(91 days)
Not Found
No
The device description and performance studies focus on mechanical components and compliance with physical standards, with no mention of AI/ML or data processing.
No.
A therapeutic device is one that treats or mitigates a disease or condition. This device is used for injecting or withdrawing fluids, which are procedures, but the device itself does not provide a therapeutic effect. Its primary function beyond fluid handling is safety (prevention of needle stick injuries).
No
This device is a syringe designed for injecting or withdrawing fluids and preventing needle stick injuries. It does not perform any diagnostic function.
No
The device description clearly outlines multiple physical components (barrel, plunger, O-ring, stopper, adapter, cannula, cap) and describes a mechanical mechanism for needle retraction and disposal. There is no mention of software as part of the device's function.
Based on the provided information, the InviroSnap Safety Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for 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 direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a syringe designed for injecting and withdrawing fluids from the body, with a safety mechanism to prevent needle sticks. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living organism) to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed for testing samples outside the body. The InviroSnap Safety Syringe is clearly designed for direct patient interaction within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
80 MEG, MEG
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.
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
health care professional
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, "Single Use Sterile Syringe"
- ISO 7886-3:2005, "Auto-disable syringes for fixed-dose immunization
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.
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).
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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 Safety | ||
| Syringe | |||
| 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 |
1
K070203
2 & 4
D. 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.
2
3 of 4
Device Description D.
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 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"
3
КОЛОЗОВ
- А4
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.
4
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.
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); 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
6
Indications For Use
510(k) Number (if known): K070203
Device Name: InviroSnap Safety Syringes, 3 ml, 5 ml and 10 ml
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)
Ants Vepre
on of Aneculestiology, General Houpliall, Jon Control, Dismal Devices
Page 1 of 1
്(k) Number:_________________________________________________________________________________________________________________________________________________________________