(119 days)
No
The summary describes a mechanical device for fluid administration and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as an "Infusion Needle" for administering fluid, which is a delivery mechanism, not a treatment in itself. Its purpose is to facilitate the delivery of a substance to the patient, rather than directly providing a therapeutic effect.
No
Explanation: The device is described as an "Infusion Needle" intended to "administer fluid" to a patient's vascular system. Its purpose is to deliver substances, not to gather information for diagnosis.
No
The device description clearly details physical components like a needle, conical fitting, and safety sheath, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein." This describes a device used for delivering substances into the body, not for testing samples taken from the body.
- Device Description: The description focuses on the physical components and how the device facilitates the administration of fluid into the vein. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device described is a medical device used for drug or fluid delivery, specifically an infusion needle.
N/A
Intended Use / Indications for Use
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.
Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system through the needle inserted into the vein
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)
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:
- ISO 9626:1991+AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
- ISO 7864: 1993 Sterile hypodermic needles for single use
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
- ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
- ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
- USP37-NF32 Bacterial Endotoxins Limit.
- ISO 11135-1:2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- 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: Test for irritation and delayed-type hypersensitivity
- ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials.
Simulated Clinical Study performed on the proposed device:
A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff. Medical Devices with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
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.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
Jiangyin Caina Technology Co., Ltd c/o Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K152323
Trade/Device Name: Disposable Infusion Needle, Safelock Disposable Infusion Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration set Regulatory Class: II Product Code: FPA Dated: November 10, 2015 Received: November 13, 2015
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 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.
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Tina Kiang -S
for 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
2
Indications for Use
510(k) Number (if known) K152323
Device Name Safelock Disposable Infusion Needle Disposable Infusion Needle
Indications for Use (Describe)
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.
Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K152323 510(k) Summary
510(k) Submitter
Jiangyin Caina Technology Co., Ltd.
No.2, Taifu Road, Huashi Town, Jiangyin, Jiangsu, 214421, China Contact Person: Jun Lu Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com
Date of Preparation: 10/20/2015
Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
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
Device Name
Trade Name: Disposable Infusion Needle Safelock Disposable Infusion Needle Common Name: Intravenous Infusion Needle
Classification Name: Set, Administration, Intravascular Classification: II; Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital
Predicate Device
Predicate Device 510(k) Number: K070362 Product Name: SURFLO Winged Infusion Set
4
Reference Device 510(k) Number: K132153 Product Name: SafeTouch PSV winged Infusion Set with/without filter
Device Description
The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.
Intended Use
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.
Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the safety sheath is designed to prevent accidental needle sticks.
Technological Characteristics
| Table 1 Comparison of Technology Characteristics | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device | |
| K070362 | Reference Device | ||
| K132153 | |||
| Product | Disposable Infusion | ||
| Needle | |||
| Safelock Disposable | |||
| Infusion Needle | SURFLO ® Winged | ||
| Infusion Set | SafeTouch PSV | ||
| winged Infusion Set | |||
| with/without filter | |||
| Product Code | FPA | FPA | FOZ |
| Regulation | |||
| Number | 880.5440 | 880.5440 | 880.5200 |
| Indications for | |||
| Use | Disposable Infusion Needle | ||
| is intended to administer | |||
| fluid by using an infusion set | |||
| to a patient' s vascular | |||
| system through the needle | |||
| inserted into the vein. | |||
| Safelock Disposable Infusion | |||
| Needle is intended to | |||
| administer fluid by using an | |||
| infusion set to a patient's | The Surflo Winged Infusion | ||
| Set is intended to access the | |||
| peripheral vascular system, | |||
| for intravenous | |||
| administration of fluids | |||
| and/or withdrawal of blood | |||
| specimens using a syringe, | |||
| luer adapter, or other | |||
| compatible/appropriate | |||
| devices | The Safe Touch PSV | ||
| Winged Infusion Set | |||
| with/without filter is | |||
| intended to be used for | |||
| insertion into a | |||
| patient's vascular | |||
| system for single use | |||
| as an indwelling device | |||
| to administer fluids | |||
| intravenously |
Table 1 Comparison of Technology Characteristics
5
| | vascular system through the
needle inserted into the vein,
and the safety sheath is
designed to prevent
accidental needle sticks. | | Secondly it is designed
with an active sharp
feature that requires
physical action by the
clinician to prevent
accidental needle
sticks. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To administer fluid into the
vein | To administer fluid into the
vein and withdraw blood
specimens | To administer fluids
into the vein |
| Safety Feature | The Safelock Disposable
Infusion needle is locked
in safety sheath by
withdraw safety needle
handle backward | None | The Safe Touch PSV
Winged infusion set
needle is locked in
safety sheath by
withdraw safety
needle handle
backward |
| Sterile | EO sterilized | EO sterilized | EO sterilized |
| Blood sampling | None | Yes | None |
| Single Use | Single use | Single use | Single Use |
| Performance | Complied with ISO
9626:1991,
AMENDMENT 1 2001
and ISO 7864:1993 | Complied with ISO
9626:1991, AMENDMENT
1 2001 and ISO 7864:1993 | Complied with ISO
9626:1991, AMENDMENT
1 2001 and ISO 7864:1993 |
| Biocompatibility | Conform with ISO 10993 | Conform with ISO 10993 | Conforms with ISO
10993 |
The subject devices are equivalent to the predicate devices with respect to technological characteristics. They shared the same operational principle, intended use, materials, biocompatibility, and sterilization.
Non-Clinical Test Conclusion
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:
-
ISO 9626:1991+AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
-
ISO 7864: 1993 Sterile hypodermic needles for single use
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
6
-
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
-
USP37-NF32 Bacterial Endotoxins Limit.
- ♪ ISO 11135-1:2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- A ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- 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: Test for irritation and delayed-type hypersensitivity
-
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials. The test provided in this submission include:
Simulated Clinical Study performed on the proposed device:
A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff. Medical Devices with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Conclusion
Based on the non-clinical tests above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.