Medline Poly-Cath Red Polymer Urethral Catheter

K183335 · Medline Industries, Inc. · GBM · Jun 12, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183335
• Device Name: Medline Poly-Cath Red Polymer Urethral Catheter
• Applicant: Medline Industries, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jun 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use, flexible, straight urinary catheter; inserted through urethra into bladder to facilitate urine drainage. Comprised of PVC compound (DEHP-free); features rounded closed tip with two oval drainage eyes and bonded funnel end. Used in clinical settings by healthcare providers. Device provides passive drainage path; no active components. Benefits patient by enabling bladder emptying in cases of urinary retention.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via biocompatibility (ISO 10993-5, -10, -11) and functional testing (BS EN 1616:1997, BS EN 1618:1997) including surface finish, dimensional analysis, strength, flow rate, and connector security. Additional testing included shelf-life, sterilization residuals, bioburden, and packaging integrity.

Technological Characteristics

Materials: PVC, colorants, adhesive. Design: Flexible, straight catheter, 16", 14 Fr, rounded closed tip, two oval drainage eyes, funnel end. Sterilization: Ethylene Oxide. Standards: ISO 10993-1, BS EN 1616:1997, BS EN 1618:1997. Single-use, prescription-only.

Indications for Use

Indicated for intermittent urinary bladder drainage in male adults unable to urinate voluntarily. Not for indwelling use.

Regulatory Classification

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).

Predicate Devices

• DOVER ROB-NEL Catheter (K040897)

Submission Summary (Full Text)

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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.

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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/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 ([e-mail]) or phone [phone] 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

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## 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)

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: [phone] Email: [e-mail]

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

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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<br>Analysis |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Poly-Cath™ Red<br>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<br>Polymer Urethral Catheter is<br>intended for intermittent<br>catheterization to drain urine<br>from the urinary bladder.<br>The product is intended for<br>use on patients who are not<br>capable of voluntary<br>urination. | DOVER® ROB-NEL Catheter<br>is intended for intermittent<br>catheterization to drain urine<br>from the urinary bladder. The<br>product is intended for use on<br>patients who are not capable of<br>voluntary urination. | Same |
| Indications for Use | Medline Poly-Cath Red<br>Polymer Urethral Catheter is<br>intended for use in the<br>drainage of urine from the<br>bladder, and it is indicated for<br>the intermittent catheterization<br>of male and female adults who<br>are not capable of voluntary<br>urination. This product is not<br>designed for use as an<br>indwelling catheter. | The proposed device is<br>intended for use in the<br>drainage of urine from the<br>urinary bladder. The product is<br>intended for intermittent<br>catheterization on patients who<br>are not capable of voluntary<br>urination. This product is not<br>designed for use as an<br>indwelling catheter. | Similar |
| Design Features | Flexible, straight catheter with<br>two staggered eyes, a rounded<br>closed tip and a funnel end. | Flexible, straight catheter with<br>two staggered holes, a rounded<br>closed tip and a funnel end. | Same |

#### TABLE 1 - Comparison of Proposed and Predicate Devices

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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<br>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<br>Duration | ISO 10993-1,<br>Limited Contact (<24h) | ISO 10993-1,<br>Limited Contact (<24h) | Same |
| Performance Testing | Conforms to applicable<br>standard specification for<br>urethral catheters | Conforms to applicable<br>standard specification for<br>urethral catheters | Same |
| Sterile vs. Non-Sterile | Sterile | Sterile | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |

## Summary of Non-Clinical Testing

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. Specifically, the proposed device has been evaluated through the following tests:

#### Biocompatibility Testing

The biocompatibility evaluation was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA.

The following tests were performed to evaluate the biocompatibility of Medline Poly-Cath™ Red Polymer Urethral Catheter:

- 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".

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Image /page/6/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst symbol above it. The background is a dark blue square. The logo is cropped on the right side.

ledline Industries. Inc Three Lakes Drive Northfield, IL 60093

- 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)

Functional performance testing was carried out on the final finished form of the proposed device. The table below provides a summary of all functional testing performed.

| Test Objective | Testing Standards | Performance Results |
|-------------------------------|------------------------------------|-----------------------------------------------------------------------------|
| Catheter Surface Finish | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.2<br>Requirements |
| Catheter Dimensional Analysis | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.3<br>Requirements |
| Catheter Strength | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.4<br>Requirements |
| Catheter Flow Rate | BS EN 1616:1997<br>BS EN 1618:1997 | Meet BS EN 1616:1997 § 4.8<br>Requirements and BS EN<br>1618:1997 § Annex E |
| Connector Security | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.5<br>Requirements |

#### TABLE 1 - Summary of Performance Testing

#### Additional Non-Clinical Evaluations

- Stability (Shelf-Life) Testing. ●
- Ethylene Oxide Sterilization Residuals Evaluation.
- Bioburden Evaluation.
- Simulated Shipping Testing.
- Packaging Integrity Testing.

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Image /page/7/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white star-like shape is behind the text, with its points extending beyond the letters. The logo is simple and clean, with a focus on the company name and a distinctive graphic element.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

#### Conclusion

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Poly-Cath™ Red Polymer Urethral Catheter is substantially equivalent to the predicate device, DOVER ROB-NEL Catheter (K040897).