(187 days)
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Not Found
No
The 510(k) summary describes a pre-filled syringe for flushing IV catheters and tubing, which is a simple mechanical device and does not mention any AI or ML components.
No.
The device is used for flushing IV catheters and tubing, not for treating a disease or condition. It explicitly states, "This device is not to be used for anticoagulant therapy."
No
The device is a pre-filled syringe containing Heparin Lock Flush Solution, intended for flushing IV catheters and tubing. Its purpose is to maintain patency of the IV line, not to diagnose a medical condition.
No
The device description explicitly states "Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml," which describes a physical medical device (a pre-filled syringe containing a solution), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "Flushing of IV catheters and IV tubing only." This is a direct interaction with the patient's vascular access system, not a test performed on a sample taken from the body.
- Device Description: The device is a pre-filled syringe containing Heparin Lock Flush Solution. This solution is administered directly into the patient's IV line.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in a sample
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis
This device is a medical device used for a therapeutic or procedural purpose (maintaining patency of IV lines), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Protect from freezing and avoid excessive heat. Store at 25°C (77° F); excursions permitted to 15° - 30°C (59°-86°F)
Prescription Use X (21 CFR Part 801 Subpart D)
Product codes
NZW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
IV catheters and IV tubing
Indicated Patient Age Range
Not Found
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
Not Found
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): 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.
Not Found
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
§ 880.5200 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The logo is simple and clean, with a focus on the symbolic representation of the department.
Public Health Service
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Lumia President Excelsior Medical Corporation 1923 Heck Avenue Neptune, New Jersey 07753
Re: K023740
Trade/Device Name: Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: May 6, 2003 Received: May 7, 2003
Dear Mr. Lumia:
This letter corrects our substantially equivalent letter of May 13, 2003.
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 (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 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. Lumia
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Luane
Susan Runner, DDS, MA Acting 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 Statement
510(k) Number: K023740
Syrex Pre-Filled Syringe Device Name:
Indication for Use:
Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Protect from freezing and avoid excessive heat. Store at 25°C (77° F); excursions permitted to 15° - 30°C (59°-86°F)
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Murphy 16
(Division Sign Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Division Sign-Off Office of Device Evaluation
510(k) K023740
510(k) Number: K023740