(108 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a ureteral access sheath, with no mention of AI or ML technologies.
No.
A therapeutic device actively treats a disease or condition. This device is used to facilitate other procedures by establishing a conduit, not to directly treat a condition.
No
Explanation: The device is described as establishing a conduit for the passage of endoscopes and instruments, which is a procedural function, not a diagnostic one.
No
The device description clearly details a physical, single-use, sterile device made of known materials, including a sheath with lumens and a hydrophilic coating. It also mentions bench testing and physical properties like friction, buckling, and kink resistance, all indicative of a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a device used in vivo (within the body) for a procedural purpose, not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a physical sheath used to create a passage within the urinary tract. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls.
The device is clearly a surgical/procedural tool used directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
FED
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
two years of age and older.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K961904, K030438, K033778, K993650, K990775, K030956
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.
0
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
1
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.
2
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.
3
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
4
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