(22 days)
Not Found
No
The device description and intended use describe a standard, mechanical insulin syringe with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: This device is for injecting substances (insulin), not for treating or curing a disease itself. It's a delivery method.
No
Explanation: The device is an insulin syringe, intended for the subcutaneous injection of insulin. It is used for administering a substance, not for identifying or investigating a disease, injury, or other condition.
No
The device description clearly states it is a physical hypodermic syringe with a needle, which is a hardware device.
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 is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The description details a syringe and needle, which are tools for administering substances, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to deliver a substance into the human body.
N/A
Intended Use / Indications for Use
The proposed device is intended for the subcutaneous injection of U-100 Insulin.
Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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 a 30g x 5/16 inch needle.
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.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
EXHIBIT # 9
510(k) Summary
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: October 17, 2003
-
Contact Person 1.
David A. Olson Vice President, Regulatory Affairs (508) 261-8530 -
- Name of Medical Device
Monoject Insulin Syringe Trade Name: Piston Syringe Classification Name: Insulin Syringe Common or Usual Name:
- Name of Medical Device
3. Identification of Legally Marketed Device
The proposed Kendall Monoject® Insulin Syringe are substantially equivalent in intended use, design and function to Becton Dickinson's Ultra - Fine™ II Insulin Syringe, 510(k) No. K024112 and the Kendall Monoject Insulin Syringe, 510(k) No. K991758.
Device Description 4.
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 a 30g x 5/16 inch needle.
1
5. Device Intended Use
The proposed device is intended for the subcutaneous injection of U-100 Insulin.
6. 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 – 31 Gage x 5/16" Length. This needle is of smaller diameter than the current Monoject 30 Gage x 5/16" 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 presence of the 31 gage (0.26 mm OD.) needle which is not contained in the standard and in regard to certain marking requirements.
The new Monoject 31 Gage x 5/16" insulin needle is identical in materials, design and intended use to 31 Gage x ½ " insulin needles currently marketed by Becton-Dickinson.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized image of an eagle with its wings spread.
Public Health Service
NOV 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tyco HealthCare Mr. David A. Olson Vice President, Regulatory Affairs Kendall 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K033373
Trade/Device Name: Monoject® Insulin Syringe Regulation Number: 880.5570, 880.5860 Regulation Name: Hypodermic Single Lumen Needle Piston Syringe Regulatory Class: II Product Code: FMI Dated: October 17, 2003 Received: October 22, 2003
Dear Mr. Olson:
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.
3
Page 2 - Mr. Olson
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. 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act 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,
Quls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ¿c 3 33 7 3
Device Name: Monoject® Insulin Syringe
Indications for Use: Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.
Please Do Not Write Below This Line - Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109) OR
Over-The-Counter
Pataria Cuccente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033375