(45 days)
Not Found
No
The device description and intended use are for simple mechanical fluid control devices (stopcocks and manifolds) and there is no mention of AI, ML, or any computational processing.
No
Explanation: The device, Elcam Stopcocks and Manifolds, is described as controlling fluid flow and providing access ports. Its intended use is for fluid administration and pressure monitoring, which are supportive functions rather than direct therapeutic interventions.
No
The "Intended Use" section describes the device for "fluid flow directional control and for providing access port(s) for administration of solutions." Typical uses include "pressure monitoring, intravenous fluid administration and transfusion." These functions are related to therapeutic and operational aspects of patient care, not diagnostic.
No
The device description clearly outlines physical components (body, ports, handle, connectors, lubricant) and mentions standard testing related to function and stress-testing, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fluid flow directional control and for providing access port(s) for administration of solutions." This describes a device used for managing fluids within the body or for administering substances, not for testing samples taken from the body to diagnose conditions.
- Device Description: The description details the physical components of a stopcock/manifold used for fluid management, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, 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's function is purely related to fluid handling.
N/A
Intended Use / Indications for Use
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Product codes
FMG
Device Description
Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.
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
Standard testing relating to function and stress-testing has been conducted on Elcam Stopcocks and Manifolds, including testing related to product label claims and testing comparing performance with existing products or materials.
A biocompatibility assessment was performed on the patient-contact and fluid-path materials of Elcam Stopcocks and Manifolds with satisfactory results.
Key Metrics
Not Found
Predicate Device(s)
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
OCT 1 8 2002
510(k) Summary for Elcam Stopcocks and Manifolds
1. SPONSOR
Elcam Plastic Kibbutz BarAm Merom Hagalil 13860 Israel
Contact Person: Shachar Regev
2. Device Name
Proprietary Name: Elcam Stopcocks and Manifolds Stopcocks and Manifolds Common/Usual Name: Classification Information:
Stopcocks have been classified as Class II devices under the following classification name:
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Intravenous Stopcock Set | FMG | 880.5440 | General Hospital |
3. PREDICATE DEVICES
Elcam Stopcocks and Manifolds are substantially equivalent to Elcam/RAM Development stopcocks, 510(k) No. K862691.
DEVICE DESCRIPTION 4.
Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.
1
5. INTENDED USE
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Elcam Stopcocks and Manifolds and Elcam/RAM Development stopcocks have the same indications for use. They have the same basic shape and both use luer fittings. Elcam Stopcocks and Manifolds have additional materials, are available sterile and have a wider range of inner diameters.
PERFORMANCE TESTING 7.
Standard testing relating to function and stress-testing has been conducted on Elcam Stopcocks and Manifolds, including testing related to product label claims and testing comparing performance with existing products or materials.
A biocompatibility assessment was performed on the patient-contact and fluid-path materials of Elcam Stopcocks and Manifolds with satisfactory results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel J. Dillon Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K022895
Trade/Device Name: Elcam Stopcocks and Manifolds Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: August 30, 2002 Received: September 3, 2002
Dear Mr. Dillon:
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.
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.
3
Page 2 - Mr. Dillon
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy . Ulatowski 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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510(k) Number (if known):
Device Name: Elcam Stopcocks and Manifolds Dorios Plants: 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Valeria A. (en) RAC
(Division Sign (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 0223617
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)