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 Story
Ureteral access sheaths establish conduit for endoscopic urological procedures; facilitate passage of endoscopes/instruments into urinary tract. Device consists of sheath and dilator; dilator features tapered, hydrophilically coated distal tip. Parallel Rapid Release model includes skive/slit in dilator tip allowing wire guide to run outside/parallel to sheath; enables wire guide release in situ to serve as safety wire. Used in clinical/hospital settings by urologists. Sheath constructed of Nylon with 304 Stainless Steel coil and TFE liner; dilator constructed of polyethylene. Available in 9.5-14 Fr diameters and 13-55 cm lengths. Supplied sterile for single-time use. Provides stable access to urinary tract; reduces trauma during repeated instrument passage; safety wire feature allows maintenance of access during procedure.
Clinical Evidence
Bench testing only. Testing included mechanical (buckling force, tensile strength), functional (lubricity, kink resistance, simulated use, tip flexibility, lumen passability/durability), radiopacity, biocompatibility (cytotoxicity, sensitization, irritation), sterilization, and shelf-life/stability testing.
Technological Characteristics
Materials: Nylon sheath with 304 Stainless Steel coil and TFE liner; polyethylene dilator. Hydrophilic coating on dilator tip. Dimensions: 9.5-14 Fr OD, 13-55 cm length. Single lumen. Energy: None (mechanical). Connectivity: None. Sterilization: ETO. Features: Rapid release skive/slit on dilator tip (Parallel model).
Indications for Use
Indicated for establishing a conduit during endoscopic urological procedures to facilitate passage of endoscopes and instruments into the urinary tract. 13 cm length indicated for pediatric patients 2 years of age and older.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K172217
Device Name Flexor® Ureteral Access Sheath
#### Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
### 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."
{3}------------------------------------------------
# Indications for Use
510(k) Number (if known) K172217
#### Device Name
Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath
Indications for Use (Describe)
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.
Type of Use *(Select one or both, as applicable)*
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
#### 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."
{4}------------------------------------------------
# 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 Incorporated<br>750 Daniels Way<br>Bloomington, 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 and<br>Flexor® 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.
{5}------------------------------------------------
## De vice 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. Table 2-1 presents the sizes of devices that will be available.
| | | 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.
{6}------------------------------------------------
### Intended Use :
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.
### 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.
{7}------------------------------------------------
| | PRIMARY PREDICATE<br>DEVICE (1) | SECONDARY<br>PREDICATE DEVICE (2) | SUBJECT DEVICES |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cook® Pediatric Flexor<br>Ureteral Access Sheath<br>(K043418) | Coloplast A/S Re-Trace<br>Ureteral Access Sheath<br>(K140523) | Flexor® Ureteral Access<br>Sheath<br>AND<br>Flexor® Parallel™ Rapid<br>Release™ Ureteral Access<br>Sheath |
| Manufacturer | Cook Incorporated | Coloplast A/S | Cook Incorporated |
| Regulation | 876.1500<br>Endoscope and Accessories<br>FED | 876.1500<br>Endoscope and Accessories<br>FED | Identicalto Predicate 1 & 2 |
| Product Code | Endoscopic Access Overtube,<br>Gastroenterology-Urology | Endoscopic Access Overtube,<br>Gastroenterology-Urology | Identical to Predicate 1 & 2 |
| Classification | II | II | Identical to Predicate 1 & 2 |
| Indications for Use | Used to establish a conduit<br>during endoscopic urological<br>procedures to facilitate the<br>passage of endoscopes and<br>other instruments into the<br>urinary tract. | Used to establish a continuous<br>conduit during urological<br>endoscopic procedures<br>facilitating the passage of<br>endoscopes and other<br>instruments into the urinary<br>tract. | Used to establish a conduit<br>during endoscopic urological<br>procedures to facilitate the<br>passage of endoscopes and<br>other instruments into the<br>urinary tract. |
| | The Cook® Pediatric Flexor<br>Ureteral Access Sheath is<br>intended for Pediatric Use in<br>patients two years of age and<br>older. | | The 13 cm length Flexor®<br>Ureteral Access Sheaths are<br>intended for Pediatric Use in<br>patients two years of age and<br>older. |
| Dilator Material | Polyethylene | Outer Surface: (PVC)<br>Radiopaque Polyvinyl<br>Chloride<br>Inner Surface: (PTFE)<br>Polytetrafluoroethylene | Identical to Predicate 1 |
| Hydrophilic Coating | Yes | Yes | Identical to Predicate 1 |
| Sheath Material | Nylon 12 with 304 Stainless<br>Steel Coil and PTFEliner | Polyether Block Amide<br>(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 Release<br>Feature | No | Yes | Yes, on Flexor Parallel Rapid<br>Release Ureteral Access<br>Sheath 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.
{8}------------------------------------------------
## 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).
