(56 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a simple, mechanical device for fluid transfer. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is described as an "aseptic dispensing" device for solutions and fluids, and its function is to transfer fluids from containers. It does not exert any direct therapeutic action on the patient.
No
Explanation: The device is intended for aseptic dispensing and transfer of solutions from IV containers, not for diagnosing medical conditions.
No
The device description clearly states the devices are "one piece, injection molded hollow tubes with one or more spiked ends," indicating they are physical hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "aseptic dispensing of solutions from I.V. containers," "dispense fluids from flexible bags," "dispense fluids from glass vials," and "transfer fluids from container to container." These are all actions related to handling and transferring fluids, not analyzing biological samples in vitro (outside the body).
- Device Description: The description of the device as "one piece, injection molded hollow tubes with one or more spiked ends" further supports its function as a fluid transfer tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ValuMed decanting devices do not fit this description.
N/A
Intended Use / Indications for Use
The ValuMed decanting devices are decanting devices intended for the aseptic dispensing of solutions from Iv containers. Each device is used as follows:
Bag Decanter: Used to dispense fluids from flexible bags
Vial Decanter: Used to dispense fluids from glass vials
Transfer Device: Used to dispense fluids from small vials, or to transfer fluid from container to container.
Product codes
LHI
Device Description
The ValuMed decanting devices are one piece, injection molded hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, single use, disposable 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)
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
SECTION 4
DEC 1 7 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter:
ValuMed 1439 Live Oak Street, Suite A Niceville, FL 32578 (850) 897-3321 - Phone (850) 897-1280 - Fax Thomas Cottone, President - Contact Person qa@valumed.net
Date Summary Prepared: October 21, 2002
Device Name:
- 매 Trade Name - Bag Decanter, Vial Decanter, Transfer Device
- 해 Common Name - Decanting Devices
- . Classification Name: I.V. Container Accessories
Devices for Which Substantial Equivalence is Claimed:
Device Description:
The ValuMed decanting devices are one piece, injection molded hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, single use, disposable devices.
Intended Use of the Device:
The ValuMed decanting devices are decanting devices intended for the aseptic dispensing of solutions from Iv containers. Each device is used as follows:
| Bag Decanter: | Used to dispense fluids from flexible bags |
|---|---|
| Vial Decanter: | Used to dispense fluids from glass vials |
| Transfer Device: | Used to dispense fluids from small vials, or to transfer fluid from container to container. |
Substantial Equivalence:
The ValuMed decanting devices are substantially equivalent to several other legally marketed devices in the United States. The decanting devices marketed by Steri-Systems, Corp, and the transfer devices by Medical Specialty Innovations, Inc. are substantially identical in materials, dimensions, performance, packaging, sterilization and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas E. Cottone President ValuMed 1439 Live Oak Street, Suite A Niceville, Florida 32578
Re: K023539
Trade/Device Name: Decanting Devices Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 21, 2002 Received: October 22, 2002
Dear Mr. Cottone:
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.
2
Page 2 - Mr. Cottone
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 (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), 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 Uhthoff
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
SECTION 3
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
STATEMENT OF INDICATIONS FOR USE
The ValuMed decanting devices are devices intended for the aseptic dispensing of solutions from I.V. containers. Each device is used as follows:
| Bag Decanter: | Used to dispense fluids from flexible bags |
|---|---|
| Vial Decanter: | Used to dispense fluids from glass vials |
| Transfer Device: | Used to dispense fluids from small vials, or to transfer fluids |
| from container to container. |
Titaux Vincente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023557