The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

Device Description

The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.

AI/ML Overview

The provided documentation describes the 1cc Insulin SafePro Safety Syringe and its substantial equivalence to predicate devices, rather than a study involving acceptance criteria and device performance in the context of an AI or diagnostic device.

Therefore, many of the requested fields cannot be filled, as the document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic tool. The "performance" discussed relates to design and material equivalence, as well as the safety features of the syringe itself.

Here's an attempt to extract relevant information, with an emphasis on what cannot be answered given the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a study for a diagnostic or AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily shown through the comparison matrix and claims of identical design and materials.

Factor	Acceptance Criteria (Implied)	Reported Device Performance
Primary Intended Use	Aspiration and infusion of insulin fluid	"Identical to ... SafePro Safety Syringe" (K022063) in design and materials, which is functionally equivalent.
Secondary Intended Use (Needlestick Protection)	Reduce risk of accidental needlestick injuries	Built-in safety feature; "Identical to ... SafePro Safety Syringe" (K022063) in safety features and characteristics. Claims to reduce risks of accidental needlesticks.
Material Safety/Biocompatibility	Meet established safety and biocompatibility standards	Materials identical to predicate devices (K012726, K022063) that were previously tested and found safe.
Functional & Performance Characteristics	Operate effectively and safely (e.g., manual actuation of safety mechanism, safety mechanism remains activated during disposal, integral part of device)	"Identical to ... SafePro Safety Syringe" (K022063) features and characteristics, which were previously verified and validated.
Substantial Equivalence to Predicate	Demonstrate equivalence in intended use, technology, materials	Claims "essentially equivalent" to B-D Conventional hypodermic and insulin syringe (K980580) and 1cc SafePro Safety Syringe (K022063) in design, materials, instructions for use, and product claims.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study involving a test set of data for an AI or diagnostic device. The "testing" referred to is material testing and simulated use studies for a physical device, which were previously conducted on predicate devices. There is no mention of a "test set" in the context of data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI or diagnostic device. The "ground truth" for a physical device like this is typically established through adherence to engineering standards, material specifications, and regulatory requirements.

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

Not applicable. There is no test set or adjudication method described for an algorithm or diagnostic performance.

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

Not applicable. This document pertains to a physical medical device (syringe with a safety feature), not an AI or diagnostic device requiring human reader interaction.

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

Not applicable. This device is a physical syringe, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness is largely based on:

Material compatibility and safety standards: Established through prior testing of identical materials in predicate devices (K012726, K022063).
Functional performance standards: Demonstrated by the physical design and features being identical to previously cleared devices.
Substantial Equivalence: Comparison to legally marketed predicate devices (K980580, K012726) that have already met regulatory requirements.
Guidance documents: The comparison matrix was developed in accordance with the "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".

8. The sample size for the training set

Not applicable. There is no training set for an AI or diagnostic algorithm described.

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

Not applicable. There is no training set mentioned in the context of this device.

Summary

{0}------------------------------------------------

APR 5 2005

K050134

SECTION VIII

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for 1cc Insulin SafePro* Safety Syringe

REGULATORY AUTHORITY 1.

Safe Medical Device Act of 1990, CFR 807.92.

CONTACT PERSON 2.

C. Y. Lin (Ms) Manager, Quality Assurance & Regulatory Affairs FORMOSA MEDICAL DEVICES, INC.

U.S. Liaison Office 11497 Columbia Park Drive West, Suite #9 Jacksonville, FL 32258

NAME OF MEDICAL DEVICE 3.

Classification Name: Syringe, Antistick Classification Code: MEG Common/Usual Name: Syringe 1cc Insulin SafePro* Safety Syringe Proprietary Name:

DEVICE CLASSIFICATION 4.

The General Hospital Panel has classified Antistick Syringes (21CFR880.5860) into Class II, Special Controls under section 513 of the Act.

STATEMENT OF SUBSTANTIAL EQUIVALENCE 5.

The 1cc Insulin SafePro* Safety Syringe is essentially equivalent to:

A) B-D Conventional hypodermic and insulin syringe, K980580, and
B) The 1cc SafePro Safety Syringe, K022063, in design, materials, instructions for use, and product claims.

Page VIII - 1

*Trademark

{1}------------------------------------------------

INTENDED USE 6.

The primary intended use for the 1cc Insulin SafePro* Safety Syringe is aspirating and infusing insulin fluid.

The secondary intended use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

DESCRIPTION OF DEVICE 7.

SUMMARY OF MATERIAL TESTING 8.

The materials of construction of the 1cc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro Safety Syringe. Those materials were already tested for material safety and biocompatibility as indicated in previous 510(K) submissions, K012726 and K022063. Therefore, no new biocompatibility tests are necessary.

SUMMARY OF SIMULATED USE STUDY 9.

The safety feature and other functional and performance characteristics of the Icc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro* Safety Syringe. Those features and characteristics were already verified and validated as shown in the two previous 510(k) notifications K012726 and K022063. Therefore, no new tests are necessary.

CONCLUSION 10.

The results obtained indicate that the 1cc Insulin SafePro* Safety Syringe is safe and effective for its intended use.

{2}------------------------------------------------

COMPARISON MATRIX 1cc Insulin SafePro* Safety Syringe, B-D Conventional Syringe, and 1cc SafePro* Safety Syringe

This matrix was developed in accordance with the ODE Guidance titled "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".

Factor	1cc Insulin SafePro*Safety Syringe	B-D ConventionalInsulin Syringe	1cc SafePro*Safety Syringe
510(K) Number	To Be Assigned	K980580	K012726
Intended Use and Claims
• Same Intended Use	Yes	Yes	Yes
• Tissue Puncture Device	Yes	Yes	Yes
• Sharps Injury Prevention Feature	Yes	No	Yes
• Reduces Risks of Accidental Needlesticks	Yes	No	Yes
• Delivers fluid to or draw blood frompatient, short term	Yes	Yes	Yes
• Conventional Insertion Technique withminimal training	Yes	Yes	Yes
Technological Features
• Same Technology Features	No	No	Yes
• Safety Mechanism
- Manual Actuation	Yes	Not Applicable	Yes
• Safety Mechanism Remains ActivatedDuring Disposal	Yes	Not Applicable	Yes
• Safety Mechanism is an Integral Part ofthe Device	Yes	Not Applicable	Yes
Material of Construction
• Needle• Needle Hub	• Stainless Steel•PP*	• Stainless Steel•PP	•Stainless Steel•PP* with moreneedle gauges(Different hubcolorants)
• Barrel, Plunger, Sheath	PP	PP	PP
• Gasket	Synthetic Rubber	Synthetic Rubber	Synthetic Rubber

*PP - Polypropylene resin

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

APR 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. C.Y. Lin Manager, Quality Assurance & Regulatory Affairs FORMOSA MEDICAL DEVICES, INCORPORATED 16F. No. 182. Section 2 Tunhua South Road Taipei TAIWAN, R.O.C. 106

Re: K050134

Trade/Device Name: 1cc Insulin* SafePro Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 21, 2005 Received: January 24, 2005

Dear Ms. Lin:

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.

ff 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 - Ms. Lin

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 vours.

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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

K050134

Device Name:

1cc Insulin SafePro* Safety Syringe

Indications For Use:

The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.

The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

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

Over-The-Counter Use X (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)

6 / h ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Jaron Gign Cirit ് In schon Control Liental Devices

2/2 Mar 1.0 - 1.0 1.34 5.40134

*Trademark

Page vi

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).