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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the EXELINT SecureTouch Safety Hypodermic Needle. However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is for a physical medical device (hypodermic needle) and describes its physical characteristics, materials, and non-clinical performance tests against established ISO and ASTM standards. There is no mention of an AI/algorithm, a test set, ground truth, expert readers, or MRMC studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner requested, nor can I answer questions about sample sizes, expert involvement, adjudication, or MRMC studies, as these concepts are not applicable to the device described in the provided text.

The closest relevant section is "5. Non-Clinical Test Conclusion," which lists the standards the device complies with and the performance tests performed. These are physical/material tests, not AI model evaluations.

Specifically, the document states:

"6. Clinical Test Conclusion: No clinical study is included in this submission." This means there are no human subject studies described for this device, which would be essential for an MRMC study or to evaluate human-in-the-loop performance.
The "Non-Clinical Test Conclusion" section lists various ISO and ASTM standards the device was tested against (e.g., ISO 7864 for sterile hypodermic needles, ISO 10993 for biocompatibility), and specific performance tests like "Test for Tolerance on Length," "Test for Lubricant," "Testing of Force to Activate the Safety Feature," etc. These are the "acceptance criteria" and "reported device performance" for this physical device, but they don't map to the AI-centric questions in the prompt.
The "510(k) Summary" and "Substantially Equivalent (SE) Comparison" sections compare the proposed device's characteristics and performance to a predicate device (Sol-Care Safety Needle), demonstrating substantial equivalence based on physical and functional attributes.

In summary, the provided text is about a physical medical device and its compliance with established manufacturing and safety standards, not an AI or algorithm-based device.

Summary

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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.

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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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Date of Preparation: October 15, 2015
1. 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

1. Identification of Proposed Device
  Trade Name: EXELINT SecureTouch Safety Hypodermic Needle Common Name: Safety Hypodermic Needle

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:

Device Description:

The proposed device is available in EO sterilized sealed in a sterility maintenance package.

1. Identification of Predicate Device(s)
  510(k) Number: K123684 Product Name: Sol-Care Safety Needle
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)]

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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 <85> Bacterial Endotoxins Test.
A USP <151> 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.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

Item	Proposed Devices	Predicate Devices
Product Code	FMI	FMI
RegulationNumber	21 CFR 880.5570	21 CFR 880.5570
Class	2	2
Intended Use	EXELINT SecureTouch SafetyHypodermic Needle is intendedfor use with syringes forgeneral purpose aspiration andmedication administration. Ithas an antistick mechanism tocover the needle after use. Thesafety mechanism covers theneedle after use. In theactivated position, the needlecover guards against accidentalneedle stick during normalhandling and disposal of theused needle/syringecombination.	The Sol-Care Safety HypodermicNeedle is used in conjunction with astandard syringe. This device is usedfor aspiration and administration ofmedication. The Sol-Care SafetyHypodermic Needle safetymechanism covers the needle afteruse. In the activated position, theneedle cover guards againstaccidental needle stick during normalhandling and disposal of the usedneedle/syringe combination.

Table 1 Comparison of Technology Characteristics

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Configuration	Hub, Needle Cannula, NeedleCap, Protection Shield	Hub, Needle Cannula, Needle Cap,Protection Shield
Force toactivate thesafety feature	≤4N	30G~~28G<4N;27G~~21G<5.5N;20G~18G<7.5N
Force to detachthe safetyfeature	≥30N	≥30N
OperationMode	Manual	Manual
Single Use	Yes	Yes
Needle Gauge	18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,28G, 29G, 30G	18G, 19G, 20G, 21G, 22G, 23G, 24G,25G, 26G, 27G, 28G, 29G, 30G
Performancespecification	Comply with ISO 7864, ISO9626	Comply with ISO 7864, ISO 9626
Material	Needle cannula: Stainless Steel	Needle cannula: Stainless Steel
	Needle hub and protectionshield: Polypropylene	Needle hub and protection shield:Polypropylene
	Needle cap: Polypropylene	Needle cap: Polypropylene
Biocompatibility	Conforms to ISO 10993Tests: Cytotoxicity, SkinSensitization, IntracutaneousIrritation, Systemic Toxicity, InVitro Hemolysis, Pyrogen	Conforms to ISO 10993

Substantially Equivalent (SE) Conclusion 8.

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent
(SE) to the predicate device.

Regulation Number and Section

§ 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).