(319 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a medical stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a stent, an implanted device that provides drainage and support to the ureter, which is a therapeutic function.
No
The device is a stent intended to establish drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components made of materials like polyether-urethane, ABS, stainless steel, and nylon, and describes their physical properties and testing. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "establish internal drainage from the ureteropelvic junction to the bladder" and "stenting of the ureter". This describes a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical stent made of polyether-urethane material, designed for insertion into the urinary tract. It includes components like pigtails, a locking mechanism, and a stiffening cannula, all consistent with a medical device used for drainage and stenting within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The device itself is the treatment/intervention.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Cope Nephroureterostomy Stent is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. The Cope Nephroureterostomy Stents are not intended to remain indwelling more than 90 days.
The Amplatz Ureteral Stent Set is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Amplatz Ureteral Stents are not intended to remain indwelling more than 180 days.
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The Cope Nephroureterostomy Stent is an internal/external draining stent consisting of double pigtails (proximal pigtail in the renal pelvis and distal pigtail in the bladder). The Cope nephroureterostomy stent is designed with a Mac-Loc locking mechanism. This locking mechanism consists of an ABS body, stainless steel pin, and valox lever with a 30 to 40 cm nylon filament (suture). The nylon monofilament runs between the Mac Loc® cap and extends through a 6.5 cm segment in the stent shaft corresponding with the positioning of the proximal loop and enters and exits through two puncture holes in the stent. The Cope Nephroureterostomy stents are manufactured using polyether-urethane material and are designed with sideports. The stents are available in diameters ranging from 8.5 Fr to 14.0 Fr and working lengths ranging from 10 to 32 cm. The device includes a stiffening cannula that aids in the placement of the stent and also includes a catheter securement device. All proposed devices are supplied sterile for single use.
The Amplatz Ureteral Stent Set is an internal draining stent that consists of double pigtails, with the proximal pigtail forming in the renal pelvis and the distal pigtail forming in the bladder. The set also includes a stent positioner with stent introducer catheter and loading stylet. The Amplatz Stent is composed of polyether-urethane material and designed with sideports that are located on the proximal and distal pigtails. The stents are available in diameters of 8.5 Fr or 10.2 Fr and length ranging from 10 to 30 cm. The distal end of the Amplatz Stent has a hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete. All proposed devices are supplied sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder
Indicated Patient Age Range
Not Found
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)
The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
- Dimensional and Compatibility (stent, flexible stiffener, rigid stiffener, wire . guide) - Testing in accordance with JIS T 3270 showed that dimensions and component compatibility was adequate for clinical use.
- . Tensile Testing (stent, introducer catheter, loading stylet, stent positioner, flexible stiffener) – Testing in accordance with BS EN 1617 showed that the peak load value was greater than or equal to the predetermined acceptance criterion.
- Curl Retention Strength Testing Testing in accordance with ASTM F 1828-97 . showed that the retention force greater than or equal to the predetermined acceptance criterion.
- . Liquid leakage (for Nephroureterostomy stent) - Testing in accordance with BS EN 1615 showed that the connection did not leak.
- . Flow rate Testing - Testing in accordance with BS EN 1618 showed that the minimum average flow rate greater than or equal to the predetermined acceptance criterion.
- Radiopacity Testing following the method described in ASTM F6540-12, . "Standard Test Methods for Determining Radiopacity for Medical Use" showed the radiopacity of the Nephroureterostomy Stent was determined to be noninferior to the radiopacity of the selected comparative device.
- . Kink Radius Testing - Testing was performed for characterization only
- Lubricity Testing Testing met predetermined peak force acceptance criterion. ●
- MRI Testing Testing in accordance with ASTM F2503 showed that the Cope . Nephroureterostomy Stent and the Amplatz Ureteral Stent Set are MR Conditional.
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for . cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, subchronic toxicity, material mediated pyrogenicity, implantation, and genotoxicity demonstrated that the devices are biocompatible.
For these tests, all pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 16, 2018
Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Wav Bloomington, IN 47402
Re: K171603
Trade/Device Name: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set Regulation Number: 21 CFR& 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: March 6, 2018 Received: March 7, 2018
Dear Erum B. Nasir:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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
1
statutes and regulations administered by other Federal agencies. 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.
