(194 days)
No
The summary describes a mechanical syringe for insulin infusion and does not mention any AI or ML components or functionalities.
No
The device is described as a medication reservoir for the infusion of insulin, not as a device that provides therapy itself.
No
The device is described as a medication reservoir for insulin infusion and does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it is a "medication reservoir" and lists physical materials (stainless steel, polypropylene, silicone), indicating it is a hardware device, not software only.
Based on the provided information, the Glucopro syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin into a user. This is a therapeutic delivery of medication into the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a medication reservoir for an infusion pump, used to deliver medicine solutions. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze a biological sample (like blood, urine, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Glucopro syringe's function is to deliver a substance into the body, which is the opposite of how an IVD works.
N/A
Intended Use / Indications for Use
The Glucopro Syringe is intended for subcutaneous infusion of medicine solutions, such as insulin.
The Glucopro syringe is intended for use in the subcutaneous infusion of insulin when the "InsuLoop Glucopro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.
Product codes
FMF
Device Description
The Glucopro Syringe is a medication reservoir placed within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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)
Disetronic Medical Systems AG, 3.15mL cartridge
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
K014 114
JUN 2 6 2002
Image /page/0/Picture/2 description: The image shows the logo for Nipro Corporation. The logo consists of a stylized symbol resembling two interlocked loops, followed by the word "NIPRO" in a bold, sans-serif font. The color of both the symbol and the text is black, contrasting with the white background.
3150 N W 107 Aver Miami, Florida 33171 Tel : (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS Glucopro™ Syringe
§807.92 (a)(1)
Contact Person:
Kirk Ramey Senior Vice President
December 7, 2001
Date of Summary Preparation:
§807.92 (a)(2)
Glucopro™ Syringe Trade Name:
Syringe Common Name:
Classification Name: Piston Syringe (21 CFR §880.5860), Class II
§807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Disetronic Medical Systems AG, 3.15mL cartridge
$807.92 (a)(4)
The Glucopro Syringe is a medication reservoir placed Description of Device: within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.
$807.92 (a)(5)
1
Intended Use:
The Glucopro Syringe is intended for subcutaneous infusion of medicine solutions, such as insulin.
క్ర807.92 (a)(6)
ប្រ
Comparison of Technical Characteristics:
The Glucopro Syringe is similar to legally marketed devices with the same intended use and design.
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" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
C/O Ms. Kaelyn B. Hadley Consultant Nipro Diabetes Systems, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514
Re: K014114
Trade/Device Name: Glucopro™ Syringe Regulation Number: 880.5860 Regulation Name: Syringe Regulatory Class: II Product Code: FMF Dated: April 2, 2002 Received: April 11, 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
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,
Timothy A. Ulatowski Director 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): KQ14114
Device name: Glucopro Syringe
Common Name: Syringe
Classification Name: Piston Syringe
Product code: FMF
Classification: 880.5860, Class II
Indications for use: The Glucopro syringe is intended for use in the subcutancous infusion of insuline to tast "Inte GlucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.
(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 1-2-9 )
Patricia Ciccarelli
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital D 510(k) Number _