(31 days)
The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.
The ComfortGlide™ Intermittent catheter is a hydrophilic coated, synthetic polvisorene, urinary catheter used for temporary drainage of urine from the bladder. The catheter is a tube consisting of a funnel, shaft, drainage eyes and tip. The tip of the catheter enters the bladder to allow urine to drain into the drainage eyes and then through the catheter. The catheter will be offered in multiple French sizes (10-18 Fr), lengths (6", 10" and 16") and two stiffnesses (soft and firm). Product offerings include the catheter with water sachet in a pouch as a standalone product or the catheter with water sachet in a kit configuration. The kit configuration includes two dloves, drape, benzalkonium chloride (BZK) towelette, povidoneiodine (PVI) prep pad and bag. The product is Ethylene Oxide sterilized (per ANSI/AAMI/SO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and for single use.
The provided text describes the 510(k) premarket notification for the ComfortGlide™ Intermittent Catheter. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and performance data, rather than a single study with specific acceptance criteria and performance metrics typically seen in diagnostic device evaluations.
Therefore, many of the requested points, especially those related to diagnostic performance thresholds, expert ground truth establishment, sample sizes for test/training sets, and comparative effectiveness studies (MRMC), are not applicable to the information provided for this type of medical device submission.
Here's the breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance (BS EN 1616:1997 + A1:1999) | "included testing per BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use" (Implies compliance, but specific numerical criteria/results are not detailed) |
| Coefficient of Friction | "included Coefficient of Friction Testing" (Implies testing was performed, but specific criteria/results are not detailed) |
| Biocompatibility (ISO 10993-1:2009 & FDA Bluebook G95-1) | "Nonclinical biocompatibility testing in accordance with ISO 10993-1:2009... and FDA Bluebook Memorandum G95-1... was conducted." (Implies compliance, but specific criteria/results are not detailed) |
| Substantial Equivalence (General) | "Nonclinical test data demonstrate that the device is safe and effective and is substantially equivalent to the legally marketed predicate devices." (Overall conclusion of the submission) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "nonclinical functional performance testing" and "biocompatibility testing," but does not provide details on the number of catheters or samples tested for each.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. These were nonclinical (laboratory) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a physical medical device. Ground truth as typically understood in a diagnostic study (e.g., expert consensus on images) is not relevant here. The "ground truth" would be the engineering specifications and performance standards met by the device during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a physical medical device. Adjudication methods are typically for subjective assessments in diagnostic studies.
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
- Not applicable. This is a physical medical device, not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" is defined by adherence to established international and national standards for medical devices, specifically:
- BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use (for functional performance).
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1 (for biocompatibility).
- The Coefficient of Friction testing would likely be compared against internal specifications or predicate device performance.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the ComfortGlide™ Intermittent Catheter meets acceptance criteria is a series of nonclinical functional performance and biocompatibility tests.
- Functional Performance Testing: This included adherence to BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use and Coefficient of Friction Testing. The submission states that testing was "included," implying successful compliance with the requirements of these standards.
- Biocompatibility Testing: This was conducted in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1. Again, the statement "was conducted" implies successful demonstration of biocompatibility as per these guidelines.
The overall conclusion of these tests was that the collected data demonstrated the device to be safe and effective and substantially equivalent to its predicate devices (Bard® Red Rubber All-Purpose Urethral Catheter, InterGlide™ Catheter (K951260), and InCare Intermittent Catheter (K013345)). The purpose of these tests was to show that the new device performs comparably to already marketed devices that meet regulatory standards, thus proving its acceptance for market clearance.