Benjamin R. Fisher -S
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) K171603
Device Name Cope Nephroureterostomy Stent
Indications for Use (Describe)
The Cope Nephroureterostomy Stent is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. The Cope Nephroureterostomy Stents are not intended to remain indwelling more than 90 days.
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."
3
Indications for Use
510(k) Number (if known) K171603
Device Name Amplatz Ureteral Stent Set
Indications for Use (Describe)
The Amplatz Ureteral Stent Set is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Amplatz Ureteral Stents are not intended to remain indwelling more than 180 days.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
K171603 Cope Nephroureterostomy Stent and the Amplatz Ureteral Stent Set 21 CFR, §876.4620 Date Prepared: April 13, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Erum B. Nasir |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102607 |
| Contact Fax Number: | (812) 332-0281 |
| Proposed Device: | |
| Trade Name: | Cope Nephroureterostomy Stent and the Amplatz Ureteral |
| Stent Set | |
| Regulation Number: | 21 CFR §876.4620 |
| Regulation Number: | 21 CFR §876.4620 |
|---|---|
| Regulation Name: | Ureteral stent |
| Regulatory Class: | Class II |
| Product Code: | FAD |
| Common Name: | stent, ureteral |
| Classification Panel: | Gastroenterology/Urology |
Predicate Devices:
Expel™ Nephroureteral Drainage Stent with Twist-Loc Hub System and the Expel™ Ureteral Drainage Stent System (K141344), cleared for market by FDA on October 17, 2014, and the Percuflex Nephroureteral Stent (K924608), cleared for market on January 26, 1994.
Device Description:
The Cope Nephroureterostomy Stent is an internal/external draining stent consisting of double pigtails (proximal pigtail in the renal pelvis and distal pigtail in the bladder). The Cope nephroureterostomy stent is designed with a Mac-Loc locking mechanism. This locking mechanism consists of an ABS body, stainless steel pin, and valox lever with a 30 to 40 cm nylon filament (suture). The nylon monofilament runs between the Mac
5
Loc® cap and extends through a 6.5 cm segment in the stent shaft corresponding with the positioning of the proximal loop and enters and exits through two puncture holes in the stent. The Cope Nephroureterostomy stents are manufactured using polyether-urethane material and are designed with sideports. The stents are available in diameters ranging from 8.5 Fr to 14.0 Fr and working lengths ranging from 10 to 32 cm. The device includes a stiffening cannula that aids in the placement of the stent and also includes a catheter securement device. All proposed devices are supplied sterile for single use.
The Amplatz Ureteral Stent Set is an internal draining stent that consists of double pigtails, with the proximal pigtail forming in the renal pelvis and the distal pigtail forming in the bladder. The set also includes a stent positioner with stent introducer catheter and loading stylet. The Amplatz Stent is composed of polyether-urethane material and designed with sideports that are located on the proximal and distal pigtails. The stents are available in diameters of 8.5 Fr or 10.2 Fr and length ranging from 10 to 30 cm. The distal end of the Amplatz Stent has a hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete. All proposed devices are supplied sterile for single use.
Intended Use:
The Cope Nephroureterostomy Stent is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. The Cope Nephroureterostomy Stents are not intended to remain indwelling more than 90 days.
The Amplatz Ureteral Stent Set is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Amplatz Ureteral Stents are not intended to remain indwelling more than 180 days.
Comparison to Predicates:
The Cope Nephroureterostomy Stents and predicate devices, the Expel™ Nephroureteral Drainage Stent with Twist-Loc Hub System (K141344) and the PercuflexTM Nephroureteral Stent (K924608), have similar design and intended use. Additionally, the subject devices have the same technological characteristics and methods of placement as those of the predicate device. The differences between the subject device and the predicate device include the dimensions, materials, and indwell time.
