(108 days)
Used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Cook® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older.
The Cook® Pediatric Flexor Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Cook® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older.
The Cook® Pediatric Flexor Ureteral Access Sheath is a single use sterile device that is offered as a single or dual lumen device. The Cook® Pediatric Flexor Ureteral Access Sheath will be offered in a 9.5 French inside diameter length or 12 French inside diameter 13 centimeter length single lumen version. The Cook® Pediatric Flexor Ureteral Access Sheath will also be offered in a 9.5 French inside diameter 13 centimeter length or 12 French inside diameter 13 centimeter length dual lumen version. The main lumen of the 9.5 French dual lumen version is 9.5 French inside diameter and the main lumen of the 12 French dual lumen version is 12 French inside diameter. The secondary lumen on both sizes is 3 French inside diameter. Both versions inside diamster. The occurrently a Hydrophilically coated which, when activated, allows easier insertion and removal of the sheath.
The construction materials of the Cook® Pediatric Flexor Ureteral Access Sheath are all well known in the medical field. Biocompatibility testing has shown the materials to meet the test requirements. Bench top testing, coefficient of friction testing, irrigation flow study, buckling require test, kink resistance testing, risk analysis, complaints verses sales data, clinical feedback, and published articles support our claim that the device is as safe and effective in the pediatric population as in adult use.
The provided text is a 510(k) summary for the Cook® Pediatric Flexor Ureteral Access Sheath. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically expected for AI/ML-based medical devices.
Instead, the submission relies on demonstrating substantial equivalence to already marketed predicate devices by showing similarities in:
- Indications for use
- Materials
- Physical construction
- Manufacturing process controls
- Quality Assurance Program
- Packaging and sterilization procedures
The document mentions various testing performed, but these are general engineering tests (e.g., biocompatibility, coefficient of friction, irrigation flow, buckling, kink resistance) to ensure the device's basic functionality and safety, rather than performance metrics against specific clinical acceptance criteria for an AI algorithm.
Therefore, for most of the requested information, the answer will be "Not Applicable" or "Not Provided" because the document does not describe an AI/ML-based device being validated against clinical performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (This 510(k) submission does not define specific clinical acceptance criteria for performance metrics in the context of an AI/ML device, as it is a physical device submission.) | The device underwent: Biocompatibility testing, bench top testing, coefficient of friction testing, irrigation flow study, buckling test, kink resistance testing, risk analysis, complaints vs. sales data review, clinical feedback, and review of published articles. These supported the claim that the device is "as safe and effective in the pediatric population as in adult use" and is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This document describes a physical medical device, not an AI/ML algorithm that would have a test set of data. The "testing" mentioned refers to engineering and biocompatibility tests of the device itself.
3. 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. There is no mention of "ground truth" establishment by experts in the context of validating an AI/ML algorithm's output. The "clinical feedback" likely refers to general medical professional input regarding the device's design and use, not a formal ground truth process for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no test set or adjudication method described for establishing ground truth for AI/ML performance.
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 submission does not describe an AI/ML device or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This submission does not describe an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. There is no mention of ground truth in the context of an AI/ML algorithm.
8. The sample size for the training set
Not Applicable. This submission does not describe an AI/ML algorithm that would have a training set.
9. How the ground truth for the training set was established
Not Applicable. This submission does not describe an AI/ML algorithm that would have a training set or associated ground truth.
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K0434/8
COOK®
MAR 3 1 2005
Cook Urological
1100 W. Morgan Street Spencer, IN 47460 USA Phone: 812-829-4891 Fax: 812-829-1801 www.cookgroup.com
510(k) SUMMARY l.
Submitted By:
Cindy Rumple Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 December 8, 2004
Device
Trade Name:
Cook® Pediatric Flexor Ureteral Access Sheath
Proposed Classification Name:
Sheath, for Endoscope, Ureteral Dilator Class II 78 FED 876.1500
Predicate Devices:
The Cook® Pediatric Flexor Ureteral Access Sheath is similar with respect to indications for use and technology to exist predicate devices in commercial distribution. Specifically, the Cook® Pediatric Flexor Ureteral Access Sheath is similar to the AQ Hydrophilic Dilator (K961904) manufactured by Cook Urological, Incorporated, the Bard® Aqua Guide Ureteral Conduit (K030438) manufactured by C.R. Bard, Incorporated, the Bard® Aqua Guide Ureteral Access Sheath (K033778) manufactured by C.R. Bard, Incorporated, the Ureteral Access Sheath Set (K993650) manufactured by Applied Medical Resources Corporation, the Ureteral Access Sheath Set (K990775) manufactured by Applied Medical Resources Corporation, and the Ureteral Access Sheath Set II (K030956) manufactured by Boston Scientific Corporation (Microvasive).
Device Description:
The Cook® Pediatric Flexor Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Cook® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older.
The Cook® Pediatric Flexor Ureteral Access Sheath is a single use sterile device that is offered as a single or dual lumen device. The Cook® Pediatric Flexor Ureteral Access Sheath will be offered in a 9.5 French inside diameter length or 12 French inside diameter 13 centimeter length single lumen version. The Cook® Pediatric Flexor Ureteral Access Sheath will also be offered in a 9.5 French inside diameter 13 centimeter length or 12 French inside diameter 13
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centimeter length dual lumen version. The main lumen of the 9.5 French dual lumen version is 9.5 French inside diameter and the main lumen of the 12 French dual lumen version is 12 French inside diameter. The secondary lumen on both sizes is 3 French inside diameter. Both versions inside diamster. The occurrently a Hydrophilically coated which, when activated, allows easier insertion and removal of the sheath.
The construction materials of the Cook® Pediatric Flexor Ureteral Access Sheath are all well known in the medical field. Biocompatibility testing has shown the materials to meet the test requirements. Bench top testing, coefficient of friction testing, irrigation flow study, buckling require test, kink resistance testing, risk analysis, complaints verses sales data, clinical feedback, and published articles support our claim that the device is as safe and effective in the pediatric population as in adult use.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological, Incorporated. Being similar with respect to indications for use, materials, and physical construction to predicate devices, this device meets the requirements for section 510 (K) substantial equivalence.
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Image /page/2/Picture/2 description: The image shows a circular logo with a stylized eagle in the center. The eagle is facing left and has three lines extending from its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following the curve of the logo. The text is in uppercase and appears to be in a sans-serif font.
MAR 3 1 2005
Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Rumple Regulatory Affairs Technical Writer Cook® Urological 1100 W. Morgan Street SPENCER IN 47460
Re: K043418
Ro45418
Trade/Device Name: Cook® Pediatric Flexor Ureteral Access Sheath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: February 23, 2005 Received: March 1, 2005
Dear Ms. Rumple:
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 and exceeded to the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1970, and channeling 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 ince require 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Applo rary, it 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 I edolal statested 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) (21 CFR Part 820); 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 ocgin marketing of substantial equivalence of your device to a legally prematics notification. "The PDA mainly of batisation 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 a If you desire specific advice for your device of our laboring 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" (21 CFR Also, please note the regulation entitled, " risestanting on your responsibilities under the Act from the 807.97). You may obtain other general micronal and Consumer Assistance at its toll-free number (800) Division of Sthail Manufacturers, Internet address http://www.fda.gov/cdrh/dsmadsmamain.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
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
Cook® Pediatric Flexor Ureteral Access Sheath
Used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Cook® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older.
Prescription Use _ × (Part 21 CFR 801 Subpart D) OR
Over the Counter Use_ (Part 21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Nancy C Brogdon
(Division Sign-Of Division of Reproductive, Abe and Radiological Devic 510(k) Number
§ 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.