INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC by INVIRO MEDICAL

The Inviro Snap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.

Device Description

The Inviro Snap Safety Syringe is a retractable type anti-needlestick syringe. The Inviro Snap Safety 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 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 After this coupling occurs withdrawal of the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Inviro Snap Safety Syringe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with numerical targets for each test. Instead, it describes general requirements and states that the device "met all accuracy requirements," "met all of the biocompatibility requirements," and that "any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness."

However, we can infer some criteria and reported performance from the descriptions of the tests:

Acceptance Criteria/Test	Performance Statement in Document
Biocompatibility	* "The Inviro Snap Safety Syringe met all of the biocompatibility requirements."
- Cytotoxicity	* (Part of "all biocompatibility requirements")
- Intracutaneous Reactivity	* (Part of "all biocompatibility requirements")
- Maximization Sensitization Study	* (Part of "all biocompatibility requirements")
- In Vitro Hemolysis Study	* (Part of "all biocompatibility requirements")
- USP/ISO Systemic Toxicity Studies	* (Part of "all biocompatibility requirements")
- USP Pyrogen Study	* (Part of "all biocompatibility requirements")
Scale Accuracy	* "The scale met all accuracy requirements."
Force to separate Adapter from Cannula	* "The ISO Standard requires a minimum of 4,9 lbs of force to separate the cannula from the adaptor."
* "The average force along with the standard deviation was determined for separating the cannula from the adapter."
Freedom from air and liquid leakage past seals	* "Medication leakage can occur around the plunger seal or around the needle holder. This test involves blocking the needle lumen and forcing the plunger handle forward. Pressure is increased incrementally and held for several seconds at each increment. The pressure at which leakage occurs and the location of the leak is recorded."
* Implicit acceptance: No leakage at required pressures.
Pressure Leakage Test (internal pressure)	* "In this test series, the system was submerged in liquid and an internal pressure of 43.5 and 400 PSI was applied. Any leakage past the seals was recorded."
* Implicit acceptance: No leakage at required pressures.
Plunger Action Force	* "This test measures the force to initiate plunger action as well as the maximum and minimum forces required to move the plunger within the Barrel."
* Implicit acceptance: Plunger action within acceptable force range for usability.
Force to Assemble/Disassemble Cap	* "The average force along with the standard deviation is determined to assemble and disassemble the Cap from the Barrel. A good seal between the cap and barrel will reduce the chance that the cap will fall off and expose the needle."
* Implicit acceptance: Force within a range that ensures a good seal and ease of use.
Force to Snap off Plunger	* "A torque gauge is used to snap off the plunger from the syringe. This test will verify that the plunger is not too difficult to snap off."
* Implicit acceptance: Plunger snaps off within an acceptable force range for safe disposal.
Cannula Bending Test	* "To verify the cannula can withstand the forces required to penetrate a medicine bottle septum."
* Implicit acceptance: Cannula withstands forces without bending inappropriately.
Force required to press out Adapter from Barrel	* "This test determines the force required to push/press out the adaptor from the barrel. This test will assure that the adaptor is not pushed out during an injection."
* Implicit acceptance: Adapter remains in place during injection.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size for any of the individual verification (test set) tests. It mentions "all components" for First Article Inspections and material verification but doesn't quantify the number of devices or components tested for the performance evaluations.
Data Provenance: The studies are described as nonclinical (biocompatibility, mechanical testing) and were conducted within the context of the device manufacturer and its testing processes. The country of origin for the data is not specified beyond the submitter's address being in Vancouver, BC, Canada, implying the studies were performed or overseen by entities associated with Inviro Medical. The studies appear to be prospective as they were conducted specifically for the purpose of validating this device model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable: For a device like a syringe, "ground truth" in the sense of expert medical diagnosis or interpretation (e.g., as in an AI imaging study) is not applicable. The evaluations are based on objective physical and chemical tests, and compliance with established standards (ISO, AAMI, FDA G95-1).

4. Adjudication Method for the Test Set

Not Applicable: As the tests are objective, physical, and chemical measurements against predefined criteria/standards, an adjudication method for conflicting expert opinions is not relevant. The results are binary (pass/fail) based on measurement outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without AI assistance. The Inviro Snap Safety Syringe is a mechanical medical device, not a diagnostic tool, so such a study would not be relevant.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was done, but not for an algorithm in the typical AI sense. All the described tests (biocompatibility, scale accuracy, mechanical tests like force to separate cannula, leakage tests, plunger action force, etc.) evaluate the device's inherent physical and chemical properties and performance without human intervention during the test itself. This is akin to standalone performance for a mechanical device. There is no "algorithm" to be evaluated independently of human interaction in this context; the device itself is the "algorithm" in how it functions mechanically.

