NEOMED SINGLE LUMEN UMBILICAL CATHETER

K073596 · Neomed, Inc. · FOS · Feb 22, 2008 · General Hospital

Device Facts

• Record ID: K073596
• Device Name: NEOMED SINGLE LUMEN UMBILICAL CATHETER
• Applicant: Neomed, Inc.
• Product Code: FOS · General Hospital
• Decision Date: Feb 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NeoMed Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

Silicone single lumen umbilical catheter; includes hub, luer lock connector, and 3-way stopcock with 2 female connectors. Contains barium sulfate for radiopacity. Used in clinical settings for neonatal and pediatric patients. Enables blood sampling, blood pressure monitoring, and intravenous fluid administration. Operated by healthcare professionals. Bench testing confirms functional equivalence to predicate devices.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Functional testing demonstrated performance equivalent to the predicate device.

Technological Characteristics

Silicone single lumen catheter; includes barium sulfate for radiopacity. Components include hub, luer lock connector, and 3-way stopcock. Biocompatible per ISO 10993.

Indications for Use

Indicated for neonatal and pediatric patients requiring blood sampling, blood pressure monitoring, or intravenous fluid administration.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• CATCO Umbilical Vessel Catheter (K944368)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/2 description: The image shows the word "NEOMED" in a stylized font. Below the word "NEOMED" is the word "incorporated" in a cursive font. The letters of "NEOMED" are spaced apart, and the "O" in "NEOMED" has a design inside of it. The image appears to be a logo or brand name.

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>FDA Owner/Operator #10022926<br>507 Hickory Ridge Trail<br>Suite 120<br>Woodstock, GA 30188<br>Tony Lair, President<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Penny Northcutt, RAC, CQA<br>Regulatory Consultant for NeoMed, Inc.<br>REGSolutions, LLC<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME: | NeoMed Single Lumen Umbilical Catheter |
| CLASSIFICATION<br>NAME: | Umbilical Artery Catheter |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT<br>CODE | Class II per 21 CFR §880.5200<br>Product Code: 80 FOS |
| PREDICATE<br>Device Name | CATCO Umbilical Vessel Catheter (K944368) |

#### SUBSTANTIAL EQUIVALENCE:

The NeoMed Single Lumen Umbilical Catheter is substantially equivalent to the CATCO Umbilical Vessel Catheter cleared under K944368.

Both devices have the same method of operation to sample blood, monitor blood pressure, or administer fluids intravenously. Bench testing has demonstrated that the NeoMed Single Lumen Umbilical Catheter is functionally equivalent to predicate umbilical 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 Single Lumen Umbilical Catheter is a silicone single lumen catheter with natural white barium sulfate included for radiopacity.

The device consists of the following main components: a single lumen umbilical catheter, a hub, and a luer lock connector, and 3 way stopcock with 2 female type connectors.

#### INDICATIONS FOR USE:

The NeoMed Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to patients to sample blood, monitor blood pressure, or administer fluids intravenously.

#### PERFORMANCE DATA:

The NeoMed Single Lumen Umbilical Catheter materials that come in direct contact with the patient have a long history of use in umbilical catheter manufacture and are biocompatible according to ISO 10993. Functional test results demonstrate that the NeoMed Single Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device.

#### CONCLUSION:

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

NeoMed Single Lumen Umbilical Catheter

Confidential

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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 stylized eagle with its wings spread, and three horizontal lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NeoMed, Incorporated C/O Ms. Penny Northcutt Executive Director REGSolutions, LLC 717 Lakeglen Drive Suwanee, Georgia 30024

Re: K073596

Trade/Device Name: NeoMed Single Lumen Umbilical Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOS Dated: December 19, 2007 Received: December 21, 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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Page 2 - Ms. Northcutt

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 vour 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chih-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K073596

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510(k) Number (if known): K073596

Device Name: Neo med Single Lumen Umbilical Catheter

Indications For Use:

The Neo Med Single Lumen Umbilical Catheter
is intended for use in neonatal and pediatric

patients to sample blood , monitor blood parties of administer Fluids intravenously

Prescription Use
X
(Part 21 CFR 801 Subpart D)

**AND/OR**

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

LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EEDED

Concurrence of CDRH, Office of Device Evaluation (OD

Charles B. for Aho

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K073596