(76 days)
Not Found
Not Found
No
The description focuses on a mechanical, elastomeric pump system with a pre-set rate, and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training/test sets and performance metrics typically associated with AI/ML.
Yes
The device is described as an "infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management." This indicates it's used for medical treatment, specifically pain management, which falls under therapeutic use.
No
Explanation: The device is described as a disposable infusion system for delivering prescribed solutions, specifically for post-operative pain management. Its function is to infuse substances into a patient, not to diagnose a condition or disease.
No
The device description explicitly states it includes physical components such as an elastomeric pump, IV catheter/introducer, and infusion catheter, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management." This involves delivering substances into the body, not testing samples from the body.
- Device Description: The device is described as an "infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion." This is a delivery mechanism, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering medication.
N/A
Intended Use / Indications for Use
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
Product codes
MEB, FOZ, BSO
Device Description
The Biomet Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, an IV catheter/introducer and an infusion catheter. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
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
general hospital setting as well as at home
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for Biomet INC. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Proprietary Name: Disposable Infusion Pump Kit
Common Name: Disposable Infusion Pump Kit
Classification Name and Reference: Pump Pump, Infusion, Elastomeric, External (21 CFR 880.5725) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: MEB IV Catheter/Introducer Catheter, Intravascular, short term (21 CFR 880.5200) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: FOZ Infusion Catheter Catheter, Conduction, Anesthetic (21 CFR 868.5120) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 73 Device Product Code: BSO
Device description:
Infusion of liquids in to a patient in the general hospital setting as well as at home is frequently required in medical treatment. For example, in orthopedics a disposable device is often indicated after outpatient arthroscopic surgery in order to infuse topical anesthetics for several days following the patient's return home. The infusion catheter is usually removed when the patient returns to the physician's office for a follow-up visit.
The Biomet Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, an IV catheter/introducer and an infusion catheter. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate.
The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
Intended use: The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581 0587
.
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
.
()FFICE 211).267.6639
ドハメ .219.267.815.7
E-MAIL biomet@biomet.com
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Image /page/1/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 an abstract symbol that resembles an eagle or bird-like figure, with three stylized human profiles integrated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 7 2000
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Incorporated Corporate Headquarters P.O. Box 587 46581-0587 Warsaw, Indiana
K993972 Re: Disposable Infusion Pump Kit Trade Name: Requlatory Class: II Product Code: MEB Dated: January 13, 2000 Received: January 20, 2000
Dear Ms. Beres:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
2
Page 2 - Ms. Beres
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.
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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K993972_
Device Name: Disposable Infusion Pump Kit
Indications For Use:
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
VaNANAPy/Amr on PXC
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
5100