Who is the manufacturer of GUIDEWIRE, MODEL G-V220-3527S AND OTHERS?

Accellent, Inc. filed the 510(k) submission for GUIDEWIRE, MODEL G-V220-3527S AND OTHERS (K072354).

What is the FDA product code for GUIDEWIRE, MODEL G-V220-3527S AND OTHERS?

OCY. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for GUIDEWIRE, MODEL G-V220-3527S AND OTHERS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GUIDEWIRE, MODEL G-V220-3527S AND OTHERS?

Olympus Guidewire G-205-3545S, G205-3.545A (K021179).

Who can help prepare an FDA 510(k) submission like GUIDEWIRE, MODEL G-V220-3527S AND OTHERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GUIDEWIRE, MODEL G-V220-3527S AND OTHERS

K072354 · Accellent, Inc. · OCY · Dec 7, 2007 · Gastroenterology, Urology

Device Facts

Record ID	K072354
Device Name	GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
Applicant	Accellent, Inc.
Product Code	OCY · Gastroenterology, Urology
Decision Date	Dec 7, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Device Story

Disposable guidewire designed for use with Olympus endo-therapy accessories; facilitates guiding and exchanging endoscopic instruments within biliary duct system (common bile, cystic, pancreatic, hepatic ducts). Device features straight, V-taper, or angled tip configurations. Used by clinicians during endoscopic procedures; provides mechanical support for accessory exchange. Benefits include procedural efficiency and continued access during sphincterectomy. No complex processing or software involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nickel Titanium alloy core; PTFE and Pebax coating; lubricious surface. Available in straight, V-taper, and angled tip configurations. Sterilized via Ethylene Oxide.

Indications for Use

Indicated for guiding and exchanging endoscopic accessories within the biliary duct system, including common bile, cystic, pancreatic, and hepatic ducts, in patients undergoing endoscopic procedures.

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.

Predicate Devices

Olympus Guidewire G-205-3545S, G205-3.545A (K021179)

Related Devices

K021179 — DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A · Olympus Optical Co., Ltd. · Jul 5, 2002
K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO · Flexmedics · Mar 15, 1999
K141991 — SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP · Olympus Medical Systems Copr. · Mar 31, 2015
K153264 — EasyPass Guidewire · Medi-Globe Corporation · May 19, 2016
K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A · Terumo Corp. · May 22, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ K072354 163 # 510(k) Summary | Date Prepared: | August 20, 2007 | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by: | Accellent, Inc. 100 Fordham Rd. Wilmington, MA 01887 Establishment Registration: To be submitted to FDA upon 510(k) clearance. | | Official Correspondent: | Karl Steineck Quality Manager Accellent, Inc. | DEC 07 2007 | Telephone Number: | 303-432-4939 | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fax: | 303-424-6700 | | Manufacturing Facility: | Accellent Inc. S.A. De C.V. 1525 Hertz Street Industrial Park J. Bermudez of C.D. Juarez, Chihuahua 32470 Mexico CP Establishment Registration: 9680001 | | Submitted Device Trade Name: Model Numbers: | Disposable Guidewire G-V220-3527S, G-V220-3527A, G-V220-3545S, G-V220-3545A, G-V220-2527S, G-V220-2527A, G-V220-2545S, G-V220-2545A, G-V230-3527S, G-V230-3527A, G-V230-3545S, G-V230-3545A. | | Common Name: | Guidewire | | Classification: | Endoscope and accessories 21 CFR 876.1500 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 | manipulations 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 {1}------------------------------------------------ K077354 2 of 6.3 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, eybtoscopod) oybedanoscopes, 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. | Predicate Device: | Olympus Guidewire G-205-3545S, G205- 3.545A #K021179 | |-------------------|---------------------------------------------------------| |-------------------|---------------------------------------------------------| #### Product Description: Coated guidewire. Removal of the guidewire is not necessary during sphinctecterotomy. Three guidewire configurations, straight, V taper and angled tip. These instruments have been designed to be used with the Olympus Endo-Therapy Accessories. #### Intended Use of the Device(s): This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts. ### Statement of substantial equivalence: When compared to the predicate device, the new device does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect the safety or effectiveness. | Feature | Olympus Guidewire (Predicate Device) | Olympus ERCP Guidewire | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | This instrument has been designed to be used with the Olympus Endo-therapy Accessories. The instrument is used as a guidewire of endoscopic accessories for biliary duct, including but not | This instrument has been designed to be used with the Olympus Endo-therapy Accessories. The instrument is used as a guidewire of endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic, right and left | Table 1 arison between the predicate device and new device {2}------------------------------------------------ K072354 3 of 3 : | | limited to the common bile, cystic, pancreatic, right and left hepatic ducts. | hepatic ducts. | |----------------------|----------------------------------------------------------------------------------------|------------------------------| | Materials | Nickel Titanium alloy | Nickel Titanium alloy | | | Polyurethane -coating | Polytetrafluoroethylene PTFE | | | Hydrophilic -coating | Pebax | | | Silicone - coating | Lubricious | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | : {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three flowing lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OEC 0 7 2007 Mr. Karl Steineck Ouality Manager Accellent, Inc. 5000 Independence Street ARVADA CA 80002 K072354 Re: > Trade/Device Name: Disposable Guidewire Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: November 9, 2007 Received: November 13, 2007 Dear Mr. Steineck: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {4}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K072354 191 ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Disposable Guidewire Indications for Use: This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Herbert Lehman (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number (Posted November 13, 2003)