(94 days)
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.
During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the Radifocus Glidewire Advantage Track. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility testing. It does not describe an AI/ML-driven device or a study involving human readers or expert consensus for ground truth establishment. Therefore, most of the requested information regarding AI acceptance criteria and study methodology (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.
Here's an analysis based on the information that is present in the document:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that "All testing met acceptance criteria" and "The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria" for performance testing. However, the exact acceptance criteria values themselves are not explicitly detailed in a table; rather, it lists the standards against which the tests were conducted (e.g., ISO 11070:2014, FDA Guidance, In-house Standard). For biocompatibility, it states "Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product."
Table of Acceptance Criteria and Reported Device Performance (as inferred):
| Test | Standard/Type of Acceptance Criteria | Reported Performance |
|---|---|---|
| Performance Testing | ||
| Surface | ISO 11070: 2014 Section 4.3 | Met acceptance criteria |
| Corrosion resistance | ISO 11070: 2014 Section 4.4 | Met acceptance criteria |
| Radio-detectability | ISO 11070: 2014 Section 4.5 | Met acceptance criteria |
| Size designation | ISO 11070: 2014 Section 8.2 | Met acceptance criteria |
| Fracture test | ISO 11070: 2014 Section 8.4 | Met acceptance criteria |
| Flexing test | ISO 11070: 2014 Section 8.5 | Met acceptance criteria |
| Peak tensile force of guidewire | ISO 11070: 2014 Section 8.6 | Met acceptance criteria |
| Torque strength | FDA Guidance, In-house Standard | Met acceptance criteria |
| Torqueability (Torque control) | FDA Guidance, In-house Standard | Met acceptance criteria |
| Tip Flexibility (Tip impact) | FDA Guidance, In-house Standard | Met acceptance criteria |
| Coating Adherence/Integrity | FDA Guidance, In-house Standard | Met acceptance criteria |
| Particulate test | FDA Guidance, In-house Standard | Met acceptance criteria |
| Ease of removing from the holder | In-house Standard | Met acceptance criteria |
| Sliding friction (hydrophilic coating portion) | In-house Standard | Met acceptance criteria |
| Sliding friction (PTFE coating portion) | In-house Standard | Met acceptance criteria |
| Proximal shaft stiffness | In-house Standard | Met acceptance criteria |
| Biocompatibility Testing | ISO 10993 series, particularly ISO 10993-1 and ISO 10993-7 | Device is biocompatible throughout the shelf life of the product. |
| Cytotoxicity (Non-aged & Accelerated-aged) | ISO 10993 standards | Met acceptance criteria |
| Sensitization | ISO 10993 standards | Met acceptance criteria |
| Intracutaneous Reactivity | ISO 10993 standards | Met acceptance criteria |
| Acute Systemic Toxicity | ISO 10993 standards | Met acceptance criteria |
| Pyrogenicity | ISO 10993 standards | Met acceptance criteria |
| Hemolysis (Non-aged & Accelerated-aged) | ISO 10993 standards | Met acceptance criteria |
| Thrombogenicity | ISO 10993 standards | Met acceptance criteria |
| Complement Activation (Immunology) | ISO 10993 standards | Met acceptance criteria |
| Physicochemical Profile (Physicochemical and FT-IR) (Non-aged & Accelerated-aged) | ISO 10993 standards | Met acceptance criteria |
| Sterilization Residuals | ISO 10993-7 | Residual EO will not exceed 4 mg per device; residual ECH will not exceed 9 mg per device. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the document. This is a non-clinical submission, and specific sample sizes for each mechanical/biocompatibility test are typically found in detailed test reports, not the 510(k) summary itself.
- Data Provenance: The tests are conducted by the manufacturer, Terumo Medical Corporation (Ashitaka Factory in Japan). The data is generated prospectively through laboratory testing.
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 device (guidewire), not an AI/ML diagnostic tool requiring human expert interpretation or ground truth establishment in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this is not an AI/ML diagnostic device with human interpretation.
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. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. Performance tests mentioned are for the physical guidewire itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this device, "ground truth" equates to the established standards and specifications for medical guidewires (e.g., ISO 11070:2014, in-house standards for physical properties, ISO 10993 for biocompatibility). Test results are compared against these predetermined specifications. There is no diagnostic ground truth (like pathology or expert consensus) involved.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2017
Terumo Medical Corporation Mr. Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921
Re: K163004
Trade/Device Name: Radifocus Glidewire Advantage Track Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 25, 2016 Received: November 2, 2016
Dear Mr. Lu:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel
Fernando Aguel
-S
for Bram D. Zuckerman, M.D. 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) K163004
Device Name Radifocus Glidewire Advantage Track
Indications for Use (Describe)
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Terumo logo. The logo consists of a red, curved line above the word "TERUMO" in green, block letters. The red line appears to be a stylized representation of a bird's wing or a swoosh, adding a dynamic element to the design.
