(47 days)
KPE
Not Found
No
The summary describes a reservoir bag for infusion pumps, a purely mechanical component, with no mention of AI/ML terms or functionalities.
No
The MPS Reservoir Bag is a container for fluids and drugs used in infusion therapy, but it does not provide therapy itself. It is an accessory to infusion pumps which deliver the therapy.
No
Explanation: The MPS Reservoir Bag is described as being used with infusion pumps for continuous infusion therapy of fluids and drugs. Its function revolves around holding and delivering substances, not diagnosing conditions. The document provides no indication of diagnostic capabilities.
No
The device description clearly indicates a physical product ("MPS Reservoir Bag") that is sterilized and packaged, not a software application.
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 "continuous infusion therapy" and "infusion of I.V. fluids, and drugs." This describes a device used for administering substances directly into the body, not for testing samples taken from the body.
- Device Description: The description focuses on the physical characteristics of a bag designed to hold fluids for infusion.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering substances into the body.
N/A
Intended Use / Indications for Use
- The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII 1. pumps for continuous infusion therapy.
-
- For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use.
-
- For use up to 24 hours per CDC guidelines or per hospital protocol.
-
- For use with standard luer taper connections.
-
- For single patient use.
Product codes
KPE
Device Description
Each MPS Reservoir Bag is sterilized in sealed individual pouches. Full labeling information is provided with each MPS Reservoir Bag. 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)
Baxter Drug Bag
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).
0
JUL 27 1998 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: | May 29, 1998 |
| 4. | Device trade name: | MPS Reservoir Bag |
| | Common name: | I.V. container (21 CFR § 880.5025)
Drug bag
Drug reservoir |
| 5. | Predicate device: | Baxter Drug Bag |
| 6. | Description: | Each MPS Reservoir Bag is sterilized in sealed individual
pouches. Full labeling information is provided with each MPS
Reservoir Bag. Multi-unit shelf packs of individual pouches or
trays are provided for convenience. |
Intended Use: 7.
- The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII 1. pumps for continuous infusion therapy.
-
- For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use.
-
- For use up to 24 hours per CDC guidelines or per hospital protocol.
-
- For use with standard luer taper connections.
-
- For single patient use.
1
- Technological comparison to predicate device: 8.
The technological characteristics are intended to be substantially equivalent (in materials, design, and intended use) to the devices currently marketed as the Baxter Drug Bag.
Difference between the proposed and predicate devices are in the color coding scheme for vented and non-vented luer caps. And that the slide clamp is attached to the bag in the MPS Reservoir Bag design where the clamp is enclosed in the interior sterile pouch in the Baxter design.
-
- 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 Reservoir Bag 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 1998
Mr. Dan Hyun ·President Medical Product Specialists, Incorporated 499 Nibus Street, Suite E Brea, California 92821
K982048 Re: MPS Reservoir Bag Trade Name: Requlatory Class: II Product Code: KPE May 29, 1998 Dated: June 10, 1998 Received:
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 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 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 aqainst 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. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Hyun
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" (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,
Patricia Cucentiffex
Timothy A. Ulatowski anoval Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 982047
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
(As required by ODE for all 510(k) received after Jan. 1, 1996.)
510(k) Number:
MPS Huber Needle Extension Set Device Name:
Indications For Use:
- The MPS Huber Needle Extension Set is intended for use with a. implanted infusion ports for continuous or intermittent infusion therapy.
- For use for infusion of I.V. fluids, blood, blood products and b. drugs.
- C. Change per CDC guidelines or per hospital Protocol.
(Do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Palacios Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
or
510(k) Number 1982047
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
2-5