(246 days)
510(K) 073705
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe and needle, with no mention of AI or ML.
No.
A therapeutic device is one that treats or mitigates a disease, or affects the structure or function of the body. A syringe itself does not meet this definition; it is a tool used for delivery of substances that may be therapeutic.
No
The device is a syringe for injecting or withdrawing fluids, which are procedures for treatment or sample collection, not diagnosis. The "Intended Use" explicitly states its function is to "inject fluid into, or withdraw fluids from, part of the body below the surface of the skin."
No
The device description clearly states it is a physical syringe with a needle, which are hardware components. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluid into, or withdraw fluids from, part of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a syringe and needle, which are tools for administering or collecting substances from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe and needle are used for direct interaction with the body itself.
N/A
Intended Use / Indications for Use
The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
Product codes
FMF, FMI
Device Description
The ShiFeng Disposable Syringe is a sterile, single use device consisting of a needle attached to a syringe. The device consists of a metal tube that is sharpened at one end and the end joined to a female connector (hub) designated to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
part of the body below the surface of the skin
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
The following tests were performed on the Shifeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd, China in accordance with ISO 7886-1:1993/Cor. 1: 1995: Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Lubricant, Tolerance on graduated capacity, Scale, Numbering of scale, Overall length of scale to nominal capacity line, Position of scale, Dimensions, Finger grips, Design, Fit of piston in barrel, Fiducial line, Conical fitting, Position of nozzle on end of barrel, Nozzle lumen, Dead space, Freedom from air and liquid leakage past piston, Primary container, Secondary container, Storage container, Transport wrapping.
Additional Safety Information: The sterilization conditions are validated according to ISO 11135-1:2007 to provide a Sterility Assurance Level (SAL) of 10-8. Ethylene Oxide residual levels after 7 days aeration resulting from EtO sterilization will not exceed the maximum daily dose levels proposed 10993-7:2008. The device's materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #g95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. Results of the testing demonstrate that the blood contacting materials are biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
510(K) 073705
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:
No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address: +86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011(@163.com Tel:
MAR - 1 2012
240 (K) Summary
Device Name
Proprietary Name:
Shifeng Disposable Syringe with or without needle
Classification Name:
Piston Syringe 21 CFR, Section 880.5860 21 CFR, Section 880.5570 Classification: Class II
Common Name;
Piston Syringe with or without needle
Intended Use
The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
Device Description
The ShiFeng Disposable Syringe is a sterile, single use device consisting of a needle attached to a syringe. The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969. (Refer to Pic 1)
1
Company: Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Shifeng Piston Syringe with or without needle Product: Address: No.46; 740 group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China +86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011@163.com Tel:
The device consists of a metal tube that is sharpened at one end and the end joined to a female connector (hub) designated to mate with a male connector ( nozzle ) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger
XinJin Shifeng buy the Shangdong Qiaopai needle (510(K) 073705) and do the assembly with the syringe together.
Image /page/1/Figure/3 description: The image shows a diagram of a syringe with labels. The syringe consists of four parts: needle, piston, plunger, and barrel. The needle is labeled as "1. Needle", the piston is labeled as "2. Piston", the plunger is labeled as "3. Plunger", and the barrel is labeled as "4. Barrel".
Pic 1
Predicate Device Name and 510(K) No. :
IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969
Substantial Equivalence
The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.
Principle of Operation/Technology
Both devices are operated manually
2
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product: No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address: +86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011@163.com Tel:
Materials
The materials used in the ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China are same as the predicate devices, which do not raise any new issues of safety or effectives.
| Parts | Material | Specification |
|---|---|---|
| Barrel | Polypropylene | K4912 |
| Plunger | Polypropylene | V30G |
| Lubricant | Polydimethysiloxane | HC-SS36 |
| Piston | Synthetic rubber | SK1 |
| Primary Package Material | Medical rubberizing Dialysis paper | |
| and PE | 65g/m² Medical rubberizing | |
| Dialysis paper | ||
| Needle | Qiaopai needle ( 510(K) 073705) |
Specifications
| Syringe | Needle |
|---|---|
| 1ml Luer Slip_sterile | 0.45 (26G) |
| 2ml Luer Slip_sterile | 0.50 (25G) |
| 3ml Luer Slip_sterile | 0.60 (23G) |
| 5ml Luer slip_sterile | 0.60 (23G) , 0.7 (22G) |
| 10ml Luer Slip_sterile | 0.90 (20G), 1.2 (18G) |
3
| Company: | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. |
|---|---|
| Product: | Shifeng Piston Syringe with or without needle |
| Address: | No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China |
| Tel: | +86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011@163.com |
Performance
The following tests were performed on the Shifeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd, China in accordance with ISO 7886-1:1993/Cor. 1: 1995:
| ISO Clause No. | Test Items |
|---|---|
| 5 | Cleanliness |
| 6 | Limits for acidity or alkalinity |
| 7 | Limits for extractable metals |
| 8 | Lubricant |
| 9 | Tolerance on graduated capacity |
| 10.1 | Scale |
| 10.2 | Numbering of scale |
| 10.3 | Overall length of scale to nominal capacity line |
| 10.4 | Position of scale |
| 11.1 | Dimensions |
| 11.2 | Finger grips |
| 12.1 | Design |
| 12.2 | Fit of piston in barrel |
| 12.3 | Fiducial line |
| 13.1 | Conical fitting |
| 13.1 | Conical fitting |
| 13.2 | Position of nozzle on end of barrel |
| 13.2 | Position of nozzle on end of barrel |
| 13.3 | Nozzle lumen |
| 14.1 | Dead space |
| 14.2 | Freedom from air and liquid leakage past piston |
| 14.2 | Freedom from air and liquid leakage past piston |
| 15.1 | Primary container |
| 15.2 | Secondary container |
| 16.1 | Primary container |
| 16.2 | Secondary container |
| 16.3 | Storage container |
| 16.4 | Transport wrapping |
.
