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

Device Description

The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.

AI/ML Overview

This document describes the NeoMed Dual Lumen Umbilical Catheter and its substantial equivalence to a predicate device. It does not contain information about an AI device, therefore, the requested information about acceptance criteria, study details, ground truth establishment, or sample sizes related to AI performance cannot be provided.

The document focuses on the regulatory clearance of a medical device based on its similarity to an existing device (predicate device). The "performance data" mentioned refers to design verification tests demonstrating that the new catheter performs its intended use and is equivalent to the predicate device, not performance against specific acceptance criteria for an AI algorithm.

To explicitly address the numbered points:

A table of acceptance criteria and the reported device performance
- Not applicable as this document is not about an AI device or a study with specific performance metrics against acceptance criteria. The document states, "Bench testing has demonstrated that the NeoMed Dual Lumen Umbilical Catheter is functionally equivalent to predicate NeoMed Single Lumen Umbilical Catheter and that any minor differences do not affect safety or effectiveness." and "Design verification performance test results demonstrate that the NeoMed Dual Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document refers to "bench testing" and "design verification performance test results," which implies laboratory testing of the physical device rather than a study using a test set of data. No information on sample size or data provenance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of experts establishing ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of a test set or adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth for an AI algorithm is not relevant to this submission. The "ground truth" equivalent for this device would be its functional performance in laboratory tests, confirming it meets design specifications and operates as intended, similar to the predicate.
The sample size for the training set
- Not applicable. This is not an AI device, so there is no training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI device, so there is no training set or ground truth establishment relevant to AI.

Summary

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SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/2 description: The image shows the logo for NeoMed Incorporated. The logo features the word "NeoMed" in a simple, sans-serif font, with the "O" in "Neo" replaced by a circle with a small, cartoonish face inside and a swirl above it. Below the word "NeoMed" is the word "incorporated" in a smaller, cursive font.

'JUL 2 1 2008

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	NeoMedFDA Owner/Operator #10022926507 Hickory Ridge TrailSuite 120Woodstock, GA 30188Tony Lair, PresidentTel: 770-516-2225Fax: 770-516-2448Email: lair1@concentric.net
OFFICIALCORRESPONDENT	Penny Northcutt, RAC, CQARegulatory Consultant for NeoMed, Inc.REGSolutions, LLCTel: 678-428-6978Fax: 678-513-0937Email: pennynorthcutt@theregsolutions.com
TRADE NAME:	NeoMed Dual Lumen Umbilical Catheter
CLASSIFICATIONNAME:	Umbilical Artery Catheter
DEVICECLASSIFICATION	Class II per 21 CFR §880.5200
AND PRODUCTCODE	Product Code: 80 FOS
PREDICATEDEVICE NAME	NeoMed Single Lumen Umbilical Catheter (K073596)

SUBSTANTIAL EQUIVALENCE:

The NeoMed Dual Lumen Umbilical Catheter is substantially equivalent to the NeoMed Single Lumen Umbilical Catheter cleared under K073596.

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 Dual Lumen Umbilical Catheter is functionally equivalent to predicate NeoMed Single Lumen Umbilical Catheter and that any minor differences do not affect safety or effectiveness.

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DESCRIPTION OF THE DEVICE:

The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity.

The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.

INDICATIONS FOR USE:

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

PERFORMANCE DATA:

The NeoMed Dual 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. Design verification performance test results demonstrate that the NeoMed Dual 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 Dual Lumen Umbilical Catheter is equivalent to the predicate NeoMed Single Lumen Umbilical Catheter with respect to intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NeoMed, Incorporated C/O Ms. Penny Northcutt Regulatory Consultant REGSolutions, LLC 717 LakeGlen Drive Suwance, Georgia 30024

JUL 2 1 2008

Re: K081515

Trade Device Name: NeoMed Dual Lumen Umbilical Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOS Dated: June 26, 2008 Received: June 30, 2008

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 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known): K081515

Device Name: NeoMed Dual Lumen Umbilical Catheter

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

H.Q.Q. for Au Lin

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

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510(k) Number: K081515

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).