(63 days)
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
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.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | 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 Equivalence | Functional test results demonstrate that the NeoMed Single Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device. |
| Safety and Effectiveness | 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. |
| Substantial Equivalence | The NeoMed Single Lumen Umbilical Catheter is substantially equivalent to the CATCO Umbilical Vessel Catheter cleared under K944368. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This submission relies on "bench testing" and a comparison to a predicate device, rather than a clinical study with a distinct test dataset. The data provenance is also not explicitly stated as the evaluation is based on bench testing of the new device and comparison to an established predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided. The evaluation is based on bench testing of the device itself and comparison to a predicate, not on human interpretation or "ground truth" derived from expert consensus on a test set of data.
4. Adjudication Method for the Test Set
This information is not applicable or provided. As there's no defined "test set" requiring expert evaluation, no adjudication method would have been used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on bench testing and material biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance data" described refers to standalone testing of the device itself through "bench testing." This is a medical device, not an AI algorithm, so the concept of an "algorithm only" study doesn't directly apply here. However, the evaluation of the device's functional integrity is conducted independently.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device is established primarily through engineering specifications, material science standards (ISO 10993 for biocompatibility), and functional performance metrics demonstrated through bench testing. The "truth" is whether the physical device meets these established performance and safety requirements. The predicate device's established performance serves as a comparative "ground truth" for equivalence.
8. The Sample Size for the Training Set
This information is not applicable or provided. This is not an AI/machine learning device that involves training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment in that context.
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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 | 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 Single Lumen Umbilical Catheter |
| CLASSIFICATIONNAME: | Umbilical Artery Catheter |
| DEVICECLASSIFICATIONAND PRODUCTCODE | Class II per 21 CFR §880.5200Product Code: 80 FOS |
| PREDICATEDevice 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
1 of 1
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
Page 1 of
510(k) Number: K073596
§ 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).