Radifocus Glidewire Endoscopic Wire

K151471 · Terumo Medical Corporation · OCY · Sep 17, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151471
• Device Name: Radifocus Glidewire Endoscopic Wire
• Applicant: Terumo Medical Corporation
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: Sep 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

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.

Device Story

Radifocus Glidewire Endoscopic Wire is a sterile, single-use manual guidewire; used by clinicians during endoscopic biliary procedures. Device consists of a Nickel-Titanium alloy core wire coated with polyurethane containing tungsten and a hydrophilic polymer (hydrogel). Available in various diameters (0.020", 0.025", 0.035") and lengths (260 cm, 450 cm) with straight or angled distal tips. Includes a guide wire inserter. Operates manually to facilitate catheter introduction and exchanges in biliary ducts. Radiopaque under fluoroscopy to assist physician visualization. Benefits include improved access to biliary anatomy during endoscopic procedures.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including radiodetectability, fracture, flexing, and tensile force tests per ISO 11070:2014, and internal performance testing (flexibility, torque, sliding resistance, integrity, bending strength). Biocompatibility assessed per ISO 10993-1.

Technological Characteristics

Core: Nickel-Titanium alloy. Coatings: Polyurethane with Tungsten, Hydrophilic polymer (Half-ester Methyl Vinyl Ether-maleic Anhydride Copolymer). Dimensions: 0.020"-0.035" diameter, 260-450 cm length. Radiopaque. Sterilization: Ethylene Oxide (ISO 11135). Biocompatibility: ISO 10993-1 (Limited contact <24 hrs).

Indications for Use

Indicated for selective cannulation of biliary ducts (common bile, cystic, right/left hepatic) during endoscopic biliary procedures for catheter introduction and exchanges.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• 450cm Guide Wire for G.I. Use (K910722)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines representing hair or fabric.

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 [phone] or [phone] 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 [phone] or [phone] 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)

K151471

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. [phone] |
| | Fax [phone] |

| 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. [phone] Fax [phone] E-mail: [e-mail]

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 | |
|---------------------|--------------------|---------------------------------------------------------------------------------------|
| Guide<br>Wire | Core Wire | Nickel-Titanium Alloy |
| | First Coating* | Polyurethane containing Tungsten |
| | | Tungsten |
| | | Polyurethane |
| | Second Coating* | Hydro Gel |
| | | Hydrophilic Polymer<br>(Half-ester Methyl Vinyl Ether-<br>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 Glidewire<br>Endoscopic 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: Radifocus<br>Glidewire Endoscopic Wire | Predicate: 450cm Guide Wire<br>for G.I. Use (K910722) | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer | Ashitaka Factory of Terumo<br>Corporation | same | |
| Indication for Use | The Radifocus Glidewire<br>Endoscopic Wire is intended to<br>be used for selective cannulation<br>of the biliary ducts, including but<br>not limited to, the common bile,<br>cystic, right and left hepatic ducts<br>during endoscopic biliary<br>procedures for catheter<br>introduction and exchanges | Guide wire for gastrointestinal<br>use<br>Note: Indication for Use was not<br>included at the time of 510(k)<br>submission | |
| Principle of<br>Operation/Technology | Manual | same | |
| Specifications | Diameter: 0.020", 0.025", 0.035"<br>Length: 260cm and 450cm | Diameter: 0.032" and 0.035"<br>Length: 400cm and 450cm | |
| Materials | Guide<br>wire | • Core wire:<br>o Nickel-Titanium alloy<br>• First Coating:<br>o Polyurethane containing<br>Tungsten<br>• Tungsten<br>• Polyurethane<br>• Second Coating:<br>o Hydro gel<br>• Hydrophilic polymer<br>(Half-ester methyl<br>vinyl ether-maleic<br>anhydride copolymer)<br>o Under coat<br>• Polyvinyl chloride | same |
| | Guide<br>wire<br>inserter | Polyethylene | |
| Radiopacity | Radiopaque under fluoroscopy | same | |

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| Device Characteristic | New Device: Radifocus<br>Glidewire Endoscopic Wire | Predicate: 450cm Guide Wire<br>for G.I. Use (K910722) |
|-----------------------|----------------------------------------------------|-------------------------------------------------------|
| Packaging Material | Polyester-polyethylene laminated<br>film 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.