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Liang Lu |
|---|---|
| Senior Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| Tel. (410) 392-7321 | |
| Fax (410) 398-6079 |
Prepared for: Owner/Operator
Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo Japan 151-0072 Owner/Operator Number: 8010026
Manufacturer and Sterilization Facility (Applicant)
Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 9681834
Contact Person: Liang Lu
Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com
Date prepared: January 23, 2016
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Image /page/4/Picture/1 description: The image shows the Terumo logo. The logo consists of a red angled line above the word "TERUMO" in green. The red line is positioned above and to the left of the word, creating a sense of forward movement.
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Radifocus Glidewire Advantage Track |
|---|---|
| Common Name: | Guide Wire |
| Classification Name: | Wire, Guide, Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21CFR870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed are:
- K122590 and K063372 Radifocus Glidewire Advantage manufactured by . Ashitaka Factory of Terumo Corporation.
| 510(K) No. | Competitor's product | Competitor's name |
|---|---|---|
| K033742 | V-18 | Boston Scientific |
| K112745 | V-14 | Boston Scientific |
| K052339 | Miracle | ASAHI INTECC |
| K122573 | Command | Abbott Vascular |
| K152709 | Spartacore | Abbott Vascular |
The following competitors' devices were used as reference devices:
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the Radifocus Glidewire Advantage Track, manufactured by Ashitaka Factory of Terumo Corporation, for the modifications on the previously cleared predicate device (K122590 and K063372) manufactured by the same factory.
The proposed Radifocus Glidewire Advantage Track is identical to the predicate Radifocus Glidewire Advantage (K122590 and K063372) with the exception of the following:
- . The proximal core wire material of the predicate device (K063372 and K122590 Radifocus Glidewire Advantage) is being modified from NiTi (Nickel Titanium alloy) to Stainless Steel;
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Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.
- . The angle of the angle-shape wire distal tip is being modified from 45° to 35°;
- . The labeling for the proposed Radifocus Glidewire Advantage Track is being slightly modified
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The Radifocus Glidewire Advantage Track is operated by manual process.
Design/Construction
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.
During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.
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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word.
Materials
The materials for the Radifocus Glidewire Advantage Track are provided in Table 1 below.
| Part | Raw material | |
|---|---|---|
| Core wire*(Proximal portion from junction) | Stainless steel | |
| Core wire*(Distal portion from junction) | Nickel-Titanium alloy | |
| First coating* | Polyurethane containing tungsten | |
| Second coating on distal portion of wire*(Hydrophilic polymer) | -Hydrophilic polymerHalf-ester methyl vinyl ether-maleicanhydridecopolymer-Under coatPolyvinyl chloride | |
| PTFE spiralcoating onproximal portionof wire | Under coatingTop coating*Spiral coating* | Polytetrafluoroethylene (PTFE) |
| Edge protectionpart | Metal part*Solder* | Platinum/ Iridium (Pt/Ir)Tin/Silver (Sn/Ag) |
| Third coating on edge protection part*(Hydrophilic polymer) | Dimethyle acrylamideglycidylmethacrylate copolymer | |
| Tip coil marker | Gold (Au) |
| Table 1: List of Materials | |
|---|---|
| ---------------------------- | -- |
- Blood contacting material
Specifications
The specifications for the Radifocus Glidewire Advantage Track are provided in the Table 2 below.
| Part | Specification |
|---|---|
| Diameter of Wire | 0.014 and 0.018" |
| Length of Wire | 180 and 300 cm* |
| Shapes of Wire (distal tip) | Angled (Tip angle 35°) |
- tolerance: ± 20 mm
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Image /page/7/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and positioned above and to the left of the word.
F. INDICATIONS FOR USE (807.92(a)(5))
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
Note: The indications for use are identical to the predicate device, Radifocus Glidewire Advantage (K122590 and K063372).
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Radifocus Glidewire Advantage Track, subject of this traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:
- Predicate Device: K063372 and K122590 Radifocus Glidewire Advantage, . manufactured by Ashitaka Factory of Terumo Corporation.
A comparison of the technological characteristics is summarized in Table 3 below.
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Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and slightly to the left of the word.
