(107 days)
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.
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.
The provided 510(k) summary for the Accellent, Inc. Disposable Guidewire (K072354) does not contain a study that demonstrates the device meets specific acceptance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Olympus Guidewire G-205-3545S, G205-3.545A #K021179) by comparing key features such as intended use, materials, and sterilization method. This is a common approach for Class II medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria are often not required if substantial equivalence can be shown.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets acceptance criteria, as such information is not present in the provided text.
Here's why and what information is available:
- No Acceptance Criteria or Performance Data: The document explicitly states: "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." This statement, along with the comparison table, serves as the primary "proof" for substantial equivalence rather than a detailed performance study against predefined acceptance criteria.
- Focus on Substantial Equivalence: The entire submission hinges on demonstrating that the Accellent Disposable Guidewire is as safe and effective as a legally marketed predicate device. This is achieved by showing similarities in design, materials, and intended use, and by asserting that there are no significant changes that would raise new questions of safety or effectiveness.
Summary of available information as per your requested points (where applicable):
-
A table of acceptance criteria and the reported device performance:
- Not Applicable. The submission does not define specific acceptance criteria or report performance data against them. The "performance" is implicitly deemed equivalent to the predicate device due to no significant changes.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or associated data is described, as the submission relies on substantial equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment for a test set is mentioned.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is mentioned.
-
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 is a medical device (guidewire), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
-
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.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth as typically understood for diagnostic device evaluation is used. The "ground truth" for showing substantial equivalence is the predicate device itself and its established safety and effectiveness profile.
-
The sample size for the training set:
- Not Applicable. No "training set" in the context of machine learning or complex device development is described.
-
How the ground truth for the training set was established:
- Not Applicable.
What the document does provide in relation to demonstrating "performance" (via substantial equivalence):
- Predicate Device: Olympus Guidewire G-205-3545S, G205-3.545A (#K021179)
- Comparison of Features (Table 1):
- Intended Use: Identical for both predicate and new device (guiding and exchanging endoscopic accessories for the biliary duct, including common bile, cystic, pancreatic, right and left hepatic ducts).
- Materials:
- Predicate: Nickel Titanium alloy, Polyurethane -coating, Hydrophilic -coating, Silicone - coating
- New Device: Nickel Titanium alloy, Polytetrafluoroethylene PTFE, Pebax, Lubricious
- (Note: While some materials differ in coating/polymer type, the submission implies these differences do not affect safety or effectiveness significantly enough to require new studies beyond this comparison.)
- Sterilization Method: Identical (Ethylene Oxide).
Essentially, the "proof" for this guidewire's acceptability is its demonstrated similarity to an already legally marketed and safe device.
{0}------------------------------------------------
K072354
163
510(k) Summary
| Date Prepared: | August 20, 2007 |
|---|---|
| Submitted by: | Accellent, Inc.100 Fordham Rd.Wilmington, MA 01887Establishment Registration: To be submitted toFDA upon 510(k) clearance. |
| Official Correspondent: | Karl SteineckQuality ManagerAccellent, Inc. |
DEC 07 2007
| Telephone Number: | 303-432-4939 |
|---|---|
| Fax: | 303-424-6700 |
| Manufacturing Facility: | Accellent Inc.S.A. De C.V.1525 Hertz StreetIndustrial Park J. Bermudez of C.D.Juarez, Chihuahua 32470Mexico CPEstablishment Registration: 9680001 |
| Submitted DeviceTrade Name:Model Numbers: | Disposable GuidewireG-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 876.1500Identification. An endoscope and accessories is a device usedto provide access, illumination, and allow observation ormanipulation of body cavities, hollow organs, and canals. Thedevice 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 hasbeen designed to beused with the OlympusEndo-therapyAccessories. Theinstrument is used as aguidewire ofendoscopic accessoriesfor biliary duct,including but not | This instrument has beendesigned to be used with theOlympus Endo-therapyAccessories. The instrument isused as a guidewire ofendoscopic accessories forbiliary duct, including but notlimited 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 commonbile, cystic, pancreatic,right and left hepaticducts. | 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)
§ 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.