K Number
K051800
Device Name
IN6 SAFETY SYRINGE, MODEL 3ML
Date Cleared
2005-10-21

(108 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The In6 Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.
Device Description
The In6 Safety Syringe (3ml) is sterile, single-use, disposable, Non-reusable, Retractable, Piston Syringe, provided with needle attached in place., which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick (sharps injury). In6 Safety Syringe (3ml) works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safely inside the empty syringe barrel for disposal. The In6 Safety Syringe (3ml) consist of the following major components. 1. Plunger, 2. Barrel, 3. Piston, 4. O- Ring, 5. Spring, 6. Needle Hub, 7. U.V. Glue, 8. Cannula, 9. Needle Protector.
More Information

Not Found

No
The device description focuses on a mechanical safety mechanism (spring action) for needle retraction and does not mention any computational or learning components.

No
The device is a safety syringe designed for injecting medical fluids, not for treating a disease or condition itself. Its primary function is to safely deliver medication, and its 'therapeutic' aspect is limited to facilitating the administration of therapeutic substances rather than being a therapeutic substance or device itself.

No

Explanation: The In6 Safety Syringe is designed for the "injection of medical fluids into the body" and "injection of medication into a patient." Its primary function is the delivery of substances, not the identification or assessment of a medical condition.

No

The device description clearly outlines physical components such as a plunger, barrel, piston, spring, needle, etc., indicating it is a hardware device.

Based on the provided information, the In6 Safety Syringe (3ml) is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for the "injection of medical fluids into the body." This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically in a lab setting).
  • Device Description: The description details a syringe designed for injecting medication into a patient and preventing needle-stick injuries. This aligns with an in vivo medical device.
  • Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) for diagnostic purposes, which is the core function of an IVD.

Therefore, the In6 Safety Syringe (3ml) is a medical device intended for in vivo use, not an IVD.

N/A

Intended Use / Indications for Use

The In6 Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.

Product codes

MEG

Device Description

The In6 Safety Syringe (3ml) is sterile, single-use, disposable, Non-reusable, Retractable, Piston Syringe, provided with needle attached in place., which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick (sharps injury).

In6 Safety Syringe (3ml) works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safely inside the empty syringe barrel for disposal.

The In6 Safety Syringe (3ml) consist of the following major components. 1. Plunger , 2. Barrel , 3. Piston, 4. O- Ring ,5. Spring, 6. Needle Hub, 7. U.V. Glue, 8. Cannula , 9. Needle Protector.

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

Bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Key Metrics

Not Found

Predicate Device(s)

K980069

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

051800

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

  • In6 IncuVestor® Inc. Submitter's Name: 1.
    No. 413 Ming-Hsouie Rd., Taipei, Taiwan Address: 886-2-2532-2825 Phone: 886-2-2532-2822 Fax: Ms. Lin Lee, Lee / PRESIDENT Contact:

    1. Device Name :
      In6 IncuVestor® Inc. Trade Name: Safety Syringe (provided with needle) Common Name: Anti-Stick Syringe Classification name
  • Class II 3. Classification: 880.5860 Regulatory Number: MEG Product Code:

  • VANISHPOINT SYRINGE (K980069) marketed by Predicate Device: ◆ 4. RETRACTABLE

  • Device Description: The In6 Safety Syringe (3ml) is sterile, single-use, disposable , 5. Non-reusable, Retractable, Piston Syringe, provided with needle attached in place., which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick (sharps injury).

In6 Safety Syringe (3ml) works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safely inside the empty syringe barrel for disposal.

The In6 Safety Syringe (3ml) consist of the following major components. 1. Plunger , 2. Barrel , 3. Piston, 4. O- Ring ,5. Spring, 6. Needle Hub, 7. U.V. Glue, 8. Cannula , 9. Needle Protector.

FDA 510(K) SUMMARY

1

  • The In6 Safety Syringe (3ml) is designed as an anti-stick ·6. Intended Use: reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.
    1. Performance In terms of Physical specification, Chemical specification, Biological Summary: specification & Sterilization Specification, the device conforms to applicable standards included ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc.

8. Conclusions:

The In6 Safety Syringe (3ml) has the same intended use and similar technological characteristics as the VANISHPOINT SYRINGE (K980069) marketed by RETRACTABLE TECHNOLOGIES, INC.. Moreover, bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the In6 Safety Syringe (3ml) is substantially equivalent to the predicate devices.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IN6 Incuvestor, Incorporated C/O Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail Flaggstaff, Arizonia 86001

Re: K051800

Trade/Device Name: IN6 SAFETY SYRINGE, MODEL 3ML Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 13, 2005 Received: October 17, 2005

Dear Ms. Reich:

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.

3

Page 2 - Ms. Reich

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snitte H. Michael Dmd.

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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K051800
1 of 1

NUMBER (IF KNOWN): ___________________________________________________________________________________________________________________________________________________________ K051800 510 (k)

In6 Safety Syringe (3ml) DEVICE NAME: In6 IncuVestor® Inc.

INDICATIONS FOR USE:

The In6 Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pease

Division of Anasibesiology. General Hospital. Infection Control, Dental Devic

510(k) Number: K051890

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