(30 days)
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No
The description focuses on a mechanical, gravity-driven flow regulator and does not mention any computational or learning capabilities.
No
Explanation: The device is described as a "flow regulator" for I.V. solutions, controlling the rate of fluid delivery. While it is used with medical treatments, its function is solely to manage the flow of the solution, not to directly treat a disease or condition itself. Thus, it is an accessory to therapy rather than a therapeutic device.
No
Explanation: The device is described as a gravity-driven flow regulator for controlling the flow rate of IV solutions into the human body. Its purpose is to administer fluids, not to diagnose a condition or disease.
No
The device description explicitly states that GraviTech™ is a "single use, disposable gravity-driven flow regulator," which is a physical hardware component used in conjunction with other physical hardware components (I.V. administration sets and extension sets). There is no mention of software as the primary or sole component of the device.
Based on the provided information, the GraviTech™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- GraviTech™ Function: The description clearly states that GraviTech™ is a flow regulator used to control the rate of I.V. solutions being infused into the human body. This is a direct interaction with the patient's circulatory system, not an analysis of a specimen taken from the body.
Therefore, GraviTech™ falls under the category of a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.
GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.
GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.
Note: The use of any Needleless connector may aid in the prevention of needle stick injuries.
Product codes
FPA
Device Description
GraviTech™ is a single use, disposable gravity-driven flow regulator
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Public Health Service
MAR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael G. Simon President IV Medical, Incorporated 7854 Sitio Coco Carlsbad, California 92009
Re: K030467
Trade/Device Name: GraviTech™ Flow Controller Primary Set/ GraviTech™ Flow Controller Extension Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 27, 2003 Received: February 12, 2003
Dear Mr. Simon:
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 - Mr. Simon
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 Office of Compliance at (301) 594-4618. 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.
Susan Raono
Susan Runner, DDS, MA Interim 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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IV MEDICAL INC. 510(k) NOTIFICATION
INDICATIONS FOR USE:
Device Name:
GraviTech™ Flow Controller Primary Set GraviTech™ Flow Controller Extension Set
Indications For Use:
GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.
GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.
GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.
Note: The use of any Needleless connector may aid in the prevention of needle stick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Per 21 CFR Section §801.109
Patricia Cussonitz
. General Hosnital
510(k) Number: K030467