(202 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable syringe, with no mention of AI or ML technology.
No.
The syringe is used to inject or withdraw fluids, which are actions often performed in the context of therapy, but the syringe itself is a delivery/withdrawal device, not a therapeutic agent.
No
The device is described as a syringe intended for injecting or withdrawing fluids, not for diagnosing medical conditions. The performance studies focus on mechanical properties and safety.
No
The device description clearly states it is a physical syringe with a barrel, plunger, and Luer Lock connector, indicating it is a hardware device.
Based on the provided information, the BAIXIN Disposable Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body." This describes a direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a device for injecting or withdrawing substances from the body, consistent with in vivo use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health condition, or disease. This is the core function of an IVD.
Therefore, the BAIXIN Disposable Syringe is a medical device intended for in vivo use, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.
Product codes
FMF, FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:
Syringe Column Sealing: 300 Kpa Positive Pressure - No leakage; 88 Kpa Negative Pressure - No leakage
Volume: +/- 4%
Tip Sealing Property: No Leakage
Indicating Ruler - 0 level line: Within 1/4 range
Tip Size: No separation at 25N
Draw Strength: Not specified
Residue Contents:
§ 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).
0
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
1
Class: Il
Panel: 80-
Procodes: FMF - Piston Syringe FMI - Hypodermic Single Lumen Needle
Device Description:
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.
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 Column | |
| Sealing | 300 Kpa Positive Pressure - No |
| leakage | |
| 88 Kpa Negative Pressure - No | |
| leakage | |
| Volume | $\pm$ 4% |
| Tip Sealing Property | No Leakage |
| Indicating Ruler - 0 | |
| level line | Within 1/4 range |
| Tip Size | No separation at 25N |
| Draw Strength | |
| Residue Contents | 1. 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. . .
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
. . . .
3
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.
4
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
5
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)
like
(Division Sign-Ott) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083
VIII