(263 days)
Not Found
No
The description focuses on the mechanical and user-controlled aspects of insulin delivery, with no mention of AI or ML for decision-making or control.
Yes
The device is described as an "infusion pump" intended for the "subcutaneous infusion of insulin," which is a therapeutic intervention for medical conditions like diabetes.
No
The device, the GlucoPro Infusion Pump, is intended for the subcutaneous infusion of insulin, meaning its primary function is to deliver medication, not to diagnose a condition.
No
The device description explicitly details physical hardware components such as the pump dimensions, weight, battery, syringe, and infusion set, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous infusion of insulin." This describes a therapeutic action (delivering medication into the body), not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the pump delivers insulin into the subcutaneous tissue. It focuses on the mechanism of drug delivery, not on analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health status, diagnose conditions, or monitor treatment. This device does none of those things.
The GlucoPro Infusion Pump is a therapeutic device used for drug delivery.
N/A
Intended Use / Indications for Use
The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.
Product codes (comma separated list FDA assigned to the subject device)
LZG
Device Description
The Gluc. Pro Infusion Pump is intended for use with the disposable compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction.
The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Not Found
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
§ 880.5725 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
Ka/3309
JUN 2 4 2002
SO N.W. 107 Ave Mismi Florida 3317 1. (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF S \FETY AND EFFECTIVENESS Gl. copro™ Infusion Pump
$807.92 (a)(1)
Contact Person:
Kirk Ramey Senior Vice President
June 19, 2002
Date of Summary Preparation:
$807.92 (a)(2)
Trade Name:
Glucopre M Infusion Pump
Classification Name: Electrical vision infusion pump (21 CFR $880.5725), Class II
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Devices: Disetronic H-Tron Plus V100 infusion pump (K973044) and Minimed Model 507 (K960001)
$807.92 (a)(4)
The Gluc. Pro Infusion Pump is intended for use with the disposable Description of Device: compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction.
The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.
-8-
1
5807,92 (a)(5)
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
Intended Use:
The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The GlucoPro Infusion Pump is similar to legally marketed devices with the same intended use and design.
2
Image /page/2/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
C/O Ms. Kaelyn B. Hadley Consultant Nipro Diabetes Systems, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514
Re: K013309
Trade/Device Name: GlucoPro Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 21, 2002 Received: March 28, 2002
Dear Ms. Hadley:
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.
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.
3
Page 2 - Ms. Hadley
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 and additionally 21 CFR Part 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" (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,
Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) number (if known): K013309
Device name: GlucoPro Infusion Pump
Common Name: Syringe pump
Classification Name: Electrical piston infusion pump
Product code: LZG
Classification: 880.5725, Class II
Indications for use: The GlucoPro Infision Pump is intended for the subcutaneous infusion of insulin.
(Please do not write below this line- concinue 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 1-2-9)
K. Autchison
(Division Sign-Off) Division of Dental, Infection Control, and Ganeral Hospital Devices ్