(484 days)
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No
The summary describes a mechanical valve for IV connections and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a "continuous or intermittent multiple access connection port between IV devices," indicating it is an accessory for IV administration rather than a device that directly treats a medical condition.
No
Explanation: The device is described as a connection port for IV devices, which facilitates the delivery of fluids or medications, not the diagnosis of a medical condition. Its function is to provide a physical connection point for safe access to the patient's vascular system, as indicated by its "sharps injury prevention feature" and activation by "inserting a standard male luer."
No
The description clearly indicates a physical device (valve) with a sharps injury prevention feature activated by inserting a standard male luer. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for connecting IV devices for fluid administration and access. This is a therapeutic or procedural device, not a diagnostic one.
- Mechanism of Action: The device functions as a connection port activated by a luer. This is a mechanical function related to fluid delivery, not a test performed on a sample from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Continuous or intermittent multiple access connection port between IV devices such as patient access sites, catheters, syringes, or IV administrations sets. The sharps injury prevention feature of this device is the need for a needle. The device (valve) is activated by inserting a standard male luer on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.
Product codes
FPA
Device Description
The device (valve) is activated by inserting a standard male luer on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
MAY 31 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Caputo Tiva Medical, Incorporated 2157 Vista La Nisa Carlsbad, California 92009
Re: K990331 Trade Name: Surgen Valve Regulatory Class: II Product Code: FPA Dated: April 15, 2000 Received: April 17, 2000
Dear Mr. Caputo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Caputo
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely_yours,
L. Susan Funkey
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 2 - REQUIRED STATEMENTS
2.1 Statement of Indications for Use
510(k) Number (if known): K990331 Device Name: SurgeN
Indications for Use:
Continuous or intermittent multiple access connection port between IV devices such as patient access sites, catheters, syringes, or IV administrations sets.
The sharps injury prevention feature of this device is the need for a needle. The device (valve) is activated by inserting a standard male luer on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laitiere Cucerents
Division S.A.M.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic
510(k) Number K990531