SteriCap Mini Needle

K183016 · Ocujet, LLC · FMI · May 7, 2019 · General Hospital

Device Facts

• Record ID: K183016
• Device Name: SteriCap Mini Needle
• Applicant: Ocujet, LLC
• Product Code: FMI · General Hospital
• Decision Date: May 7, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

SteriCap Mini Needle is a single lumen hypodermic needle (23G-33G) designed for drug delivery via body surface puncture. Device attaches to standard luer-tip syringes. Features spring-loaded needle cap to protect needle and prevent contamination from surrounding hairs/tissue prior to use. Operated manually by clinicians or patients. Output is fluid delivery into body. Benefits include needle protection and compatibility with standard luer fittings.

Clinical Evidence

Bench testing only. Verification included needle cap sliding force, twist lock release force, luer compatibility (ISO 594-1 & 2), bond strength, and needle quality (ISO 9626, ISO 7864). Testing confirmed compliance with dimensional, physical, and material strength requirements.

Technological Characteristics

Single lumen hypodermic needle; 23G-33G gauges; 20mm total length, 5.5mm exposed length. Materials: stainless steel cannula, polypropylene hub/cap, silicone lubricant, polyacrylate adhesive. Features spring-loaded needle cap. Sterilized via ethylene oxide. Complies with ISO 594-1/2 (luer), ISO 7864 (needles), ISO 9626 (tubing), and ISO 6009 (color coding).

Indications for Use

Indicated for drug administration via body surface puncture using a luer-tip syringe. Applicable to patients requiring hypodermic injection.

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 (K170768)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] 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

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.

- 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<br>(K170768)- Primary<br>Predicate |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SteriCap™ Mini<br>Needle is intended for<br>use with a luer-tip<br>syringe for the<br>administration of<br>drugs. | The Mini Needle is<br>intended for use with a<br>luer-tip syringe for the<br>administration of drugs |
| Principle of Operation | SAMEas K170768 | Manual |
| Design/Construction | SAMEas K170768 | • Needle Assembly<br>(cannula, needle hub,<br>spring loaded needle<br>cap)<br>• Designed to fit standard<br>6% luer fittings |
| Materials | SAMEas K170768 | Cannula-Stainless steel<br>Lubricant-Silicone<br>Adhesive- polyacrylate<br>Hub-polypropylene<br>Needle Cap-<br>polypropylene<br>Spring-stainless steel |
| Needle Taper | SAMEas K170768 | None |
| Needle Length-total | SAMEas K170768 | 20 mm |
| Needle length-projected | SAMEas K170768 | 5.5mm |
| Needle Gauge | 33G<br>32G<br>30G<br>29G<br>27G<br>25G<br>23G | 33G<br>32G<br>30G |
| 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.