(177 days)
The BARD® Vertus™ Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
The BARD® Vertus™ Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon, once inflated, retains the catheter within the bladder. The shaft has two lumens: one to allow for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter. The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is provided sterile via ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products - ethylene oxide - Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is a single use, prescription-only device.
The provided document does not contain information about an AI/ML medical device and therefore does not describe acceptance criteria or a study proving its performance.
The document is a 510(k) premarket notification for a BARD® Vertus™ Foley Catheter, which is a physical medical device (a urological catheter). The review focuses on its substantial equivalence to a predicate device (BARD® LubriGuard™ Foley Catheter) based on:
- Indications for Use: Both are for drainage, collection, and measurement of urine.
- Technological Characteristics: Both are made of synthetic polyisoprene, hydrogel-coated, and have the same design features (shaft, eyelets, balloon, drainage funnel, inflation arm).
- Performance Data: This primarily involves biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity) and non-clinical functional performance testing (e.g., compliance with ASTM F623-99/(R)2013 for Foley Catheters, and coefficient of friction for lubricity).
There is no mention of any AI or machine learning component, nor any study involving human readers, ground truth establishment by experts, or any of the criteria typically associated with AI/ML device performance evaluation as outlined in your prompt's requirements.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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September 19, 2018
C. R. Bard, Inc. Sharon Lambert, RAC Regulatory Affairs Specialist II 8195 Industrial Blvd. Covington, GA 30014
Re: K180781
Trade/Device Name: BARD® Vertus™ Foley Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: August 14, 2018 Received: August 16, 2018
Dear Sharon Lambert:
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. 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Mark R. Kreitz -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180781
Device Name BARD® Vertus™ Foley Catheter
Indications for Use (Describe)
The BARD® Vertus™ Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
| 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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Attachment 9 - Page 1 of 1
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Bard Medical Division
C. R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 Tel: (770) 784-6209 Fax: (770) 385-4706
Image /page/3/Picture/5 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are thick and blocky, with a unique design where the "A" is formed by two triangles meeting at the top. The color of the text is a dark green, and the background is white, providing a strong contrast that makes the word stand out. The overall impression is one of a logo or branding element.
BARD® Vertus™ Foley Catheter 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
BARD Medical Division C. R. BARD, Inc. 8195 Industrial Blvd Covington, GA 30014
Phone: (770) 784-6208 Fax: (770) 385-4706
Contact Person: Sharon Lambert, RA Specialist II Date of Submission: August 14, 2018
Subject Device Name:
| Name of Device: | BARD® Vertus™ Foley Catheterwith product codes 0165B14, 0165B16, 0165B18 |
|---|---|
| Common or UsualName: | Urological Catheter |
| ClassificationNumber | 21 CFR 876.5130 |
| Classification Name: | Urological Catheter and Accessories |
| Product Code | EZL |
| Product Code Name | Catheter, Retention Type, Balloon |
| Regulatory Class: |
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Predicate Device:
| Name of Device: | Bard® LubriGuard™ Foley Catheterwith product codes 0165B14, 0165B16, 0165B18 |
|---|---|
| Common or UsualName: | Urological Catheter |
| ClassificationNumber | 21 CFR 876.5130 |
| Classification Name: | Urological Catheter and Accessories |
| Product Code | EZL |
| Product Code Name | Catheter, Retention Type, Balloon |
| Regulatory Class: | II |
| 510(k) | K150699 |
Device Description:
The BARD® Vertus™ Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon, once inflated, retains the catheter within the bladder. The shaft has two lumens: one to allow for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter.
The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is provided sterile via ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products - ethylene oxide - Requirements for development, validation and routine control of a sterilized process for medical devices).
The catheter is a single use, prescription-only device.
Indications for Use of Device:
The BARD® Vertus™ Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
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Technological Comparison to Predicate Devices:
The BARD® Vertus™Foley Catheter has identical technological characteristics and performance specifications as the predicate device, Bard® LubriGuard™ Foley Catheter (K150699). Both devices are manufactured from synthetic polyisoprene which has similar properties to natural rubber latex. Both subject and predicate devices are hydrogel-coated and possess the same design features and indications for use. In conclusion, the subject device is substantially equivalent to the predicate device and nonclinical test data demonstrate substantial equivalence.
Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation of the subject device was conducted in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices and testing within a risk management process – July 21, 2016. The subject device is considered a mucosal contacting surface device with prolonged duration. The battery of testing included the following.
- Cytotoxicity (ISO 10993-5 and AS/NZS 2696:1996) .
- Sensitization (ISO 10993-10) ●
- . Vaginal Mucosal Irritation (ISO 10993-10)
- . Systemic Toxicity (ISO 10993-11)
- . Sub-Acute Systemic Toxicity (ISO 10993-11)
- . Muscle Implantation (ISO 10993-6)
- . Genotoxicity (ISO 10993-3)
Non-clinical functional performance testing
Non-clinical functional performance testing of the subject device was performed in accordance with ASTM F623-99/(R)2013, Standard Performance Specification for Foley Catheter. Coefficient of friction (CoF) was also conducted for lubricity evaluation.
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Conclusions:
The BARD® Vertus™ Foley Catheter is substantially equivalent to the legally marketed predicate device, BARD® LubriGuard™ Foley Catheter, as demonstrated by the same intended use, indications for use, and technological characteristics. Non-clinical performance data demonstrates that the subject device is safe and effective.
§ 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.