BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

AI/ML Overview

The provided text describes the acceptance criteria and the summary of testing for the BAIXIN™ Disposable Syringe. It focuses on the device's adherence to ISO 7886-1:1993, a consensus standard for sterile hypodermic syringes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Testing Items	Acceptance Criteria (Code Requirement)	Reported Device Performance
Syringe Column Sealing (Positive Pressure)	300 Kpa Positive Pressure - No leakage	Meets criteria (implied by "Data supporting conformance")
Syringe Column Sealing (Negative Pressure)	88 Kpa Negative Pressure - No leakage	Meets criteria (implied by "Data supporting conformance")
Volume	$\pm$ 4%	Meets criteria (implied by "Data supporting conformance")
Tip Sealing Property	No Leakage	Meets criteria (implied by "Data supporting conformance")
Indicating Ruler - 0 level line	Within 1/4 range	Meets criteria (implied by "Data supporting conformance")
Tip Size	No separation at 25N (This seems to be a strength/connection test for the tip)	Meets criteria (implied by "Data supporting conformance")
Draw Strength	Not specified in the table's "Code Requirement" column.	Not explicitly reported numerically, but implied conformance.
Residue Contents	< 0.075 cc	Meets criteria (implied by "Data supporting conformance")
Sliding Property	Average < 10N	Meets criteria (implied by "Data supporting conformance")
Appearance	Clean, Smooth	Meets criteria (implied by "Data supporting conformance")
Non-bacteria	Non-bacteria	Meets criteria (implied by "Data supporting conformance")
Pyrogen	Pyrogen-free	Meets criteria (implied by "Data supporting conformance")
Toxicity	Non-toxic, no toxicity reaction for human body	Meets criteria (implied by "Data supporting conformance")

Note: The document states, "Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd." which implies that the device met all the listed acceptance criteria. No specific numerical results are provided for the "Reported Device Performance" column beyond the criteria themselves.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the sample size used for the testing. It only mentions "All materials used in the fabrication... were evaluated".
Data Provenance: The testing was performed by Anhui Kangda Medical Products Co., Ltd. in China. The data would be considered retrospective in the context of this 510(k) submission, as the tests were conducted prior to 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 applicable to this type of device. The "ground truth" for a disposable syringe is established by objective physical and chemical testing against a recognized standard (ISO 7886-1:1993), not by expert consensus or interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not applicable. The testing involves objective measurements against predefined thresholds from a standard, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical image analysis or diagnostic devices where human readers interpret results, and an AI's impact on their performance is being evaluated. This is not applicable to a disposable syringe.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance evaluation was not done. The device is a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements and chemical/biological tests against the specific requirements and limits defined in the international consensus standard ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of testing a physical medical device like a disposable syringe. This concept applies to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as #8.

Summary

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510(K) SUMMARY

K083686
1 of 3

Submitted by:

Anhui Kangda Medical Products Co., Ltd.

JUL - 2 2009

88 Zhenxing Road,

Yangeun Town,

Tianchang City,

Anhui Province

P. R. China

Phone: +86 0550 7764218

+86 0550 7093858 Fax:

Preparation Date: Jun. 10. 2008

Contact Person/Prepared by:

Official Correspondent:

bian wei giang SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. 1707 yinqiao bldg 58 jinxin road jinqiao, pudong, shanghai, CHINA 201206 Phone: 86-21-50324423

US Agent: ROBERTJ.EDWARDS BOCA MEDICAL PRODUCTS, INC. 3550 nw 126th ave coral springs, FL 33065 Phone: 954 346 Fax: 954 346 Email: bob@bocapharmacal.com

510(K) Summary of Safety and Effectiveness for the:

Trade/Proprietary Name: BAIXIN™ Disposable Syringe, Multiple Sizes Common Name: Piston Syringe, Hypodermic

Classification Name: Piston Syringe

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Class: Il

Panel: 80-

Procodes: FMF - Piston Syringe FMI - Hypodermic Single Lumen Needle

Device Description:

Intended Use:

The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

Statement to conform to ISO 7886-1; 1993

Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes corm to the FDA recognized consensus standard, ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Lid.

Summary of Testing:

All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:

Testing Items	Code Requirement
Syringe ColumnSealing	300 Kpa Positive Pressure - Noleakage88 Kpa Negative Pressure - Noleakage
Volume	$\pm$ 4%
Tip Sealing Property	No Leakage
Indicating Ruler - 0level line	Within 1/4 range
Tip Size	No separation at 25N
Draw Strength
Residue Contents	< 0.075 cc
Sliding Property	Average < 10N
Appearance	Clean, Smooth
Non-bacteria	Non-bacteria
Pyrogen	Pyrogen-free

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Toxicity	Non-toxic, no toxicity reaction for human body
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K08 3686

1000

. . . . . . . . . . . . .

September 19. :

:

Conclusion:

: .

. .

The materials, performance, and operational features of both the submitted device rne materials, portormanos, and stantially equivalent and are safe and effective for . their intended use. . .

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. . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three overlapping wing-like shapes.

JUL - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anhui Kangda Medical Products Company, Limited C/O Mr. Bian Wei Qiang Shanghai Carelife International Trading Company, Limited 1707 Yinqiao Building 58 Jinxin Road Jinqiao, Pudong, Shanghai CHINA 201206

Re: K083686

Trade/Device Name: BAIXIN™ Disposable Syringe, Multiple Sizes (BAIXINI™) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 3, 2009 Received: June 3, 2009

Dear Mr. Qiang:

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 - Mr. Qiang

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,

Anthony D. Auster bu

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

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510(k) Number (if known): K083686

Device Name: BAIXIN™ Disposable Syringe, Multiple Sizes (BAIXIN™)

Indications for Use: The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K083

VIII

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).