(63 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and sterilization of syringes and needles, with no mention of AI or ML.
No
The device, consisting of syringes and needles, is intended for injecting or withdrawing fluids, which are procedures, not therapeutic actions themselves.
No
The intended use of the device is to inject or withdraw fluids from the body, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states it contains syringes and needles, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject fluids into or withdraw fluids from the body." This describes a device used for direct interaction with the body, not for testing samples taken from the body.
- Device Description: The description focuses on the physical components (syringes and needles) and their function in injecting or withdrawing fluids. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic, monitoring, or screening information
- Use in a laboratory setting
The device described is a standard medical device used for administering or collecting substances directly from a patient.
N/A
Intended Use / Indications for Use
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Necdles are intended to be used with a legally marketed syrings intended to injoct fluids into or withdraw fluids from the body.
Product codes
FMF, FMI
Device Description
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body.
The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle.
Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, The test results demonstrated that the proposed device complies with the following standards:
- A ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use;
- A ISO 7864:1993 Sterile hypodermic needles for single use.
- ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
- /A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
- A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
- A ISO11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Premarket Notification 510(k) Submission
JUL 2 5 2014
Exhibit #3 510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
K141359 The assigned 510(k) Number:
- Date the summary was prepared: April 5, 2014
Sponsor Identification 2.
Jiangyin Caina Technology Co., Ltd. No.2, Taifu Road. Huashi Town, Jiangyin. Jiangsu, 214421. China
Establishment Registration Number: 3005670221
Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com
3. Submission Correspondent
.
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
E3-1
1
Proposed Device Identification 4.
Proposed Device Name: Hard pack syringe Proposed Device Common Name: Syringe with or without needle
Regulatory Information: Classification Name: Piston Syringe; Classification: II; Product Code: FMF; Additional Product Code: FMI; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital:
Indications for Use:
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.
-
- Predicate Device Identification
510(k) Number: K113091 Product Name: Syringes with or without needles: Needles Manufacturer: Jiangyin Caina Technology Co., Ltd.
- Predicate Device Identification
-
Device Description 6.
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body.
The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle.
Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.
-
- Non-Clinical Test Conclusion
E3-2
- Non-Clinical Test Conclusion
2
1
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, The test results demonstrated that the proposed device complies with the following standards:
- A ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use;
- A ISO 7864:1993 Sterile hypodermic needles for single use.
- 产 ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
- /A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
- A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
- A ISO11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
-
- Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
Item | Proposed Devices | Predicate Devices |
---|---|---|
K113091 | ||
Product Code | FMF& FMI; | FMF& FMI; |
Regulation Number | 21CFR 880.5860 & 21 CFR 880.5570 | 21CFR 880.5860 & 21 CFR 880.5570 |
Intended Use | Syringes with or without needle are | |
intended to inject fluids into or withdraw | ||
fluids from the body. | ||
Needles are intended to be used with a | ||
legally marketed syringe intended to | ||
inject fluids into or withdraw fluids from | ||
the body. | Syringes with or without needle are | |
intended to inject fluids into or | ||
withdraw fluids from the body. | ||
Needles are intended to be used with a | ||
legally marketed syringe intended to | ||
inject fluids into or withdraw fluids | ||
from the body. | ||
Component | Syringes and Needles | Same |
Sterile | Yes | Same |
Single Use | Yes | Same |
Shelf Life | Five year | Same |
Biocompatibility | ISO 10993:5 Standard | |
ISO 10993:10 Standard | Same |
Table 3-1 Comparison of Technology Characteristics | ||
---|---|---|
E3-3
3
·
.
| Performance | ISO 7864 Standard
ISO 7886 Standard
ISO 9626 Standard
ISO 594-1 Standard
SIO 594-2 Standard | Same |
|-------------------|---------------------------------------------------------------------------------------------------------|--------------|
| Immediate Package | Hard pack package | Soft package |
The proposed devices, Hard pack syringe, are determined to be Substantially Equivalent (SE) to the predicate devices. Syringes and needles (K113091). in respect of safety and effectiveness.
4
Image /page/4/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter, reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". In the center is a stylized emblem of an eagle with three lines representing its body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25. 2014
Jiangyin Caina Technology Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited Post Office Box 120-119 Shanghai CHINA 200120
Re: K141359
Trade/Device Name: Hard pack syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 23, 2014 Received: June 30, 2014
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. Please note: CDRH docs 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.
5
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141359
Device Name Hard pack svringe
Indications for Use (Describe)
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Necdles are intended to be used with a legally marketed syrings intended to injoct fluids into or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
2 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 -S |
Date: 2014.07.25 |
08:45:03 -04'00' |
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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