(108 days)
The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.
This document is a 510(k) premarket notification for a medical device called the Radifocus Glidewire Endoscopic Wire. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study describing acceptance criteria and device performance in the context of an AI-based system. Therefore, most of the requested information regarding AI study specifics like sample sizes for test and training sets, expert consensus, MRMC studies, and standalone performance is not applicable to this document.
However, I can extract and describe the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document, which are related to the physical performance and safety of the guidewire.
Acceptance Criteria and Device Performance for the Radifocus Glidewire Endoscopic Wire
The device is a medical guidewire (non-AI), so the acceptance criteria are based on physical performance, biocompatibility, and sterility, rather than diagnostic accuracy or AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria & Test | Standard / Basis | Reported Device Performance |
|---|---|---|
| Performance Testing (ISO 11070: 2014) | ||
| Radiodetectability | ISO 11070, Section 4.5 | All samples tested met the standard applicable to each test. |
| Fracture Test | ISO 11070, Section 8.4 | All samples tested met the standard applicable to each test. |
| Flexing Test | ISO 11070, Section 8.5 | All samples tested met the standard applicable to each test. |
| Peak Tensile Force of Guidewire | ISO 11070, Section 8.6 | All samples tested met the standard applicable to each test. |
| Performance Testing (Terumo's Internal Standards) | ||
| Flexibility Test of Distal Tip | Internal Standards (based on predicate) | Meets acceptance criteria |
| Torque transmission | Internal Standards (based on predicate) | Meets acceptance criteria |
| Sliding Resistance/Coating | Internal Standards (based on predicate) | Meets acceptance criteria |
| Integrity (Product appearance) | Internal Standards (based on predicate) | Meets acceptance criteria |
| Bending Strength | Internal Standards (based on predicate) | Meets acceptance criteria |
| Biocompatibility | ISO 10993-1: 2009 | Concluded to be biocompatible for its intended use, identical to predicate which has a history of safe and effective use. Classified as Externally Communicating Device, Tissue/bone/dentin communicating, Limited Contact (<24 hrs). |
| Sterilization (Sterility Assurance Level - SAL) | ISO 11135 | SAL of 10^-6 (implied by "provide a SAL of 10-9" and general practice, though usually SAL of 10^-6 is specified in FDA guidances for terminally sterilized devices; assuming the document implies meeting current requirements, which would include 10^-6. The document explicitly states 10e-9) achieved. |
| Sterilization (Residual Ethylene Oxide/Ethylene Chlorohydrin) | ISO 10993-7 | Residual EO will not exceed 4 mg per device; Residual ECH will not exceed 9 mg per device. |
| Pyrogenicity | USP <85> Bacterial Endotoxins Test; FDA Guidance June 2012 | Certified to be non-pyrogenic in the unopened and undamaged package. Confirmed by LAL testing on each lot. |
| Risk Analysis | ISO 14971: 2007 | No issues of safety and effectiveness determined taking into account modifications. |
Regarding the specific questions you asked for an AI study, the following are not applicable to this 510(k) submission for a non-AI medical device (guidewire):
- Sample sizes used for the test set and the data provenance: Not applicable. Device is a physical guidewire, not an AI system processing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to the physical and chemical properties meeting specified standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, to address the core of "the study that proves the device meets the acceptance criteria" based on the document:
The studies that prove the device meets the acceptance criteria are non-clinical bench tests and material assessments. These include:
- Performance Testing per ISO 11070: 2014: This standard covers "Sterile single-use intravascular introducers, dilators and guidewires." Tests performed included Radiodetectability, Fracture Test, Flexing Test, and Peak Tensile Force of Guidewire. These tests were conducted on both non-aged and accelerated aged samples.
- Performance Testing per Terumo's Internal Standards: These tests included Flexibility Test of Distal Tip, Torque transmission, Sliding Resistance/Coating, Integrity (Product appearance), and Bending Strength. These were based on the predicate device's expected performance.
- Biocompatibility Testing: Assessed in accordance with ISO 10993-1, classifying the device and confirming material compatibility through comparison to the predicate device's established safety record and identical material composition.
- Sterilization Validation: Demonstrated compliance with ISO 11135 for Ethylene Oxide sterilization, ensuring a Sterility Assurance Level (SAL) of 10^-6 (although the document stated 10^-9, which is a higher level of assurance) and meeting residual EO/ECH limits per ISO 10993-7 for limited exposure devices.
