(270 days)
This Product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion The basic structure, construction, and coating of the CROSSLEAD are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)
The provided text describes the regulatory submission for a medical device called "CROSSLEAD Peripheral Guide Wire". This document does not contain information about an AI/ML powered device, and therefore the acceptance criteria and study details related to AI/ML device performance are not present.
The document discusses the substantial equivalence of the CROSSLEAD device to previously cleared predicate devices through non-clinical testing and biocompatibility assessments.
Here's a breakdown of the information that is provided, as it relates to the non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the CROSSLEAD met "all acceptance criteria" but does not provide specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it offers a list of tests performed.
| Test Category | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|
| Non-Clinical Performance Tests | Met all acceptance criteria (specifics not provided) | Performed similarly to the predicate devices. Functions as intended. |
| Biocompatibility (Cytotoxicity) | No signs of cellular reactivity (Grade 0) for controls | Non-cytotoxic |
| Biocompatibility (Sensitization) | No evidence of causing delayed dermal contact sensitization | Non-sensitizing |
| Biocompatibility (Irritation) | Test extract and negative control exhibit similar edema and erythema scores | Non-irritant |
| Biocompatibility (Systemic Tox.) | Test article not show significantly greater biological activity than control | No Systemic Toxicity |
| Biocompatibility (Pyrogen Test) | Not increase rectal temperature by more than 0.5 degrees Celsius | Non-pyrogenic |
| Biocompatibility (Hemolysis) | Non-hemolytic | Non-hemolytic |
| Biocompatibility (Thromboplastin) | UPTT of plasma not significantly decreased compared to controls | Not an activator |
| Biocompatibility (Complement) | No significant increase in SC5b-9 compared to controls | Not an Activator |
| Biocompatibility (Thrombogenicity) | Comparable to predicate control for thrombogenic response | Comparable thromboresistance with control |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for the non-clinical or biocompatibility tests.
- Data Provenance: Not specified. The tests were performed in a lab setting ("bench testing") and are likely internal to the manufacturer or conducted by contract research organizations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable to the non-clinical and biocompatibility testing described. These tests involve laboratory measurements against established standards, not expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable, as this refers to expert review in clinical or diagnostic assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This type of study is not relevant for the evaluation of a physical guide wire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
No. This device is not an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance benchmarks derived from relevant FDA guidance documents (e.g., "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018"). For biocompatibility, the ground truth is defined by the ISO 10993 standards and the expected biological responses.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
{0}------------------------------------------------
July 1, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Asahi Intecc Co., LTD. % Cynthia Valenzuela Director, Regulatory Affair Asahi Intecc USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K213315
Trade/Device Name: CROSSLEAD Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 20, 2022 Received: May 24, 2022
Dear Cynthia Valenzuela:
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
{1}------------------------------------------------
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 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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213315
Device Name CROSSLEAD Peripheral Guide Wire
Indications for Use (Describe)
This Product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature 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)
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 FDA 3881 (6/20)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
510(K) Summary
[as required by 21CFR § 807.92(c)]
ЛЅЛНІ ІNTECC CO.,LTD.
Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/
CROSSLEAD Peripheral Guide Wire
510(K) _K __________________________________________________________________________________________________________________________________________________________________
| DATE PREPARED: | |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD.3-100 Akatsuki-cho, SetoAichi 489-0071, Japan |
| PRIMARY CONTACT: | Mrs. Cynthia ValenzuelaDirector, Regulatory AffairsASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (714) 442 0575Fax: (949) 377 3255Email: cynthiav@asahi-intecc-us.com |
| ALTERNATE CONTACT: | Mr. Yoshi TeraiPresident, CEOASAHI INTECC USA, INC.Tustin, CA 92780 USAPhone: (949) 756 8901Fax: (949) 377 3255Email: yoshi@asahi-intecc-us.com |
| TRADE NAME: | CROSSLEAD Peripheral Guide Wire |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Catheter Guide Wire |
| PRODUCT CODE: | DQX |
| PREDICATE DEVICE(S): | Radifocus Glidewire Advantage (K063372) |
| REFERENCE DEVICE(S): | ASAHI Silverway (K183062)ASAHI Regalia XS 1.0 (K083146)Emerald guidewire (K935170)ΜΙΝΑΜΟ (K190176) |
Intended Use/Indications for Use:
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
{4}------------------------------------------------
Description:
The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion The basic structure, construction, and coating of the CROSSLEAD are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)
Accessory
The CROSSLEAD is packaged with a shaping needle.
The shaping needle can be used to facilitate shaping of the guide wire distal end. The shaping needle consists of a stainless-steel needle, a polypropylene hub and polyethylene cover.
| Predicate | Device Name | 510(K) Number |
|---|---|---|
| Primary Predicate | Radifocus Glidewire Advantage | K063372 |
| Reference Device | ASAHI Silverway | K183062 |
| Reference Device | ASAHI Regalia XS 1.0 | K083146 |
| Reference Device | Emerald guidewire | K935170 |
| Reference Device | MINAMO | K190176 |
Comparison with Predicate Device and Reference Device:
The subject device has the following similarities to those which previously received 510(k) clearance.