7. Type of Ground Truth Used for the Test Set

Objective Standards and Measurements: The ground truth for the device's performance is established by:
- International Standards: ISO 7864:1993(E), ISO 7886-1:1993(E), ANSI/AAMI/ISO 10993-1:1997.
- Regulatory Guidance: FDA G95-1 (General Program Memorandum).
- Material Specifications: Verification tests on components and materials.
- Engineering Specifications: Designed tolerances and performance characteristics (e.g., "minimum of 4.9 lbs of force to separate the cannula").
- Physical Measurements: Data collected from weighing, force gauges, pressure transducers, etc.

8. Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The Inviro Snap Safety Syringe is a manufactured medical device, not an AI model. Its design and manufacturing processes are based on engineering principles and established standards, rather than statistical learning from data in a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no training set for an AI/machine learning model, the concept of establishing ground truth for it does not apply. The device's design is based on established engineering principles, material science, and regulatory requirements, not learned from a "ground truth" dataset.

Summary

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SEP 2 4 2003

K032780

510(k) Summary (As required by 21 CFR 807.92(a))

Submitter Information A.
Inviro Medical 885 West Georgia Street Suite 1200 Vancouver, BC V6C3E8 Canada Phone Number: 604-688-6115 604-451-7002 Fax Number: F. Ross Sharp, MD Contact: President August 25, 2003 Date:
B. Device Information

Trade/Proprietary Name:	Inviro Snap Safety Syringe
Common name of device:	Piston Syringe with Safety Feature
Classification Name:	Piston Syringe with Safety Syringe
Predicate Device:	Inviro 6 cc Syringe
Predicate 510(k) #:	K941450

D. Device Description:
்

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After use, with the plunger fully compressed, a 180 degree rotation of the plunger couples the Adapter 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.

ய Intended Use:
The Inviro Snap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.
Comparison of Required Technological Characteristics: に.
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Inviro Snap Safety Syringe and the cited predicate device.
Summary and Conclusion of Nonclinical and Clinical Tests: G.
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.

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.

Tests were conducted to determine the accuracy of the scale on the Inviro Snap Safety Syringe. These tests consisted of weighing the syringe, filling the syringe to various increments, weighing the syringe, expelling the fluid and weighing the syringe once again. All weights were recorded. The mean and standard deviation was calculated for all increments. The scale met all accuracy requirements.

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Verification Testing consisted of component and interface testing and finished assembly testing. The following tests were performed to verify the compatibility between the interfacing safety syringe components:

1. Force to assemble cap In this test, the average force along with the standard deviation is determined to assemble and disassemble the Cap from the Barrel. A good seal between the cap and barrel will reduce the chance that the cap will fall off and expose the needle.
1. Force to separate Adapter from Cannula This test was conducted per ISO 7864:1993(E) paragraph 13.1. The average force along with the standard deviation was determined for separating the cannula from the adapter. The ISO Standard requires a minimum of 4,9 lbs of force to separate the cannula from the adaptor.
1. Force to Snap off Plunger A torque gauge is used to snap off the plunger from the syringe. This test will verify that the plunger is not too difficult to snap off.
1. Cannula Bending Test To verify the cannula can withstand the forces required to penetrate a medicine bottle septum.
1. Force required to press out Adapter from Barrel This test determines the force required to push/press out the adaptor from the barrel. This test will assure that the adaptor is not pushed out during an injection.

To verify that the assembled devices met the design requirements, the following tests were performed:

Freedom from air and liguid leakage past seals Medication leakage can 1. occur around the plunger seal or around the needle holder. This test involves blocking the needle lumen and forcing the plunger handle
- forward. Pressure is increased incrementally and held for several seconds at each increment. The pressure at which leakage occurs and the location of the leak is recorded.
1. Pressure Leakage Test - This test was conducted per ISO 7886-1:1993(E) Annex D. In this test series, the system was submerged in liquid and an internal pressure of 43.5 and 400 PSI was applied. Any leakage past the seals was recorded.
1. Plunger Action Force - This test was conducted per ISO 7886-1:1993(E) Annex G. This test measures the force to initiate plunger action as well as the maximum and minimum forces required to move the plunger within the Barrel. :

The intended use of the Inviro Snap Safety Syringe is identical to that of the cited predicate device. Verification testing showed that any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

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Conclusion:

The Inviro Snap Safety Syringe is substantially equivalent to the Inviro 6 cc Syringe in indications for use and technological characteristics.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines.

Public Health Service

SEP 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inviro Medical C/O Mr. James Barley Regulatory Affairs JB & Associates 28481 LA Falda Laguna Niguel, California 92677

Re: K032780

Trade/Device Name: Inviro Snap Safety Syringe, 1cc, 3cc, 5cc, and 10cc, Regulation Number: 880.5860 Regulation Name: Piston Syringe with Safety Feature Regulatory Class: II Product Code: MEG Dated: September 3, 2003 Received: September 8, 2003

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 (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.

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 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. Barley

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of 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 Division of 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 Runre

Susan Runner, DDS, MA Interim 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 Statement

510(k) Number (if known): _______________

Device Name:

Indications for Use:

Patrice Laurenti

ivision Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032780

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Use __ (Per 21 CFR 801.109)

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).