The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Device Description

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the DuoPro Safety Syringe (DuoProSS™). However, it does not contain the detailed performance study results, specific acceptance criteria, or the methodology (like expert consensus, sample sizes for training/test sets, or MRMC studies) that would typically be associated with software or AI-driven diagnostic devices.

The document is a premarket notification for a physical medical device (a syringe) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and bench testing of performance, rather than a clinical study evaluating diagnostic accuracy.

Therefore, many of the requested categories for AI/software-driven device evaluation are not applicable or not explicitly stated in this document.

Here's an attempt to answer based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility: Device materials are biologically safe.	Tests performed. Specific results not detailed, but implied to meet criteria for clearance.
Measurement of Latex Protein: Device is free from harmful levels of latex protein.	Tests performed. Specific results not detailed, but implied to meet criteria for clearance.
Packaging Integrity: Packaging maintains sterility and integrity.	Tests performed. Specific results not detailed, but implied to meet criteria for clearance.
Standards Conformity: Device meets relevant industry standards.	Tests performed. Specific results not detailed, but implied to meet criteria for clearance.
Simulated Use Test: Device performs as intended during simulated use, especially regarding safety features.	Bench testing shows that the performance of the DuoProSS™ is equivalent to the E.N.S.I. product (predicate device). This is the key "performance" claim.
Reduction of sharps injuries: Device effectively reduces this risk.	Stated as an intended function ("reducing the risk of sharps injuries"). Implied to be demonstrated through design and simulated use testing to be equivalent to predicate.
Reduction of potential for syringe reuse: Device effectively prevents reuse.	Stated as an intended function ("reducing... the potential for syringe reuse"). Implied to be demonstrated through design (manual, retractable, non-reusable) and simulated use testing to be equivalent to predicate.
Sterile, single-use, disposable, non-reusable: Meets these functional requirements.	Device described as meeting these characteristics.
Manual, retractable safety syringe: Functions as described.	Device described as meeting these characteristics.

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

Sample Size: Not specified. The document mentions "Bench testing" and "simulated use test" but does not provide the number of units tested.
Data Provenance: Not applicable in the context of clinical data for an AI/software device. For the physical device, testing was conducted to demonstrate equivalence, likely in a lab setting by the manufacturer (M.K. Meditech Co., Ltd. in Taiwan).

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

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic image or data set. The performance testing relates to physical device functions and safety mechanisms.

4. Adjudication method for the test set

Not applicable. As noted above, this is about physical device performance, not diagnostic accuracy evaluation.

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 device is a physical syringe, not an AI software.

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 AI algorithm.

7. The type of ground truth used

The "ground truth" for this device would be its functional specifications and safety requirements as defined by regulatory standards (e.g., ISO, FDA guidance) and the performance of the predicate device. For example, a "ground truth" for retraction would be successful, complete retraction every time without user error, as designed. For biocompatibility, it would be the absence of adverse biological reactions.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

In summary, the provided 510(k) summary focuses on demonstrating that a new physical medical device is "substantially equivalent" to an already legally marketed predicate device. This is primarily done through comparing design, intended use, technological characteristics, and showing that "bench testing" supports equivalent performance. It is important to note that the depth of detail requested for AI/software devices (e.g., sample sizes for training/test, expert consensus, MRMC studies) is not typically part of a 510(k) summary for a physical, non-diagnostic device.

Summary

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MAY 0 2 2002

K620623

510(k) Summary for the DuoPro Safety Syringe (DuoProSSTM) (per 21CFR807.92)

SPONSOR 1.

M.K. Meditech Co., Ltd. 4th Floor, No. 1221 Chung Cheng Road Taoyuan City Taiwan 330

Contact Person: I-Ming Shih Telephone: 886-3-3166399, extension 883 Date Prepared: February 25, 2002

2. DEVICE NAME

DuoPro Safety Syringe (DuoProSSTM) Proprietary Name: Common/Usual Name: Hypodermic Syringe (with or without needle) Classification Name: Piston syringe Hypodermic single lumen needle

3. PREDICATE DEVICE

E.N.S.I. Retractable Safety Syringe (K003348, K000572) .

DEVICE DESCRIPTION 4.

5. INTENDED USE

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of

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fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

6.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

M.K. Meditech Co., Ltd. makes a claim of substantial equivalence of the DuoProSS™ to the E.N.S.I. Retractable Safety Syringe (K003348) based on similarities in intended use, design, technological, and operational characteristics. Both are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. Both syringes are piston syringes that use single lumen hypodermic needles. The DuoProSS™ can be ordered both with and without needles, while the E.N.S.I. is not provided with needles. The DuoProSS™M currently uses a Luer slip needle connector, while the E.N.S.I. uses a Luer lock connector. Both syringes are provided sterile, single-use, and disposable. The major difference between the DuoProSS™ and the E.N.S.I. products is the syringe volume (and associated dimensions). This difference does not affect the performance of the syringe, since syringe size is typically determined by drug volume to be administered and user preference. Bench testing shows that the performance of the DuoProSS™ is equivalent to the E.N.S.I. product. Both syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break off the plunger rod, and discard the pieces. M.K. Meditech Co., Ltd. believes that the differences between the DuoPro Safety Syringe (DuoProSS™) and the predicate device are minor and they raise no new issues of safety or effectiveness.

7. PERFORMANCE TESTING

Testing provided in this premarket notification includes biocompatibility, measurement of latex protein, packaging integrity, standards conformity, and testing according to FDA guidance (including a simulated use test).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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, depicted with three parallel lines forming the shape of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 2 2002

M. K. Meditech Company Limited C/O Ms. Rosina Robinson Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K020623

Trade/Device Name: Duopro Safety Syringe (DuoProSSTM) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG and FMI Dated: February 25, 2002 Received: February 26, 2002

Dear Ms. Robinson :

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 approvisions 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.

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

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Page 2 - Ms. Rosina Robinson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timo A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

M.K. Meditech Co., Ltd., DuoPro Safety Syringe Device Name: (DuoProSS™)

Indications For Use:

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and nonreusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patara Cucente

vision Sian-Off Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

M. K. Meditech Co., Ltd. Traditional 510(k) February 25, 2002 DuoPro Safety Syringe (DuoProSSTM)

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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).