(191 days)
No
The description focuses on the physical characteristics and intended use of a simple urinary catheter, with no mention of AI or ML capabilities.
No.
A therapeutic device directly treats or cures a disease or condition. This device is used for drainage, which is a supportive function rather than a direct treatment or cure for the underlying inability to urinate.
No
The device is a urethral catheter used for the drainage of urine, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, single-use urinary catheter made of PVC, which is a hardware component. There is no mention of software as part of the device's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Medline Poly-Cath Red Polymer Urethral Catheter is a device that is inserted into the body (in vivo) to drain urine. It is a therapeutic device used for a medical procedure, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "drainage of urine from the bladder," which is a physical process, not a diagnostic test.
The information provided describes a medical device used for a physical intervention, not for analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.
Product codes
GBM
Device Description
Medline Poly-Cath™ Red Polymer Urethral Catheter is a single use, flexible, straight urinary catheter that is inserted through the urethra into the bladder allowing urine to drain. The proposed device is comprised of a polyvinyl chloride (PVC) compound that does not contain bis (2-ethylhexyl) phthalate (DEHP). The catheter has a rounded closed tip with two oval drainage eyes at one end, and a funnel bonded to the opposite end. Medline Poly-Cath™ Red Polymer Urethral Catheter is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
adults
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)
Non-clinical verification of The Medline Poly-Cath™ Red Polymer Urethral Catheter has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.
Biocompatibility Testing:
- Cytotoxicity: ISO MEM Elution (GLP) in accordance with ISO 10993-5:2009 "Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity".
- Sensitization: ISO Guinea Pig Maximization Sensitization Test (GLP) in accordance with the test guidelines described in ISO 10993-10: 2010 Standard, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Sensitization".
- Irritation: ISO Vaginal Irritation Study in Rabbits (GLP) in accordance with the test guidelines described in ISO 10993-10: 2010 Standard, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Sensitization".
- Acute Systemic Toxicity: ISO Systemic Toxicity Study in Mice (GLP) in accordance with the test guidelines described in ISO 10993-11: 2006 Standard, "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity".
Performance Testing (Bench):
- Catheter Surface Finish: Meet BS EN 1616:1997 Requirements
- Catheter Dimensional Analysis: Meet BS EN 1616:1997 Requirements
- Catheter Strength: Meet BS EN 1616:1997 Requirements
- Catheter Flow Rate: Meet BS EN 1616:1997 Requirements and BS EN 1618:1997 Annex E
- Connector Security: Meet BS EN 1616:1997 Requirements
Additional Non-Clinical Evaluations:
- Stability (Shelf-Life) Testing.
- Ethylene Oxide Sterilization Residuals Evaluation.
- Bioburden Evaluation.
- Simulated Shipping Testing.
- Packaging Integrity Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 12, 2019
Medline Industries, Inc. Dinah Rincones Regulatory Specialist Three Lakes Drive Northfield, IL 60093
Re: K183335
Trade/Device Name: Medline Poly-Cath Red Polymer Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 2, 2019 Received: May 6, 2019
Dear Dinah Rincones:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,
for 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
2
Indications for Use
510(k) Number (if known)
K183335
Device Name
Medline Poly-Cath Red Polymer Urethral Catheter
Indications for Use (Describe)
Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the Medline logo. The logo is white text on a blue background. The word "MEDLINE" is in bold, sans-serif font. Above the text is a white symbol that looks like a stylized cross or star. The background is a solid blue color. There is a small gray rectangle in the upper right corner of the image.
ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093
SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Dinah Rincones Regulatory Affairs Specialist Phone: 847-949-2687 Email: DRincones@medline.com
Summary Preparation Date
November 30, 2018
Type of 510(k) Submission
Traditional
Device Name / Classification
- Trade Name: ●
- Device Common Name:
- Regulation Name:
- . Regulation Number :
- Product Code:
- Device Class:
- . Review Panel:
Predicate Device DOVER ROB-NEL Catheter K040897
Device Description
Medline Poly-Cath™ Red Polymer Urethral Catheter Catheter, Urethral Urological Catheter and Accessories 21 CFR 8876.5130 GBM Class II Gastroenterology/Urology
Medline Poly-Cath™ Red Polymer Urethral Catheter is a single use, flexible, straight urinary catheter that is inserted through the urethra into the bladder allowing urine to drain. The proposed device is comprised of a polyvinyl chloride (PVC) compound that does not contain bis (2-ethylhexyl) phthalate
4
Image /page/4/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst-like symbol to the right of the text. The background is a solid dark blue color. There is a gray bar on the right side of the image.
Aedline Industries. Inc Three Lakes Drive Northfield, IL 60093
(DEHP). The catheter has a rounded closed tip with two oval drainage eyes at one end, and a funnel bonded to the opposite end. Medline Poly-Cath™ Red Polymer Urethral Catheter is provided sterile.
Indications for Use
Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.
Summary of Technological Characteristics
The Medline Poly-Cath™ Red Polymer Urethral Catheter is similar in design, indications for use and technological characteristics to the predicate device cleared under K040897, DOVER® ROB-NEL Catheter.
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Poly-Cath™ Red
Polymer Urethral Catheter | DOVER® ROB-NEL Catheter | N/A |
| 510(k) Reference | N/A | K040897 | N/A |
| Product Owner | Medline Industries, Inc. | Covidien | N/A |
| Intended Use | Medline Poly-Cath Red
Polymer Urethral Catheter is
intended for intermittent
catheterization to drain urine
from the urinary bladder.
The product is intended for
use on patients who are not
capable of voluntary
urination. | DOVER® ROB-NEL Catheter
is intended for intermittent
catheterization to drain urine
from the urinary bladder. The
product is intended for use on
patients who are not capable of
voluntary urination. | Same |
| Indications for Use | Medline Poly-Cath Red
Polymer Urethral Catheter is
intended for use in the
drainage of urine from the
bladder, and it is indicated for
the intermittent catheterization
of male and female adults who
are not capable of voluntary
urination. This product is not
designed for use as an
indwelling catheter. | The proposed device is
intended for use in the
drainage of urine from the
urinary bladder. The product is
intended for intermittent
catheterization on patients who
are not capable of voluntary
urination. This product is not
designed for use as an
indwelling catheter. | Similar |
| Design Features | Flexible, straight catheter with
two staggered eyes, a rounded
closed tip and a funnel end. | Flexible, straight catheter with
two staggered holes, a rounded
closed tip and a funnel end. | Same |
TABLE 1 - Comparison of Proposed and Predicate Devices
5
Image /page/5/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a stylized white starburst symbol behind it. The background is a solid dark blue color. The starburst symbol has four points, with two long points extending diagonally and two shorter points extending horizontally.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|---------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------|
| Design Configurations | One size: 16", 14 Fr | Various sizes, including 16", 14 Fr | Similar |
| Materials | PVC, colorants, adhesive | PVC, colorants | Similar |
| Prescription vs. OTC | Prescription | Prescription | Same |
| Biocompatibility, Contact
Duration | ISO 10993-1,
Limited Contact (