(133 days)
Not Found
No
The device description and performance studies indicate a standard mechanical syringe and needle, with no mention of AI or ML capabilities.
No
A syringe with a needle is used for injection or withdrawal of fluids, not for treating a disease or condition.
No
The device description clearly states its purpose is to "inject fluids into or withdraw fluid from, parts of the body below the surface of the skin," which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly outlines physical components (plunger, piston, barrel, needle) and performance testing related to these physical attributes (biocompatibility, syringe/needle performance, sterilization), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluid from, parts of the bady below the surface of the skin." This describes a direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed in vitro (outside the living organism).
- Device Description: The description details a standard syringe and needle, designed for injecting or withdrawing substances directly from the body. This aligns with in vivo procedures, not in vitro testing of samples.
- Lack of IVD Indicators: The document does not mention any components, processes, or intended uses related to analyzing biological samples or providing diagnostic information based on such analysis.
The device described is a standard medical device used for administering or collecting substances directly from a patient, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
Single Use Sterile Syringe with Needle is intended to inject fluids into or withdraw fluid from part of the body below the surface of the skin.
Single Use Sterile Syringe with Needle inject fluids into or withdraw fluid from, parts of the bady below the surface of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FMF/FMI
Device Description
The Single Use Sterile Syringe with Needle belongs to standard piston. And there are eight models - 1ml,2ml,2.5ml,5ml,10ml,20ml,30ml and 50ml within the device, which enjoy the same stucture, that is, all of the eight models consists of a piston syringe comprised of a movable plunger, piston and a calibrated hollow barrel, at one end of which there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle, and a matching hypodermic single lumen needle which consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designated to mate with a male connector (nozzle) of a piston syringe.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing is not required for a typical piston syringe device. The subject device was tested to evaluate its safety and effectiveness according to the following standards:
a. Biocompatibility Test according to ISO 10993-4: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood. ISO 10993-5: 2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10: 2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization and ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity according to the recommendations in the Blue Book Memorandum #G95-1, entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
b. Syringe Performance Effectiveness Test according to ISO 7886-11:1993. Sterile hypodermic syringes for single use - Part 1: Syringes for manual use and ISO 594/1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1 : General requirements.
c. Needle Performance Effectiveness Test according to ISO 7864:1993, Sterile hypodermic needles for single use, ISO 594/1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General requirements and ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices.
The sterilization conditions are validated in accordance with the company's own "Ethylene Oxide Steriliztion Verification Scheme" which is compiled on the basis of the requirements of ISO11135-1: 2007 from January 24,2013 to March 2,2013 to provide a Sterility Assurance Level(SAL) of 10-6. And Ethylene Oxide residual levels after 7 days aeration from EtO sterilization will not exceed the maximum daily dose levels proposed in ISO 10993-7:2008.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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).
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Image /page/0/Picture/0 description: The image shows the logo of Jiangxi Kelun Medical Devices Manufacturing Co., LTD. The logo consists of a circular emblem on the left and the company name in both Chinese and English on the right. The emblem features a stylized design with a central element resembling a cross or a stylized medical symbol, surrounded by a wreath-like border.
2 7 2014
Section 5 510(k) Summary K133493 (As required by 21 CFR 807.92(a))
5.1 Submitter Information
· Company: Jiangxi Kelun Medical Devices Manufacturing Co.,Ltd.
-
· Address: Yuanzhou District Pharmaceutical Industry Park,
336000 Yichun City, Jiangxi Province, P.R China -
· Phone: 086-791-2171882
-
· Fax: 086-791-2177766
-
· Email: kl-lanhai@kelun.com
· Contact: Lan Hai, General Manager
- · Date: June 21, 2013.
5.2 Device Information
· Trade/Proprietary Name: Single Use Sterile Syringe with Needle;
· Model: 1ml, 2ml, 2.5ml, 5ml, 10ml, 20ml, 30ml, 50ml
· Common Name: Piston Syringe
· Classification: Device Class: 2
Review Panel: General Hospital
Name: Syringe. Piston/ Needle, Hypodermic. Single Lumen Regulation Number: 21 CFR 880.5860 / 21 CFR 880.5570 Product Code: FMF/FMI
· Predicate Device: K111841 - Shifeng Disposable Syringe with or without needle manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
· Device Description:
The Single Use Sterile Syringe with Needle belongs to standard piston. And there are eight models - 1ml,2ml,2.5ml,5ml,10ml,20ml,30ml and 50ml within the device, which enjoy the same stucture, that is, all of the eight models consists of a piston syringe comprised of a movable plunger, piston and a calibrated hollow barrel, at one end of which there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle, and a matching hypodermic single lumen needle which consists of a metal tube that is sharpened at one end and at the other end joined to a
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Image /page/1/Picture/0 description: The image shows the logo of Jiangxi Kelun Medical Devices Manufacturing Co., Ltd. The logo consists of a circular emblem on the left and the company name in both Chinese and English on the right. The Chinese characters are above the English text, which reads "JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO., LTD."
female connector (hub) designated to mate with a male connector (nozzle) of a piston syringe.
