(114 days)
Not Found
No
The device is a simple saline flush syringe with a change in packaging for sterile field use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a flush syringe intended for clearing intravenous lines, not for treating a disease or condition.
No
Explanation: The device is described as a "0.9% Sodium Chloride Flush Syringe" intended for flushing intravenous lines. Its function is to clear or maintain patency of IV administration sets and indwelling intravenous access devices, not to diagnose a condition or disease.
No
The device is a physical syringe filled with a solution, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "flushing compatible intravenous administration sets and indwelling intravenous access devices." This is a direct therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical components (syringe, sodium chloride solution) and sterility, which are typical for medical devices used for administration or flushing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Focus on Flushing: The core function described is flushing, which is a mechanical action to clear lines or devices.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device".
Product codes
NGT
Device Description
The Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The predicate syringe is fluid path sterile with a Sterility Assurance Level (SAL) of 10-6. This is a single use device packaged in a dust cover.
The Modified Device, the subject of this 510(k), consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The modified device has a sterile outer wrap that maintains the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterility of the package is not open and aseptic techniques are used. The Sterility Assurance Level (SAL) is 10-6. This is a single use device.
Technical Data: The technical characteristics of the syringe for the modified device do not differ from those of the currently marketed predicate device. These syringes have the same design, the same volume, materials, and have the same intended use. The proposed modification involves a change in packaging to a sterile barrier for use in a sterile field. All other aspects of the syringe design remain the same.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial Equivalence: Non-clinical verification testing for the proposed change involved chemical-physical, functional, and package validation studies. The result of testing conducted verifies that the change in sterile packaging of the modified device performed in an equivalent manner to the predicate product as used as intended. Other special 510(k)s submitted with similar changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
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510(k) Summary
510(k) Summary of Safety and Effectiveness
As required by 809.92(a)(2).
special 510 (k) Premarket notification number: KL20 836
JUL 12 2012
Submitter and Owner of the 510(k)
AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-831-1817
Official Correspondent
Karen Thomison Director of Quality Assurance AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-831-1817
Date of Preparation 3/13/12
510(k) Application Number
Trade/Proprietary Name
0.9% Sodium Chloride Flush Syringe
Common Name/Usual Name
Saline Flush Syringe
Device Classification Name Device, Flush, Vascular Access
Regulation Number 880.5200
Device Class Class II Device
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510(k) Summary
Classification Panel
General Hospital
Classification Product Code
NGT
INDICATIONS FOR USE
INDIOATHONO FOR OOE intended use. 0.3% Odding Online Plaalling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
DEVICE DESCRIPTION:
The Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic rre Predicate Device, o ro(ty Namber. It Frob Solution that is terminally sterilized. The predicate synige is fluid path sterile with a Sterlity Assurance Level (SAL) of 10°. This is a single use device packaged in a dust cover.
The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.99% The Modified Device, the Subject of this of (1)) otterilized. The modified device has a sterile outlum Onlon of the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterily of the package is not open and aseptic techniques modified device out bo acounte Level (SAL) is 10 - This is a single use device.
Technical Data: The technical characteristics of the syringe for the modified device do not r ecoffnour Duta. The confined characted device. These syringes have the same design, the differ from those of the ouriently manietics, and have the same intended use. The proposed Same innualhemal selemans, and hostitution the dust cover with a stelle barrier modification involves a change in pastialistics for use in a sterile field. All other aspects of the syringe design remain the same.
Substantial Equivalence: Non-clinical verification testing for the proposed change involved Shemical-physical, functional, and package validation studies. The result of testing conducted verifies that the change in sterile packaging of the modified device performed in an equivalent venties that the change in Steme packaging of the used as intended. Other manner to the products as not special 510(k)s submitted with similar changes.
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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 consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Karen Thomison Director of Quality and Regulatory Affairs AMUSA 5209 Linbar Drive, Suite 640 Nashville, Tennessee 37211
JUL 12 2012
Re: K120836
Trade/Device Name: 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: June 11, 2012 Received: June 13, 2012
Dear Ms. Thomison:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
FR Bisley
Turkett MD
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
Indications for Use Statement
510(k) Number (if known):
Device Name: 0.9% Sodium Chloride Flush Syringe
Indications for Use:
"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device".
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rohit Gangulin
(Division Sign-Off) 7/12/12
Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K120836
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