The SteriCap™ 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 sizes ranging from 23G - 33G. The distal end of the needle has a spring-loaded needle cap, which protects the needle prior to use.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SteriCap Mini Needle, which is a medical device. The information provided heavily focuses on the safety and performance of this physical medical device and its equivalence to a predicate device, rather than a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered medical device, which would typically involve clinical performance metrics like sensitivity, specificity, AUC, etc.

Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document as it concerns a hypodermic needle.

However, I can extract information related to the performance data provided to support the substantial equivalence of the SteriCap Mini Needle, which serves as the "acceptance criteria" and "device performance" in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The product line extension met all specified criteria and did not raise new safety or performance questions." This indicates a pass/fail criteria for each test, implying the device performs as expected according to established standards for hypodermic needles. The document lists the types of testing performed rather than specific numerical acceptance criteria or measurements.

Acceptance Criteria (Type of Test)	Reported Device Performance (Implied)
Needle Cap Sliding Force	Met specified criteria (Implied: Passed)
Twist Lock Release Force	Met specified criteria (Implied: Passed)
Dimensional and Physical Properties Verification (ISO 594-1 & 2) - Luer compatibility	Met specified criteria (Implied: Passed)
Bond and Material Strength Verification (ISO 594-1 & 2; ISO 7864) - Needle cap bond strength	Met specified criteria (Implied: Passed)
Bond and Material Strength Verification (ISO 594-1 & 2; ISO 7864) - Needle to luer hub bond strength	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle OD	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle ID	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Overall and Exposed Needle Length Verification	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle stiffness	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Bending-breakage resistance	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Resistance to corrosion	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Limits for acidity and alkalinity	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Limits for extractable metals	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle cleanliness	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Coring	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle point sharpness	Met specified criteria (Implied: Passed)
Needle quality (ISO 9626, ISO 7864) - Needle patency	Met specified criteria (Implied: Passed)
Color coding (ISO 6009, ISO 7864)	Met specified criteria (Implied: Passed)

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

Sample Size: Not specified in the provided document. The performance data section vaguely states "The following performance data were provided in support of the substantial equivalence." without giving specific sample numbers for each test.
Data Provenance: Not specified in terms of country of origin. This would typically be laboratory test data, not patient-derived data, for a hypodermic needle. The document implies these are "in-house" or contract lab tests designed to meet ISO standards.
Retrospective or Prospective: Not applicable. These are physical component tests, not clinical studies on patient data.

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

Not Applicable. The "ground truth" for a physical device like a needle is established by engineering specifications, validated test methods (often international standards like ISO), and material properties, not by human experts adjudicating images or cases.

4. Adjudication method for the test set

Not Applicable. See point 3. Testing involves objective measurements against predefined engineering specifications.

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 a physical medical device (hypodermic needle), not an AI/ML algorithm.

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

Not Applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used

Engineering Specifications and International Standards: The 'ground truth' or benchmark for the SteriCap Mini Needle's performance is based on established ISO standards (e.g., ISO 594-1 & 2, ISO 7864, ISO 9626, ISO 6009) and the physical and mechanical properties expected of hypodermic needles.

8. The sample size for the training set

Not Applicable. This refers to an AI/ML algorithm's training data. This document is about a physical device.

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

Not Applicable. See point 8.

In summary, this document is a 510(k) submission for a conventional medical device (hypodermic needle) and describes its performance based on engineering and material testing against established international standards, not a clinical study of an AI/ML device.

Summary

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

Re: K183016

Trade/Device Name: SteriCap Mini Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: April 15, 2019 Received: April 17, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sarah Mollo

for Tina Kiang, Ph.D Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183016

Device Name SteriCap™ Needle

Indications for Use (Describe)

The SteriCap™ 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)> Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K183016

I. SUBMITTER

OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660

Contact person: Rebecca K Pine Phone: (760) 809-5178 Fax: (760) 290.3216 Date prepared: April 8, 2019 Establishment Registration Number:3012478173

II. DEVICE

Name of the device: SteriCap™ Mini Needle Common of usual name: Needle Classification name: Single lumen hypodermic needle Regulatory Class: 2 Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital

III. PREDICATE DEVICE Mini-Needle (K170768) This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE The SteriCap™ Mini Needle is intended for use with a luer-tip syringe (e.g. luerlock or slip-tip luer syringe) for the administration of drugs.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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	SteriCap™ Mini Needle	Mini Needle(K170768)- PrimaryPredicate
Intended Use	The SteriCap™ MiniNeedle is intended foruse with a luer-tipsyringe for theadministration ofdrugs.	The Mini Needle isintended for use with aluer-tip syringe for theadministration of drugs
Principle of Operation	SAMEas K170768	Manual
Design/Construction	SAMEas K170768	• Needle Assembly(cannula, needle hub,spring loaded needlecap)• Designed to fit standard6% luer fittings
Materials	SAMEas K170768	Cannula-Stainless steelLubricant-SiliconeAdhesive- polyacrylateHub-polypropyleneNeedle Cap-polypropyleneSpring-stainless steel
Needle Taper	SAMEas K170768	None
Needle Length-total	SAMEas K170768	20 mm
Needle length-projected	SAMEas K170768	5.5mm
Needle Gauge	33G32G30G29G27G25G23G	33G32G30G
Tip Configuration	SAMEas K170768	Lancet Bevel
Wall Type	SAMEas K170768	Std wall
Sterilization	SAMEas K170768	Ethylene oxide
How provided	SAMEas K170768	Sterile, single use

The technological characteristics of the modified SteriCap™ Mini Needle are similar to the technological characteristics of the SteriCap™ Mini Needle previously cleared (K170768) version of the device. The only difference is the additional needle gauges.

At a high level, the subject and predicate devices are based on the following same technological elements:

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트 all intended for use with a luer-tip syringe for the administration of drugs into the body
all have a total needle length of 20mm with an exposed length of 5.5mm
all have a lancet bevel tip configuration
트 all have a cap feature which functions as a contamination prevention feature from surrounding hairs/tissue during injection

The following technological differences exist between the subject and predicate devices:

Additional needle gauge diameters have been incorporated into the . product family, namely 23G, 25G, 27G and 29G.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence.

Needle Cap Sliding Force ■
Twist Lock Release Force
I Dimensional and Physical Properties Verification (ISO 594-1 & 2)
- . Luer compatibiility
Bond and Material Strength Verification (ISO 594-1 & 2; ISO 7864)
- Needle cap bond strength ●
- . Needle to luer hub bond strength
Needle quality (ISO 9626, ISO 7864)
- Needle OD ●
- Needle ID .
- . Overall and Exposed Needle Length Verification
- . Needle stiffness
- Bending-breakage resistance
- . Resistance to corrosion
- . Limits for acidity and alkalinity
- Limits for extractable metals
- . Needle cleanliness
- . Coring
- Needle point sharpness
- Needle patency ●
Color coding (ISO 6009, ISO 7864) .

The product line extension met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the modified SteriCap™ Mini Needle was found to have a substantially equivalent safety and effectiveness profile to the predicate device.

VIII. CONCLUSIONS

Based on the comparison and analysis above the SteriCap™ Mini Needle is considered substantially equivalent to the legally marketed predicate devices.

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).