The 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. Thirteen (13) cm length is intended for use in pediatric patients two (2) years of age and over.

The Flexor® Parallel™ Rapid Release™ 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.

Device Description

The Flexor® Ureteral Access Sheath and Flexor® ParalleI™ Rapid Release™ Ureteral Access Sheath are available with outside diameters ranging from 9.5 to 14 French and lengths ranging from 13 to 55 centimeters. These devices are available in a single lumen configuration and include a sheath and a dilator. The dilator component includes a tapered and a hydrophilically coated distal tip. In addition, the Flexor Parallel Rapid Release Ureteral Access Sheath also includes a skive and slit in the tip of the dilator which allows the wire guide to run outside and parallel to the sheath and to be separated from the sheath while inside the body to serve as a safety wire. Both Ureteral Access Sheaths are constructed of Nylon with a 304 Stainless Steel coil and a TFE liner. The dilator component is constructed of polyethylene.

AI/ML Overview

The provided text is a 510(k) summary for the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain information about:

A table of acceptance criteria and reported device performance for specific metrics. It lists types of tests performed (e.g., Dilator Buckling Force, Sheath Tensile Strength, Kink Resistance) but does not provide quantitative acceptance criteria or the specific numerical results obtained for these tests.
Sample sizes used for a test set (clinical or otherwise)
Data provenance (country of origin, retrospective/prospective)
Number of experts or their qualifications for establishing ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone algorithm performance
Type of ground truth used (pathology, expert consensus, outcomes data)
Sample size for the training set
How ground truth for the training set was established

This type of information is typically found in clinical study reports or detailed engineering design verification reports, which are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general testing categories.

Therefore, for the requested information, I must state:

The provided document does not contain the specific details regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the performance metrics of the device as if it were an AI/CADe device.

The document primarily states that "The following tests were performed to demonstrate that the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath met applicable design and performance requirements and support a determination of substantial equivalence." It then lists categories of tests:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Generic Description from Document)	Reported Device Performance (Generic Statement from Document)
Device specific testing requirements - Mechanical (e.g., Dilator Buckling Force, Sheath Tensile Strength, Dilator Tensile Strength, Sheath to Hub Tensile Strength, Dilator to Hub Tensile Strength, Dilator Tip Tensile Strength)	"met applicable design and performance requirements"
Device specific testing requirements - Functional (e.g., Lubricity Length, Kink Resistance, Bench Testing/Simulated Use, Tip Flexibility, Sheath Inner Lumen Passability (Resistance), Sheath Inner Lumen Durability)	"met applicable design and performance requirements"
Device specific testing requirements - Radiopacity	"met applicable design and performance requirements"
General testing requirements (e.g., Biocompatibility, Sterilization, Distribution Testing, Shelf Life/Stability)	"met applicable design and performance requirements"

Note: The document only provides categories of tests and a general statement of compliance, not specific quantitative criteria or results.

2. Sample size used for the test set and the data provenance: Not mentioned in the provided text. The listed tests appear to be bench and laboratory tests, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/CADe system requiring expert ground truth in this context.

4. Adjudication method for the test set: Not applicable/not mentioned.

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 is not an AI/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used: For the physical and functional tests, the ground truth would be the established engineering specifications and recognized testing standards (e.g., ISO, ASTM). For biocompatibility, it's defined by biological response criteria.

8. The sample size for the training set: Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 13, 2017

Cook Incorporated Andrew Breidenbach, Ph.D., RAC Regulatory Scientist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404

Re: K172217

Trade/Device Name: Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: November 21, 2017 Received: November 22, 2017

Dear Andrew Breidenbach:

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 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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The name is written in black and is centered on a white background. The letters are clear and easy to read. The image is simple and straightforward.

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

510(k) Number (if known) K172217

Device Name Flexor® Ureteral Access Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K172217

Device Name

Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath 21 CFR §807.92 Date Prepared: July 19, 2017

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact:	Andrew Breidenbach
Email:	regsubmissions@cookmedical.com
Contact Phone Number:	(812) 335-3575 x105147
Contact Fax Number:	(812) 332-0281

De vice Information:

Trade Name:	Flexor® Ureteral Access Sheath andFlexor® Parallel™ Rapid Release™ Ureteral Access Sheath
Common Name:	Endoscopic Access Overtube, Gastroenterology-Urology
Classification Name:	Endoscope and accessories
Regulation:	21 CFR 876.1500
Product Code:	FED
Device Class:	II
Classification Panel:	Gastroenterology/Urology

Predicate Devices:

· The Cook® Pediatric Flexor Ureteral Access Sheath (K043418) is intended for use in establishing 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 Coloplast A/S Re-Trace Ureteral Access Sheath (K140523) is intended to be used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

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De vice Description:

		Inner Diameter (Fr)
		9.5	10.7	12.0	14.0
Length (cm)	13	FUAS*/ ------	FUAS*/ ------	FUAS*/ ------	------ / ------
	20	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR
	28	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR
	35	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR
	45	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR
	55	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR	FUAS / FPRR

Table 1. Sizes of the Flexor Ureteral Access Sheath (FUAS) and Flexor Parallel Rapid Release Ureteral Access Sheath (FPRR) to be available.

Only these 3 configurations of the Flexor Ureteral Access Sheath (FUAS) are indicated for pediatric patients. The Flexor Parallel Rapid Release Ureteral Access Sheath (FPRR) does not have sizes for pediatric use.

The Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath are supplied sterile and intended for one-time use.

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Intended Use :

Comparison to Predicate De vice:

The subject Flexor Ureteral Access Sheath and the Flexor Parallel Rapid Release Ureteral Access Sheath are substantially equivalent to the Cook® Pediatric Flexor Ureteral Access Sheath (Cook Incorporated, K043418) with regard to technological characteristics, materials, intended use, and methods of construction. In addition, the Flexor Parallel Rapid Release Ureteral Access Sheath is substantially equivalent to the Coloplast A/S Re-Trace Ureteral Access Sheath (K140523) with respect to technological characteristics, intended use, and methods of construction.

The Flexor® Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath are almost identical to the Cook Pediatric Flexor Ureteral Access Sheath (K043418) and so it functions as the primary predicate. The secondary predicate, the Coloplast A/S Re-Trace Ureteral Access Sheath (K140523), has additional lengths not present in the primary predicate as well as a 14 Fr diameter to allow for use in adults. The secondary predicate also provides the wire guide rapid release function, which allows the wire guide to be released in situ from the dilator to serve as a safety wire. Table 2-2 provides a comparison of the subject devices with the predicates.

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	PRIMARY PREDICATEDEVICE (1)	SECONDARYPREDICATE DEVICE (2)	SUBJECT DEVICES
	Cook® Pediatric FlexorUreteral Access Sheath(K043418)	Coloplast A/S Re-TraceUreteral Access Sheath(K140523)	Flexor® Ureteral AccessSheathANDFlexor® Parallel™ RapidRelease™ Ureteral AccessSheath
Manufacturer	Cook Incorporated	Coloplast A/S	Cook Incorporated
Regulation	876.1500Endoscope and AccessoriesFED	876.1500Endoscope and AccessoriesFED	Identicalto Predicate 1 & 2
Product Code	Endoscopic Access Overtube,Gastroenterology-Urology	Endoscopic Access Overtube,Gastroenterology-Urology	Identical to Predicate 1 & 2
Classification	II	II	Identical to Predicate 1 & 2
Indications for Use	Used to establish a conduitduring endoscopic urologicalprocedures to facilitate thepassage of endoscopes andother instruments into theurinary tract.	Used to establish a continuousconduit during urologicalendoscopic proceduresfacilitating the passage ofendoscopes and otherinstruments into the urinarytract.	Used to establish a conduitduring endoscopic urologicalprocedures to facilitate thepassage of endoscopes andother instruments into theurinary tract.
	The Cook® Pediatric FlexorUreteral Access Sheath isintended for Pediatric Use inpatients two years of age andolder.		The 13 cm length Flexor®Ureteral Access Sheaths areintended for Pediatric Use inpatients two years of age andolder.
Dilator Material	Polyethylene	Outer Surface: (PVC)Radiopaque PolyvinylChlorideInner Surface: (PTFE)Polytetrafluoroethylene	Identical to Predicate 1
Hydrophilic Coating	Yes	Yes	Identical to Predicate 1
Sheath Material	Nylon 12 with 304 StainlessSteel Coil and PTFEliner	Polyether Block Amide(PEBA)	Identical to Predicate 1
Sheath Length (cm)	13	35-45	13*, 20, 28, 35, 45, 55
Sheath ID (French)	9.5, 12.0	12, 14	9.5, 10.7, 12.0*, 14.0
Working Channels	1 or 2	1	1
Wire Guide ReleaseFeature	No	Yes	Yes, on Flexor Parallel RapidRelease Ureteral AccessSheath model

Comparison to predicates. Table 2.

The 13-cm length sheaths will only be available in 9.5 Fr, 10.7 Fr IDs of the Flexor® Ureteral Access Sheath to serve the pediatic indication. The Flexor Parallel Rapid Release Ureteral Access Sheath will not be available in the 13-cm length.

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Technological Characteristics :

The following tests were performed to demonstrate that the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath met applicable design and performance requirements and support a determination of substantial equivalence.

Device specific testing requirements - Mechanical

Dilator Buckling Force
Sheath Tensile Strength
· Dilator Tensile Strength
Sheath to Hub Tensile Strength
Dilator to Hub Tensile Strength
Dilator Tip Tensile Strength

Device specific testing requirements - Functional

Lubricity Length
· Kink Resistance
· Bench Testing/Simulated Use
· Tip Flexibility
· Sheath Inner Lumen Passability (Resistance)
Sheath Inner Lumen Durability

Device specific testing requirements - Radiopacity

· Radiopacity
General testing requirements
· Biocompatibility for devices with < 24 hour Mucosal Membrane Contact
- Cytotoxicity
- = Sensitization
- · Irritation or Intracutaneous Reactivity
· Sterilization
- = Sterility Testing
- Residuals from ETO sterilization
· Distribution Testing
- Packaging/Transportation Testing
· Shelf Life/Stability

Conclusion:

The results of these tests demonstrate that the Flexor Ureteral Access Sheath and the Flexor Parallel Rapid Release Ureteral Access Sheath meet the design input requirements based on the intended use. They support the conclusion that these devices do not raise new questions of safety or effectiveness and are substantially equivalent to the Cook Pediatric Flexor Ureteral Access Sheath (K043418) and the Coloplast A/S Re-Trace Ureteral Access Sheath (K140523).

Regulation Number and Section

§ 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.