(9 days)
The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
The Single Use Guidewire consists of a Nickle Titanium alloy core wire with a gold coil and hydrophilic, PTFE and silicone coatings. The distal portion of the wire has been specially processed, which includes thinning, to increase the flexibility. This wire has been designed to be used with the Olympus Endo-therapy Accessories.
The provided document is a 510(k) summary for a medical device called "Single Use Guidewire." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.
However, I can extract the information related to the device's performance claims and how equivalence was established.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that the performance of the Single Use Guidewire is "substantially equivalent" to a predicate device based on bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | Substantially equivalent to the predicate device (LinearGuide, K021179) |
| Specific Performance Tests | Demonstrated through bench testing. (Details of specific tests and their outcomes are not provided in this summary.) |
| Manufacturing Controls | Include visual, functional, dimensional, and sterility tests. |
| Biocompatibility | Blood contacting materials were tested according to ISO-10993. Results demonstrate biocompatibility for externally communicating devices, tissue/bone/dentin communicating, limited contact (24 hrs). |
| Sterilization | Validated according to ANSI/AMMI/ISO 11135-1 to a SAL of 10⁻⁶. |
2. Sample size used for the test set and the data provenance
The document states that the equivalence was shown through "bench testing." It does not specify the sample size used for these tests, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe the establishment of a "ground truth" using experts. Bench testing typically relies on engineering specifications and physical measurements, not expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication process for a test set, as this involves bench testing.
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
Not applicable. This device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would be the engineering specifications, physical measurements, and performance benchmarks derived from the predicate device or established industry standards for guidewires. This is not explicitly detailed but inferred from the nature of "bench testing."
8. The sample size for the training set
Not applicable. As a physical device demonstrably equivalent through bench testing, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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" 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
JUL 2 7 2015
Terumo Corp. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K091417
Trade/Device Name: Single Use Guidewire G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S, G-240-3527A, G-240-3545A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE Itr): May 12, 2009 Received (Date on orig SE Itr): May 13, 2009
Dear Mr. Job
This letter corrects our substantially equivalent letter of May 22, 2009.
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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Indications for Use
૪૮૭૫૫૫7 510(k) Number (if known):
Device Name: Single Use Guidewire G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A. G-240-3527S. G-240-3545S. G-240-3527A., G-240-3545A
Intended Use
The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and left hepatic ducts.
Indications for use
This instrument has been designed to be used with Olympus Endo-therapy Accessories. The instrument is used as guidewire of endoscopic accessories for biliary duct including not only common bile but cystic, pancreatic right and left hepatic duct.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hudt Remus
Division Sign-Off) Division of Reproductive, and Radiological Device
510(k) Number _
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Terumo Corporation Premarket Notification - Single Use Guidewire Section II. 510(k) Summary
SECTION II. 510(K) SUMMARY
MAY 22 2009
A. Device Name
| Proprietary Name: | Single Use Guidewire |
|---|---|
| Classification Name: | Endoscope and/or accessories |
| Common Name: | Endoscopic Guidewire |
B. Intended Use
The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
Indications for use
This instrument has been designed to be used with Olympus Endo-therapy Accessories. The instrument is used as guidewire of endoscopic accessories for - biliary duct including not only common bile but cystic, pancreatic right and left hepatic duct.
C. Device Description
The Single Use Guidewire consists of a Nickle Titanium alloy core wire with a gold coil and hydrophilic, PTFE and silicone coatings. The distal portion of the wire has been specially processed, which includes thinning, to increase the flexibility. This wire has been designed to be used with the Olympus Endo-therapy Accessories.
D. Principle of Operation / Technology
The Single Use Guidewire is operated manually or by a manual process.
E. Design / Materials
The Single Use Guidewire uses similar materials as the predicate device. Differences in materials between the devices do not raise any new issues of safety and effectiveness.
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Terumo Corporation Premarket Notification - Single Use Guidewire Section II. 510(k) Summary
F. Performance
The performance of the Single Use Guidewire is substantially equivalent to the performance of the predicate device. The equivalence was shown through bench testing.
G. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The wire is classified as Externally Communicating Devices, Tissue/ bone/ dentin communicating, limited Contact (24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with ANSI/AMMI/ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10 °.
H. Substantial Equivalence
The Single Use Guidewire submitted in this 510(k) is substantially equivalent' in intended use, design, principle of operation / technology, materials and performance to the LinearGuide, which are manufactured by Olympus and cleared under K021179. Differences between the devices do not raise any issues of safety or effectiveness.
1 A statement of substantially equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977)
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Terumo Corporation Premarket Notification – Single Use Guidewire Section II. 510(k) Summary
I. Submitter Information
| Prepared By: | Mr. Mark UnterreinerSr. Regulatory Affairs Specialist |
|---|---|
| Prepared For: | Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com |
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen
.
Date Prepared: May 5, 2009
:
.
§ 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.