(82 days)
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
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.
This document is a 510(k) premarket notification for "Medical Specialty Innovations, Inc. Transfer Devices". It is a submission to the FDA requesting clearance to market a medical device. These types of documents typically do not contain detailed acceptance criteria, study designs, or performance results in the way machine learning or AI device submissions do.
The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or performance in a clinical trial setting. The “study” mentioned is a comparison to predicate devices rather than a standalone clinical performance study involving extensive data and expert reviews.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what can be inferred or explicitly stated.
Acceptance Criteria and Study for Medical Specialty Innovations, Inc. Transfer Devices
Based on the provided 510(k) summary, the "study" conducted for these transfer devices focused on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific acceptance criteria in a clinical trial.
The acceptance criteria for a 510(k) submission are generally met when the new device is shown to be as safe and effective as a predicate device. This is achieved by comparing materials, dimensions, performance, packaging, sterilization, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k)) | Reported Device Performance (from 510(k)) |
|---|---|---|
| Material Composition | Substantially identical to predicate | "substantially identical in materials" |
| Dimensions | Substantially identical to predicate | "substantially identical in dimensions" |
| Performance (Functionality) | Aseptic dispensing from IV containers; equivalent fluid transfer capabilities | "substantially identical in performance"; decanting from glass vials, flexible bags, bottles. |
| Packaging | Substantially identical to predicate | "substantially identical in packaging" |
| Sterilization Method | Substantially identical to predicate | "substantially identical in sterilization" |
| Intended Use | Aseptic dispensing of solutions from IV containers. | "intended for the asceptic dispensing of solutions from IV containers." |
| Technological Characteristics | No significant differences from predicate | "There are no differences in the characteristics of the subject devices and the predicates." |
2. Sample Size Used for the Test Set and Data Pprovenance
- Sample Size: Not applicable in the context of a 510(k) substantial equivalence claim based on physical/functional comparison. There is no "test set" of patient data or clinical images mentioned. The comparison is between the design and specifications of the new device and the predicate devices.
- Data Provenance: Not applicable. The "data" is the device's design, manufacturing specifications, and intended use, which are compared to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Experts: Not applicable. Ground truth, in the clinical or AI sense, is not established for this type of device submission. The FDA reviews the provided documentation for substantial equivalence, which is a regulatory and engineering assessment rather than a clinical expert consensus on performance.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is commonly associated with diagnostic imaging devices or AI-powered solutions, not simple transfer devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone performance study in the context of AI or algorithm performance was not conducted. The device is a physical, mechanical transfer device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes data, expert consensus). The "ground truth" for a 510(k) submission is the existence and legally marketed status of a predicate device, and the demonstration that the new device shares fundamental technological characteristics and intended use with that predicate.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. There is no "training set" or need for corresponding ground truth in this submission type.
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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
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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.
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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
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.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
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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
§ 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.