(231 days)
Not Found
No
The device description and performance studies focus on physical properties and material compatibility, with no mention of AI or ML algorithms.
Yes.
Explanation: The device is intended for the dilation of the ureter prior to ureteroscopy or stone manipulation, which is a therapeutic intervention.
No
The device is a Ureteral Dilator, intended for the dilation of the ureter prior to ureteroscopy or stone manipulation. Its purpose is to physically prepare the ureter, not to diagnose a condition or disease.
No
The device description clearly details physical components made of EVA, FEP, and stainless steel, and the performance studies focus on physical properties like tensile strength, kink resistance, and dimensions. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the dilation of the ureter prior to a medical procedure (ureteroscopy or stone manipulation). This is a direct intervention on the patient's body.
- Device Description: The device is a physical tool (dilator) used to mechanically expand a bodily passage.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Bench Testing: The performance studies focus on the physical properties and functionality of the dilator itself (tensile strength, kink resistance, lubricity, dimensions, radiopacity), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) for a therapeutic or procedural purpose.
N/A
Intended Use / Indications for Use
The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.
Product codes (comma separated list FDA assigned to the subject device)
EZN
Device Description
The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.
All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.
The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ureter
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)
Bench Testing (including time zero and applicable three-year accelerated aged testing),
- Tensile Testing The peak load preceding failure shall be greater than or equal to 15 . N. Testing performed on the dilator shaft per applicable ISO standards demonstrated that the devices met the acceptance criteria.
- Kink Resistance Testing The dilator shaft shall resist kinking at 80° angle. The . dilator tip shall fit over a 0.038 inch guide wire.
- Dilator Tip Rollback Testing The tip of the dilator shall be successfully introduced ● through the urethane membrane without showing any signs of damage such as rollback, buckle or kink at the tip. Testing performed per applicable ISO standards demonstrated that the dilator will not kink, buckle or rollback.
- Lubricity Testing The peak load during lubricity testing of the hydrophilic coated ● region of the dilators shall be less than the peak load during lubricity testing of the uncoated dilators.
- Dimensional Verification The length of the dilators shall be 60 cm ± 1 cm. FEP . dilators shall include a handle at the proximal end to facilitate removal of the dilator. Dilator markings shall be legible, defined as being able to read markings on dilators. Testing performed demonstrated that the test specimens' dimensions are within the specified tolerances. Testing performed demonstrated that the dilator is compatible with the wire guide.
- . Radiopacity -Dilators shall be radiopaque in compliance with the methods detailed in ASTM F640-12. Testing performed demonstrated that the devices are visible in the radiographic image.
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
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
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July 17, 2018
Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404
Re: K173654
Trade/Device Name: Ureteral Dilator Sets Ureteral Dilators Regulation Number: 21 CFR& 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: June 27, 2018 Received: June 28, 2018
Dear Kotei Aoki:
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 comprehensive regulatory information about medical devices and radiation-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,
Glenn B. Bell -S
for
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173654
Device Name Ureteral Dilator Sets Ureteral Dilators
Indications for Use (Describe)
The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 ER
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K173654 Page 1 of 5
Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
K173654 Ureteral Dilator Sets Ureteral Dilators 21 CFR 8807.92 Date Prepared: 27 June 2018
Submitted By:
Submission: Applicant: Applicant Address:
Traditional 510(k) Premarket Notification Cook Incorporated Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Kotei Aoki regsubmissions(a)cookmedical.com (812) 335-3575 x102630 (812) 332-0281
| Contact: |
|---|
| Email: |
| Contact Phone Number: |
| Contact Fax Number: |
Device Information:
| Trade Name: | Ureteral Dilator Sets
Ureteral Dilators |
|-----------------------|--------------------------------------------|
| Common Name: | Dilator, Catheter, Ureteral |
| Classification Name: | Ureteral Dilator |
| Regulation: | 21 CFR §876.5470 |
| Product Code: | EZN |
| Device Class: | II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Device:
The Ureteral Dilator Sets, and each individual Ureteral Dilator, is substantially equivalent to the following device: the AQ Hydrophilic Dilator (K961904, Cook Urological Inc.) cleared on October 18, 1996.
Device Description:
The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also
4
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA ONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.
All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.
The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.
