(49 days)
No
The summary describes a manually controlled infiltration pump system and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an "infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient," which is a delivery mechanism, not a device that directly treats a disease or condition. While the fluids delivered may be therapeutic, the pump itself is not.
No
The device is described as an "infiltration pump system" used to "cause a flow of fluid from an IV bag into a patient." This functionality relates to treatment or administration of fluids, not to diagnosing a condition or disease.
No
The device description explicitly states it consists of an "Infiltration Pump" and a "Y Infiltration Set," which are hardware components.
Based on the provided information, the Veinnovations Infiltration System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to "cause a flow of fluid from an IV bag into a patient". This describes a device used for administering fluids directly to a patient's body, which is an in-vivo (within the living organism) application.
- Device Description: The description of an "infiltration pump system" and "Y Infiltration Set" further supports its use in delivering fluids into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (in glass, or outside the body). The Veinnovations Infiltration System's function is to deliver fluids into the body.
N/A
Intended Use / Indications for Use
The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.
Product codes
FRN, KGZ
Device Description
The Veinnovations Infiltration System consists of the Infiltration Pump and proprietary, sterile, single use Veinnovations Y Infiltration Set.
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
Not Found
Intended User / Care Setting
health care professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its wings and body. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2005
Veinnovations, LLC C/O Ms. Rosina Robinson, RN, MEd, RAC Senior Staff Consultant, Regulatory Services Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K050474
Trade/Device Name: Veinnovations, LLC, Veinnovations Infiltration System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, KGZ Dated: February 22,2005 Received: February 24,2005
Dear Ms. Robinson:
This letter corrects our substantially equivalent letter of April 14,2005 regarding the mailing address.
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 (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 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.
1
Page-2 Ms. Robinson
Please be advised that FDA's issuance of a substantial equivalence determinationdoes 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 continue 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 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/dsma/dsmamain.html
Sincerely yours,
Senlite Michael Oms
PK. Lin, Ph.D.
Dhierlein, Ph.D.
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Veinnovations, LLC, Veinnovations Infiltration System Device Name: ____
Indications For Use:
The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.
Prescription Use _X (21 CFR 801 Subpart D) OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Artur V.m.
(Civision Sign-Off) ි
510(k) Number:_ Kys 4474
Page viii
3
APR 1 4 2005
510(k) Summary Veinnovations, LLC · Veinnovations Infiltration System
1. SPONSOR
Veinnovations, LLC 2210 Dean Street N1 St. Charles, IL 60175 Contact Person: Fred McKinney 630-416-0258 Telephone:
Date Prepared: February 22, 2005
Device Name 2.
| Proprietary Name: | Veinnovations Infiltration System |
|---|---|
| Common/Usual Name: | Infiltration pump and disposables |
| Classification Name: | Infusion pump and accessories |
PREDICATE DEVICE 3.
HK Surgical, Inc., Klein Surgical Infiltration Pump, Model KIP II - K031432.
DEVICE DESCRIPTION 4.
The Veinnovations Infiltration System consists of the Infiltration Pump and proprietary, sterile, single use Veinnovations Y Infiltration Set.
INTENDED USE 5.
The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Veinnovations Infiltration System is substantially equivalent to the cited predicate device based on its indications for use, design, materials, and operational characteristics. Veinnovations LLC believes that differences between devices are minor and raise no new issues of safety or effectiveness.