(21 days)
Not Found
No
The device description and intended use are for a simple mechanical syringe and needle. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI/ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device, an insulin syringe, is used for the administration of a drug (insulin), not for direct therapy itself. Its function is drug delivery, not therapeutic action.
No
The device description and intended use indicate that it is a syringe for administering insulin, not for diagnosing a condition.
No
The device description clearly outlines physical components like a syringe barrel, plunger rod, and hypodermic needle, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of U-100 Insulin." This describes a device used to administer a substance into the body, not to test a sample from the body.
- Device Description: The description details a syringe and needle, which are tools for injection, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to deliver a substance into the body.
N/A
Intended Use / Indications for Use
MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
Monoject Insulin Syringes are used for subcutaneous injection of U-100 Insulin. These devices are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.
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)
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.
K851090, K922522, K955235, K980580
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
§ 880.5860 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
JUN 1 4 1999
Monoject Insulin Syringe Premarket Notification May 19, 1999
ATTACHMENT 7
510K SUMMARY
Contact Person: Frank J. Fucile, Vice President, Regulatory Affairs The Kendall Company 15 Hampshire Street, Mansfield, MA 02048 Phone: (508) 261-8532 Date Prepared: May 19, 1999
Device:
Brand Name: FDA Classification Name: Common or Usual Name:
Monoject Insulin Syringes Piston Svringe, per 21 CFR 880.5860 Insulin Syringe
Predicate Devices: Monoject Insulin Syringes are substantially equivalent in intended use, function and composition to Monoject Insulin Syringe, 510K #s K851090 and K922522 and B-D Insulin Syringes, 510K #s K955235 and K980580.
Device Description/Intended Use: Monoject Insulin Syringes are used for subcutaneous injection of U-100 Insulin. These devices are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.
Summary of Technological Characteristics: The only design change being incorporated into current Monoject Insulin Syringes compared to currently marketed Monoject Insulin Syringes is the addition of a new needle size - 30 Gage x 5/16" Length. This needle is shorter and of smaller diameter than the current Monoject 29 Gage x 1/2 Length insulin needle. All other aspects are identical to current Monoject Insulin Syringes. Monoject Insulin Syringes conform to International Standard ISO 8537:1991(E) "Sterile single-use syringes, with or without needle, for insulin", except in regard to the 30 gage (0.30 mm OD.) needle which is not contained in the standard and in regard to certain marking requirements.
The new Monoject 30 Gage x 5/16" insulin needle is identical in materials, design and intended use to 30 Gage x 5/16" insulin needles currently marketed by Becton-Dickinson.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains 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 to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 1999
Mr. Frank J. Fucile Vice President, Regulatory Affairs The Kendall Company 15 Hampshire Street Mansfield, Massachusetts 02048
Re : K991758 Monoject® Insulin Syringe Trade Name: Requlatory Class: II Product Code: FMF Dated: May 19, 1999 Received: May 24, 1999
Dear Mr. Fucile:
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 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 Requlations, Title 21, Parts 800 to 895. ਚੋ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Fucile
Please note: this response to your premarket notification Please note: Enra response of Joligation you might have under submission docb not arroos any act for devices under the Sections 351 through Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis icceer wire as 0 (k) premarket notification. The FDA described in your 510(x) promatics of your device to a legally Linding of Subbeaneral Squaresults in a classification for your marketed predicate acvice burned to proceed to the market.
If you desire specific advice for your device on our labeling II you debire opeoins and additionally 809.10 for in regulacion (in devices), please contact the Office of Villo draghoscic deviceb// proad of the some on Compriance at (301) seertising of your device, please contact che promotion and liance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference fo premation on your responsibilities under the Act may be Information on your robportion of Small Manufacturers Assistance obcathed from che river (800) 638-2041 or (301) 443-6597 or at at its coll-free namber (o://www.fda.gov/cdrh/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
3
Monoject Insulin Syringe Premarket Notification May 19, 1999
ATTACHMENT ؟
INDICATIONS FOR USE STATEMENT
510K Number:
Device Name:
MONOJECT Insulin Syringes
Indications for Use:
MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR Over-the-Counter Use __
Use
Palaces Cuceniti
(Divisio Divisio and G 510(k) Numb