(56 days)
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.
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.
This document, K023539, is a 510(k) premarket notification for a medical device called "Decanting Devices." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than proving novel claims or establishing new safety and effectiveness standards through extensive clinical trials. Therefore, the information typically found in a clinical study report proving acceptance criteria is not present in this document.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
- Not available. This 510(k) submission does not include specific acceptance criteria for performance metrics or reported performance data from a study. The basis of equivalence is listed as "materials, dimensions, performance, packaging, sterilization and intended use" being "substantially identical" to predicate devices. There's no quantitative performance data provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" in the context of a performance study described in this document. The submission relies on establishing substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert review or ground truth establishment relevant to a performance study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a simple mechanical decanting device, not an AI or imaging device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual, non-algorithmic mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of a performance study is not established or discussed. The "truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth for one.
Summary of the document's approach to "proving" safety and effectiveness:
The K023539 submission for ValuMed decanting devices relies entirely on the concept of substantial equivalence to predicate devices. It states:
- "The ValuMed decanting devices are substantially equivalent to several other legally marketed devices in the United States."
- Specifically, it claims they are "substantially identical in materials, dimensions, performance, packaging, sterilization and intended use" to products from Steri-Systems, Corp (K830232) and Medical Specialty Innovations, Inc. (K961699).
Therefore, the "proof" that the device meets "acceptance criteria" (which aren't explicitly stated but implicitly align with the predicate devices' established safety and effectiveness) is the demonstration that it is fundamentally the same as devices already on the market that have been deemed safe and effective by the FDA. This is the standard pathway for 510(k) clearances for devices of this nature, where comprehensive clinical trials are typically not required.
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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.
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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.
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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
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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 fluidsfrom container to container. |
Titaux Vincente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023557
§ 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.