(49 days)
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.
The Veinnovations Infiltration System consists of the Infiltration Pump and proprietary, sterile, single use Veinnovations Y Infiltration Set.
The provided document is a 510(k) premarket notification determination letter for the "Veiinnovations Infiltration System." This type of document establishes substantial equivalence to a predicate device for marketing purposes and does not contain detailed study results or acceptance criteria in the manner requested for AI/ML device performance.
Therefore, I cannot provide the requested information as the document does not describe acceptance criteria or a study proving device conformance to such criteria. The document focuses on regulatory approval based on substantial equivalence, not detailed performance studies with acceptance criteria, sample sizes for test sets or training sets, ground truth establishment, or expert evaluations.
Here's why each point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only mentions that the device is "substantially equivalent" to a predicate device based on indications for use, design, materials, and operational characteristics. No specific performance metrics or acceptance criteria are listed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided. This is typical for a 510(k) summary focused on substantial equivalence rather than a clinical trial report.
- 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, as no test set or ground truth establishment by experts is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is described.
- 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. The device is an "infiltration pump system," a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, MRMC studies or AI assistance are irrelevant to this product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical pump system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is discussed for this type of device.
- The sample size for the training set: Not applicable, as no AI/ML model or training set is involved.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval letter for a medical device (an infiltration pump) based on substantial equivalence, not a scientific publication detailing performance studies for an AI/ML product.
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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.
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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
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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
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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.
§ 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).