6
3
Cook Incorporated - Traditional 510(k) Cope Nephroureterostomy Stent and the Amplatz Ureteral Stent Set 13 April 2018
The Amplatz Ureteral Stent Set and the predicate device, the Expel™ Ureteral Drainage Stent System (K141344), have similar design and intended use. Additionally, the subject devices have the same technological characteristics and methods of placement as those of the predicate device. The differences between the subject device and the predicate device include the dimensions, materials, and indwell time.
The substantial equivalence comparison with the predicates of each subject device is provided in Table 1 and Table 2.
7
4
Table 1 Substantial Equivalence Table – Cope Nephroureterostomy Stent
| Device | | PRIMARY PREDICATE
Expel™ Nephroureteral Drainage
Stent With Twist - Loc Hub System
K141344 | SECONDARY PREDICATE
Percuflex Nephroureteral Stent
K924608 | Cope Nephroureterostomy Stent
(Subject device) |
|-----------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | | 876.4620 | 876.4620 | Identical |
| Regulation Description | | Ureteral Stent | Ureteral Stent | Identical |
| Product Code | | FAD | FAD | Identical |
| Classification | | Class II | Class II | Identical |
| Intended Use | | The Expel Nephroureteral Stents are
delivered percutaneously and are
intended to establish internal drainage
from the ureteropelvic junction to the
bladder while maintaining external
access to the stent, as well as
providing external drainage. | The Percuflex Nephroureteral
Stent is intended for use in
Percutaneous Drainage to
establish internal drainage from
the uteropelvic junction to the
bladder while maintaining
external access to the stent. | The Cope Nephroureterostomy Stent is
delivered percutaneously and is intended
to establish internal drainage from the
ureteropelvic junction to the bladder
while maintaining external access to the
stent. The Cope Nephroureterostomy
Stents are not intended to remain
indwelling more than 90 days. |
| Stent Size (Fr) | | 8.3, 10.3 | 8, 10 | 8.5, 10.2, 12.0, 14,0 |
| Stent Length
(cm) | | 22, 28 | 22, 24, 26, 28 | 20, 22, 24, 26, 28 |
| Stent Material | | Flexithane™ (Polyurethane) | Percuflex (proprietary olefinic
block copolymer) | Polyether-Urethane |
| Marker Bands | | Unknown | Unknown | Platinum/Iridium |
| Stent | Stent Coating
(Distal portion
only) | Unknown hydrophilic coating | Unknown hydrophilic coating | Slip-coat |
| | Suture Material | Unknown | Unknown | Monofilament - Nylon |
| | Sideports | Yes | Yes | Yes |
| | Pigtails | Double Pigtail (proximal pigtail in the
renal pelvis and distal pigtail in the
bladder) | Double Pigtail (proximal pigtail
in the renal pelvis and distal
pigtail in the bladder) | Identical |
| | Pigtail Curl
Diameter | Unknown | Unknown | 2.0 cm – 3.0 cm |
| Pigtail Curl Arcs | | 360°, both ends | Unknown | Identical to Primary Predicate |
| Device | | PRIMARY PREDICATE
Expel™ Nephroureteral Drainage
Stent With Twist - Loc Hub System
K141344 | SECONDARY PREDICATE
Percuflex Nephroureteral Stent
K924608 | Cope Nephroureterostomy Stent
(Subject device) |
| Stent | End Hole Side
(inch) | Unknown | Unknown | 0.038 |
| | Locking
Mechanism | Loc Hub System | Locking Hub | Mac-Loc |
| Flexible
Stiffening
Cannula | Shaft Material | Unknown | Unknown | Nylon |
| | Securement Device | Unknown | Unknown | Yes |
| Indwelling Time | | 30 Days | 90 Days | 90 Days |
| Sterilization method | | Unknown | Unknown | Ethylene oxide |
| Sterility level | | Unknown | Unknown | 10⁻⁶ |
| Device | | Expel™ Ureteral Drainage
Stent System - Predicate
K141344 | Amplatz Ureteral Stent Set -
Subject Device | |
| | Regulation Number | 876.4620 | Identical | |
| | Regulation Description | Ureteral Stent | Identical | |
| | Product Code | FAD | Identical | |
| | Classification | Class II | Identical | |
| Intended Use | | The Expel Ureteral Stent
System is delivered
percutaneously and is intended
to establish drainage from the
ureteropelvic junction to the
