Medline Catheter Specimen Collector

K172541 · Medline Industries, Inc. · EZD · Feb 22, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172541
• Device Name: Medline Catheter Specimen Collector
• Applicant: Medline Industries, Inc.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

Device Story

Sterile, single-use PVC catheter; inserted through urethra into bladder to collect urine samples. Includes straight tube, protective sheath, pre-attached collection container, and cap. Features closed rounded tip with four drainage eyelets. Available in 5FR and 8FR sizes; lengths 6.5 to 14 inches. Used in clinical settings by healthcare providers to facilitate fluid passage from urinary tract. Output is a urine sample for diagnostic testing. Benefits patient by providing uncontaminated specimen when non-invasive methods fail.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including biocompatibility (ISO 10993-5, -10), functional performance (BS EN 1616:1997 for surface, dimensions, strength, flow rate), package integrity (ASTM F1929), and sterilization residuals.

Technological Characteristics

Materials: Polyvinyl chloride (PVC). Design: Straight catheter with closed rounded tip, 4 drainage eyelets. Sizes: 5FR, 8FR. Lengths: 6.5-14 inches. Sterilization: Ethylene Oxide. Standards: BS EN 1616:1997 (catheter performance), ISO 10993 (biocompatibility), ASTM F1929 (packaging).

Indications for Use

Indicated for patients requiring urinary collection procedures to obtain a urine sample via catheterization when clean catch methods are insufficient or to avoid urethral contamination.

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

• Busse Hospital Disposable Urethral Catheter (K041464)

Submission Summary (Full Text)

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February 22, 2018

Medline Industries, Inc. Dinah Rincones Regulatory Specialist Three Lakes Drive Northfield. IL 60093

Re: K172541

Trade/Device Name: Medline Catheter Specimen Collector Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: December 28, 2017 Received: January 2, 2018

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. 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); 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The name is written in a clear, sans-serif typeface, making it easily readable. The overall impression is clean and professional.

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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# Indications for Use

510(k) Number (if known) K172541

Device Name Medline Catheter Specimen Collector

Indications for Use (Describe)

Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image is a logo for Medline. The logo is set against a blue background. The word "MEDLINE" is written in white, bold, sans-serif font. Behind the word is a white, stylized starburst shape, with the points of the star extending above and below the word. The starburst is oriented vertically.

edline Industries. Inc Three Lakes Drive Northfield. IL 60093

# 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Summary Preparation Date August 21, 2017

## Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

### Submission Correspondent

Dinah Rincones Regulatory Specialist Phone: [phone] Fax: [phone] Email: [e-mail]

Type of 510(k) Submission Traditional

# Device Name / Classification

Device Common Name - Catheter, Straight Proprietary Name - Medline Catheter Specimen Collector Classification - Class II Panel - Gastroenterology / Urology Product Code - EZD Regulation # - 21 CFR 876.5130 Urological Catheter and Accessories

### Predicate Device

Busse Hospital Disposable Urethral Catheter (K041464)

### Indications for Use

Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

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Image /page/4/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst-like symbol behind it. The background is a solid dark blue. There is a gray bar on the right side of the image.

ledline Industries. Inc Three Lakes Drive Northfield. II 60093

### Device Description

The Medline Catheter Specimen Collector is a sterile, single-use device consisting of a straight polyvinyl chloride (PVC) tube that is inserted through the urethra and utilized for passage of fluids from the urinary tract directly into a collection container. It is intended to be used in urinary collection procedures as a way to obtain a urine sample through a catheter inserted through the urethra into the bladder. The sample is obtained by this method to avoid contamination from the urethra, or if urine cannot be obtained from the patient using the clean catch method.

The Medline Catheter Specimen Collector includes a straight urethral catheter, a sheath to protect the catheter during shipping, a pre-attached collection container, and a cap. The catheter is made of polyvinyl chloride (PVC) and features a closed rounded tip with four (4) drainage eyelets. It is available in a combination of French sizes (5FR and 8FR) and lengths ranging from 6.5 to 14 inches.

