The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes. The distal end of the needle cap, which protects the needle prior to use.

AI/ML Overview

This document is a 510(k) Premarket Notification for the "Mini Needle" device and focuses on establishing substantial equivalence to a predicate device rather than a comprehensive study proving novel acceptance criteria for a new type of device. Therefore, some of the requested information (like effect size of MRMC studies, number of experts for ground truth, or training set details) is not applicable or not provided in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mini Needle are primarily based on demonstrating substantial equivalence to a predicate device (TSK Hypodermic Needle) and meeting relevant ISO standards for medical needles. The device performance is reported as meeting these specified criteria.

Acceptance Criteria (Based on ISO Standards & Predicate Device Equivalence)	Reported Device Performance
Dimensional and Physical Properties Verification (ISO 594-1/-2)	Met all specified criteria
Bond and Material Strength Verification (ISO 594-1/-2)	Met all specified criteria
Biocompatibility Testing (ISO 10993)	Met all specified criteria
Sterilization Validation (ISO 11137-1/2)	Met all specified criteria
Packaging Validation	Met all specified criteria
Intended Use Equivalence	Substantially equivalent
Principle of Operation Equivalence	Substantially equivalent
Technological Characteristics Equivalence	Substantially equivalent
Absence of New Safety or Performance Questions	Did not raise new questions

2. Sample Size Used for the Test Set and Data Provenance

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size used for each of the listed tests (Dimensional, Bond/Material Strength, Biocompatibility, Sterilization, Packaging).

Data Provenance: The data appears to be from prospective testing conducted by the manufacturer, OcuJect, LLC, on their Mini Needle devices. There is no mention of country of origin for the data beyond the manufacturer's location in Newport Beach, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission. For mechanical devices like needles, "ground truth" is typically established through adherence to engineering specifications and ISO standards, not expert consensus on medical images or diagnoses. The testing involves physical and chemical evaluations by qualified personnel in laboratories, not medical experts establishing a "ground truth" for a diagnostic outcome.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert opinions might differ on a diagnostic outcome (e.g., classifying an image). For mechanical and physical testing of a needle, the results are objective measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The Mini Needle is a physical medical device (a hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The Mini Needle is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering specifications and international standards (ISO standards) for hypodermic needles. These standards detail acceptable dimensional tolerances, material properties, strength, sterility, and biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device, the Mini Needle does not involve a "training set" in the context of machine learning or AI development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2015

Ocujet, LLC Ms. Rebecca Pine Official Correspondent 1441 Avocado Ave. Suite 204 Newport Beach, California 92660

Re: K151571

Trade/Device Name: Mini Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 3, 2015 Received: September 4, 2015

Dear Ms. Pine:

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 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

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Indications for Use

510(k) Number (if known) K151571

Device Name Mini Needle

Indications for Use (Describe)

The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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6. 510(k) Summarv

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	OcuJect, LLC
DATE PREPARED:	October 14, 2015
CONTACT PERSON:	Rebecca K Pine1441 Avocado Ave, Suite 204Newport Beach, CA 92660(760) 809-5178
TRADE NAME:	Mini Needle
COMMON NAME:	Needle
CLASSIFICATIONNAME:	Single lumen hypodermic needle
DEVICECLASSIFICATION:	Class 2, per 21 CFR 880.5570
PRODUCT CODE	FMI
	PREDICATE DEVICES: (primary) TSK Hypodermic Needle (K970370)

Substantially Equivalent To:

The Mini Needle is substantially equivalent in intended use, principal of operation and technological characteristics to the predicate devices identified above.

Description of the Device Subject to Premarket Notification:

Indication for Use:

The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs

Technical Characteristics:

The Mini Needle has similar physical and technical characteristics to the predicate devices, as shown in the table below.

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	Mini Needle	TSK HypodermicNeedle
Intended Use	The Mini Needle is intended for use with a luer-tip syringe for the administration of drugs into the body.	The TSK Hypodermic needle is a single lumen needle intended to inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Principle of OperationDesign/Construction	Manual• Needle Assembly (cannula, needle hub, needle cap, clip)• Designed to fit standard 6% luer fittings	Manual• Needle Assembly (cannula, needle hub, protector cap)• Designed to fit standard 6% luer fittings
Materials	Cannula- Stainless steelLubricant- SiliconeAdhesive- polyacrylateHub- polypropyleneNeedle Cap- polypropylene with TPE tipClip- polypropylene	Cannula- Stainless steelAdhesive - epoxyLubricant- SiliconeProtector Cap- unknownHub- polypropylene
Needle Taper	None	None
Needle Length	5.5mm	9mm13mm
Needle Gauge	30G32G33G	14G to 31G
Tip Configuration	Lancet Bevel	Lancet Bevel
Wall Type	Std wall	Std wall
Sterilization	Irradiation	Irradiation
How provided	Sterile, single use	Sterile, Single Use

Each of the technical attributes of the Mini Needle are present in the predicate devices. The materials, needle bevel and other fundamental design characteristics are all the same. The slightly smaller needle gauge of the Mini Needle has no effect on the fundamental operational characteristics of the device. The effective length of the Mini Needle is within the established lengths of the predicate device. The Mini Needle has a sliding needle cap

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to prevent needle contamination from surrounding tissues/hairs during injection. This element is an augmentation to the overall design and has no effect on the fundamental design of the device. The Mini Needle is indicated for the delivery of drugs into the human body, whereas the TSK Needle is indicated for the delivery and withdrawal of fluids into and from the human body. This difference does not affect the substantial equivalence of the device, as the Mini Needle indications are merely more specific regarding the type of fluid and more precise based on the design of the device.

Performance Data:

All necessary testing has been performed for the Mini Needle to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device design was qualified through the following tests:

Dimensional and Physical Properties Verification (ISO 594-1/-2)
Bond and Material Strength Verification (ISO 594-1/-2) ●
Biocompatibility Testing (ISO 10993)
Sterilization Validation (ISO 11137-1/2) ●
. Packaging Validation

The Mini Needle met all specified criteria and did not raise new safety or performance questions.

Basis for Determination of Substantial Equivalence:

Conclusion

Upon reviewing the information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Mini Needle is substantially equivalent 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).