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 medicines and vaccines 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:

l Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
2 Plunger - After using the syringe, the plunger is retracted and snapped off leaving the needle in the barrel of the syringe.
3 O-Ring - The O-ring minimizes the risk of leakage around the Adapter.
Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
Adapter The Adapter facilitates passage of the fluid 5 between the cannula and the barrel. In addition, the cannula/needle is bonded to the Adapter.
6 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
7 Cap - Covers the cannula/needle until the syringe is to be used.

After use, the health care professional fully depresses the plunger to engage the Adapter Needle assembly. Once the Adapter Needle Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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.

AI/ML Overview

This 510(k) summary describes a special 510(k) submission for the InviroSnap Safety Syringe, which is an updated version of a previously cleared device. The submission primarily focuses on demonstrating substantial equivalence to the existing predicate device through compliance with recognized standards rather than extensive clinical studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
ISO 594-1:1986 "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part One: General Requirement"	Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance".
ISO 594-2:1986 "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part Two: Locked Connector"	Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance".
ISO 7886-1:1993 "Single Use Sterile Syringe"	Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance".
ISO 7886-3:2005 "Auto-disable syringes for fixed-4 - dose immunization"	Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance".

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

The document does not explicitly state the sample size used for the performance testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the general statement that "performance testing consisted of compliance to the applicable sections of the following voluntary standards." This suggests that the testing was likely conducted in a controlled lab environment and is not based on patient data.

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

Not applicable. This submission relies on engineering and device performance standards, not expert-adjudicated clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as the testing is based on engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical and functional equivalence of the device to standards, not human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical device (syringe), not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the specified voluntary international standards (ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-3). These standards define the expected physical and functional characteristics for syringes.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device. The design and manufacturing process would adhere to an established quality system and engineering specifications, which are based on the requirements of the referenced ISO standards.

Summary

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K070203

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

Submitter Information A.

Inviro Medical 3235 Satellite Blvd. Bldg 400, Suite 300 Duluth, GA 30096

APR 2 3 2007

Phone Number:	770-291-2186
Fax Number:	770-291-2181
Contact:	Jim Barley
	Director RA/QA

. .

Trade Name:

InviroSnap Safety Syringe

Device Information B.

	Trade/Proprietary Name:		InviroSnap Safety Syringe
	Common name of device:		Safety Syringe
	Classification Name:		Piston Syringe with SafetySyringe
	Product Code:		80 MEG
	Regulatory Class:	II
	Classification Number:		880.5860
	Reason for 510(k):		Special 510(k)
C.	Predicate Device:		INVIRO 6 cc Syringe
	Predicate 510(k) #:		K941450
	Predicate product code:		MEG

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K070203
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D. Device Description

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

l Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
2 Plunger - After using the syringe, the plunger is retracted and snapped off leaving the needle in the barrel of the syringe.
3 O-Ring - The O-ring minimizes the risk of leakage around the Adapter.
Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
Adapter The Adapter facilitates passage of the fluid 5 between the cannula and the barrel. In addition, the cannula/needle is bonded to the Adapter.
6 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
7 Cap - Covers the cannula/needle until the syringe is to be used.

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Device Description D.

Statement of Indications for Use E.

The InviroSnap Safety Syringe is used to inject medicine or vaccines into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Insulin 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 InviroSanp 3 ml, 5 ml and 10 ml Safety Syringe and the cited predicate device.

Summary and Conclusion of Nonclinical and Clinical Tests: G.

The intended use of the InviroSnap 3 ml, 5 ml and 10 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.

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"

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КОЛОЗОВ

Summary and Conclusion of Nonclinical and Clinical Tests: G

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, "Single Use Sterile Syringe" 3.
ISO 7886-3:2005, "Auto-disable syringes for fixed-4. dose immunization

Conclusion:

The InviroSnap 3 ml, 5 ml and 10 ml Safety Syringes are substantially equivalent to the Inviro 6 ml Syringe in indications for use and technological characteristics.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted as a staff with two snakes entwined around it and wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Barley Director of Regulatory Affairs/Quality Assurance Inviro Medical Devices, Incorporated 3235 Satellite Boulevard, Building 400, Suite 300 Duluth, Georgia 30096

APR 2 3 2007

Re: K070203

Trade/Device Name: InviroSnap Safety Syringe, 3ml, 5ml and 10ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 23, 2007 Received: March 26, 2007

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susa Rungs
Chiu Lin, Ph.D.

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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K070203

Indications For Use

510(k) Number (if known): K070203

Device Name: InviroSnap Safety Syringes, 3 ml, 5 ml and 10 ml

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)

Ants Vepre

on of Aneculestiology, General Houpliall, Jon Control, Dismal Devices

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്(k) Number:_________________________________________________________________________________________________________________________________________________________________

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).