(76 days)
Needleless Transfer Device
Not Found
No
The device description focuses on mechanical components and fluid transfer, with no mention of AI or ML technologies.
No
The device is described as a system to transfer and mix drugs for administration, and to deliver reconstituted drug through a catheter. Its primary function is drug preparation and delivery assistance, not to directly treat or diagnose a disease or condition. It is an accessory to drug administration.
No
The device is described as a closed reconstitution and instillation system used to transfer and mix drugs for administration to a patient. Its function is to prepare and deliver medication, not to diagnose a medical condition or disease.
No
The device description clearly outlines a physical system with components like a syringe socket, drug container socket, stopcock, and syringe plunger rod, indicating it is 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 is to "transfer and mix drugs contained in two containers into a syringe for administration to the patient." This describes a device used for preparing and delivering medication to a patient, not for testing samples from a patient to diagnose or monitor a condition.
- Device Description: The description details a system for reconstituting and delivering drugs through a catheter. It focuses on preventing leakage and environmental exposure during drug preparation and administration. This aligns with a drug delivery system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In vitro diagnostic devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the preparation and delivery of a therapeutic substance to the patient.
N/A
Intended Use / Indications for Use
To transfer and mix drugs contained in two containers into a syringe for administration to the patient.
Product codes
LHI
Device Description
CIStem™ is a closed reconstitution and instillation system used to deliver reconstituted drug through a catheter. This closed system is designed to prevent leakage and prevent exposure of drug to the environment, and is easy to use. The syringe is inserted into the syringe socket of the device and the drug container is inserted into the other socket. A stopcock is used to direct and control the flow between the syringe, drug container and catheter. The syringe plunger rod is pushed to deliver liquid into the drug container. Next the plunger rod is pulled back and forth until all of the drug is mixed. Then the reconstituted drug in the syringe is delivered through the catheter.
There are two variations of CIStem™. These variations provide flexibility for the type of drug container. They both have the same intended use and similar safety features.
The materials that make up the fluid contact path in CIStem™ have passed ISO 10993-1 biocompatibility testing.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Needleless Transfer Device
Reference Device(s)
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
510(k) Summary 5
JAN 0 7 2002
Submitted by:
Shire Biologics Inc. 30 Bearfoot Road Northborough, MA 01532
Contact Person:
David Mantus, Ph.D. Director, Regulatory Affairs
Date of Preparation:
October 12, 2001
Name and Address of Owner 1
Shire Biologics Inc. 30 Bearfoot Road Northborough, MA 01532
2 Product Name
Trade Name: CIStem™
Common Name: Fluid Transfer Device
3 Claim of Substantial Equivalence
CIStem™ is substantially equivalent to the Needleless Transfer Device. Both the CIStem™ and the Needleless Transfer Device connect containers with drug and diluent to transfer and mix the two products so they can be drawn into a syringe and administered to the patient.
4 Device Description
CIStem™ is a closed reconstitution and instillation system used to deliver reconstituted drug through a catheter. This closed system is designed to prevent leakage and prevent exposure of drug to the environment, and is easy to use. The syringe is inserted into the
1
syringe socket of the device and the drug container is inserted into the other socket. A stopcock is used to direct and control the flow between the syringe, drug container and catheter. The syringe plunger rod is pushed to deliver liquid into the drug container. Next the plunger rod is pulled back and forth until all of the drug is mixed. Then the reconstituted drug in the syringe is delivered through the catheter.
There are two variations of CIStem™. These variations provide flexibility for the type of drug container. They both have the same intended use and similar safety features.
The materials that make up the fluid contact path in CIStem™ have passed ISO 10993-1 biocompatibility testing.
5 Intended Use
C1Stem™ simultaneously attaches to the drug container, syringe with diluent and catheter adapter, forming a closed system. This configuration allows users to mix and deliver reconstituted drugs to the patient without exposure to potentially hazardous aerosols and spills that can occur during the reconstitution, administration and disposal processes.
2
Image /page/2/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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping stripes, resembling an abstract representation of an eagle or a similar bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2002
Shire Biologics, Incorporated C/O Ms. Angela Rogers Parexel International Worldwide Regulatory Affairs 10182 Telesis Court San Diego, California 92121
Re: K013523
Trade/Device Name: CIStem™ Regulation Number: K013523 Regulation Name: Fluid Transfer Device Regulatory Class: II Product Code: LHI Dated: October 22, 2001 Received: October 23, 2001
Dear Ms. Rogers:
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
3
Page 2 - Ms. Rogers
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 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 A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KO13523
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
To transfer and mix drugs contained in two containers into a syringe for administration to the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ← (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
Patricia Cescente
inn Sign-Off) sion of Dental, Infection Control, eneral Hospital Devices 10 11:2013033