(15 days)
Not Found
No
The summary describes a mechanical stopcock for fluid administration and does not mention any AI or ML components or functionalities.
No.
The device is a stopcock providing needleless access and multi-directional flow for fluid administration, which is an accessory to fluid lines rather than a device designed to treat a disease or condition.
No
The device is a stopcock, providing an access port and multi-directional flow for fluid administration. Its intended use is for fluid administration, not for diagnosing medical conditions.
No
The device description explicitly states it is a "single use 4-way stopcock" made of "polycarbonate and silicone," indicating it is a physical 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 is "fluid administration to a patient's vascular system." This describes a device used in vivo (within the body) for delivering fluids directly to a patient.
- Device Description: The description of a "stopcock with a needleless injection port" further supports its use in fluid delivery to a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing blood, urine, tissue, or other biological samples.
Therefore, the Robertsite® stopcock is a medical device used for fluid administration to a patient, not for in vitro diagnostic testing of a patient's samples.
N/A
Intended Use / Indications for Use
The Robertsite® 4-way stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FMG
Device Description
The device is a single use 4-way stopcock with one Robertsite® needleless injection port. The major device materials are polycarbonate and silicone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing did not raise new types of safety or effectiveness questions. The new device was tested according to the 15 April, 2005 FDA Guidance for Intravascular Administration Sets and the ISO 8536-10:2004 - Infusion equipment for medical use -Accessories for fluid lines for use with pressure infusion equipment - international standard and in-house protocols. Test data demonstrate that the new device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Med-Net Stopcock (K955782), Robertsite® Needleless Injection Site (K002689), Robertsite® Vial Adapter (K040634)
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.
Not Found
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).
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/0 description: The image shows the logo for Halkey-Roberts, which is written in a bold, sans-serif font. Below the company name, it says "An Atrion company" in a smaller font. The logo is black and white and the text is slightly slanted.
K$\phi$6//43
11600 Dr. Martin Luther King, Jr. Street North St. Petersburg, FL 33716 USA 727-577-1300 / 800-303-4384 Fax 727-578-0450
January 31, 2006
Food and Drug Administration, Center for Devices and Radiological Health (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850.
510(k) SUMMARY
On behalf of Halkey-Roberts Corporation,
Contact: Address: Gordon Hicks, OA/RA Director 11600 Dr. Martin Luther King, Jr. St. N. St. Petersburg, FL 33716 Phone (727) 577-1300 / (800) 303-4384 Ext. 224 January 31, 2006
Date of Summary Preparation: Device Name:
Tradename: Robertsite® Stopcock Common name: IV set stopcock Classification Name: Intravascular Administration Set Accessory
Legally Marketed Substantially Equivalent Devices:
Med-Net Stopcock (K955782) Robertsite® Needleless Injection Site (K002689) Robertsite® Vial Adapter (K040634)
Description of Device:
The device is a single use 4-way stopcock with one Robertsite® needleless injection port. The major device materials are polycarbonate and silicone.
Intended Use:
The Robertsite® 4-way stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.
Technological Characteristics of device:
The new device's technological characteristics are similar to the predicate devices in materials and design. Features from the predicate devices have been combined to produce an integrated needleless connection to allow needleless IV access to a stopcock. The performance testing did not raise new types of safety or effectiveness questions. The new device was tested according to the 15 April, 2005 FDA Guidance for Intravascular Administration Sets and the ISO 8536-10:2004 - Infusion equipment for medical use -Accessories for fluid lines for use with pressure infusion equipment - international standard and in-house protocols. Test data demonstrate that the new device is substantially equivalent to the predicate devices.
MAY 10 2006
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
Halkey-Roberts Corporation C/O Mr. Jeffrey D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K061143
Trade/Device Name: Robertsite® 4-Way Stopcock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: April 21, 2006 Received: April 25, 2006
Dear Mr. Rongero:
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.
2
Page 2 - Mr. Rongero
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 (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/industry/support/index.html.
Sincerely yours,
Chiu-Ling, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| K461143 | |
|---|---|
| -- | --------- |
510(k) Number (if known): Device Name: Indications for Use:
Robertsite® 4-Way Stopcock
The Robertsite® stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.
Prescription Use
AND / OR
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antheny Di Zuz
Ancathesiology, General Hospital, on Control, Dental Devices
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