(82 days)
Not Found
No
The device description and intended use clearly describe a simple mechanical decanting device with no mention of any computational or data-driven features.
No
The device is described as a "decanting device" intended for "aseptic dispensing of solutions from IV containers." It facilitates the transfer of fluids but does not provide any therapeutic effect itself.
No
The device description clearly states its purpose is for "aseptic dispensing of solutions from IV containers" and "transfer solutions from container to container." This functionality aligns with fluid transfer and decanting, not the identification or analysis of medical conditions, which is the role of a diagnostic device.
No
The device description clearly states it is a physical, injection-molded tube with spiked ends, indicating it is a 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 described as "asceptic dispensing of solutions from IV containers." This is a physical manipulation of fluids for administration, not for diagnostic testing of samples taken from the body.
- Device Description: The device is described as "one piece, injection molded transparent hollow tubes with one or more spiked ends." This is a mechanical device for fluid transfer, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information.
- Predicate Devices: The predicate devices listed are also described as "decanters," which are devices for transferring fluids, not for diagnostic testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device's function is purely for the safe and sterile transfer of pre-prepared solutions.
N/A
Intended Use / Indications for Use
The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows
VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container
Product codes
LHI
Device Description
The MSI transfer devices are one piece, injection molded transparent hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, disposible devices.
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)
K811233, K811234, K811268, K811269
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K972 117
AUG 26 1997
Attachment 1 510(k) Summary
Medical Specialty Innovations, Inc. Transfer Devices
Submitter Information:
Medical Specialty Innovations, Inc. (MSI) 440 Nine McFarland Drive, Suite 100 Alpharetta, GA. 30201
510(k) Summary Prepared by:
ﻤﻠﻌﺎﺕ
Carolann Kotula Official Correspondent for MSI c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared: May 30 , 1997
Name/Classification of the Device:
IV Container Accessories Classification Name: Transfer device: bottle or bag Common Name: decanter, transfer spike MSI Bottleflow, Transflow, Vialflow Proprietary Name: and Rapidflow
1
Classification:
These have been classified by the General Hospital Panel as Class II devices.
Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: These devices are substantially equivalent to the transfer devices legally marketed by MediPlast International, Inc. as:
| IV Plastic Bag decanter: | K811233 |
|---|---|
| IV Rigid (Bottle) decanter: | K811234 |
| Bottle to Bottle decanter: | K811268 |
| Glass Vial decanter: | K811269 |
The subject device and predicate are substantially Comparative Information: identical in materials, dimensions, performance, packaging, sterilization and intended use.
Description of the Subject Device: The MSI transfer devices are one piece, injection molded transparent hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, disposible devices.
Intended Use of the Subject Device: The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows
used to dispense fluids from glass vials VialFlow: RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container
Technological Characteristics of the Subject Device: There are no differences in the characteristics of the subject devices and the predicates.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1997
Ms. Carolann Kotula Vice President Medical Specialty Innovations, Incorporated (MSI) . C/O MDI Consultants, Incorporated work 55 Northern Boulevard Great Neck, New York 11021
.. . . .
Re : K972117 MSI Bottleflow, Transflow, Vialflow Trade Name: Requlatory Class: II Product Code: LHI May 30, 1997 Dated: Received: June 5, 1997
Dear Ms. Kotula:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realer book in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to . comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
.Page 2 - Ms. Kotula
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo av A. Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT #3
510(k) Number (if known)
Device Name: Medical Specialty Innovations, Inc. Transfer Devices
Indications for Use:
The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows
VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container
(Please Do Not Write Below this Line/Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972117
Prescription Use
OR
Over the Counter Use