- Pyrogen Testing Validation: Conducted using Limulus Amebocyte Lysate (LAL) testing (Photometric Quantitative Method) in accordance with USP <85> and FDA guidance.
- Risk Analysis: Performed according to ISO 14971 to identify and mitigate potential risks.
These non-clinical tests collectively demonstrate that the Radifocus Glidewire Endoscopic Wire is safe and effective and substantially equivalent to the predicate device, fulfilling the regulatory requirements for the 510(k) submission. No clinical trials were conducted or required for this submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2015
Terumo Medical Corporation Phebe Varghese Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset, NJ 08873
Re: K151471
Trade/Device Name: Radifocus Glidewire Endoscopic Wire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: August 11, 2015 Received: August 11, 2015
Dear Phebe Varghese,
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.
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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 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.
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 yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Radifocus Glidewire Endoscopic Wire
Indications for Use (Describe)
The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
| 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) |
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510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Phebe Varghese |
|---|---|
| Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| Tel. (732) 412-4166 | |
| Fax (732) 302-4905 |
| Prepared for: | Owner/Operator |
|---|---|
| Terumo Corporation | |
| 44-1, 2-Chome, Hatagaya | |
| Shibuya-Ku, Tokyo, Japan 151-0072 | |
| Registration Number: 801 002 6 |
Manufacturer and Sterilization Facility
Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka, Japan 418-0015 Registration No: 968 183 4
- Contact Person: Phebe Varghese
Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (732) 412-4166 Fax (732) 302-4905 E-mail: phebe.varghese@terumomedical.com
Date prepared: May 29, 2015
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Radifocus Glidewire® Endoscopic Wire |
|---|---|
| Common Name: | Endoscopic Guidewire |
| Classification Name: | Endoscopic Guidewire, Gastroenterology-Urology |
| Classification Panel: | Gastroenterology/Urology |
| Regulation: | 21 CFR 876.1500 |
| Product Code: | 78 OCY |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed is:
K910722 - 450cm Guide Wire for G.I. Use, manufactured by Ashitaka Factory of Terumo Corporation.
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the Radifocus Glidewire Endoscopic wire, to include 2 smaller diameters and one length that were not included in the original 450cm Guide Wire for G.I. Use (K910722) submission. This submission also includes a clear indication for use statement.
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The Radifocus Glidewire Endoscopic Wire is operated manually or by manual process.
Design/Construction
The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff;
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the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.
Materials
The materials for the Radifocus Glidewire Endoscopic Wire are provided in Table 5.1 below.
| Part | Raw Material | |
|---|---|---|
| GuideWire | Core Wire | Nickel-Titanium Alloy |
| First Coating* | Polyurethane containing Tungsten | |
| Tungsten | ||
| Polyurethane | ||
| Second Coating* | Hydro Gel | |
| Hydrophilic Polymer(Half-ester Methyl Vinyl Ether-maleic Anhydride Copolymer) | ||
| Under Coat | ||
| Polyvinyl Chloride | ||
| Guide Wire Inserter | Polyethylene |
Table 5.1: Radifocus Glidewire Endoscopic Wire Materials (All Wire Diameters)
- Blood contacting material
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Specifications
The specifications for the Radifocus Glidewire Endoscopic Wire are provided in
Table 5.2 below.
| Part | Radifocus GlidewireEndoscopic Wire |
|---|---|
| Diameter of Wire | 0.020", 0.025", 0.035" |
| Length of Wire | 260 cm and 450 cm |
| Distal Tip Shape | Straight, Angled |
| Accessory Device | Guide wire inserter |
Table 5.2: Radifocus Glidewire Endoscopic Wire Specifications
F. INDICATIONS FOR USE (807.92(a)(5))
The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Note: The indication for use statement was not included for the submission of 450cm Guide Wire for G.I. Use (K910722); however, the intended use of the subject device is identical to that of the predicate device.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Radifocus Glidewire Endoscopic Wire, the subject device of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the 450cm Guide Wire for G.I. Use, cleared under K910722, manufactured by Ashitaka Factory of Terumo Corporation. A comparison of the technological characteristics is summarized in Table 5.3 below.
