(52 days)
No
The summary describes a physical catheter and its components, with no mention of software, algorithms, or AI/ML terms. Performance studies focus on equivalence to a predicate device, not algorithmic performance.
No
The device is used for sampling blood, monitoring blood pressure, or administering fluids intravenously, which are diagnostic or supportive functions, not therapeutic.
No
The device is described as a catheter used for sampling blood, monitoring blood pressure, or administering fluids. These are primarily monitoring and interventional functions, not diagnostic ones that provide information about the presence, absence, or nature of a disease or condition. While monitoring blood pressure can aid diagnosis, the device itself is a tool for measurement and administration, not a diagnostic system.
No
The device description clearly outlines physical components like a silicone catheter, hub, extension legs, stopcock, and injection site, indicating it is a hardware device.
Based on the provided information, the NeoMed Dual Lumen Umbilical Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "sampling blood, monitor blood pressure, or administer fluids intravenously." These are all procedures performed in vivo (within the living body) on the patient.
- Device Description: The description details a catheter designed for insertion into the umbilical vein or artery. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, etc., which are not described here.
Therefore, the NeoMed Dual Lumen Umbilical Catheter is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
80 FOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
NeoMed Single Lumen Umbilical Catheter (K073596)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 | NeoMed
FDA Owner/Operator #10022926
507 Hickory Ridge Trail
Suite 120
Woodstock, GA 30188
Tony Lair, President
Tel: 770-516-2225
Fax: 770-516-2448
Email: lair1@concentric.net |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Penny Northcutt, RAC, CQA
Regulatory Consultant for NeoMed, Inc.
REGSolutions, LLC
Tel: 678-428-6978
Fax: 678-513-0937
Email: pennynorthcutt@theregsolutions.com |
| TRADE NAME: | NeoMed Dual Lumen Umbilical Catheter |
| CLASSIFICATION
NAME: | Umbilical Artery Catheter |
| DEVICE
CLASSIFICATION | Class II per 21 CFR §880.5200 |
| AND PRODUCT
CODE | Product Code: 80 FOS |
| PREDICATE
DEVICE 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.
1
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.
2
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.
3
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
4
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
Page 1 of 1
510(k) Number: K081515