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

Device Description

The Inviro Medical InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries. The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components: Barrel, Plunger, O-Ring, Stopper, Luer Assembly, Cannula, Locking Ring, Cap. After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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 InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.

AI/ML Overview

The provided text describes the regulatory clearance for the InviroSnap Safety Syringe (K092430). The submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria tied to human or algorithm performance metrics. Therefore, a direct answer to some of the requested points, such as "number of experts used to establish ground truth" or "effect size of human readers with AI," is not applicable as these types of studies were not performed for this 510(k) submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against recognized international standards. The acceptance criteria are implicitly defined by compliance with these standards, not by specific numerical thresholds for, for example, diagnostic accuracy or clinical outcomes.

Acceptance Criteria (Defined by Standard Compliance)	Reported Device Performance
ISO 594-1:1986 (Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part One: General Requirement)	The submission indicates "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." This implies the device met the requirements of this standard for general luer connector specifications.
ISO 594-2:1986 (Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part Two: Locked Connector)	The submission indicates "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." This implies the device met the requirements of this standard for locked luer connector specifications.
ISO 7886-1:1993 (Sterile hypodermic syringes for single use)	The submission indicates "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." This implies the device met the requirements of this standard for general sterile hypodermic syringes for single use.
ISO 7886-4:2006 (Sterile hypodermic syringes for single use, Syringes with re-use prevention feature)	The submission indicates "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." This implies the device met the requirements of this standard specific to syringes with re-use prevention features, which is a key safety aspect of the InviroSnap.
ISO 11135:2007 (Medical Devices Validation and Routine Control of EO Sterilization)	The submission indicates "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." This implies the device met the requirements for validation and routine control of Ethylene Oxide (EO) sterilization.

2. Sample Size for Test Set and Data Provenance

The provided text does not specify a "test set" in the context of clinical data for performance evaluation. The performance testing was based on compliance with international standards, likely involving engineering tests, material evaluations, and sterilization validation, not patient-specific data. Therefore, details like "country of origin" or "retrospective/prospective" are not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this type of device (a safety syringe) is established through engineering and materials testing to meet specified performance standards and safety features, not through expert consensus on medical images or clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this submission.

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

No. An MRMC study is typically performed for diagnostic devices or AI algorithms that analyze clinical data and require human interpretation. This device is a physical medical device (safety syringe); therefore, an MRMC study was not conducted. The submission does not mention AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical safety syringe, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance, as demonstrated in the 510(k) submission, is compliance with established international performance and safety standards (ISO standards). This involves demonstrating that the device physically functions as intended (e.g., proper luer lock, needle retraction, sterilization efficacy) through laboratory and engineering tests, rather than clinical outcomes or expert diagnoses.

8. Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or clinical data analysis for this device. The development and testing of a physical medical device do not typically involve this concept.

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

Not applicable. As there was no training set, this information is not relevant.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The study proving the InviroSnap Safety Syringe meets acceptance criteria was a series of non-clinical performance tests demonstrating compliance with relevant voluntary international standards. The 510(k) submission states: "Performance testing consisted of compliance to the applicable sections of the following voluntary standards: ISO 594-1:1986, ISO 594-2:1986, ISO 7886-1:1993, ISO 7886-4:2006, and ISO 11135:2007."

The rationale for regulatory clearance (510(k)) was based on the demonstration of substantial equivalence to a predicate device (InviroSnap 1, 3, 5 and 10 ml Safety Syringe, K032780). The submitter asserted that "Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness." This means that the device was shown to perform comparably to an already legally marketed device and pass the stipulated engineering and sterilization standards. No clinical studies with human participants were required or conducted as part of this specific 510(k) submission to prove the device's safety or effectiveness beyond its equivalence and compliance with standards.

Summary

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K092430

SEP - 4 2009

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

Submitter Information A.

Inviro Medical, Inc. 1755 North Brown Road Suite 150 Lawrenceville, GA 30043

· Phone Number: Fax Number:

678-405-4037 678-405-4044

Establishment Number:

3005147037

Trade Name:

InviroSnap Safety Syringe

Safety Syringe

Syringe

80 MEG

880.5860

B. Device Information

Trade/Proprietary Name:

InviroSnap Safety Syringe

Piston Syringe with Safety

Common name of device:

Classification Name:

Product Code:

Regulatory Class:

Classification Number:

Reason for 510(k):

C. Predicate Device:

InviroSnap 1, 3, 5 and 10 ml Safety Syringe

Special 510(k)

Predicate 510(k) #: K032780

Predicate product code: MEG

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Device Description D.

The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:

Barrel The barrel has a scale showing the capacity of the ﻠﺴﻴﻨﻴﺎ syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
Plunger Once the plunger is fully depressed, it engages the 2 needle assembly. As the plunger is retracted, the needle assembly is retracted into the barrel. Once the plunger is fully retracted and locked in place, the plunger is snapped off leaving the needle in the barrel of the syringe.
O-Ring The O-ring minimizes the risk of leakage around 3 the Adapter.
Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
Luer Assembly -- The Luer Assembly facilitates passage of the 5 fluid between the cannula and the barrel. In addition, the Luer Assembly holds the needle and engages the plunger after the injection.
Cannula The cannula/needle penetrates the patient's skin to 6 iniect/withdraw fluid from the body.
Locking Ring A plastic insert at the top of the barrel. After 7. the injection, the health care professional retracts the plunger with the needle into the barrel. Once the plunger is fully retracted, the plunger is locked into position at the top of the barrel. This safety mechanism makes sure the needle can not be pushed back out the tip of the barrel.
Cap Covers the cannula/needle until the syringe is to be used. 8

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D. Device Description

After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back 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 InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas 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.

Statement of Indications for Use E.

The InviroSnap 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: F.

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroSnap 1, 3, 5, 10 and 20 ml Safety Syringe and the cited predicate device.

Summary and Conclusion of Nonclinical and Clinical Tests: G.

The intended use of the InviroSnap 1, 3, 5, 10 and 20 ml Safety Syringes is identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

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Summary and Conclusion of Nonclinical and Clinical Tests: G.

Performance testing consisted of compliance to the applicable sections of the following voluntary standards:

ISO 594-1:1986, "Syringe, Syringe Needle and Other 1. Medical Apparatus 6% (Lu-Er) Taper Connector -Part One: General Requirement"
ISO 594-2:1986, "Syringe, Syringe Needle and Other 2. . Medical Apparatus 6% (Lu-Er) Taper Connector -Part Two: Locked Connector"
ISO 7886-1:1993, Sterile hypodermic syringes for 3. single use
ISO 7886-4:2006, Sterile hypodermic syringes for 4. single use, Syringes with re-use prevention feature
ISO 11135:2007; Medical Devices Validation and 5. Routine Control of EO Sterilization,

Conclusion:

The InviroSnap 1, 3, 5, 10 and 20 ml Safety Syringes are substantially equivalent to the InviroSnap 1, 3, 5 and 10 ml Safety Syringe in indications for use and technological characteristics.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines extending upwards from its body.

SEP - 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. James Barley Director of Regulatory Affairs/Quality Assurance Inviro Medical Devices, Incorporated 1755 North Brown Road, Suite 150 Lawrenceville, Georgia 30043

Re: K092430

Trade/Device Name: InviroSnap Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: July 31, 2009 Received: August 7, 2009

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 ffor 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 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); 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/ReportaProblem/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. Watson be

Susan Runner, D.D.S., M.A. Acting Division 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 (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092430 Page 1 of 1

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).