(35 days)
No
The description details a mechanical syringe and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a syringe for fluid aspiration/injection and handling of fluids and medications, not for treating a disease or condition.
No
The device description and intended use indicate it is for fluid aspiration/injection, reconstituting, dispensing, transferring, administering, and disposal of fluids, focusing on safe handling, rather than diagnosing a condition.
No
The device description clearly states it is a "single use piston syringe" and describes physical components like a "syringe" and a "closed male luer device," indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device for fluid aspiration/injection, reconstituting, dispensing/transferring, administering, and disposal of fluids, including potentially hazardous ones. This is a direct interaction with fluids for patient care or handling, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a syringe and a closed male luer device designed for safe fluid handling and administration. It focuses on preventing leakage during drug handling and administration to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is purely related to the physical handling and administration of fluids.
Therefore, the Texium™ Syringe is a medical device used for fluid management and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Texium™ Syringe is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the administration of the drug to the patient, and waste handling. The Texium™ Syringe is intended to reduce environmental surface contamination of the work area.
The Texium™ Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Texium™ Syringe is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
Product codes
FMF
Device Description
The Texium™ Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL or 60mL) permanently bonded to a closed male luer device (Texium™ Closed Male Luer, K053049). The Texium™ Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Texium™ Syringe is a passive device - it requires no cap and automatically seals upon disconnection.
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
healthcare professionals
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 data indicate that the Texium™ Syringe meets specified requirements and is substantially equivalent to the predicate devices.
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
Cardinal Health, Alaris® Products®
Ko71108
TEXIUM™ SYRINGE
MAY 2 4 2007
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7830 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Stacy L. Lewis |
| Principal Regulatory Affairs Specialist | ||
| Cardinal Health, Alaris® Products | ||
| E. | Date Summary Prepared: | April 18, 2007 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Intravascular Administration Set |
|---|---|---|
| B. | Trade/Proprietary Name: | TexiumTM Syringe |
| C. | Classification: | Class II |
| D. | Product Code: | FMF, Piston Syringe |
DEVICE DESCRIPTION
The Texium™ Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL or 60mL) permanently bonded to a closed male luer device (Texium™ Closed Male Luer, K053049). The Texium™ Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Texium™ Syringe is a passive device - it requires no cap and automatically seals upon disconnection.
1
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products TEXIUM™ SYRINGE Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Texium™ Syringe is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Texium™ Closed Male Luer | |||
| (originally submitted as the | |||
| Alaris® Safety Male Luer | Cardinal Health, Alaris® | ||
| Products | K053049 | 1/12/06 | |
| Becton Dickinson Syringe | Becton Dickinson & Company | K954064 | 11/21/95 |
INTENDED USE
The Texium™ Syringe is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the administration of the drug to the patient, and waste handling. The Texium™ Syringe is intended to reduce environmental surface contamination of the work area.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Texium™ Syringe and the predicate devices has been performed. The results of this comparison demonstrate that the Texium™ Syringe is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Texium™ Syringe meets specified requirements and is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Ms. Stacy L. Lewis Principal Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateride Circle San Diego, California 92121
Re: K071108
Trade/Device Name: Texium™ Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 18, 2007 Received: April 19, 2007
Dear Ms. Lewis:
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.
I I I
3
Page 2 - Ms. Lewis
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 (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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
4
INDICATIONS FOR USE
510(k) Number:
07-1108
(To Be Assigned By FDA)
Device Trade Name:
Texium™ Syringe
Indications for Use:
The Texium™ Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Texium™ Syringe is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton v. m
Anesthesiology, General Hospital, Control, Dental Devices
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