The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.

The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin.

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) Summary for medical devices (syringes and needles) and does not contain information typically found in a study proving a device meets acceptance criteria for complex AI/ML-driven diagnostic devices. Specifically, this document is a premarket notification for general medical devices, not a study report. Therefore, most of the requested information regarding AI/ML device performance evaluation methods (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.

However, I can extract the device acceptance criteria implicitly mentioned and the general conclusion regarding meeting those criteria.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Meet all design specifications.	"Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications..." (Section 7)
Be substantially equivalent to predicate devices (K980987, K071630, K070440).	"...and was substantially equivalent to the predicate device." (Section 7) "The subject device, Double-Dove Syringes and Needle, is substantially equivalent to the predicate device." (Section 8) FDA's conclusion: "...have determined the device is substantially equivalent..." (Page 4)
Function for intended use: - Sterile Hypodermic Syringe: dispensing/administering fluids, collecting/sampling of fluid. - Sterile Insulin Syringe: manual aspiration of insulin, injection of insulin. - Sterile Hypodermic Needle: use with syringes for fluid injection/aspiration.	The successful substantial equivalence determination implies that the devices are expected to perform their stated intended uses as safely and effectively as their predicate devices.

Study Details (Based on available information and understanding of 510(k) for these types of devices)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For physical medical devices like syringes and needles, testing typically involves a sufficient number of units to demonstrate statistical confidence in meeting specific physical and chemical standards (e.g., sterility, fluid tightness, material compatibility, needle sharpness, break force, etc.).
- Data Provenance: Not specified, but generally, such testing is performed in accredited laboratories. Given the sponsor's location (Shanghai, China), the testing would likely have been conducted in China, potentially at their own facilities or a contract research organization. The document indicates "Laboratory testing was conducted."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For these types of devices, "ground truth" is established through engineering and quality control tests comparing performance against defined standards (e.g., ISO standards, ASTM standards) and predicate device specifications, rather than expert interpretation of diagnostic images or clinical observations.
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (especially for AI/ML) where there is ambiguity in human interpretation. For physical device testing, the results are typically quantitative measurements against objective pass/fail criteria.
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 is a premarket notification for physical medical devices (syringes and needles), not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Standards and Predicate Device Performance: The "ground truth" here would be established by:
  - International and national standards for sterile medical devices (e.g., ISO, ASTM).
  - Performance specifications based on predicate devices.
  - Measured physical, chemical, and biological properties (e.g., sterility, dimensional accuracy, mechanical strength, material safety).
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not Applicable. No training set is involved.

In summary: The document confirms that laboratory testing was conducted to verify that the Double-Dove Syringes and Needles met all design specifications and were substantially equivalent to the predicate devices. This type of regulatory submission for general medical devices relies on objective physical and chemical testing against established standards and predicate device performance, rather than the complex clinical study paradigms used for AI/ML diagnostic tools.

Summary

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JUN 1 2 2009 Chapter III 510(k) Summary

(As required by 21 CFR 807.92)

The assigned 510(k) Number is:

1. Date Prepared: March 17, 2009
1. Sponsor Information

Shanghai Double-Dove Industry Co.,Ltd

No.1888 Huhang Road FengXian Economic Zone Shanghai, 201400, China

Contact Person: Mr. Sanba Yang, Quality Manager Tel: +86-21-67104888 Fax: +86-21-67104666 E-Mail: Yangsbmaster@hotmail.com

3. Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China

Device Name and Classification:

a. Sterile Hypodermic Syringe for single use

(1) Classification Name: Syringe, Piston

(2) Regulation Number: 880.5860

(3) Product Code: FMF
(4) Class: II

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Kogor29

b. Sterile Insulin Syringe for single use, with fixed needle

(1) Classification Name: Syringe, Piston

(2) Regulation Number: 880.5860

(3) Product Code: FMF

(4) Class: II

(5) Review Panel: General Hospital

c. Sterile Hypodermic Needle for single use

(1) Classification Name: Needle, Hypodermic, Single Lumen

(2) Regulation Number: 880.5570

(3) Product Code: FMI ·

(4) Class: II

(5) Review Panel: General Hospital

5. Predicate Device Identification:

a. K number: K980987

Trade Name: Becton Dickinson Single Use Hypodermic Syringes

b. K number: K071630 Trade Name: TERUMO 31G ThinPro Insulin Syringe

c. K number: K070440 Trade Name: BD Hypoint

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Device Name	Intended Use	Nozzel	Volume	Material	Remark
Sterile HypodermicSyringe for single use	The Sterile Hypodermic Syringe for SingleUse is intended for dispensing/administering fluids, and collecting/sampling of fluid in medical practice. Theirfunction is mechanical.	Luer SlipLuer Lock	1ml、3ml、5ml、10ml、20ml、30ml、50ml	Medical GradePolypropylene	With or Without Needle
Sterile InsulinSyringe for singleuse, with fixed needle	The sterile Insulin Syringe for single usewith fixed needle is a device intended formedical purposes for the manual aspirationof insulin, and for the injection of insulininto parts of the body below the surfaceskin.	Fixed	0.3ml、0.5ml、1ml	Medical GradePolypropylene	With Fixed Needle
Sterile HypodermicNeedle for single use	The Sterile Hypodermic Needle for singleuse is intended for use with syringes andinjection devices for general purpose fluidinjection/aspiration	Luer SlipLuer Lock	0.312.7; 0.325; 0.3312.7;0.3312.7; 0.3325;0.412.7; 0.425; 0.4516;0.4525; 0.516; 0.525;0.5516; 0.5525; 0.625;0.630; 0.725; 0.732;0.825; 0.838; 0.925;0.938; 1.125; 1.138;1.225; 1.2*38	Stainless Steel

K090929

III-3

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K090929

Premarket Notification Submission - Chapter III 510(K) Summary Report No.: A2008-034-061

7. Test Conclusion

Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications and was substantially equivalent to the predicate device.

8. Substantially Equivalent Conclusion:

The subject device, Double-Dove Syringes and Needle, is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Double-Dove Industry Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road (S) Shanghai CHINA 200030

JUN 1 2 2009

Re: K090929

Trade/Device Name: Sterile Insulin Syringe for Single Sue Needle, with Fixed Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 31, 2009 Received: April 2, 2009

Dear Ms. Hong:

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 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. Hong

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Susan Roane

Susan Runner, D.D.S., M.A. Acting 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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Indication for Use

510(k) Number:

Device Name: Sterile Hypodermic Syringe for Single Use

Indications for Use:

The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sta Carlsson

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090929

Page 1 of 3

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Indication for Use

510(k) Number:

Device Name: Sterile Insulin Syringe for single sue needle, with fixed needle

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Adall
(Division Sign-on)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090939

Page 2 of

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Indication for Use

510(k) Number:

Device Name: Sterile Hypodermic Needle for single use

Indications for Use:

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Prescription Use N (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090229

Page 3 of 3

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).