- . Have the similar intended use and indications for use
- Use the same operating principle; ●
- Incorporate the same basic designs; and
- Incorporate the same materials ●
{5}------------------------------------------------
Comparison with Predicate Device and Reference Device
| Name of Devices | CROSSLEAD | Radifocus GlidewireAdvantage | ASAHI Silverway | ASAHI Regalia XS 1.0 | |
|---|---|---|---|---|---|
| Subject | Predicate | Reference | Reference | ||
| 510(k) | TBD | K063372 | K183062 | K083146 | |
| Manufacturer | ASAHI INTECC | TERUMO | ASAHI INTECC | ASAHI INTECC | |
| Classification Regulation | 21 CFR 830.1330, Cardiovascular | ||||
| Common Name | Catheter Guide Wire | ||||
| Product Code | DQX | ||||
| Class | II | ||||
| Intended Use | Guide wire for percutaneous intervention | ||||
| Indications for Use | This product is designed todirect a catheter to thedesired anatomical locationin the peripheralvasculature duringdiagnostic or interventionalprocedures. | The Radifocus GlidewireAdvantage is designed todirect catheter to the desiredanatomical location duringdiagnostic or interventionalprocedures. | This product is intended to beused for the adjustment of theposition of interventionaldevices in a blood vessel andas an aid in moving thecatheter. It is not for use incoronary arteries orintracranial vessels. | This product is intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures. Thisdevice is intended forperipheral vascular use only. | |
| Nominal OD | 0.89mm (0.035inch) | 0.36mm (0.014inch)0.45mm (0.018inch)0.89mm (0.035inch) | 0.89mm (0.035inch) | 0.36mm (0.014inch) | |
| Overall Length | 200cm, 300cm | 180cm, 260cm, 300cm | 150cm, 180cm, 200cm220cm, 260cm, 300cm | 180cm, 300cm | |
| Outer Coil | SUS | Gold | SUS | Pt-Ni and SUS | |
| Core Wire | Ni-Ti alloy | Nitinol alloy | SUS | SUS | |
| Tip Shape | Straight, Angled | 45°Angle | Angled, J-Shape (1.5mm),J-Shape (3.0mm) | Straight | |
| Coating | Hydrophilic Hydrophobic | Hydrophilic Hydrophobic | <Distal, Proximal>Hydrophobic Hydrophilic | Hydrophilic Hydrophobic | |
| Sterilization | Provided sterile via EthyleneOxide to SAL 10-6 | Provided sterile via EthyleneOxide to SAL 10-6 | Provided sterile via EthyleneOxide to SAL 10-6 | Provided sterile via EthyleneOxide to SAL 10-6 |
{6}------------------------------------------------
Non Clinical Testing / Performance Data:
The substantial equivalence of the CROSSLEAD was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018.
- Tensile Strength
- Torque Strength .
- Torqueability ●
- Tip Flexibility ●
- Coating Adhesion / Integrity ●
- . Catheter Compatibility
- Appearance and Cleanliness ●
- Corrosion Resistance ●
- Kink Resistance ●
- Radio - detectability
- . Dimensional Verification
The in vitro bench tests demonstrated that the CROSSLEAD met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.
BIOCOMPATIBILITY:
The CROSSLEAD was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed:
| Test | Test Summary | Conclusion |
|---|---|---|
| Cytotoxicity - ISO 10993-5L929 cells/MEM Elution Test | The test system is considered suitable if nosigns of cellular reactivity (Grade 0) are notedfor both the negative control article and themedium control. | Non-cytotoxic |
| Sensitization - ISO 10993-10KLIGMAN Maximization Test | The extracts should show no evidence ofcausing delayed dermal contact sensitizationin the guinea pig. | Non-sensitizing |
| Irritation - ISO 10993-10Intracutaneous Injection Test | The test extract and the negative control mustexhibit similar edema and erythema scores. | Non-irritant |
| Systemic Toxicity - ISO 10993-11Acute System Toxicity Test | The test article must not show significantlygreater biological activity than the control. | No SystemicToxicity |
| Systemic Toxicity - ISO 10993-11Rabbit Pyrogen Test (materialmediated) | The test article should not increase the rectaltemperature of any of the animals by morethan 0.5 degrees Celsius. | Non-pyrogenic |
| Hemocompatibility - ISO 10993-4Rabbit Blood Hemolysis Test | Test article in direct contact with blood andtest article extract must be non-hemolytic. | Non-hemolytic |
| Hemocompatibility - ISO 10993-4Unactivated Partial ThromboplastinTime Test | The UPTT of the plasma exposed to testarticle extract should not significantlydecreased when compared to untreated andnegative controls. | Not an activator |
| Hemocompatibility - ISO 10993-4Complement Activation Assay(SC5b-9) | The plasma exposed to test article mustexhibit no significant increase in SC5b-9 whencompared to activated NHS and negativecontrol after 60 minutes exposure. | Not an Activator |
| Hemocompatibility - ISO 10993-4Thrombogenicity Study in Dogs | Compare results of test article to predicatecontrol for Thrombogenici response.Determine acceptability of results as part ofrisk management. | Comparablethromboresistancewith control |
Biocompatibility Results (brief)
{7}------------------------------------------------
CONCLUSION:
The CROSSLEAD has similar intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference device. Performance data demonstrates that the device functions as intended.
Therefore, the CROSSLEAD is substantially equivalent to the predicate device.
§ 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.