NEOMED URINARY CATHETER

K072997 · Neomed, Inc. · EZD · Dec 19, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072997
• Device Name: NEOMED URINARY CATHETER
• Applicant: Neomed, Inc.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.

Device Story

NeoMed Urinary Catheter is a single-lumen silicone catheter designed for neonatal and pediatric urine sampling and temporary drainage. Device components include catheter, hub, and luer lock connector; available with orange or white radiopaque stripe (barium sulfate). Operated by clinicians in clinical settings for temporary patient contact. Functions via passive drainage through single lumen. Provides clinicians with urine access for sampling or drainage management. Benefits include safe, temporary urinary access for pediatric populations.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility of materials established via history of use in similar catheters. Functional testing demonstrated performance equivalent to the predicate device.

Technological Characteristics

Silicone single-lumen catheter with hub and luer lock connector. Includes barium sulfate for radiopacity (orange or white stripe). Non-balloon type. Biocompatible materials. Manual operation; no energy source or software.

Indications for Use

Indicated for neonatal and pediatric patients requiring urine sampling or temporary urinary drainage. Not for use as a Foley (balloon) catheter. Intended for temporary use (<30 days).

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

• CATCO Urological Catheter (K944782)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "NEOMED incorporated". The text is written in a stylized font, with the letters appearing to be slightly faded or distressed. The word "NEOMED" is written in larger letters than the word "incorporated", which is placed below it. The overall impression is that of a logo or brand name.

K072997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | NeoMed<br>507 Hickory Ridge Trail<br>Suite 120<br>Woodstock, GA 30188<br>Tony Lair, President<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | DEC 1 9 2007 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| OFFICIAL<br>CORRESPONDENT | Penny Northcutt, RAC, CQA<br>Regulatory Consultant for NeoMed, Inc.<br>REGSolutions, LLC<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| TRADE NAME: | NeoMed Urinary Catheter | |
| CLASSIFICATION<br>NAME: | Urethral Catheter, Urological catheter and accessories | |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT<br>CODE | Class II per 21 CFR §876.5130<br>Product Code: 78 GBM | |
| PREDICATE<br>DEVICE NAME | CATCO Urological Catheter (K944782) | |

#### SUBSTANTIAL EQUIVALENCE:

The NeoMed Urinary Catheter is substantially equivalent to the CATCO Urological Catheter cleared under K944782.

Both devices have the same method of operation, drainage of urine through a single lumen catheter. Bench testing has demonstrated that the NeoMed Urinary Catheter is functionally equivalent to predicate urinary catheters currently on the market and that any minor differences do not affect safety or effectiveness.

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## DESCRIPTION OF THE DEVICE:

The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine.

The device consists of the following main components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter).

# INDICATIONS FOR USE:

This product is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.

## PERFORMANCE DATA:

The NeoMed Urinary Catheter materials that come in direct contact with the patient have a long history of use in catheter and urethral catheter manufacture and are biocompatible. Functional test results demonstrate that the NeoMed Urinary Catheter performs its intended use of urine drainage and is equivalent to the predicate device.

#### CONCLUSION:

Based on the performance testing, it can be concluded that the NeoMed Urinary Catheter is equivalent to the predicate CATCO Urological Catheter with respect to intended use and technological characteristics.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three arms or wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# C 1 9 2007

NeoMed. Inc. % Ms. Penny Northcutt Executive Director REGSolutions. LLC 717 Lakeglen Drive SUWANEE GA 30024

Re: K072997

Trade/Device Name: NeoMed Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and GBM Dated: October 22, 2007 Received: October 24, 2007

#### Dear Ms. Northcutt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Confidential

510(k) Number (if known):

Device Name: NEOMED URINARY CATHETER

Indications for Use:

The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------|--------------------------------------------------------|-------------------------|
| | (Division Sign-Off) | |
| | Division of Reproductive, Abdominal and | |
| | Radiological Devices | |
| 510(k) Number | K672997 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | |
| Traditional 510(k) | | NeoMed Urinary Catheter |
| NeoMed, Inc. | | Confidential |

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