(98 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard hypodermic syringe, with no mention of AI or ML capabilities.
No.
The device is a syringe used for fluid delivery and withdrawal, which are not considered therapeutic actions in and of themselves.
No
The device is a syringe, used for injecting medicines or withdrawing fluids, which are actions related to treatment or sample collection, not diagnosis.
No
The device description clearly outlines physical components (barrel, plunger, stopper, cap) and manufacturing processes (sterilization, packaging), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject medicines and vaccines into, or withdraw fluids from, the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes on the patient, not for testing samples from the body in a laboratory setting.
- Device Description: The description details a standard hypodermic syringe, which is a tool for administering or collecting substances directly from a living organism.
- 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, etc.) to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed for testing samples in vitro (outside the body) to gain information about a person's health. This syringe is used in vivo (within the body).
N/A
Intended Use / Indications for Use
The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
The piston syringe is a plastic disposable htpodermic syringe made of the following components:
- 1 -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 - The plunger is used to aspirate and inject fluids into and out of the syringe.
- 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
- 4 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are 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 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, "Single Use Sterile Syringe" 3.
- ANSI/AAMI/ISO 11135:2007 "Medical Devices -4. Validation and Routine Control of Ethylene Oxide Sterilization
- ISO 11607;2003 Packaging for terminally sterilized medical devices
- ISO 10993-4:2006 Biological evaluation of medical 6. devices Part 4: Selection of tests for interactions with blood
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
510(k) Summary (As required by 21 CFR 807.92(a))
April 29, 2010 Date prepared:
AUG 2 0 2010
Submitter Information A.
Inviro Medical, Inc. 1755 North Brown Road Suite 150 Lawrenceville, GA 30043
Phone Number: Fax Number: Contact:
949-433-3058 949481-5745 Jim Barley Director of RA/QA
Trade Name:
InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes
B. Device Information
Trade/Proprietary Name:
InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes
Common name of device:
Classification Name:
Product Code:
Regulatory Class:
Classification Number:
Reason for 510(k):
InviroStripe 1, 3, 5, 10, 20, 30
and 60 ml Standard Luer Lock
syringes
Piston Syringe
Piston Syringe
80 FMF
II
880.5860
Special 510(k) - Change in packaging, expansion of product line and change of contract manufacturer.
1
C. Predicate Device:
InviroStripe 3, 5 and 10 ml Standard Luer Lock syringes
Predicate 510(k) #:
Predicate product code: FMF
- D. Device Description
The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
The piston syringe is a plastic disposable htpodermic syringe made of the following components:
- 1 -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 - The plunger is used to aspirate and inject fluids into and out of the syringe.
- 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
- 4 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
2
- Statement of Indications for Use E.
The InviroStripe Standard Luer Lock Syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.
Comparison of Required Technological Characteristics: F.
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroStripe Standard Luer Lock Syringes and the cited predicate device.
- Summary and Conclusion of Nonclinical and Clinical Tests: G.
The intended use of the InviroStripe Standard Luer Lock Syringes are 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"
- 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.
- ANSI/AAMI/ISO 11135:2007 "Medical Devices -4. Validation and Routine Control of Ethylene Oxide Sterilization
- ISO 11607;2003 Packaging for terminally sterilized ડ. medical devices
- ISO 10993-4:2006 Biological evaluation of medical 6. devices Part 4: Selection of tests for interactions with blood
3
Conclusion:
The InviroStripe 1, 3, 5, 10, 20, 30 and 10 ml Standard Luer Lock Syringes are substantially equivalent to the InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes 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 features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jim Barley Director of Regulatory Affairs/ Quality Assurance Inviro Medical Devices, Incorporated 1755 North Brown Road, Suite 150 Lawrenceville, Georgia 30043
AUG 20 2010
Re: K101359
Trade/Device Name: Inviro Medical Luer Lock Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 30, 2010 Received: August 03, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Pease
Anthony D. Watson, B.S., M.S., M.B.A. 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): K101359
Device Name:_Inviro Medical Luer Lock Syringe
Indications For Use:
The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
Prescription Use X (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)
Ri C. A
(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K101359 510(k) Number: __
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