(29 days)
Not Found
Not Found
No
The summary describes a device for applying a fibrin sealant and contains no mention of AI, ML, image processing, or any related concepts.
No
The device is intended for the application of a fibrin sealant, which is a therapeutic product, but the device itself is an application device, not a therapeutic device. It delivers a therapeutic agent, but does not perform a therapeutic function on its own.
No
The device is described as an "Application Device" intended for "simultaneous topical application" of components, which indicates a therapeutic or procedural function, not a diagnostic one.
No
The intended use describes a device for the "simultaneous topical application of the two biological components of EVICEL™ fibrin sealant via dripping or spraying," which clearly indicates a hardware device for delivering a substance, not a software-only device.
Based on the provided information, the EVICEL™ Application Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "simultaneous topical application of the two biological components of EVICEL™ fibrin sealant... onto the surface." This describes a device used on the body (topical application) to deliver a therapeutic substance (fibrin sealant).
- Definition of IVD: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The EVICEL™ Application Device is used in vivo (on the body) for the application of a therapeutic product, not for testing specimens in vitro.
N/A
Intended Use / Indications for Use
The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL™ fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.
Product codes
FMF
Device Description
Not Found
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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 curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sara Horn Vice President, Clinical and Regulatory Affairs Omrix Biopharmaceuticals Limited MDA Blood Bank, Sheba Hospital, Tel Hashomer Ramat Gan ISRAEL 52621
K090162 Re:
Trade/Device Name: EVICEL™ Application Device · Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 18, 2009 Received: January 22, 2009
Dear Ms. Horn:
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 centrols 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.
FEB 2 0 2009
1
Page 2 - Ms. Horn
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). veremarket 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.
Sincerety vours
Anthony D. watson pa
Ginette Y. Michaud, M.D.
Acting Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known)
EVICELTM Application Device Device Name
The EVICELTM Application Device is intended for the simultaneous topical Indications application of the two biological components of EVICEL™ fibrin sealant via for Use dripping (no air Pressure) or via spraying (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801. 109)
OR
Over-The-Counter Use
Susan Jones
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: