(109 days)
Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter.
The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide.
The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.
This document describes the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter and its substantial equivalence to predicate devices, focusing on performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Predicate) | Reported Device Performance (GentleCath) |
|---|---|---|
| 1) Catheter Flow Rate | (Implied: similar to predicate) | Similar or superior |
| 2) Strength of Tube and Connector Attachment | (Implied: similar to predicate) | Similar or superior |
| 3) Angle of Coudé Tip | (Implied: similar to predicate) | Similar or superior |
| 4) Diameter of Ball | (Implied: similar to predicate) | Similar or superior |
Note: The document states "All the parameters are similar or superior for the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter" compared to the predicate devices. Specific quantitative acceptance criteria are not explicitly listed in this summary but are referenced as being in Section 18 of the submission.
2. Sample Size Used for the Test Set and Data Provenance:
The document summarizes performance testing ("Bench Performance Testing") and states that "Details relating to performance testing of the subject device and the 2 predicate devices can be found in section 18 of this submission." This summary does not provide the specific sample sizes used for each test.
The data provenance is not explicitly stated as "country of origin." However, the applicant is ConvaTec Ltd. which has an address in Deeside, Flintshire, UK. The tests are described as "laboratory testing," suggesting they were conducted in a controlled environment, likely by the manufacturer. The study is retrospective in the sense that it compares features of a new device to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes bench testing of a medical device (catheter) and not a study involving human interpretation of data where "experts" would establish ground truth in the traditional sense. The "ground truth" here is based on quantifiable physical properties and performance metrics of the catheters themselves, as measured by standard laboratory methods. Therefore, this section is not applicable in the context of this submission. Device performance is measured against established engineering and regulatory standards and predicate device characteristics.
4. Adjudication Method for the Test Set:
Not applicable, as this is a bench testing study of a physical device, not an interpretation-based study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study is focused on the physical and functional equivalence of a medical device through bench testing, not on the effectiveness of human readers using the device or interpreting associated data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, this can be considered a standalone study in the sense that the device's physical and functional performance was tested independently of human interaction during the actual measurement process. The tests evaluate the intrinsic properties of the catheter itself (flow rate, strength, tip angle, ball diameter). There is no "algorithm" involved in this type of device.
7. Type of Ground Truth Used:
The ground truth used for this study is based on measurable physical properties and functional performance characteristics of the catheters. These include:
- Catheter flow rate
- Strength of tube and connector attachment
- Angle of Coudé tip
- Diameter of the ball
These are objective, quantitative measurements determined by laboratory testing, often against established standards for medical devices of this type, or established performance of the predicate devices.
8. Sample Size for the Training Set:
This document describes performance testing for substantial equivalence, which primarily relies on comparison to predicate devices and established standards. There is no explicit "training set" mentioned, as this is bench testing of a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this physical device testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
ConvaTec Ltd. Clare Williamson Senior Regulatory Affairs Executive Unit 20, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU UK
Re: K140953
Trade/Device Name: GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: June 24, 2014 Received: June 27, 2014
Dear Clare Williamson,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -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
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Indications for Use
510(k) Number (if known) K140953
Device Name
GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter
Indications for Use (Describe)
Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
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)
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)
Herbert P. Lerner -S 2014.08.01 15:42:53 -04'00'
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Image /page/3/Picture/0 description: The image shows the logo for ConvaTec. The logo consists of the word "ConvaTec" in a sans-serif font, followed by a circular emblem. The emblem contains a stylized image of a building with three columns, enclosed within a circle.
Unit 20, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU Telephone: 01244 584000 Facsimile: 01244 584011
Section 5
510(k) Summary
Applicant: ConvaTec Ltd.
Applicant Address: Unit 20, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU nK
Contact: Clare Williamson Senior Regulatory Affairs Executive
ConvaTec Ltd. Unit 20, First Avenue, Deeside Industrial Park Deeside Flintshire CH5 2NU nK
Tel: +44 (0)1244 584155 Fax: +44 (0)1244 584011 Email: clare.williamson@convatec.com
Date Prepared: April 07, 2014
Device Identification:
Trade Name: GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter
Common Name: Urological Catheter
Requlation Number: 21 CFR §876.5130
Classification Panel: Gastroenterology and Urology
Classification Name: Urological catheter and accessories
Regulatory Class: II
Product Code: KOD
Product Reference: 508979, 508980, 508981, 508982, 508983, 508984
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Predicate Devices:
| 510(k) number: K896729 | GentleCath Male Tiemann Intermittent UrinaryCatheter(formerly known as Unoplast Nelaton-, Female- orTiemann Catheter) |
|---|---|
| Product reference: 501011, 501012, 501013, 501014,501015, 501016 | |
| 510(k) number: K100878 | Self-Cath Olive Tip Coudé Male Intermittent UrinaryCatheterProduct reference: 504710/808, 504720/810,504730/812, 504740/814, 504750/816, 504760/818 |
Device Description
The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter.
The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide.
The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.
Intended Use
The GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter is a single use device indicated for the routine short term drainage of the bladder. The catheter is inserted through the urethra.
Performance Testing - Bench
Details relating to performance testing of the subject device and the 2 predicate devices can be found in section 18 of this submission. The following comparison tests were performed to demonstrate substantial equivalence:
-
- Catheter Flow Rate
-
- Strength of Tube and Connector Attachment
-
- Angle of Coudé Tip
-
- Diameter of Ball
The laboratory testing shows no differences that would indicate the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for
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the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter. Therefore, the testing has demonstrated substantial equivalence of the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter to the predicate devices.
Substantial Equivalence Conclusion
.
It has been demonstrated through comparison of design and features and performance testing, that the proposed device and its predicates have been found to be substantially equivalent; see following pages.
§ 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.