(141 days)
Not Found
No
The device description and performance studies focus on mechanical aspects of a syringe, with no mention of AI/ML terms or functionalities.
No
The device is described as being for "subcutaneous injection of insulins," which is a delivery method for medication, not a therapeutic treatment itself. Therapeutic devices are used to treat illnesses or conditions, whereas this device is for administering a drug that performs the therapy.
No
The device is described as being for "subcutaneous injection of insulins," indicating its function is to deliver medication, not to diagnose a condition.
No
The device description explicitly lists physical components like a barrel, plunger, piston, and cannula, indicating it is a hardware device for insulin injection, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the subcutaneous injection of insulins." 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 components of a syringe, which is a tool for injection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for administering medication.
N/A
Intended Use / Indications for Use
This device is intended for the subcutaneous injection of insulins.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
This device is intended for the subcutaneous injection of insulins
This device is consisting of barrel, plunger, piston, cannula (which is tixed in the barrel nozzle lumen), top cap and cannula cap (orange color) with different gauges and cannula length.
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)
| Performance Characteristics | Test Method | Acceptance Criteria | IMC Insulin Syringe | BD Insulin Syringe K024112 |
|---|---|---|---|---|
| Hub/needle bond strength | ISO 7894 : 1993 | 25G-30G: >22N | Meets Standard Criteria | Meets Standard Criteria |
| Graduation | ISO 8537:1991(E) | A- Volumes less than half the nominal capacity : +/-(1.5% of the nominal capacity +2% of the expelled volume) B - Volumes equal to or greater than half the nominal capacity : +/- (5% of the expelled volume) | Meets Standard Criteria | Meets Standard Criteria |
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
§ 880.5860 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
8. 510(K) SUMMARY
| Proprietary Name: | IMC Insulin Syringe |
|---|---|
| Common Name: | Insulin Syringe |
| Classification Name: | Piston Syringe (21 CFR 880.5860) |
| Device Clarification: | Class II |
| Panel Code: | 80 |
| Product Code: | FMF |
| Submitter Information: | International Medsurg Connection |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Summary Prepared By: | Peter Kim |
| Director of Quality Assurance | |
| International Medsurg Connection | |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Telephone: 847-619-9926 | |
| Fax: 847-619-9927 | |
| e-mail: peterkim@intlmedsurg.com | |
| Date Prepared: | March 14, 2011 |
| Predicate Devices: | Becton Dickinson Consumer Healthcare (BD) - K024112 |
Device Name(s):
IMC Insulin Syringe (non-sterile and sterile)
Classification Panel:
General Hospital
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Insulin Syringe with the currently marketed:
| 11 4 8 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Jescription | ፡ 22N | Meets Standard
Criteria | Meets Standard
Criteria |
| Graduation | ISO 8537:1991(E) | A- Volumes less than
half the nominal
capacity : +/-(1.5% of
the nominal capacity
+2% of the expelled
volume)
B - Volumes equal to or
greater than half the
nominal capacity : +/-
(5% of the expelled
volume) | Meets Standard
Criteria | Meets Standard
Criteria |
Conclusions:
The indications for use, technology, specification, safety of the IMC Insulin Syringe and the predicate device K024112 is essentially the same. The differences between the Insulin Syringe are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Insulin Syringes are substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three wavy lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
International Medsurg Connection C/O Peter Kim Director of Quality Assurance 935 N Plum Grove Road, Suite F Schaumburg, Illinois 60173
Re: KI10882
AUG 1 8 2011
Trade/Device Name: IMC Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 3, 2011 Received: August 8, 2011
Dear Mr. Kim:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 – Mr. Kim
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony D. Owh
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number :
Device Name: IMC Insulin Syringe
Indications For Use: This device is intended for the subcutaneous injection of insulins.
Name/Description
| Size | Gauge | Size | Sterility |
|---|---|---|---|
| 0.3cc | 28G | ½" (12.7mm) | Sterile & Non-sterile |
| 29G | ½" (12.7mm) | Sterile & Non-sterile | |
| 30G | ½" (12.7mm) & 5/16" (8mm) | Sterile & Non-sterile | |
| 31G | 5/16" (8mm) | Sterile & Non-sterile | |
| 0.5cc | 28G | ½" (12.7mm) | Sterile & Non-sterile |
| 29G | ½" (12.7mm) | Sterile & Non-sterile | |
| 30G | ½" (12.7mm) & 5/16" (8mm) | Sterile & Non-sterile | |
| 31G | 5/16" (8mm) | Sterile & Non-sterile | |
| 1cc | 28G | ½" (12.7mm) | Sterile & Non-sterile |
| 29G | ½" (12.7mm) | Sterile & Non-sterile | |
| 30G | ½" (12.7mm) & 5/16" (8mm) | Sterile & Non-sterile | |
| 31G | 5/16" (8mm) | Sterile & Non-sterile |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital ifection Control, Dental Devices
§10(k) Number: K110882