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| Table 5.3: Summary of Comparative Information between Radifocus Glidewire |
|---|
| Endoscopic Wire and 450cm Guide Wire for G.I. Use (K910722) |
| Device Characteristic | New Device: RadifocusGlidewire Endoscopic Wire | Predicate: 450cm Guide Wirefor G.I. Use (K910722) | |
|---|---|---|---|
| Manufacturer | Ashitaka Factory of TerumoCorporation | same | |
| Indication for Use | The Radifocus GlidewireEndoscopic Wire is intended tobe used for selective cannulationof the biliary ducts, including butnot limited to, the common bile,cystic, right and left hepatic ductsduring endoscopic biliaryprocedures for catheterintroduction and exchanges | Guide wire for gastrointestinaluseNote: Indication for Use was notincluded at the time of 510(k)submission | |
| Principle ofOperation/Technology | Manual | same | |
| Specifications | Diameter: 0.020", 0.025", 0.035"Length: 260cm and 450cm | Diameter: 0.032" and 0.035"Length: 400cm and 450cm | |
| Materials | Guidewire | • Core wire:o Nickel-Titanium alloy• First Coating:o Polyurethane containingTungsten• Tungsten• Polyurethane• Second Coating:o Hydro gel• Hydrophilic polymer(Half-ester methylvinyl ether-maleicanhydride copolymer)o Under coat• Polyvinyl chloride | same |
| Guidewireinserter | Polyethylene | ||
| Radiopacity | Radiopaque under fluoroscopy | same |
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| Device Characteristic | New Device: RadifocusGlidewire Endoscopic Wire | Predicate: 450cm Guide Wirefor G.I. Use (K910722) |
|---|---|---|
| Packaging Material | Polyester-polyethylene laminatedfilm and paper | same |
| Sterilization | Ethylene Oxide | same |
| Shelf - life | 24 months | same |
H. NON CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the safety and effectiveness of the Radifocus Glidewire Endoscopic Wire throughout the device's shelf life, verify conformity to the applicable ISO standards, and demonstrate substantial equivalence to the predicate device.
No new issues of safety and effectiveness were raised with the testing performed. The following tests were performed on non-aged and accelerated aged samples according to currently accepted ISO 11070: 2014 Sterile single-use intravascular introducers, dilators and guidewires.
| Test | Standard |
|---|---|
| Radiodetectability | ISO 11070, Section 4.5 |
| Fracture Test | ISO 11070, Section 8.4 |
| Flexing Test | ISO 11070, Section 8.5 |
| Peak Tensile Force of Guidewire | ISO 11070, Section 8.6 |
Table 5.4: Performance Testing per ISO Standards
All samples tested met the standard applicable to each test.
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Additionally, performance testing other than to the above ISO Standard was performed on the device in accordance with Terumo's internal standards. The device complies with the acceptance criteria established for each test based on the predicate.
| Performance Test | Results |
|---|---|
| Flexibility Test of Distal Tip | Meets acceptance criteria |
| Torque transmission | Meets acceptance criteria |
| Sliding Resistance/Coating | Meets acceptance criteria |
| Integrity (Product appearance) | Meets acceptance criteria |
| Bending Strength | Meets acceptance criteria |
Table 5.5: Performance Testing per Internal Standards
Performance testing demonstrates that the Radifocus Glidewire Endoscopic Wire conforms to the ISO standard and is substantially equivalent to that of the predicate device and is safe and effective for its intended use.
Biocompatibility
In accordance with ISO 10993-1, the Radifocus Glidewire Endoscopic Wire is classified as Externally Communicating Device, Tissue/bone/dentin communicating, Limited Contact (<24 hrs). This is the same classification as the predicate 450cm Guide Wire for G.I. Use (K910722).
All of the subject device's materials are the same as the predicate device. These devices have the same intended use, body contact, and contact duration classification based on ISO 10993-1: 2009. Additionally the 450cm Guide Wire for G.I. Use product line have a demonstrated history of safe and effective use. We conclude, therefore, that the Radifocus Glidewire Endoscopic Wire is biocompatible for its intended use.
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Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135, Sterilization of Health Care Products - Ethylene Oxide -Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-9. 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.
Pyrogen Testing
The Radifocus Glidewire Endoscopic Wire is certified to be non-pyrogenic in the unopened and undamaged package. Limulus Amebocyte Lysate (LAL) (Photometric Quantitative Method) testing is performed on each lot of product in accordance to the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers; June 2012".
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 issues of safety and effectiveness.
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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 Endoscopic Wire, subject of this 510(k), is
substantially equivalent in its intended use, technology/principal of operation,
materials, and performance to the predicate device(s):
K910722 – 450cm Guide Wire for G.I. Use, manufactured by Ashitaka Factory of
Terumo Corporation.
There is no significant difference that raises any new issues of safety and
effectiveness.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.