Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on physical properties, biocompatibility, and sterilization, with no mention of AI, ML, or related concepts.

Therapeutic

Yes
The device is described as "intended for use with a luer-tip syringe ... for the administration of drugs," which is a therapeutic purpose.

Diagnostic

No

The device description clearly states its purpose as "a means of fluid injection and aspiration to and from the body" for "administration of drugs," which aligns with therapeutic/interventional use, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a single lumen needle with a spring-actuated sliding cap or a removable clear cap, which are physical hardware components. The performance studies also focus on physical properties, biocompatibility, and sterilization of a physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "for the administration of drugs." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
Device Description: The description focuses on the physical characteristics of a needle used for injection and aspiration, which are procedures performed on a patient, not on a sample in a lab.
Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for drug delivery and fluid aspiration from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SteriCapTM Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.

V. INDICATIONS FOR USE The SteriCap Mini Needle and standard Needles are intended for use with a luertip syringe (e.g. luer- lock or slip-tip luer syringe) for the administration of drugs

Product codes

FMI

Device Description

The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.

The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.

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

The following performance data are available in support of the substantial equivalence.

Dimensional and Physical Properties Verification (ISO 9626:2016, ISO l 7864:2016)
Needle quality (ISO 9626:2016, ISO 7864:2016)
Color coding (ISO 6009:2016, ISO 7864:2016)

Key Metrics

Not Found

Predicate Device(s)

K183016

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 30, 2021

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

Re: K212805

Trade/Device Name: SteriCapTM Mini Needle and Standard Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 31, 2021 Received: September 2, 2021

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

1

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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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, if 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Alan Stevens Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212805

Device Name SteriCap™ Mini Needle and standard needles

Indications for Use (Describe)

The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

K212805 510(k) Summary

DATE 9/30/2021

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 Email: beky@cox.net

II. DEVICE

Name of the device: SteriCap Mini Needle and Needles Common of usual name: Needle Classification name: Single lumen hypodermic needle Regulatory Class: 2 Product Code: FMI Regulation: 21 CFR 880.5570

III. PREDICATE DEVICE SteriCap Mini Needle (K183016)- primary predicate This predicate has not been subject to a design-related recall

IV. DEVICE DESCRIPTION

The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.

The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.

V. INDICATIONS FOR USE The SteriCap Mini Needle and standard Needles are intended for use with a luertip syringe (e.g. luer- lock or slip-tip luer syringe) for the administration of drugs
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

4

The technological characteristics of the modified SteriCap Mini Needle and Needles product family are highly analogous to the technological characteristics of the cleared SteriCap Mini Needle (K183016).

| Characteristics | SteriCap Mini Needle
K183016 | SteriCap Mini Needle and Needle
K212805 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SteriCap™ Mini Needle is a device intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip syringe) for administration of drugs | The SteriCap Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs. |
| Prescription Only or OTC | RX | RX |

The similarities and differences are illustrated in the tables below:

The indications for use statement for the subject device is identical to the predicate device.

| | SteriCap Mini Needle
(K183016) | SteriCap Mini
Needle and Needle
(subject device) | Similarities/
differences |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Functional
Construct | Single lumen needle | Single lumen needle | SAME |
| Principle of
Operation | Connects to a luer type
syringe to serve as a conduit
for the movement of fluid | Connects to a luer
type syringe to serve
as a conduit for the
movement of fluid | SAME |
| Design/ Const. | Needle Assembly (cannula,
needle hub, spring loaded
needle cap)
Designed to fit standard 6%
luer fittings | Needle Assembly
(cannula, needle hub,
spring loaded needle
cap)
Designed to fit
standard 6% luer
fittings | SAME |
| Materials | Cannula- Stainless steel
Lubricant- Silicone
Adhesive- polyacrylate
Hub- polypropylene
Needle Cap- polypropylene
Spring- stainless steel | Cannula- Stainless
steel
Lubricant- Silicone
Adhesive-
polyacrylate
Hub- polypropylene
Needle Cap-
polypropylene
Spring- stainless steel
(Mini Needle only) | SAME |
| Needle Taper | None | None | SAME |
| | SteriCap Mini Needle
(K183016) | SteriCap Mini
Needle and Needle
(subject device) | Similarities/
differences |
| Needle Length-
total | 20 mm | SteriCap Mini Needle
19.5mm
20 mm
21.5mm
Needle
16mm
20.5mm | Different (see
Comment 1) |
| Needle Length-
Exposed | 5.5mm | SteriCap Mini Needle
5.5mm
6 mm
4 mm

Needle
13 mm
8 mm | Different (see
Comment 1) |
| Needle Gauge | 33G
32G
30G
29G
27G
25G
23G | SteriCap Mini Needle
33G x 5.5mm
32G x 5.5mm
30G x 5.5mm
29G x 5.5mm
27G x 5.5mm
25G x 5.5mm
23G x 5.5mm
30G x 6mm
31G x 6mm
33G x 6mm
31G x 4mm
33G x 4mm

5

Comment 1: The additional exposed needle lengths for the product family, namely 4mm, 6mm, 8mm and 13mm are consistent with other commercially available hypodermic needles. The 4mm and 6mm lengths are highly similar to the existing Mini Needle length (e.g. 5.5mm). The 8mm and 13mm lengths are highly similar to other standard hypodermic needle lengths. The overall length of the needle have been modified based on the new exposed lengths. In the case of the 19.5mm and 21.5mm

6

overall lengths, these lengths are highly similar to the existing Mini Needle overall length of 20mm. The addition of the 16mm and 20.5mm are highly similar to other standard hypodermic needle lengths. Performance testing per ISO 9626:2016, ISO 7864:2016 verified the substantial equivalence of the new lengths.

Comment 2: The new needle gauges, specifically the 31G is within the established needle gauge range (23G-33G) for the Mini Needle product family. Performance testing per ISO 9626:2016, ISO 7864:2016, ISO 6009:2016 verified the substantial equivalence of the new gauges.

The performance test data demonstrating compliance with ISO 9626:2016- Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. ISO 7864:2016- Sterile hypodermic needles for single use- Requirements and test methods and ISO 6009:2016- Hypodermic needles for single use- color coding for identification demonstrate that the additional needle configurations have no adverse effect on the established safety and performance characteristics of the device and demonstrate substantial equivalence.

The technological characteristics of the modified SteriCap Mini Needle and Needles are similar to the technological characteristics of the SteriCap Mini Needle previously cleared (K183016) version of the device. The fundamental difference is the additional needle lengths.

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

. all intended for use with a luer-tip syringe for the administration of drugs into the body
All are fabricated from the same materials
all have a lancet bevel tip configuration ●
all SteriCap Mini Needles 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 lengths have been incorporated into the product family, namely 4mm, 6mm, 8mm and 13mm

An additional needle gauge has been incorporated into the product family, namely 31G

VII. PERFORMANCE DATA The following performance data are available in support of the substantial equivalence.

7

Dimensional and Physical Properties Verification (ISO 9626:2016, ISO l 7864:2016)
Needle quality (ISO 9626:2016, ISO 7864:2016)
Color coding (ISO 6009:2016, ISO 7864:2016)

Biocompatibility

In accordance with ISO 10993-1, the needle is classified as: Externally communicating Device, Blood Path Indirect, Limited contact (