IMC INSULIN SYRINGE

K110882 · International Medsurg Connection · FMF · Aug 18, 2011 · General Hospital

Device Facts

• Record ID: K110882
• Device Name: IMC INSULIN SYRINGE
• Applicant: International Medsurg Connection
• Product Code: FMF · General Hospital
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended for the subcutaneous injection of insulins

Device Story

IMC Insulin Syringe is a manual piston syringe for subcutaneous insulin delivery. Components include barrel, plunger, piston, and cannula. Operated manually by patients or clinicians to draw and inject insulin. Device facilitates precise dosing via graduated barrel markings. Benefits include reliable insulin administration for diabetes management. No electronic or automated components.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 7894:1993 (hub/needle bond strength) and ISO 8537:1991(E) (graduation accuracy). Results met all established acceptance criteria and were comparable to the predicate device.

Technological Characteristics

Piston syringe; materials: Polypropylene barrel, Polyisoprene piston, HDPE plunger/cap, SUS 304 cannula; silicone lubricant; sizes: 0.3cc, 0.5cc, 1cc; gauges: 28G, 29G, 30G, 31G; lengths: 5/16" (8mm) and 1/2" (12.7mm); tip: bevel; manual operation; sterile and non-sterile options.

Indications for Use

Indicated for subcutaneous insulin injection in patients requiring insulin therapy. Available in 0.3cc, 0.5cc, and 1cc sizes with 28G-31G needles.

Regulatory Classification

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.

Predicate Devices

• Becton Dickinson Consumer Healthcare (BD) - K024112

Submission Summary (Full Text)

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K110882

#### 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<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173 |
| Summary Prepared By: | Peter Kim<br>Director of Quality Assurance<br>International Medsurg Connection<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| 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:

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|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Chine of Acres of Acres of Children<br>A CLASS CLASS COLLEGE OF CHARGES OF<br>DDI<br>חזונפע<br>Svringe | 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/Description<br>Category | 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<br>(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: 21.5mm<br>½" size: 25.5mm<br><br>All gauges have the same dimension. | 5/16" size: 21.5mm<br>½" size: 25.5mm<br><br>All 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:

| Performance<br>Characteristics | Test Method | Acceptance Criteria | IMC Insulin<br>Syringe | BD Insulin Syringe<br>K024112 |
|--------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------|
| Hub/needle bond strength | ISO 7894 : 1993 | 25G-30G: >22N | Meets Standard<br>Criteria | Meets Standard<br>Criteria |
| Graduation | ISO 8537:1991(E) | A- Volumes less than<br>half the nominal<br>capacity : +/-(1.5% of<br>the nominal capacity<br>+2% of the expelled<br>volume)<br><br>B - Volumes equal to or<br>greater than half the<br>nominal capacity : +/-<br>(5% of the expelled<br>volume) | Meets Standard<br>Criteria | Meets Standard<br>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.

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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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital ifection Control, Dental Devices

§10(k) Number: K110882