Mini Needle

K170768 · Ocuject, LLC · FMI · Jul 10, 2017 · General Hospital

Device Facts

• Record ID: K170768
• Device Name: Mini Needle
• Applicant: Ocuject, LLC
• Product Code: FMI · General Hospital
• Decision Date: Jul 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Mini Needle is a single lumen hypodermic needle (30G, 32G, 33G) with 5.5mm exposed length; designed for fluid delivery via body surface puncture. Device features a spring-loaded needle cap that shields the needle prior to use to prevent contamination. Operated manually by clinicians or patients; attaches to standard 6% luer-tip syringes. Spring mechanism simplifies cap operation compared to predicate. Device provides a sterile, single-use interface for drug administration. Benefits include ease of use and contamination prevention during injection.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional/physical properties (ISO 594-1 & 2), bond/material strength, biocompatibility (ISO 10993-1, -7), sterilization validation (ISO 11135), and packaging validation (ASTM D4169-16, ASTM F88/F88M-15).

Technological Characteristics

Single lumen needle; 30G/32G/33G; 5.5mm exposed length. Materials: stainless steel cannula/spring, polypropylene hub/cap, silicone lubricant, polyacrylate adhesive. Manual operation; fits standard 6% luer fittings. Sterilization: Ethylene oxide. Packaging: blister pouch.

Indications for Use

Indicated for the administration of drugs into the human body via body surface puncture using a luer-tip syringe.

Regulatory Classification

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.

Predicate Devices

• Mini- Needle (K151571)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 Pine<br>1441 Avocado Ave, Suite 204<br>Newport Beach, CA 92660<br>[phone] |
| TRADE NAME: | Mini Needle |
| COMMON NAME: | Needle |
| CLASSIFICATION<br>NAME: | Hypodermic single lumen needle |
| DEVICE<br>CLASSIFICATION: | 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:

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.

#### 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<br>(K151571) |
|--------------|-----------------------------------------------|-----------------------------------------------|
| Intended Use | The Mini Needle is<br>intended for use with a | The Mini Needle is<br>intended for use with a |

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| | Mini Needle | Mini Needle<br>(K151571) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | luer-tip syringe for the<br>administration of drugs<br>into the body. | luer-tip syringe for the<br>administration of drugs<br>into the body. |
| Principle of Operation | SAME | Manual |
| Design/Construction | • Needle Assembly<br>(cannula, needle hub, spring loaded needle cap)<br>• Designed to fit standard 6% luer fittings | • Needle Assembly<br>(cannula, needle hub, needle cap, clip)<br>• Designed to fit standard 6% luer fittings |
| Materials | Cannula- Stainless steel<br>Lubricant- Silicone<br>Adhesive- polyacrylate<br>Hub- polypropylene<br>Needle Cap- polypropylene<br>Spring- stainless steel | Cannula- Stainless steel<br>Lubricant- Silicone<br>Adhesive- polyacrylate<br>Hub- polypropylene<br>Needle Cap- polypropylene with<br>TPE tip, retaining ring<br>Clip- polypropylene |
| Needle Taper | SAME | None |
| Needle Length- total | SAME | 20 mm |
| Needle length- exposed | SAME | 5.5mm |
| Needle Gauge | SAME | 30G<br>32G<br>33G |
| 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.