| Table 3:Comparison ofDeviceCharacteristics | New Device:Radifocus Glidewire Advantage Track | Predicate Device:Radifocus GlidewireAdvantage (K063372) | Predicate Device:Radifocus GlidewireAdvantage (K122590) |
|---|---|---|---|
| Manufacturer | Ashitaka Factory of Terumo Corp. | Same | Same |
| IntendedUse/IndicationforUse | Designed to direct a catheter to thedesired anatomical location in theperipheral vasculature during diagnosticor interventional procedures. This deviceis not intended for neurovascular orcoronary interventions. | Same | Same |
| Operation Principle | Manual | Same | Same |
| Design/Construction | The Radifocus Glidewire AdvantageTrack consists of a Nickel Titanium alloy(distal) and stainless steel (proximal) corewire.A polyurethane and hydrophilic coating isapplied to the distal portion of the wirewhile a PTFE coating is applied to theproximal portion. The wire distalsegment comes in angled configuration.The wire contains a distal radiopaquegold coil.The wire is packed in a plastic holdercontained within an individual package. Aguide wire inserter is contained within theindividual package to assist with the | The Radifocus GlidewireAdvantage consists of aNickel Titanium alloy corewireSame (the distal radiopaquegold coil is for the 0.018"only). | The Radifocus GlidewireAdvantage consists of aNickel Titanium alloy corewire.Same |
| Same unless mentioned below: | Same as K063372 unless mentioned below: | ||
| Materials | Core wire (Proximal portion from junction): Stainless steel (Distal portion from junction): Nickel-Titanium alloy First coating: Polyurethane containing tungsten Second coating on distal portion of wire (Hydrophilic polymer): Half-ester methyl vinyl ether-maleic anhydridecopolymer Under coat: Polyvinyl chloride PTFE spiral coating on proximal portion of wire: Polytetrafluoroethylene (PTFE) Edge protection part Metal part: Platinum/ Iridium (Pt/Ir) Solder: Tin/Silver (Sn/Ag) Third coating on edge protection part (Hydrophilic polymer): Dimethyle acrylamideglycidyl methacrylate copolymer Tip coil marker: Gold (Au) available for 0.014" and 0.018" | Core wire: Nickel-Titanium alloy First coating: Polyurethane containing tungsten Tip coil marker: Gold (Au) only available for 0.018" | Tip coil marker: Gold (Au) only available for 0.014" |
| Package | Individual package on which the product label and the peel-off labels are attached 1 unit per package | Same | Same |
| Specifications | Diameter of Wire: 0.014 and 0.018" Length of Wire: 180 and 300 cm* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 35°) Accessory Devices: Guide wire inserter | Diameter of Wire: 0.018 - 0.038" Length of Wire: 150 - 300 cm* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°), straight, J shaped Accessory Devices: Guide wire inserter | Diameter of Wire: 0.014" Length of Wire: 180 and 300 cm* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°) Accessory Devices: Guide wire inserter |
| Sterilization | Ethylene oxide | Same | Same |
| Shelf Life | 24 months | Same | Same |
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Image /page/9/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red, curved line above the word "TERUMO" in green, block letters. The red line is positioned above and to the left of the word, creating a sense of motion or direction.
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Image /page/10/Picture/1 description: The image contains the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the word. The swoosh starts above the "T" and extends to the right.
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Image /page/11/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the company name.
H. NON CLINICAL TESTS (807.92(b)(1))
Performance Testing
Performance testing was conducted to demonstrate substantial equivalence to the predicate device, to verify conformity to applicable external and internal standards, and verify that aging does not affect the Radifocus Glidewire Advantage Track. All testing met acceptance criteria. Table 4 below provides a list of the performance tests that were performed on the proposed Radifocus Glidewire Advantage Track.
| Test | Standard |
|---|---|
| Surface | ISO 11070: 2014 Section 4.3 |
| Corrosion resistance | ISO 11070: 2014 Section 4.4 |
| Radio-detectability | ISO 11070: 2014 Section 4.5 |
| Size designation | ISO 11070: 2014 Section 8.2 |
| Fracture test | ISO 11070: 2014 Section 8.4 |
| Flexing test | ISO 11070: 2014 Section 8.5 |
| Peak tensile force of guidewire | ISO 11070: 2014 Section 8.6 |
| Torque strength | FDA GuidanceIn-house Standard |
| Torqueability(Torque control) | FDA GuidanceIn-house Standard |
| Tip Flexibility(Tip impact) | FDA GuidanceIn-house Standard |
| Coating Adherence/Integrity | FDA GuidanceIn-house Standard |
| Particulate test | FDA GuidanceIn-house Standard |
| Ease of removing from the holder | In-house Standard |
| Sliding friction(hydrophilic coating portion) | In-house Standard |
| Sliding friction(PTFE coating portion) | In-house Standard |
| Proximal shaft stiffness | In-house Standard |
Table 4: Summary of Performance Testing
The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria. Based on the results of the performance testing, the proposed Radifocus Glidewire Advantage Track is substantially equivalent to the predicate.
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Image /page/12/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO."
Biocompatibility
In accordance with ISO 10993-1, the Radifocus Glidewire Advantage Track is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). This is the same classification as the predicate.
The finished device's patient contacting parts were tested in accordance with the tests recommended in the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff issued on June 16, 2016. Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product.
The Table 5 below provides a list of biocompatibility tests conducted on the proposed Radifocus Glidewire Advantage Track.
| Non-aged, sterile, whole device |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity |
| Complement Activation (Immunology) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (2 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |
Table 5: Summary of ISO 10993 Biocompatibility Testing
Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
Sterilization
The sterility of the device is assured using a sterilization method validated in
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Image /page/13/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red angled line above the company name, which is written in green, block letters. The red line is above and to the left of the company name.
accordance with ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals.
Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device after 24 hours of aeration.
Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, taking into account the modifications to the previous device, and it was determined that there were no new issues of safety or effectiveness.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the Radifocus Glidewire Advantage Track, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance 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.