(154 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 software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats a disease or condition. While the syringe is used to deliver medicine that might be therapeutic, the syringe itself does not provide the therapy; it is a delivery mechanism.
No
Explanation: The device is a hypodermic syringe, which is used for injecting or withdrawing fluids, not for diagnosing conditions. Its description and intended use clearly state its function as a tool for administration or collection, not for diagnostic purposes.
No
The device description clearly outlines physical components (barrel, plunger, stopper, cannula, cap) and manufacturing processes (sterilization, packaging), indicating it is a hardware medical device.
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 medicine or vaccines into, or withdraw fluids from, the body." 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 standard hypodermic syringe, which is a tool for administering or collecting substances from the body, not for performing tests on those substances outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. The components and function are solely related to the physical act of injection or withdrawal.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This syringe is a tool for obtaining or delivering substances, not for analyzing them.
N/A
Intended Use / Indications for Use
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.
The InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes are used to inject medicines into, or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
80 FMF
Device Description
The InviroStripe Standard 3, 5 and 10 ml 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 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 5 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case 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 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"
-
- ANSI/AAMI/ISO 11135 - "Medical Devices -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 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
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510(k) Summary (As required by 21 CFR 807.92(a))
OCT 2 2 2008
- Submitter Information A.
BMDI Pty Ltd. 63-79 Parramatta Road Suite 306 Silverwater, Australia NSW 2128
| Phone Number: | 949-433-3058 |
|---|---|
| Fax Number: | 949481-5745 |
| Contact: | Jim Barley |
| US Agent |
Trade Name:
C.
InviroStripe Standard 3, 5 and 10 ml hypodermic syringes
- B. Device Information
| Trade/Proprietary Name: | InviroStripe Standard 3, 5 and
10 ml hypodermic syringes |
|-------------------------|-------------------------------------------------------------|
| Common name of device: | Piston Syringe |
| Classification Name: | Piston Syringe |
| Product Code: | 80 FMF |
| Regulatory Class: | II |
| Classification Number: | 880.5860 |
| Reason for 510(k): | New Device |
| Predicate Device: | Yi Xin Sterile Syringe for Single Use |
| Predicate 510(k) #: | K050999 |
| | |
Predicate product code: FMF
1
K051436
2 of 3
- D. Device Description
The InviroStripe Standard 3, 5 and 10 ml 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 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 5 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case 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 InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.
2
208/436
343
-
F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroStripe Standard 3, 5 and 10 ml hypodermic syringes and the cited predicate device. -
G. Summary and Conclusion of Nonclinical and Clinical Tests:
The intended use of the InviroStripe Standard 3, 5 and 10 ml hypodermic 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"
-
- ANSI/AAMI/ISO 11135 - "Medical Devices -Validation and Routine Control of Ethylene Oxide 、 Sterilization
- ISO 11607;2003 Packaging for terminally sterilized న. medical devices
-
- ISO 10993-4:2006 - Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
Conclusion:
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are substantially equivalent to the Yi Xin Sterile Syringe for Single Use in indications for use and technological characteristics.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2008
BMDI Pty Limited C/O Mr. James Barley James Barley 33572 Sea Wind Court Dana Point, California 92629
Re: K081436
Trade/Device Name: InviroStripe 3,5 and 10 ml Luer Lock Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 1, 2008 Received: October 6, 2008
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.
4
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 (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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Chris S. Lim, Ph.D.
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication For Use
510(k) Number (if known): K081436
Device Name: InviroStripe 3, 5 and 10 ml Luer Lock Syringes
Indication For Use:
The InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes are used to inject medicines into, or withdraw fluids from the body.
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)
Charles Brown for ADW
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081434 Page 1 of 1