(31 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and sterilization of a standard intermittent catheter, with no mention of AI or ML capabilities.
No
The device is used for draining urine, which is a diagnostic or maintenance function rather than a therapeutic one, as it does not treat a disease.
No
The ComfortGlide™ Intermittent Catheter is described as a device for draining urine from the bladder, which is a therapeutic function, not a diagnostic one. It does not mention any ability to detect, analyze, or monitor medical conditions.
No
The device description clearly outlines a physical, hardware-based medical device (a catheter) and its associated components (funnel, shaft, drainage eyes, tip, water sachet, gloves, drape, towelette, prep pad, bag). There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ComfortGlide™ Function: The ComfortGlide™ Intermittent Catheter is a device that is inserted into the body to drain urine directly from the bladder. It is a therapeutic device used for a physical process (drainage), not a diagnostic test performed on a sample.
The description clearly states its purpose is for "draining urine from the bladder," which is a direct intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.
Product codes
KOD, EZD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
adult and pediatric
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pre-amendment Device, K951260, K013345
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Division
C. R. BARD, Inc.
8195 Industrial Blvd.
Covington, GA 30014 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Stacci Cronk, RAC
Regulatory Affairs Specialist II
Bard Medical Division
C. R. Bard, Inc.
Ph: 770-784-6994
Fax: 770-385-4706
E-mail: stacci.cronk@crbard.com |
| Date Prepared: | June 22, 2011 |
| Subject Device: | Trade Name: ComfortGlide™ Intermittent Catheter
Common/Usual Name: Urological Catheter
Classification Name: Urological catheter and accessories
Regulation: 21 CFR §876.5130
Classification: II
Product 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 Urethral | ||
| Catheter | C. R. Bard, Inc. | Pre-amendment |
| Device | ||
| Urinary Intermittent Catheter with and | ||
| without Hydromer® Hydrophilic Lubricant | ||
| (InterGlideTM Catheter) | Biosearch Medical Products, Inc. | K951260 |
| InCare Intermittent Catheter | Hollister, Inc. | K013345 |
1
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.
2
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.
3
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
4
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 ____________________________________________________________________________________________________________________________________________________________________