### Summary of Technological Characteristics

The Medline Catheter Specimen Collector is similar in design, intended use, function and technological characteristics to the predicate device cleared under K041464. Busse Hospital Disposable Urethral Catheter.

| Device Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Catheter Specimen<br>Collector | Busse Hospital Disposable<br>Urethral Catheter | Different |
| 510(k) Reference | TBD | K041464 | Different |
| Product Owner | Medline Industries, Inc. | Busse Hoapital Disposables,<br>Inc. | Different |
| Product Code | EZD | EZD | Same |
| Intended Use | The Medline Catheter<br>Specimen Collector is a tubular<br>device that is inserted through<br>the urethra and utilized for<br>passage of fluids from the<br>urinary tract. | The Busse Hospital Disposable<br>Urethral Catheter is a tubular<br>device that is inserted through<br>the urethra and utilized for<br>passage of fluids from or to the<br>urinary tract. | Same |
| Description | The device is used in urinary<br>collection procedures as a way<br>to obtain a urine sample. The<br>urine is obtained by this method<br>to avoid contamination from<br>the urethra, or if urine cannot<br>be obtained from the patient<br>using the clean catch method. | The device is used in urinary<br>collection procedures as a way<br>to obtain a urine sample. The<br>urine is obtained by this method<br>to avoid contamination from<br>the urethra, or if urine cannot<br>be obtained from the patient<br>using the clean catch method. | Same |

### TABLE 1: Comparison of proposed and predicate device

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Image /page/5/Picture/1 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. A small gray square is visible in the upper right corner of the image.

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

| Regulation Number | 21 CFR 876.5130 | 21 CFR 876.5130 | Same |
|------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|---------|
| Design Feature -<br>Catheter Sizes | Available in 5FR and 8FR<br>designs | Available in 5FR and 8FR<br>designs | Same |
| Design Feature -<br>Drainage Eyes | Tip features 4 drainage eyes | Tip features 2 or 3drainage eyes | Similar |
| Catheter Material | Clear PVC | Clear PVC | Same |
| Packaging | Heat-sealed in soft pouch with<br>Tyvek lid | Heat-sealed in soft pouch with<br>Tyvek lid | Same |
| Performance<br>Specifications | Conforms to recognized<br>standard for urethral catheters | Conforms to recognized<br>standard for urethral catheters | Same |
| Prescription vs. OTC | Prescription | Prescription | Same |
| Contact Duration | Limited ( ≤ 24 h) | Limited ( ≤ 24 h) | Same |
| Sterile vs. Non-Sterile | Sterile | Sterile | Same |
| Disposable vs. Non-<br>Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |

# Summary of Non-Clinical Testing

Non-clinical verification of The Medline Catheter Specimen Collector 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:
- > Cytotoxicity MEM Elution per ISO 10993-5
- Sensitization Guinea Pig Maximization Test per ISO 10993-10 A
- A Irritation - Intracutaneous Reactivity per ISO 10993-10
- Functional Performance Testing: ●
- Catheter Surface Finish per BS EN 1616:1997 §4.2 A
- Catheter Dimensions per BS EN 1616:1997 §4.3 A
- Catheter Strength per BS EN 1616:1997 §Annex A A
- A Catheter Flow Rate per BS EN 1616:1997 §Annex E

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Image /page/6/Picture/1 description: The image features the Medline logo, set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The starburst is oriented vertically, with its apex pointing upwards and its base pointing downwards. A gray bar is visible on the right side of the blue square, adding a subtle design element to the composition.

edline Industries. Inc Three Lakes Drive Northfield. IL 60093

- Additional Non-Clinical Evaluations: ●
- A Bioburden Testing
- Package Seal Integrity per ASTM F1929 A
- A Stability (Shelf-Life) Testing
- Ethylene Oxide and Ethylene Chlorohydrin Residual Evaluation Studies >
- A Internal Risk Analysis

## Summary of Clinical Testing

Not applicable.

### 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 Catheter Specimen Collector is substantially equivalent to the predicate device, Busse Hospital Disposable Urethral Catheter (K041464).