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 with a 5.5mm exposed length. The distal end of the needle has a spring-loaded needle cap, which shields the needle prior to use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Mini Needle." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML or diagnostic device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, F-measure, sample sizes for test/training sets, expert consensus, MRMC studies) is not applicable to this document.

This document describes a conventional medical device (hypodermic single lumen needle) and its premarket notification process. The "Performance Data" section details engineering and biocompatibility tests performed to ensure the device performs as intended and is safe, rather than a clinical performance study with AI/ML-specific metrics.

Here's a breakdown of the available information in the context of the device described:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests, but it does not provide quantitative acceptance criteria or numerical reported device performance in the format typically seen for AI/ML or diagnostic studies. Instead, it states that "The Mini Needle met all specified criteria and did not raise different safety or performance questions."

Acceptance Criteria (Implied)	Reported Device Performance
ISO 594-1 & 2 (Dimensional and Physical Properties)	Met all specified criteria
ISO 594-1 & 2 (Bond and Material Strength)	Met all specified criteria
ISO 10993-1; ISO 10993-7 (Biocompatibility)	Met all specified criteria
ISO 11135 (Sterilization Validation)	Met all specified criteria
Packaging Validation (ASTM D4169-16, ASTM 2069-11, ASTM F88/F88M-15)	Met all specified criteria and performed as intended (packaging integrity)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated for each test. The document mentions "All testing was performed on test units representative of finished devices," implying a sample size appropriate for engineering validation but not specified numerically.
Data Provenance: Not applicable in the context of AI/ML data. The tests are laboratory-based engineering and material science tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable to the engineering and biocompatibility testing described. Ground truth established by medical experts is relevant for diagnostic or AI/ML performance, not for verifying physical and material properties of a needle.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic or AI/ML studies, which is not relevant here.

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:

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

For Dimensional and Physical Properties, Bond and Material Strength, Sterilization Validation, and Packaging Validation, the "ground truth" would be established by the engineering specifications and relevant ISO/ASTM standards.
For Biocompatibility Testing, the "ground truth" is based on the biological response observed in accordance with ISO 10993 standards, determining if the material is non-toxic or non-irritating.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This device does not involve a training set.

Summary

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

July 10, 2017

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

Re: K170768

Trade/Device Name: Mini Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 7, 2017 Received: June 8, 2017

Dear Rebecca 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.

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

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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.

James P. Bertram -S

for

Lori A. Wiggins, MPT, CLT Acting 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) K170768

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary- K170768

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:	July 6, 2017
CONTACT PERSON:	Rebecca K Pine1441 Avocado Ave, Suite 204Newport Beach, CA 92660(760) 809-5178
TRADE NAME:	Mini Needle
COMMON NAME:	Needle
CLASSIFICATIONNAME:	Hypodermic single lumen needle
DEVICECLASSIFICATION:	Class 2, per 21 CFR 880.5570
PRODUCT CODE	FMI
PREDICATE DEVICE:	Mini- Needle (K151571)

Reason for submission:

Modification to previously cleared device K151571.

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 drug.

Technical Characteristics:

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

	Mini Needle	Mini Needle(K151571)
Intended Use	The Mini Needle isintended for use with a	The Mini Needle isintended for use with a

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	Mini Needle	Mini Needle(K151571)
	luer-tip syringe for theadministration of drugsinto the body.	luer-tip syringe for theadministration of drugsinto the body.
Principle of Operation	SAME	Manual
Design/Construction	• Needle Assembly(cannula, needle hub, spring loaded needle cap)• Designed to fit standard 6% luer fittings	• Needle Assembly(cannula, needle hub, needle cap, clip)• Designed to fit standard 6% luer fittings
Materials	Cannula- Stainless steelLubricant- SiliconeAdhesive- polyacrylateHub- polypropyleneNeedle Cap- polypropyleneSpring- stainless steel	Cannula- Stainless steelLubricant- SiliconeAdhesive- polyacrylateHub- polypropyleneNeedle Cap- polypropylene withTPE tip, retaining ringClip- polypropylene
Needle Taper	SAME	None
Needle Length- total	SAME	20 mm
Needle length- exposed	SAME	5.5mm
Needle Gauge	SAME	30G32G33G
Tip Configuration	SAME	Lancet Bevel
Wall Type	SAME	Std wall
Sterilization	Ethylene oxide	Irradiation
How provided	SAME	Sterile, single use

Each of the technical attributes of the Mini Needle are present in the predicate device. The materials, needle bevel and other fundamental design characteristics are all the same. The Needle Cap design has been modified from the predicate device, to incorporate a spring for ease of use. The incorporation of the spring feature eliminated the need for the Clip, as well as the retaining ring feature and TPE tip on the Needle Cap. These modifications have no effect on the fundamental operational characteristics of the device. The needle cap continues to function as a contamination prevention feature for the needle from surrounding tissues/hairs during injection. The primary sterile barrier is modified from a Tyvek pouch to a blister pouch. The sterilization method has been changed to exposure to ethylene oxide (EtO). EtO is well-known sterilization process common in the medical device industry

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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 10993-1; ISO 10993-7) ●
Sterilization Validation (ISO 11135) ●
Packaging Validation ●
- 0 Climatic Cycling & Transit Testing (ASTM D4169-16)
- o Pouch Seal Testing (ASTM 2069-11 and ASTM F88/F88M-15)

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

Basis for Determination of Substantial Equivalence:

Conclusion

The Mini Needle has the same intended use, technological characteristics and performance and 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).