(69 days)
The Inviro Snap Safety Insulin Syringes are intended for the subcutaneous injection of insulins. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.
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 After this coupling occurs withdrawal of the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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.
The Inviro Snap Safety Insulin Syringe is a medical device intended for the subcutaneous injection of insulins and designed to prevent needle stick injuries. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with human readers or large-scale outcome data. Therefore, many of the requested elements (like MRMC studies, effect sizes of AI assistance, sample sizes for training sets with detailed ground truth establishment, expert qualifications for ground truth) are not applicable or detailed in this type of submission for this device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, but it does not explicitly state numerical acceptance criteria for each test. It simply states that the "Inviro Snap Safety Insulin Syringe met all requirements." Without specific thresholds for "force to assemble/disassemble," "pressure leakage," "plunger action force," or "accuracy," a quantitative comparison in a table is not possible. However, the tests performed and the general conclusion are listed below:
| Acceptance Criteria (Implicitly Met) | Reported Device Performance |
|---|---|
| Biocompatibility Requirements: | |
| Cytotoxicity | Met all requirements |
| Intracutaneous Reactivity | Met all requirements |
| Maximization Sensitization Study | Met all requirements |
| In Vitro Hemolysis Study | Met all requirements |
| USP and ISO Systemic Toxicity Studies | Met all requirements |
| USP Prorogen Study | Met all requirements |
| Component Interface Tests: | |
| Force to assemble/disassemble cap | Met all requirements |
| Force to separate Adapter from Cannula | Met all requirements |
| Force to Snap off Plunger | Met all requirements |
| Cannula Bending Test | Met all requirements |
| Force required to press out Adapter from Barrel | Met all requirements |
| Syringe Assembly Tests: | |
| Freedom from air and liquid leakage past seals | Met all requirements |
| Pressure Leakage Test | Met all requirements |
| Plunger Action Force | Met all requirements |
| Accuracy | Met all requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each performance test performed. It generally refers to "Prior to testing, First Article Inspections were conducted on all components" and "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."
The data provenance is from Inviro Medical, based in Vancouver, BC, Canada. The testing appears to be retrospective in the sense that it was conducted on manufactured devices before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided as the device tests are engineering and biocompatibility tests, not diagnostic or interpretive tasks requiring human expert consensus for a "ground truth" in the traditional sense of medical image analysis or clinical data. The "ground truth" for these tests would be objective measurements against established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
This is not applicable as the tests are objective engineering and biocompatibility measurements, not subjective human interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is evaluated. The Inviro Snap Safety Insulin Syringe is a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The "standalone" performance in this context refers to the device's own performance against engineering and biocompatibility standards, which was done. The listed tests (biocompatibility, component interface, and syringe assembly tests) are all evaluations of the device itself, independent of human interaction beyond normal use.
7. The Type of Ground Truth Used:
The ground truth used for the performance tests was based on established engineering standards, biocompatibility protocols (e.g., ISO, USP), and regulatory guidelines (FDA G95-1). This is a form of objective, quantitative measurement against predefined criteria.
8. The Sample Size for the Training Set:
This information is not applicable as this device is a physical medical product, not a software algorithm that undergoes machine learning training. There is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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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
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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:
-
- Force to assemble/disassemble cap
-
- Force to separate Adapter from Cannula
-
- Force to Snap off Plunger
-
- Cannula Beriding Test
-
- Force required to press out Adapter from Barrel
The following tests were conducted to qualify the syringe assembly:
-
- Freedom from air and liquid leakage past seals
-
- Pressure Leakage Test
-
- Plunger Action Force
-
- 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
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
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 (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 maj overni 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,
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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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
§ 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).