4
| Company: | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. |
|---|---|
| Product: | Shifeng Piston Syringe with or without needle |
| Address: | No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China |
| Tel: | +86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011@163.com |
None of the data raises any new issues of safety and effectiveness.
The Shifeng Disposable Syringe with or without needle manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.
Comparison table:
The Shifeng Disposable syringe with or without needle manufactured by XinJin Shifeng in Sichuang, China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.
| Element of Comparison | Subject Device | Claimed SE Device |
|---|---|---|
| Syringe Type | Piston Syringe | |
| Classification II, FMF | Same | |
| Intended Use (s) | are intended to be used to inject | |
| fluid into or withdraw fluids from, | ||
| the body. | Same | |
| Principle of Operation | The operation principle is | |
| pushing or pulling the plunger to | ||
| inject fluid into or withdraw fluids | ||
| from the body, suitable for | ||
| human skin, muscle, | ||
| intravenous injection, etc | Same | |
| Specific Drug Use | NO | Same |
| Length | Various sizes complying with | |
| ISO 7886-1, 11.1 | Same | |
| Barrel Diameter | 1ml: 4.65-4.70mm | |
| 2ml: 8.85-8.90mm | ||
| 3ml: 9.00-9.05mm | ||
| 5ml: 12.40-12.45mm | ||
| 10ml: 14.95-15.00mm | Similar | |
| Tip Type | Centric | Same |
| Volume | Size various from 1ml to 10 ml | Same |
| Nozzle Type | Slip tip | Same |
| Barrel Marking Specs | Complying with ISO7886-1 | Same |
| Gradations legibility | Legible | Same |
| Lubricant amount / cm2 | Not exceed 0.25mg | Same |
| Barrel Transparency | Transparent | Same |
5
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Product: Shifeng Piston Syringe with or without needle
No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:
Tel:
+86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011(@163.com
| Delivery Accuracy | Complying with ISO 7886-1,
10.1 ~10.4 | Same |
|-----------------------|-------------------------------------------|---------------------------------------------|
| Reuse Durability | Not applicable, single use
device | Same |
| Biocompatibility | Complying with ISO 10993 | Same |
| Materials | | |
| • Lubricant | Polydimethylsiloxane | Similar
See Section VIII, A.1,
page 5 |
| • Barrel | Polypropylene | Same |
| • Plunger | Polypropylene | Same |
| • Piston | Synthetic rubber | Similar
See Section VIII, A.2,
page 9 |
| Labeling | Complying with ISO7886-1:
1993 | Same |
| Sterilization | ETO, ISO 11135 compliance | Same |
| Needle & Needle Cover | Shangdong Qiaopai needle
510(K) 073705 | Similar |
Additional Safety Information
The sterilization conditions are validated according to ISO 11135-1:2007 to provide a Sterility Assurance Level (SAL) of 10-8.
Ethylene Oxide residual levels after 7 days aeration resulting from EtO sterilization will not exceed the maximum daily dose levels proposed 10993-7:2008 and indicated as follows:
| Ethylene Oxide | 1.501ug/device (Lot. 20100301) |
|---|---|
| 10.9ug/device (Lot. 20110926) | |
| ECH | 10.9ug/device (Lot. 20110926) |
The device's materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #g95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation
6
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:
No.46, 70 group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:
Tel:
+86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011(@163.com
and Testing. Results of the testing demonstrate that the blood contacting materials are biocompatible.
Conclusion
The Shifeng Disposable Syringe with or without needle manufactured by XinJin Shifeng in Sichuang, China is substantially to the Disposable Hypodermic Syringe manufactured by IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969 with respect to intended use, design, technology/principles of operation, materials and performance. Differences between the devices do not raise any new issues of safety or effectiveness.
Date Prepared:
2011-11-15
Prepared by:
Name: Position: Tel: Fax: E-mail:
Mr. Xinglong Tian QA & RA Vice President +86-28-62812121 +86-28-82459393 xjshifeng2011@163.com
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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all caps. To the left of the text is a symbol that appears to be three lines that are curved.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Document Control Room -WO
- 1 2012 Silver Spring, MD 20993-0002
Mr. Xinglong Tian Ouality Assurance & Regulatory Affairs Vice President Chengdu Xinjin Shifeng Medical Apparatus & Instrument Company, Limited No.46, 7th Group Wanjie Village, Xinping Town Xinjin County Chengdu City P.R. CHINA
Re: K111841
Trade/Device Name: Shifeng Disposable Syringe with or without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF / FMI Dated: February 16, 2012 Received: February 16, 2012
Dear Mr. Tian:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
8
Page 2 - Mr. Tian
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
9
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:
No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:
Tel:
+86(028)85757683, Fax: +86(028)85157183, Email: xjshifeng2011@163.com
510(k) Number (if known): K111841
Shifeng Disposable Syringe with or without needle Device Name:
Indications for Use:
The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
(PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109vision Sign-Off)
OR
Over-The-Counter Use
3/1/12
(Per 21 CFR 807.19)Vision Sign-On
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
(Optional Format 1-2-96)
510(k) Number. K111841
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