Indications for Use:
The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
The Ureteral Dilators are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
Comparison to Predicate Device:
The Ureteral Dilator Sets, and each individual Ureteral Dilator, and the predicate device, the AQ Hydrophilic Dilator (K961904), are substantially equivalent in that these devices have the similar intended use and are identical in technological characteristics and method of placement. Additionally, the proposed devices have similar indications for use and dimensions as the predicate device. The differences between the proposed device and the predicate device, including the materials, dimensions, and indications for use do not raise any new issues of safety and effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in a smaller, sans-serif font. The background of the logo is a solid red color.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Table 1: Substantial Equivalence Table
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| AQ Hydrophilic Dilators | ||
| (K961904) | Ureteral Dilator Sets | |
| Regulation | 21 CFR §876.5520 | |
| 21 CFR §876.5470 | 21 CFR §876.5470 | |
| Product Code | KOE, EZN | EZN |
| Classification | II | Identical |
| Indications for Use | Intended to dilate the suprapubic and/or | |
| nephrostomy fascial tract, urethra, and | ||
| ureters | Intended for dilation of the ureter prior | |
| to ureteroscopy or stone manipulation | ||
| Device for One-Time | ||
| Use | Yes | Identical |
| Distal Taper | Yes | Identical |
| Endhole Diameter | 0.040 in | Identical |
| Set Components | Dilator, Wire Guide | Identical |
| Sterilization Method | EtO | Identical |
| Sterility Assurance | ||
| Level | 10-6 | Identical |
| Dilator O.D. | 5.0 - 36.0 Fr. | 6.0 - 18.0 Fr. |
| Dilator Length | 20 - 60 cm | 60 cm |
| Dilator Material | Polyurethane, Polyethylene, Vinyl | Ethylene Vinyl Acetate |
| Fluorinated Ethylene Propylene | ||
| Hydrophilic Coating | Yes | Optional (EVA only) |
| Packaging | Tyvek-Poly Pouch | Tray (sets only) |
| Tyvek-Poly Pouch | ||
| Tyvek Peel Pouch |
Technological Characteristics:
The subject devices, Ureteral Dilator Sets and Ureteral Dilators, were subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Bench Testing (including time zero and applicable three-year accelerated aged testing),
- Tensile Testing The peak load preceding failure shall be greater than or equal to 15 . N. Testing performed on the dilator shaft per applicable ISO standards demonstrated that the devices met the acceptance criteria.
- Kink Resistance Testing The dilator shaft shall resist kinking at 80° angle. The . dilator tip shall fit over a 0.038 inch guide wire.
- Dilator Tip Rollback Testing The tip of the dilator shall be successfully introduced ● through the urethane membrane without showing any signs of damage such as rollback, buckle or kink at the tip. Testing performed per applicable ISO standards demonstrated that the dilator will not kink, buckle or rollback.
6
Image /page/6/Picture/1 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, with the word "MEDICAL" underneath it in a smaller font. The background is a solid red color. The word "MEDICAL" is on a white angled rectangle.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
- Lubricity Testing The peak load during lubricity testing of the hydrophilic coated ● region of the dilators shall be less than the peak load during lubricity testing of the uncoated dilators.
- Dimensional Verification The length of the dilators shall be 60 cm ± 1 cm. FEP . dilators shall include a handle at the proximal end to facilitate removal of the dilator. Dilator markings shall be legible, defined as being able to read markings on dilators. Testing performed demonstrated that the test specimens' dimensions are within the specified tolerances. Testing performed demonstrated that the dilator is compatible with the wire guide.
- . Radiopacity -Dilators shall be radiopaque in compliance with the methods detailed in ASTM F640-12. Testing performed demonstrated that the devices are visible in the radiographic image.
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, and . intracutaneous irritation demonstrated the biocompatibility of the subject device.
Sterility Testing:
- The established method used to validate the sterilization cycle is consistent with the ● half-cycle method as described in ISO 11135:2014.
- . Residual levels of ethylene oxide (EO) and ethylene chlorohydrin (ECH) have been evaluated and verified to be no greater than the maximum limits as specified in ANSI/AAMI/ISO 10993-7:2008(R)2012.
- The subject device is not an implant, nor labeled non-pyrogenic, nor intended to be in ● contact with intravascular, intralymphatic, or intrathecal fluid systems. Therefore, these devices do not require testing for the presence of bacterial endotoxins according to USP.
Packaging Integrity and Distribution Testing:
- Packaging integrity testing after simulated distribution of these packaging materials . has been performed on a worst-case representative device. Simulated distribution testing was performed according to ASTM D4169-16. All test methods are as recommended in Annex B of AAMI/ISO 11607-1:2006/(R)2015.
7
Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Conclusion:
The results of these tests confirm that the Ureteral Dilator Sets, and each individual Ureteral Dilator, meet the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, AQ Hydrophilic Dilator (Cook Urological, Inc., K961904).