(78 days)
Intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.
The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is made of layers of polyurethane and PTFE with a stainless steel coil sandwiched in between (the coil provides kink resistance). The sheath has a funnel at the proximal end to ease the insertion of an LDPE dilator. The dilator is equipped with a polypropylene luer connector for injection of irrigation or contrast. The dilator is removable from the sheath by means of a clip fixed to the luer connector. The outside of the sheath has a lubricious coating for ease of insertion into the ureter. For ease of visualization, the dilator and sheath are radiopaque. Two holes (suture loops) are incorporated into the funnel to facilitate attachment to surgical drapes for stabilization of the sheath during surgery.
The provided text describes the UroPass® Ureteral Access Sheath, its intended use, and its substantial equivalence to predicate devices for 510(k) clearance. However, it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific study types based on the provided input. This type of information is typically found in detailed design verification and validation reports, which are not part of the 510(k) summary provided.
The document states: "The fundamental technology of the modified device has not changed. The UroPass Ureteral Access Sheath remains a ureteral access sheath that permits direct passage of catheters, endoscopes and other devices through the urinary tract. The UroPass Ureteral Access Sheath is substantially equivalent in design, materials and intended use to previously cleared devices." This indicates that the clearance was based on similarity to already approved devices, not necessarily a new clinical study with specific acceptance criteria.
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SEP 0 2 2005
510(k) Summary
| Submitted by: | ACMI Corporation136 Turnpike RoadSouthborough MA 01772-2104866 879-0640 |
|---|---|
| Contact Person: | Graham A. L. Baillie |
| Date Prepared: | June 15, 2005 |
| Proprietary Name: | UroPass® Ureteral Access Sheath |
| Common Name: | Ureteral Access Sheath |
| Classification Name: | Urological catheter and accessories |
| Predicate Device(s): | Snap-N-Peel™ IntroducerK981611Applied Medical Ureteral Access SheathK993650 |
Description of the Device:
The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is made of layers of polyurethane and PTFE with a stainless steel coil sandwiched in between (the coil provides kink resistance). The sheath has a funnel at the proximal end to ease the insertion of an LDPE dilator. The dilator is equipped with a polypropylene luer connector for injection of irrigation or contrast. The dilator is removable from the sheath by means of a clip fixed to the luer connector. The outside of the sheath has a lubricious coating for ease of insertion into the ureter. For ease of visualization, the dilator and sheath are radiopaque. Two holes (suture loops) are incorporated into the funnel to facilitate attachment to surgical drapes for stabilization of the sheath during surgery.
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K051593
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intended Use of the Device:
The UroPass Ureteral Access Sheath is intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.
Technological Characteristics and Substantial Equivalence:
The fundamental technology of the modified device has not changed. The UroPass Ureteral Access Sheath remains a ureteral access sheath that permits direct passage of catheters, endoscopes and other devices through the urinary tract. The UroPass Ureteral Access Sheath is substantially equivalent in design, materials and intended use to previously cleared devices.
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Image /page/2/Picture/2 description: The image shows a black and white emblem. The emblem features a stylized bird in flight, with three lines representing its body and wings. The bird is oriented towards the upper right. Encircling the bird is text, which appears to be part of the emblem's design. The text is arranged in a circular fashion, following the curve of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
SEP 0 2 2005
Mr. Graham Baillie Senior Regulatory Specialist ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104
Re: K051593
Trade/Device Name: UroPass® Ureteral Access Sheath Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: August 11, 2005 Received: August 16, 2005
Dear Mr. Baillie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed four ever 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 May 20, 1710, and chance 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 do not require approvations provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 (Premarket It your do roo is older to such additional controls. Existing major regulations affecting your Apployal, It the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA a vious built of announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast of advisor may 1 by i on that your device complies with other requirements of the Act or any FDA has made a decembers and inistered by other Federal agencies. You must comply with all the I carrates and regulrene and 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) (21 CFR Part 800); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin manceing your .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket nothication. The I DA midnig of backannal - 1 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 If you desire specific advice for your corres of 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 the Allso, please note the regulation entitled, "Responsibilities under the Act from the 807.97). Tou may outlin other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Device Name: UroPass® Ureteral Access Sheath
510(k) Number: K051593
Indications for use:
Intended to be a conduit for the passage of endoscopes and other urological inkondou to be a connece of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ____________________________________________________________________________________________________________________________________________________________
OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
David R. Lyman
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devic 510(k) Number
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.