(248 days)
Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.
The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.
This document describes the Cook Incorporated UPJ Occlusion Balloon Catheter (K183323). This is a physical medical device, not an AI/ML powered device. As such, the information you requested about acceptance criteria and studies is not applicable in the context of an AI/ML device.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML models (e.g., sensitivity, specificity, AUC). Instead, it lists performance data in the form of engineering and material testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements |
| Tensile Strength | Met requirements |
| Kink Radius | Met requirements |
| Leakage and Lumen Blockage | Met requirements |
| Radiopacity | Met requirements |
| Balloon Fatigue and Burst | Met requirements |
| Dimensional Measurement and Compatibility | Met requirements |
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided. The "testing" mentioned is for a physical device, and typically involves a certain number of manufactured units or material samples. The document does not specify quantities or data provenance (e.g., country of origin, retrospective/prospective) because these concepts are not applicable to the engineering tests described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For physical devices, "ground truth" is established through engineering and material standards, not expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the testing involves physical device properties, not diagnostic interpretations.
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:
This information is not applicable as the device is a physical catheter, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical catheter, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this physical device is based on established engineering and material standards, and compliance with the device's design specifications and intended use. This is demonstrated through various physical and material performance tests.
8. The sample size for the training set:
This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.
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August 5, 2019
COOK Incorporated Johnathan Liu Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47404
Re: K183323
Trade/Device Name: UPJ Occlusion Balloon Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EYB Dated: July 19, 2019 Received: July 22, 2019
Dear Johnathan Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] 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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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) K183323
Device Name UPJ Occlusion Balloon Catheter
Indications for Use (Describe)
Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.
| 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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K183323 Page 1 of 3
Cook Incorporated - Traditional 510(k) UPJ Occlusion Balloon Catheter November 29, 2018
2.0 510(k) Summary
UPJ Occlusion Balloon Catheter 21 CFR §807.92 Date Prepared: August 5, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Primary Contact: | Johnathan Liu |
| Secondary Contact: | Karthik Pillai, PhD |
| Email: | RegSubmissions@cookmedical.com |
| Contact Phone: | (812)-335-3575 x104509 |
| Contact Fax: | (812)-332-0281 |
| Device Information: | |
| Trade Name: | UPJ Occlusion Balloon Catheter |
| Device Common Name: | Catheter, Ureteral, Gastro-Urology |
| Classification Name: | Urological Catheter and Accessories |
| Classification Regulation: | 21 CFR §876.5130 |
| Product Code: | EYB |
| Device Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |
Predicate Device:
Occluder™ Occlusion Balloon Catheter (K133750)
Device Description:
The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone
3
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Cook Incorporated - Traditional 510(k) UPJ Occlusion Balloon Catheter November 29, 2018
and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter.
The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.
Indications for Use:
Used to temporarily occlude the ureteropelvic junction to prevent stone fragments from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.
Comparison to Predicate Device:
The subject device. UPJ Occlusion Balloon Catheter, and the predicate device. Occluder™ Occlusion Balloon Catheter (K133750), are similar in intended uses, fundamental technological characteristics, and methods of operation. Differences between the characteristics of the subject device and the predicate device include:
- Indications for Use .
- Design Features
- Dimensions
- Materials ●
Differences between the characteristics of the subject device and the predicate device are supported by testing. The subject device raises no new questions of safety and effectiveness as compared to the predicate device.
Performance Data:
The following testing was performed to demonstrate that the UPJ Occlusion Balloon Catheter met applicable design requirements.
- Biocompatibility ●
- Tensile Strength
- Kink Radius
- . Leakage and Lumen Blockage
- Radiopacity
- Balloon Fatigue and Burst
- Dimensional Measurement and Compatibility .
4
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Cook Incorporated - Traditional 510(k) UPJ Occlusion Balloon Catheter November 29, 2018
Results of the testing provide reasonable assurance that the subject device, UPJ Occlusion Balloon Catheter will perform as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate devices. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.