(81 days)
Not Found
No
The device description and intended use focus on a physical guidewire and its features (coating, shape, laser markers) for endoscopic procedures. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is a guidewire used for endoscopic accessories in the biliary duct, which is a medical intervention intended to treat or manage a medical condition.
No
The device is described as a guidewire for endoscopic accessories, used for placement and maneuvering within ducts, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "resin-treated coated guidewire" and mentions physical characteristics like diameter and distal portion types, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a guidewire used within the body during endoscopic procedures in the biliary duct. It is a surgical/interventional tool, not a diagnostic test performed on a sample outside the body.
The description clearly indicates its function as a guidewire for endoscopic accessories and its use in anatomical sites within the biliary system. This aligns with the definition of a medical device used for treatment or intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be use with Olympus Endo-therapy Accessories. The instrument is used as guidwire of endoscopic accessories for billiary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts
Product codes
OCY
Device Description
G-201-35-45, G-202-35-45 are resin-treated coated gidwire. Removal of the guidewire is not necessary during sphinctecterotomy . G-201-35-45 is straight distal portion type, G-202-35-45 is angle distal portion type. These instruments have been designed to be used with Olympus Endo-Therapy Accessories. which are applicable for φ0.89mm (0.035 inch) diameter guidewires. These instruments are equipped with Laser-markers at the distal portion to conform guidewire placement under fluoroscopy endoscopic maneuvering.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
billiary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus Optical Co., Ltd. % Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157
JUL 2:2, 2015
Re: K021179
Trade/Device Name: Olympus Disposable Guidewire, Models G-205-3545S and G-205-3545A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE ltr): April 11, 2002 Received (Date on orig SE Itr): April 15, 2002
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of July 5, 2002.
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
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Page 2 -
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 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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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K021179 510(k) Number (if known):
Device Name: Disposable Guidewire G-205-3545S. G-205-3545A
Indications for Use:
This instrument has been designed to be use with Olympus Endo-therapy Accessories. The instrument is used as guidwire of endoscopic accessories for billiary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Counter Use (Per 21 CFR 801.109) OR
Qyer-The-
Nancy C. Hodsdon
(Optional Format 1-2-96)
3
A. Submitter's Name, Address, Phone and Fax Numbers
| 1. Submitter's Name | |
|---|---|
| Name & Address of manufacturer: | Olympus Optical Co., Ltd. |
| 2-3-1 Shinjyuku Monolis Nishi-Shinjuku, | |
| Shinjyuku-ku Tokyo, 163-0914 Japan | |
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers: | 2951 Ishikawa-Cho, |
| of R&D Department, | Hachioji-shi, Tokyo 192-8507 |
| Endoscope Division | Japan |
| TEL | 81- 426-42-5177 |
| FAX | 81-426-46-5613 |
| 2. Manufacturer site/Sterilization site | |
| Name & Address of manufacturer: | Ashitaka Factory of Terumo Corporation |
| 150, Mainmaigi-cho, Fujinomiya-City | |
| Shizuoka, 418-0015, Japan | |
| Registration No. | 9681834 |
| B. Name of Contact Person | |
| Name: | Ms. Laura Storms-Tyler |
Address, Phone and Fax Numbers:
Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (631) 844-5688 FAX: (631) 844-5416
1621179
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name: | Disposable Guidwire G-205-3545S, G205-3545A | |
|---|---|---|
| Common Name: | Guidewire | |
| Classification: | Endoscope and accessories 21 CFR 876.1500 | |
| Predicate Device: | Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) | |
| #K933110 | ||
| Climber (Terumo) | ||
| #K971937 | ||
| Lagwire 5658-1/5659-1 (Boston Scientific) | ||
| #K922302 |
D. Description of the Device(s)
G-201-35-45, G-202-35-45 are resin-treated coated gidwire. Removal of the guidewire is not necessary during sphinctecterotomy . G-201-35-45 is straight distal portion type, G-202-35-45 is angle distal portion type. These instruments have been designed to be used with Olympus Endo-Therapy Accessories. which are applicable for φ0.89mm (0.035 inch) diameter guidewires. These instruments are equipped with Laser-markers at the distal portion to conform guidewire placement under fluoroscopy endoscopic maneuvering.
E. Intended Use of the Device(s)
This instrument has been designed to be use with Olympus Endo-therapy Accessories.
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The instrument is used as guidwire of endoscopic accessories for biliary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts
F. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, Disposable Guidewire G-205-3545S, G-205-3545A does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.