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Section 5: 510(k) Summary 510(k) Premarket Notification: ComfortGlide™ Intermittent Catheter, Page 1 of 2
K112137
page 1 of 2
AUG 26 2011
Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, GA 30014
BAIRD | MEDICAL
. J
The following information is provided as required by 21 CFR §807.92 for the ComfortGlide™ Intermittent Catheter 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Sponsor: | BARD Medical DivisionC. R. BARD, Inc.8195 Industrial Blvd.Covington, GA 30014 |
|---|---|
| Contact: | Stacci Cronk, RACRegulatory Affairs Specialist IIBard Medical DivisionC. R. Bard, Inc.Ph: 770-784-6994Fax: 770-385-4706E-mail: stacci.cronk@crbard.com |
| Date Prepared: | June 22, 2011 |
| Subject Device: | Trade Name: ComfortGlide™ Intermittent CatheterCommon/Usual Name: Urological CatheterClassification Name: Urological catheter and accessoriesRegulation: 21 CFR §876.5130Classification: IIProduct Code: KOD |
Predicate Device(s): The ComfortGlide™ Intermittent Catheter is substantially equivalent with respect to the following predicate devices:
| Product | Company | 510(k) Number |
|---|---|---|
| Bard® Red Rubber All-Purpose UrethralCatheter | C. R. Bard, Inc. | Pre-amendmentDevice |
| Urinary Intermittent Catheter with andwithout Hydromer® Hydrophilic Lubricant(InterGlideTM Catheter) | Biosearch Medical Products, Inc. | K951260 |
| InCare Intermittent Catheter | Hollister, Inc. | K013345 |
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Section 5: 510(k) Summary 510(k) Premarket Notification: ComfortGlide™ Intermittent Catheter, Page 2 of 2
The ComfortGlide™ Intermittent catheter is a hydrophilic coated, Device Description: synthetic polvisorene, urinary catheter used for temporary drainage of urine from the bladder. The catheter is a tube consisting of a funnel, shaft, drainage eyes and tip. The tip of the catheter enters the bladder to allow urine to drain into the drainage eyes and then through the catheter. The catheter will be offered in multiple French sizes (10-18 Fr), lengths (6", 10" and 16") and two stiffnesses (soft and firm). Product offerings include the catheter with water sachet in a pouch as a standalone product or the catheter with water sachet in a kit configuration. The kit configuration includes two dloves, drape, benzalkonium chloride (BZK) towelette, povidoneiodine (PVI) prep pad and bag. The product is Ethylene Oxide sterilized (per ANSI/AAMI/SO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and for single use.
Intended Use: The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.
Technological Characteristics: The ComfortGlide™ Intermittent Catheter has the same technological characteristics as the predicate devices. The subject device is made using synthetic polyisoprene, where the soft option is similar in stiffness to the natural rubber latex predicate device (Bard® Red Rubber All-Purpose Urethral Catheter) and the firm option is similar in stiffness to the PVC predicate device (InterGlide™ Catheter, K951260). The ComfortGlide™ Intermittent Catheter utilizes a water sachet inside the package for patient convenience. Water is required to activate the hydrophilic coating for the ComfortGlide™ Intermittent Catheter and the InterGlide™ Catheter (K951260).
Performance Data: Nonclinical functional performance testing included (1) testing per BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use and (2) Coefficient of Friction Testing. Nonclinical biocompatibility testing in accordance with ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" was conducted.
Substantial Equivalence: The ComfortGlide™ Intermittent Catheter has the same intended use as the predicate devices. Nonclinical test data demonstrate that the device is safe and effective and is substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bard Medical Division C.R. Bard, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
AUG 26 2011
Re: K112137
Trade/Device Name: ComfortGlide™ Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: August 15, 2011 Received: August 16, 2011
Dear Mr. Job:
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 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). 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Mr. Mark Job
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 (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Helmut Reinicke
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 4: Indications for Use Statement .
510(k) Premarket Notification: ComfortGlide™ Intermittent Catheter, Page 1 of 1
ndications for Use Statement
510(k) Number:
Device Name:
Indications for Use:
K 112137
ComfortGlide™ Intermittent Catheter
The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.
Prescription Use: ਖ
Or
Over the Counter Use [_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
tive, Gastro-Renal, and
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.