· Intended Use:
Single Use Sterile Syringe with Needle is intended to inject fluids into or withdraw fluid from part of the body below the surface of the skin.
| Item | Subject Device | Predicate Device |
|---|---|---|
| Syringe Type | Standard Syringe | 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 too inject fluid into or withdraw fluids from the body, suitable for human skin, muscle, intravenous injection, etc. | Same |
| Specific Drug Use | No | Same |
| Dimensions | Same length complying with ISO 7886-1, Clause 11.1 | |
| Similar diameter | ||
| Similar tip type | ||
| Similar volumes | Similar | |
| Nozzle Type | Slip Tip | Same |
| Barrel Marking Specs | Complying with ISO 7886-1 | Same |
| Gradations Legibility | Legible | Same |
| Lubricant Composition | Polydimethylsiloxane | Same |
| Lubricant Amount/cm2 | Accord with ISO 7886-1, | |
| Clause 8 | Same | |
| Barrel Transparency | Transparent | Same |
| Delivery Accuracy | Comply with ISO 7886-1, | Same |
| Clause 10.1~10.4 | ||
| Reuse Durability | Not applicable, single use device | Same |
| Biocompatibility | Comply with ISO 10993 | Same |
| Materials | ||
| · Barrel | Polypropylene | Same |
| · Plunger | Polypropylene | Same |
| · Piston | Natural rubber | Similar |
| Labeling | Comply with ISO 7886-1, Clause 16 | Same |
| Sterilization | ETO in fixed chamber | Same |
| Packaging | Comply with ISO 7886-1, Clause 15 | Same |
| Needle & Needle Cover | Accord with the requirement of ISO 7864. | Similar |
5.3 Comparison of Required Technology Characteristics
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Image /page/2/Picture/0 description: The image shows a black and white emblem. The emblem is circular and features a crown on top of a cross-like symbol. The cross-like symbol has three horizontal bars. The emblem is surrounded by a wreath-like design.
JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO., LTD.
Brief Summary:
First, the Single Use Sterile Syringe with Needle incorporates the same syringe type, intended use and principle of mode with the predicate device. Secondly, the subject device shares almost the same design and fundamental technological characteristics with the predicate device, for example, they both have no specific drug use, enjoy almost the same physical, mechanical and biological specifications, share the same sterilization methods and qualified labeling and packaging. Though they are not identical in dimensions, piston material and needle specifications, such difference have been further verified by relevant FDA recognized standards, thus will not bringing new safety and effectivity concerns.
3
Image /page/3/Picture/0 description: The image shows the logo for Jiangxi Kelun Medical Devices Manufacturing Co., Ltd. The logo consists of a circular emblem on the left and the company name in both Chinese and English on the right. The Chinese characters are above the English text, which reads "JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO., LTD."
5.4 Discussion of Tests Performed
· Clinical Tests:
Clinical testing is not required for a typical piston syringe device.
· Non-Clinical Tests
The subject device was tested to evaluate its safety and effectiveness according to the following standards:
a. Biocompatibility Test according to ISO 10993-4: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood. ISO 10993-5: 2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10: 2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization and ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity according to the recommendations in the Blue Book Memorandum #G95-1, entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
b. Syringe Performance Effectiveness Test according to ISO 7886-11:1993. Sterile hypodermic syringes for single use - Part 1: Syringes for manual use and ISO 594/1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1 : General requirements. c. Needle Performance Effectiveness Test according to ISO 7864:1993, Sterile hypodermic needles for single use, ISO 594/1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General requirements and ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices.
· Steriilzation
Moreover, the sterilization conditions are validated in accordance with the company's own "Ethylene Oxide Steriliztion Verification Scheme" which is compiled on the basis of the requirements of ISO11135-1: 2007 from January 24,2013 to March 2,2013 to provide a Sterility Assurance
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4
Image /page/4/Picture/0 description: The image shows the logo of Jiangxi Kelun Medical Devices Manufacturing Co., Ltd. The logo consists of a circular emblem on the left and the company name in both Chinese and English on the right. The Chinese characters are arranged horizontally above the English text, which reads "JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO., LTD."
Level(SAL) of 10-6.
And Ethylene Oxide residual levels after 7 days aeration from EtO sterilization will not exceed the maximum daily dose levels proposed in ISO 10993-7:2008.
5.5 Conclusion:
First, the subject device Single Use Sterile Syringe with Needle enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device.
In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure with three arms raised, positioned to the right. Encircling the graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
March 27. 2014
Jiangxi Kelun Medical Devices Manufacturing Company, Ltd C/O Helen Nan General Manager Room 302, NO. 21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang 325000
Re: K133493
Trade/Device Name: Single Use Sterile Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF/FMI Dated: June 21, 2013 Received: March 7, 2014
Dear Ms. Nan:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
6
Page 2 - Ms. Nan
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary-S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 Sae PRA Statement on last page.
のお気になる。
510{k} Number (if known) K133493
Device Name Single Use Sterile Syringe with Needle
Indications for Use (Describe)
Single Use Sterile Syringe with Needle inject fluids into or withdraw fluid from, parts of the bady below the surface of the skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by
Richard C. Chapman
Date: 2014.03.27
13:32:07 -04'00'
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