bladder and stenting of the
ureter for all patients in whom
it is desirable to place a drain
which does not extend
externally. | The Amplatz Ureteral Stent Set is
delivered percutaneously and is
intended to establish drainage from
the ureteropelvic junction to the
bladder and stenting
of the ureter for all patients in whom
it is desirable to place a drain which
does not extend externally. The
Amplatz Ureteral Stents are not
intended to remain indwelling more
than 180 days. | |
| | Stent Size (Fr) | 6.3, 8.3, 10.3 | 8.5, 10.2 | |
| Stent | Stent Working Length
(cm) | 12, 28 | 10.0-30.0 | |
| | Stent material | Flexithane™ (Polyurethane) | Polyether-Urethane | |
| | Stent Coating
(Distal portion only) | Unknown Hydrophilic Coating | Slip-Coat | |
| | Pigtails | Pigtail on each end (proximal
pigtail in the renal pelvis and
distal pigtail in the bladder) | Identical | |
| | Pigtail Curl Diameter | Unknown | 2.0 cm – 3.0 cm | |
| | Pigtail Curl Arcs | 360°, both ends | 360°, both ends | |
| | Sideport | Yes | Yes | |
| | Marker Bands | Unknown | Platinum/Iridium | |
| | Suture | Unknown | Monofilament - Nylon | |
| | Cap Material | Unknown | Nylon | |
| Stent | Y-Fitting Material | Unknown | Acetal | |
| Positioner | Hub | Unknown | Nylon | |
| Introducer | Shaft Material | Unknown | Vinyl | |
| Catheter | Material | Unknown | Polytetrafluoroethylene | |
| | Marker Band | Unknown | Platinum/Iridium | |
| Loading | Cannula Material | Unknown | Stainless Steel | |
| Stylet | Hub Material | Unknown | Polypropylene | |
| Indwelling Time | | 30 Days | 180 Days | |
| Sterilization method | | Unknown | Ethylene oxide | |
| Sterility level | | Unknown | 10⁻⁶ | |
8
5
Table 1 Substantial Equivalence Table – Cope Nephroureterostomy Stent (contd)
9
Table 2 Substantial Equivalence Table - Amplatz Ureteral Stent Set
10
Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
- Dimensional and Compatibility (stent, flexible stiffener, rigid stiffener, wire . guide) - Testing in accordance with JIS T 3270 showed that dimensions and component compatibility was adequate for clinical use.
- . Tensile Testing (stent, introducer catheter, loading stylet, stent positioner, flexible stiffener) – Testing in accordance with BS EN 1617 showed that the peak load value was greater than or equal to the predetermined acceptance criterion.
- Curl Retention Strength Testing Testing in accordance with ASTM F 1828-97 . showed that the retention force greater than or equal to the predetermined acceptance criterion.
- . Liquid leakage (for Nephroureterostomy stent) - Testing in accordance with BS EN 1615 showed that the connection did not leak.
- . Flow rate Testing - Testing in accordance with BS EN 1618 showed that the minimum average flow rate greater than or equal to the predetermined acceptance criterion.
- Radiopacity Testing following the method described in ASTM F6540-12, . "Standard Test Methods for Determining Radiopacity for Medical Use" showed the radiopacity of the Nephroureterostomy Stent was determined to be noninferior to the radiopacity of the selected comparative device.
- . Kink Radius Testing - Testing was performed for characterization only
- Lubricity Testing Testing met predetermined peak force acceptance criterion. ●
- MRI Testing Testing in accordance with ASTM F2503 showed that the Cope . Nephroureterostomy Stent and the Amplatz Ureteral Stent Set are MR Conditional.
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for . cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, subchronic toxicity, material mediated pyrogenicity, implantation, and genotoxicity demonstrated that the devices are biocompatible.
For these tests, all pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended
11
Cook Incorporated - Traditional 510(k) Cope Nephroureterostomy Stent and the Amplatz Ureteral Stent Set 13 April 2018
use, and support the conclusion that these devices are substantially equivalent to the predicate devices.