INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905

K040036 · Inviro Medical · MEG · Mar 18, 2004 · General Hospital

Device Facts

• Record ID: K040036
• Device Name: INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
• Applicant: Inviro Medical
• Product Code: MEG · General Hospital
• Decision Date: Mar 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inviro Snap Safety Insulin Syringes are intended for the subcutaneous injection of insulins. In addition, the Inviro Snap Safety Insulin Syringe is designed to aid in the prevention of needle stick injuries.

Device Story

Inviro Snap Safety Insulin Syringe is a 1 cc retractable piston syringe with a 100-unit scale. Device facilitates subcutaneous insulin delivery while incorporating an antineedlestick safety mechanism. Operation involves manual injection; post-injection, user rotates plunger 180 degrees to couple needle/adapter to plunger. Withdrawal of plunger retracts needle into barrel. Lateral pressure on plunger against flange causes controlled fracture, securing needle within barrel for disposal in sharps container. Device is sterile, single-use, and intended for clinical or home settings. Safety mechanism reduces risk of accidental needlestick injuries to healthcare providers or patients during disposal.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, hemolysis, systemic toxicity, pyrogenicity) and mechanical performance (force to assemble/disassemble, cannula bending, pressure leakage, plunger action, and accuracy).

Technological Characteristics

1 cc piston syringe with retractable needle mechanism. Materials verified via First Article Inspection. Sterilized via gamma irradiation. Complies with ANSI/AAMI/ISO 10993-1:1997 for external communicating, blood path, indirect contact (<30 days).

Indications for Use

Indicated for subcutaneous insulin injection in patients requiring insulin therapy. No specific age or gender restrictions stated.

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

• B-D 1 cc Insulin Syringe (K024112)
• Inviro 6 cc Syringe (K941450)

Submission Summary (Full Text)

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K040036

MAR 1 8 2004

510(k) Summary (As required by 21 CFF 807 92(a))

- A. Submitter Information
Inviro Medical 885 West Georgia Street Suite 1200 Vancouver, BC V6C3E8 Canada

Phone Number:

604-688-6115

Fax Number:

604-451-7002

Contact:

F. Ross Sharp, MD President January 7, 2004

- B. Device Information
Date:

Trade/Proprietary Name:

Common name of device:

Classification Name:

- Predicate Device: C:
Predicate 510(k) #:

Inviro Snap Safety 1 cc Insulin Syringe

Piston Syringe with Safety Feature

Piston Syringe with Safety Syringe

B-D 1 cc Insulin Syringe Inviro 6 cc Syringe

K024112 K941450

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## Device Description: D.

The Inviro Snap Safety Insulin Syringe is a 1 cc retractable type antineedlestick syringe. The syringe has a 100 unit scale in 1 unit increments. The Inviro Snap Safety Insulin Syringe is sterilized by gamma irradiation and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

After use, with the plunger fully compressed, a 180 degree rotation of the plunger couples the Adapter/Needle to the end of the plunger. After this coupling occurs withdrawal of the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.

- E. Intended Use:
The Inviro Snap Safety Syringes are intended for the subcutaneous injection of insulins. In addition, the Inviro Snap Safety Insulin Syringe is designed to aid in the prevention of needle stick injuries.

- F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Inviro Snap Safety Insulin Syringe and the cited predicate devices.

- G. Summary and Conclusion of Nonclinical and Clinical Tests:
Prior to testing, First Article Inspections were conducted on all components. In addition, material verification was performed on all components.

The Inviro Snap Safety Syringe assembly was tested per the requirements of the ISO-FDA Modified Matrix, FDA/ODE General Program Memorandum - # G95-1 and ANSI/AAMI/ISO 10993-1:1997 for a External communicating device, Blood path, indirect for a period less than 30 days,

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Biocompatibility testing included Cytotoxicity, Intracutaneous Reactivity, Maximization Sensitization Study, In Vitro Hemolysis Study, USP and ISO Systemic Toxicity Studies and USP Prorogen Study. The Inviro Snap Safety Syringe met all of the biocompatibility requirements.

The following performance tests were conducted to qualify the interface between the various components:

- 1. Force to assemble/disassemble cap
- 2. Force to separate Adapter from Cannula
- 3. Force to Snap off Plunger
- 4. Cannula Beriding Test
- 5. Force required to press out Adapter from Barrel

The following tests were conducted to qualify the syringe assembly:

- 1. Freedom from air and liquid leakage past seals
- 2. Pressure Leakage Test
- 3. Plunger Action Force
- 4. Accuracy

The Inviro Medical Snap Safety 1 cc Insulin Syringe met all requirements.

The intended use of the Inviro Snap Safety Insulin Syringe is identical to that of the B-D 1 cc Insulin Syringe. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

Conclusion:

The Inviro Snap Safety Insulin Syringe is substantially equivalent to the B-D 1 cc Insulin Syringe in indications for use and technological characteristics.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2004

Inviro Medical C/O Mr. James Barley Regulatory Affairs JB & Associates 885 West Georgia Street Suite 1200 Vancouver, BC V6C3E8 CANADA

Re: K040036

Trade/Device Name: Inviro Snap Insulin Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 7, 2004 Received: January 9, 2004

Dear Mr. Barley:

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 (P.MA). 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 fourd 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. Barley

Please be advised that FI)A's issuance of a substantial equivalence determination does not I lease be act rised that 1 2 a determination that your device complies with other requirements mount that I Dri may made statutes and regulations administered by other Federal agencies. or the Act or any I ouchal tike Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 807), ideality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are it 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) I mis letter will and in Jorle FDA finding of substantial equivalence of your device to a premarket notification. - The First 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), If you desire specific at Compliance at [phone]. 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 maj overni Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Russo

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

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K040036

Page 1 of 1

## Indications for Use Statement

510(k) Number (if known): K040036

Device Name:

Indications for Use:

The Inviro Snap Safety Insulin Syringes are intended for the subcutaneous injection of insulins. In addition, the Inviro Snap Safety Syringe is designed to aicl in the prevention of needle stick injuries.

Vola Hieberal

(Division Sign-Off) (Division Sign Off, Oth, Oth, General Hospital, Infection Control, Dental Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ーーー Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The- Counter Use レ