(28 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and compliance with standard syringe performance and sterilization standards. There is no mention of AI, ML, or any computational analysis of data.
No
The device is described as a safety syringe used for injecting or withdrawing fluids and preventing needle stick injuries, and it does not state that it treats or cures any disease or condition.
No
Explanation: The device is described as a safety syringe used for injecting or withdrawing fluids and preventing needle stick injuries. There is no mention of it being used to identify or diagnose a disease or condition.
No
The device description clearly outlines physical components like a barrel, plunger, and needle, and describes a mechanical action for needle retraction, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body" and to "aid in the prevention of needle stick injuries." This describes a device used for administering or collecting substances directly from a living organism, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe with a safety mechanism for preventing needle sticks. This is a medical device used for direct patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other activities typically associated with in vitro diagnostics.
In summary, the InviroSnap Safety Syringe is a medical device used for administering and withdrawing fluids from the body, with a focus on safety. It does not perform any diagnostic testing on samples outside the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MEG
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 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.
- Plunger Once the plunger is fully depressed, it engages the 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 the Adapter.
- Stopper The Stopper maintains the fluid in the barrel between the Adapter and Plunger.
- Luer Assembly -- The Luer Assembly facilitates passage of the 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 iniect/withdraw fluid from the body.
- Locking Ring A plastic insert at the top of the barrel. After 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing consisted of compliance to the applicable sections of the following voluntary standards:
- ISO 594-1:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part One: General Requirement"
- ISO 594-2:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part Two: Locked Connector"
- ISO 7886-1:1993, Sterile hypodermic syringes for single use
- ISO 7886-4:2006, Sterile hypodermic syringes for single use, Syringes with re-use prevention feature
- ISO 11135:2007; Medical Devices Validation and Routine Control of EO Sterilization,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
II
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
1
Device Description D.
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 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
2
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.
3
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.
4
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.
5
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
6
Indications For Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
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.
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