(141 days)
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.
The provided document describes the IMC Insulin Syringe, a Class II medical device, and its substantial equivalence to a predicate device (BD Insulin Syringe: K024112). The performance data section, which is crucial for understanding acceptance criteria and proof of device performance, focuses on two key characteristics: "Hub/needle bond strength" and "Graduation" (volume accuracy).
Here's an analysis of the provided information based on your requested points:
Acceptance Criteria and Device Performance for IMC Insulin Syringe
1. Table of acceptance criteria and the reported device performance
| Performance Characteristics | Test Method | Acceptance Criteria | Reported Device Performance (IMC Insulin Syringe) | Predicate Device Performance (BD Insulin Syringe K024112) |
|---|---|---|---|---|
| Hub/needle bond strength | ISO 7894: 1993 | 25G-30G: >22N | Meets Standard Criteria | Meets Standard Criteria |
| Graduation (Volume Accuracy) | ISO 8537:1991(E) | A- Volumes less than half the nominal capacity: +/-(1.5% of the nominal capacity + 2% of the expelled volume) | Meets Standard Criteria | Meets Standard Criteria |
| B - Volumes equal to or greater than half the nominal capacity: +/- (5% of the expelled volume) | Meets Standard Criteria | Meets Standard Criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for either the hub/needle bond strength or graduation tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided as the tests relate to physical performance characteristics of a device (bond strength, volume accuracy) rather than diagnostic interpretations or expert consensus on patient data.
4. Adjudication method for the test set
This information is not applicable and not provided due to the nature of the tests (engineering performance metrics). Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert interpretations of data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The IMC Insulin Syringe is a physical insulin delivery device, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance evaluation (as defined for AI algorithms) was not applicable and not done. This device does not involve an algorithm. The reported performance data (hub/needle bond strength, graduation) are intrinsic physical properties of the syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria is based on established international standards (ISO 7894:1993 for hub/needle bond strength and ISO 8537:1991(E) for graduation). These standards define objective, measurable physical properties and their acceptable limits.
8. The sample size for the training set
This information is not applicable and not provided. The IMC Insulin Syringe is a physical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
Summary of Study Proof:
The proof that the IMC Insulin Syringe meets the acceptance criteria is stated as "Meets Standard Criteria" for both the Hub/needle bond strength and Graduation (volume accuracy) tests. These tests were conducted according to international standards ISO 7894:1993 and ISO 8537:1991(E), respectively. The document asserts that the IMC Insulin Syringe's performance is substantially equivalent to the predicate device (BD Insulin Syringe K024112) based on these performance characteristics, along with similarities in intended use, materials, and other features. The specific raw data or detailed test reports, including sample sizes and statistical analysis, are not included in this 510(k) summary but would have been part of the full submission to the FDA.
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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 Connection935 N Plum Grove Rd, STE FSchaumburg, Illinois 60173 |
| Summary Prepared By: | Peter KimDirector of Quality AssuranceInternational Medsurg Connection935 N Plum Grove Rd, STE FSchaumburg, Illinois 60173Telephone: 847-619-9926Fax: 847-619-9927e-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 4Jescription | ፡ <10/k) Number |
|---|---|
| Chine of Acres of Acres of ChildrenA CLASS CLASS COLLEGE OF CHARGES OFDDIחזונפעSvringe | KO24117 |
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.
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Statement of Intended Use
Indications For Use: This device is intended for the subcutaneous injection of insulins
| Name/DescriptionCategory | Description | Sterility |
|---|---|---|
| Insulin Syringe | 0.3cc Insulin Syringe with 28G x ½" | Sterile & Non-sterile |
| 0.3cc Insulin Syringe with 29G x ½" | Sterile & Non-sterile | |
| 0.3cc Insulin Syringe with 30G x ½" | Sterile & Non-sterile | |
| 0.3cc Insulin Syringe with 30G x 5/16" | Sterile & Non-sterile | |
| 0.3cc Insulin Syringe with 31G x 5/16" | Sterile & Non-sterile | |
| 0.5cc Insulin Syringe with 28G x ½" | Sterile & Non-sterile | |
| 0.5cc Insulin Syringe with 29G x ½" | Sterile & Non-sterile | |
| 0.5cc Insulin Syringe with 30G x ½" | Sterile & Non-sterile | |
| 0.5cc Insulin Syringe with 30G x 5/16" | Sterile & Non-sterile | |
| 0.5cc Insulin Syringe with 31G x 5/16" | Sterile & Non-sterile | |
| 1cc Insulin Syringe with 28G x ½" | Sterile & Non-sterile | |
| 1cc Insulin Syringe with 29G x ½" | Sterile & Non-sterile | |
| 1cc Insulin Syringe with 30G x ½" | Sterile & Non-sterile | |
| 1cc Insulin Syringe with 30G x 5/16" | Sterile & Non-sterile | |
| 1cc Insulin Syringe with 31G x 5/16" | Sterile & Non-sterile |
ne/Description n.
New Devices as Compared to Marketed Device(s)
The IMC Insulin Syringe and the predicate device (BD Insulin Syringe) are intended for the subcutaneous injection of insulins
| Feature/Characteristic | IMC Insulin Syringe | BD Insulin Syringe: K024112 (Predicate) |
|---|---|---|
| Intended Use | This device is intended for the subcutaneous injection of insulins | BD Insulin Syringes is intended for the subcutaneous injection of insulins |
| Material | ||
| Barrel | Polypropylene (PP) | Similar |
| Piston | PolyIsoprene | Similar |
| Plunger | High Density Polyethylene (HDPE) | Similar |
| Cannula (or Needle) | SUS 304 | Similar |
| Cannula cap (or Needle cap) | High Density Polyethylene (HDPE) | Similar |
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| Feature/ Characteristic | IMC Insulin Syringe | BD Insulin Syringe: K024112(Predicate) |
|---|---|---|
| Top cap | High Density Polyethylene (HDPE) | Similar |
| Lubricant | Silicone | Similar |
| Length | 5/16" (8mm) and ½" (12.7mm) | 5/16" (8mm) and ½" (12.7mm) |
| Gauge | 28G, 29G, 30G and 31G | 30G and 31G |
| Needle Cover Length | 5/16" size: 21.5mm½" size: 25.5mmAll gauges have the same dimension. | 5/16" size: 21.5mm½" size: 25.5mmAll gauges have the same dimension. |
| Cover color | Orange (for all gauges) | Orange(for all gauges) |
| Tip configuration | Bevel | Bevel |
| Size | 1cc , 0.5cc & 0.3cc | 1cc , 0.5cc & 0.3cc |
Performance Data:
| PerformanceCharacteristics | Test Method | Acceptance Criteria | IMC InsulinSyringe | BD Insulin SyringeK024112 |
|---|---|---|---|---|
| Hub/needle bond strength | ISO 7894 : 1993 | 25G-30G: >22N | Meets StandardCriteria | Meets StandardCriteria |
| Graduation | ISO 8537:1991(E) | A- Volumes less thanhalf the nominalcapacity : +/-(1.5% ofthe nominal capacity+2% of the expelledvolume)B - Volumes equal to orgreater than half thenominal capacity : +/-(5% of the expelledvolume) | Meets StandardCriteria | Meets StandardCriteria |
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.
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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.
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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
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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
§ 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).