated pull cycles through silicone pads. | Acceptance criteria were met. |
| Tip Shapeability, Tip Shape Retention | Shaped the guide wire to a specific angle and unshaped for a total of 5 times, check under 40x magnification to ensure there is no rupture or damage of any kind. Measure the immediate angle after shaping, and the tip shape retention after tracking the guidewire through a tortuous simulated use model. | Acceptance criteria were met. |
| Tip Integrity | Shape, straighten and reverse reshape the guide wire for a total of 5 times, then perform simulated use, check under 40x magnification to ensure there is no rupture or damage of any kind. | Acceptance criteria were met. |
| Flexure | Subjected the guidewire to multiple flexure cycles around cylindrical pins. | Acceptance criteria were met. |
| Fracture | Subjected the guidewire to multiple wrappings around cylinder and visually inspected for signs of fracture. | Acceptance criteria were met. |
| Torque Device - Appearance | Ensure appearance of the Torque Device is clean and free of impurities. | Acceptance criteria were met. |
| Torque Device -Fixed Strength of Micro-guidewire | Ensure that the torsion has no axial slippage. | Acceptance criteria were met. |

Page 7 of 9

{11}

Shanghai Achieva Medical Suzhou Co., Ltd.
Premarket Notification, Traditional 510(k)
DCwire™ Micro-guidewire

| Torque Device - Fixable Dimension | Ensure the Torque Device can lock the proximal end of the micro-guidewire and drive the micro-guidewire to rotate. | Acceptance criteria were met. |
| --- | --- | --- |
| Torque Device - Micro-guidewire Damage | Ensure the Torque Device does not cause visually observable damage to the micro-guidewire. | Acceptance criteria were met. |
| Torque Device - Torque Slip Force | Ensure that the torsion has no circular slippage. | Acceptance criteria were met. |
| Introducer - Visual Inspection | Ensure the appearance of the Introducer is clean and free of impurities. | Acceptance criteria were met. |
| Introducer - Dimensional Verification | Ensure the dimensions of the Introducer comply with specifications. | Acceptance criteria were met. |
| Introducer - Functionality | Ensure the Introducer can assist in guiding the micro-guidewire into the microcatheter. | Acceptance criteria were met. |

## Sterilization and Shelf-Life Testing

The device is provided sterile and it is sterilized by Ethylene Oxide. The sterilization process of Ethylene Oxide consists of four stages. The sterilization cycle was validated to achieve a sterility assurance level (SAL) of $10^{-6}$ according to ISO 11135:2014.

Accelerated aging was used to simulate the storage of 3 years for the DCwire™ Micro-guidewire, then the bench performance tests as well as the package integrity tests were performed on the accelerated aged samples and met the pre-determined acceptance criteria.

## Performance Data - Animal, Clinical

No animal or clinical studies were conducted as the intended use and the fundamental scientific technology are the same as that of the predicate. Substantial equivalence of the subject device has been established to the predicate devices through the results of non-clinical performance testing.

## Biocompatibility Testing

The DCwire™ Micro-guidewire is an externally communicating medical device directly contacting circulating blood for a limited (≤24 hours) duration. Therefore, as per “Table A.1: Biocompatibility Evaluation Endpoints” of FDA biocompatibility guidance, the following assessments were conducted.

Table 3. Biocompatibility Testing Summary

| Test Item | Standard | Conclusion |
| --- | --- | --- |
| MEM Elution Cytotoxicity Assay (ISO) | ISO 10993-5 | Pass: Non-cytotoxic |

Page 8 of 9

{12}

Shanghai Achieva Medical Suzhou Co., Ltd.

Premarket Notification, Traditional
510(k)

DCwire™ Micro-guidewire

| Test Item | Standard | Conclusion |
| --- | --- | --- |
| Sensitization-Guinea Pig Maximization Test (ISO) | ISO 10993-10 | Pass: Non-sensitizing |
| Intracutaneous Reactivity Test (ISO) | ISO 10993-23 | Pass: Non-reactive |
| Acute Systemic Toxicity Test (ISO) | ISO 10993-11 | Pass: No evidence of acute systemic toxicity |
| Material Mediated Pyrogenicity Test (ISO/USP) | ISO 10993-11/ USP General Chapter <151> | Pass: Non-pyrogenic |
| Hemolysis Assay – Direct and Indirect (ISO) | ISO 10993-4/ ASTM F756 | Pass: Non-hemolytic |
| Complement Activation Assay (ISO) | ISO 10993-4 | Pass: No significant complement activation observed |
| Partial Thromboplastin Time (PTT) Assay (ISO) | ASTM F 2382 | Pass: No significant effect on coagulation time |
| Heparinized Blood Platelet and Leukocyte Count Assay (ISO) | ASTM F2888 | Pass: No significant impact on platelet and leukocyte counts |
| Thrombogenicity – Non-Anticoagulated Venous Implant Study in a Canine Model | ISO 10993-4 | Pass: No evidence of thrombogenicity in canine model |

## Conclusion

The subject device is substantially equivalent to the predicate devices with regards to device design, materials, intended use, and patient population. The conclusions drawn from the non-clinical testing conducted demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices.

Page 9 of 9