(76 days)
Not Found
No
The device description focuses on mechanical components and gravity-based fluid delivery, with no mention of AI or ML terms or functionalities.
No.
The device is an IV set designed to control the flow rate of fluids and drugs, not to treat a disease, injury, or condition itself.
No
Explanation: The device is designed to control the flow rate of IV fluids and drugs, not to diagnose a medical condition.
No
The device description explicitly details physical components such as a bag spike, drip chamber, PVC tubing, clamp, and luer lock, 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 clearly states it's for "gravity infusion of I.V. fluids and drugs" and "maintains a pre-selected flow rate for I.V. fluids and drugs to a patient." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details components like a bag spike, drip chamber, tubing, clamp, and luer lock, all consistent with an IV administration set. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents
In summary, the MPS Gravity Flow Control Set is a medical device used for administering fluids intravenously, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs.
The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Gravity Flow Control Sets will be available in both primary I.V. sets and extension sets. It incorporates a standard bag spike, flexible drip chamber, PVC tubing, Clamp and ending with a standard male luer lock. Various flow rates are established by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet.
Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Gravity Flow Control Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
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)
Nonclinical test summary: Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JAN 20 1999
510(k) Summary
| 1. | Submitter: | Medical Product Specialists, Inc. (MPS)
499 Nibus Street, suite E
Brea, CA 92821
Tel: 714-257-0470
Fax: 714-257-0513 |
|----|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Dan Hyun, President
Medical Products Specialists |
| 3. | Date prepared: | November 2, 1998 |
| 4. | Device trade name: | MPS Gravity Flow Control Set |
| | Common name: | Intravenous (I.V.) Sets Accessory |
| 5. | Predicate device: | Master Medical Corporation
Marketed by ConMed Corp.
310 Broad St. Utica, NY 13051
K871753 and K852254 |
| 6. | Description: | The MPS Gravity Flow Control Set is a family of specialized IV
sets designed to deliver a fluid flow at a specified rate. The
MPS Gravity Flow Control Sets will be available in both primar
I.V. sets and extension sets. It incorporates a standard bag
spike, flexible drip chamber, PVC tubing, Clamp and ending
with a standard male luer lock. Various flow rates are
established by rotating the barrel to vary the position of the
accurate slot in the barrel relative to the oppositely disbursed
inlet and outlet.
Each MPS Gravity Flow Control Set is sterilized in sealed
individual pouches or trays. Full labeling information is
provided with each MPS Gravity Flow Control Set. Multi-unit
shelf packs of individual pouches or trays are provided for
convenience. |
7. Intended Use:
-
- The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs.
-
- The MPS Gravity Flow Control Set incorporates a rotary device to set and maintain a pre-selected flow rate for I.V. fluids and drugs to a patient.
- 3 The MPS Gravity Flow Control Set is intended for single use in the I.V. infusion. Change per CDC guidelines or per hospital protocol.
1
-
- Do not use the MPS Gravity Flow Control set with a pressure infusion device.
- Do not administer blood, blood product or enteral solution. 5.
-
- Technological comparison to predicate device:
The technological characteristics are intended to be substantially equivalent (in materials, design, and intended use) to the devices currently marketed as the ConMed Corporation STAT-2 (original 510(k) was issued to Master Medical Corp.)
There are no technological differences between the Master Medical STAT-2 set and the MPS Gravity Flow Control Set. Both devices control gravity flow rates by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet.
-
- Nonclinical test summary:
Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible.
- Nonclinical test summary:
-
- Conclusion: The MPS Gravity Flow Control Set is substantially equivalent to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Mr. Dan Hyun President Medical Products Specialists, Incorporated 499 Nibus Street, Suite E Brea, California 92821
K983926 Re : MPS Gravity Flow Control Set Trade Name: Regulatory Class: II Product Code: FPA Dated: November 2, 1998 Received: November 5, 1998
Dear Mr. Hyun:
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 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), You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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 requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 - Mr. Hyun
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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/dsma/dsmamaifi.html".
Sincerely yours
Timothy A. Ulatowski
Ulatowski Timo Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
REVISED
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
(As required by ODE for all 510(k) received after Jan. 1, 1996.)
K983926 510(k) Number: MPS Gravity Flow Control Set Device Name:
Indications For Use:
- The MPS Gravity Flow Control Set is intended only for a gravity 1. infusion of I.V. fluids and drugs.
- The MPS Gravity Flow Control Set maintains a pre-selected flow 2. rate for I.V. fluids and drugs to a patient.
(Do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) 25 (Division of Dental, Infection of Dentale, and General Hospital, Infection
S100->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 510(k) Number _ K98
prescription Use
(Per 21 CFR 801.109) ✓
or
over-the-counter Use _