Mini Needle

K151571 · Ocujet, LLC · FMI · Oct 14, 2015 · General Hospital

Device Facts

• Record ID: K151571
• Device Name: Mini Needle
• Applicant: Ocujet, LLC
• Product Code: FMI · General Hospital
• Decision Date: Oct 14, 2015
• 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

Single lumen hypodermic needle; 30G, 32G, 33G sizes; 5.5mm length. Manual operation; attaches to standard 6% luer-tip syringes. Features sliding needle cap to prevent contamination from surrounding tissues/hairs during injection. Used by healthcare professionals for drug delivery via body surface puncture. Provides sterile, single-use fluid delivery mechanism.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional/physical properties (ISO 594-1/-2), bond/material strength (ISO 594-1/-2), biocompatibility (ISO 10993), sterilization validation (ISO 11137-1/2), and packaging validation.

Technological Characteristics

Single lumen hypodermic needle. Materials: stainless steel cannula, polypropylene hub/cap/clip, polyacrylate adhesive, silicone lubricant, TPE tip. 30G, 32G, 33G gauges; 5.5mm length. Lancet bevel. Manual operation; fits standard 6% luer fittings. Sterilization: irradiation. Single-use.

Indications for Use

Indicated for administration of drugs into the human body via body surface puncture using a luer-tip syringe. No specific patient population, age, or gender restrictions stated.

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

• TSK Hypodermic Needle (K970370)

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

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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

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

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.

### 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 Hypodermic<br>Needle |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Operation<br>Design/Construction | Manual<br>• Needle Assembly (cannula, needle hub, needle cap, clip)<br>• Designed to fit standard 6% luer fittings | Manual<br>• Needle Assembly (cannula, needle hub, protector cap)<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 with TPE tip<br>Clip- polypropylene | Cannula- Stainless steel<br>Adhesive - epoxy<br>Lubricant- Silicone<br>Protector Cap- unknown<br>Hub- polypropylene |
| Needle Taper | None | None |
| Needle Length | 5.5mm | 9mm<br>13mm |
| Needle Gauge | 30G<br>32G<br>33G | 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.