IN6 SAFETY SYRINGE, MODEL 3ML by IN6 INCUVESTOR INC.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the In6 Safety Syringe (3ml). It establishes substantial equivalence by comparing it to a predicate device and relies on bench testing and simulated use studies. However, the document does not include detailed acceptance criteria or the specific results of a study that proves the device meets those criteria in the format requested.

The document states:

"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."
"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."

This indicates that studies were performed, but the specific acceptance criteria and the numerical performance results are not detailed in this summary. Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Physical Specification	Conforms to ISO 7864, ISO 7886-1	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Chemical Specification	Conforms to ISO 10993 series	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Biological Specification	Conforms to ISO 10993 series, USP Pyrogenic standards	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Sterilization Specification	Conforms to ISO 11607-1, ISO 11135	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Sharps Injury Reduction	Designed to reduce risk of sharps injuries	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Syringe Reuse Prevention	Designed to reduce potential for syringe reuse	"demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Retraction Mechanism	Needle retracts safely inside empty syringe barrel for disposal	"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."

Missing Information (Not available in the provided text):

Specific numerical thresholds for "conforms to standards" (e.g., specific force required for retraction, leakage rates, biocompatibility results).
Detailed quantitative results from the "bench testing & simulated use study."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document mentions "bench testing & simulated use study" but does not give the number of syringes tested or the specifics of the test designs.
Data Provenance: Not specified. It's likely from Taiwan, given the company's address, but not explicitly stated for the study data. The studies are described as "bench testing & simulated use study," which implies prospective data collection for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the text. The studies appear to be primarily engineering/performance testing against established standards, rather than studies requiring expert medical interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the text. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a medical device (syringe) and not an AI/imaging diagnostic device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is a medical device (syringe) with a mechanical safety feature, not an algorithm. So, this question is not applicable. The "standalone" performance would be the device's ability to retract the needle as designed, which was assessed via "bench testing & simulated use study."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance claims appears to be compliance with international standards (ISO, USP) and the intended mechanical function (needle retraction). This would be established through objective measurements and physical/chemical/biological tests.

8. The sample size for the training set:

This is a medical device (syringe) with a mechanical safety feature, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.

9. How the ground truth for the training set was established:

This question is not applicable as there is no training set in the AI/ML sense for this device.

Summary

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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).

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

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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.

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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.

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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:

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

Page 1

Regulation Number and Section

§ 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).