(89 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a safety hypodermic needle, with no mention of AI or ML.
No.
This device is described as a hypodermic needle for medication administration, which is a delivery mechanism, not a therapeutic agent itself.
No
Explanation: The device is a safety hypodermic needle intended for medication administration and aspiration, which are therapeutic/procedural uses, not diagnostic.
No
The device description clearly outlines a physical hypodermic needle with a safety mechanism, available in various gauges and lengths. The performance studies focus on physical properties and biological compatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with syringes for general purpose aspiration and medication administration." This describes a device used for directly interacting with the body (drawing fluids or injecting substances), not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic needle with a safety mechanism. This is a medical device used for accessing the body, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like reagents, test strips, analyzers, etc.), which are characteristic of IVD devices.
- Performance Studies: The performance studies focus on the physical and biological properties of the needle itself (tolerance, lubricant, bond strength, sterility, biocompatibility), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
EXELINT SecureTouch Safety Hypodernic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle.
The proposed device is available in EO sterilized sealed in a sterility maintenance package.
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 (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 7864 Third Edition 1993-05-15, Sterile Hypodermic Needles For Single Use.
- ISO 9626 First Edition 1991-09-01, Stainless Steel Needle Tubing For The Manufacture Of Medical Devices [Including: Amendment 1 (2001)]
- ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-7:2008(R) 2012, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
- ISO 10993-11:2006/(R) 2010, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity.
- ASTM F756-13, Standard Practice for Assessment of Hemolytic Properties of Materials.
- ASTM F88/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.
- USP Bacterial Endotoxins Test.
- USP Pyrogen Test.
The performance tests performed on the proposed device are as follows:
- Test for Tolerance on Length
- Test for Lubricant
- Test for Bond between Hub and Needle Tube
- Test for Patency Lumen
- Dimension Test
- Stiffness Test
- Test for Resistance of Tubing to Breakage
- Test for Resistance to Corrosion
- Testing of Force to Activate the Safety Feature
- Testing of Force to Detach the Safety Feature
No clinical study is included in this submission.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with a wing-like shape above them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2015
EXELINT International Co. Mr. Navid Hamid Senior Regulatory Affairs 2500 Santa Fe Avenue Redondo Beach, California 90278
Re: K152183
Trade/Device Name: EXELINT SecureTouch Safety Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 4, 2015 Received: August 5, 2015
Dear Mr. Hamid:
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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
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) K152183
Device Name EXELINT SecureTouch Safety Hypodermic Needle
Indications for Use (Describe)
EXELINT SecureTouch Safety Hypodernic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.
| 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)
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3
510(k) Summary
-
- Date of Preparation: October 15, 2015
-
- Sponsor Identification
EXELINT International, Co.
2500 Santa Fe Avenue Redondo Beach, CA 90278 Establishment Registration Number: 1035907 Contact Person: Navid Hamid Position: Manager Tel: 310-649-0707 Fax: 310-649-1168 Email: navid(@exelmed.com
-
- Identification of Proposed Device
Trade Name: EXELINT SecureTouch Safety Hypodermic Needle Common Name: Safety Hypodermic Needle
- Identification of Proposed Device
Regulatory Information: Classification Name: Hypodermic single lumen needle Classification: 2 Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital
Intended Use Statement:
EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.
Device Description:
EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle.
The proposed device is available in EO sterilized sealed in a sterility maintenance package.
-
- Identification of Predicate Device(s)
510(k) Number: K123684 Product Name: Sol-Care Safety Needle
- Identification of Predicate Device(s)
-
న్. 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 7864 Third Edition 1993-05-15, Sterile Hypodermic Needles For Single Use. A
- A ISO 9626 First Edition 1991-09-01, Stainless Steel Needle Tubing For The Manufacture Of Medical Devices [Including: Amendment 1 (2001)]
4
-
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-7:2008(R) 2012, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
-
ISO 10993-11:2006/(R) 2010, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity.
-
ASTM F756-13, Standard Practice for Assessment of Hemolytic Properties of Materials.
-
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
- A ASTM F1140/F1140M-13, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
-
USP Bacterial Endotoxins Test.
- A USP Pyrogen Test.
The performance tests performed on the proposed device are as follows:
- Test for Tolerance on Length i.
- ii. Test for Lubricant
- Test for Bond between Hub and Needle Tube iii.
- Test for Patency Lumen iv.
- V. Dimension Test
- vi. Stiffness Test
- vii. Test for Resistance of Tubing to Breakage
- viii. Test for Resistance to Corrosion
- ix. Testing of Force to Activate the Safety Feature
- Testing of Force to Detach the Safety Feature X.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Devices | Predicate Devices |
|---|---|---|
| Product Code | FMI | FMI |
| Regulation | ||
| Number | 21 CFR 880.5570 | 21 CFR 880.5570 |
| Class | 2 | 2 |
| Intended Use | EXELINT SecureTouch Safety | |
| Hypodermic Needle is intended | ||
| for use with syringes for | ||
| general purpose aspiration and | ||
| medication administration. It | ||
| has an antistick mechanism to | ||
| cover the needle after use. The | ||
| safety mechanism covers the | ||
| needle after use. In the | ||
| activated position, the needle | ||
| cover guards against accidental | ||
| needle stick during normal | ||
| handling and disposal of the | ||
| used needle/syringe | ||
| combination. | The Sol-Care Safety Hypodermic | |
| Needle is used in conjunction with a | ||
| standard syringe. This device is used | ||
| for aspiration and administration of | ||
| medication. The Sol-Care Safety | ||
| Hypodermic Needle safety | ||
| mechanism covers the needle after | ||
| use. In the activated position, the | ||
| needle cover guards against | ||
| accidental needle stick during normal | ||
| handling and disposal of the used | ||
| needle/syringe combination. |
Table 1 Comparison of Technology Characteristics
5
| Configuration | Hub, Needle Cannula, Needle
Cap, Protection Shield | Hub, Needle Cannula, Needle Cap,
Protection Shield |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Force to
activate the
safety feature | ≤4N | 30G~28G