(126 days)
Not Found
No
The 510(k) summary describes a simple hypodermic needle and explicitly states "Not Found" for mentions of AI, DNN, or ML. The performance studies focus on physical and material properties, not algorithmic performance.
No
The device is intended for the administration of drugs, which is a key component of therapeutic intervention, but the device itself (a needle) is a delivery mechanism, not a therapeutic agent.
No
Explanation: The device is described as a needle for administering drugs into the body, which is a therapeutic function, not diagnostic.
No
The device description clearly describes a physical needle, which is a hardware component, not a software-only device.
Based on the provided information, the Mini Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the administration of drugs into the body." This describes a device used in vivo (within the living body) for therapeutic purposes (drug delivery).
- Device Description: The description details a needle for "fluid delivery into the human body via body surface puncture." This further reinforces its in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples for diagnostic or other medical purposes. The Mini Needle's function is to deliver substances into the body, which is the opposite of an IVD's function.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface puncture
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TSK Hypodermic Needle (K970370)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
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
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 |
| 1441 Avocado Ave, Suite 204 | |
| Newport Beach, CA 92660 | |
| (760) 809-5178 | |
| TRADE NAME: | Mini Needle |
| COMMON NAME: | Needle |
| CLASSIFICATION | |
| NAME: | Single lumen hypodermic needle |
| DEVICE | |
| 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.
4
| | Mini Needle | TSK Hypodermic
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
Design/Construction | Manual
• Needle Assembly (cannula, needle hub, needle cap, clip)
• Designed to fit standard 6% luer fittings | Manual
• Needle Assembly (cannula, needle hub, protector cap)
• Designed to fit standard 6% luer fittings |
| Materials | Cannula- Stainless steel
Lubricant- Silicone
Adhesive- polyacrylate
Hub- polypropylene
Needle Cap- polypropylene with TPE tip
Clip- polypropylene | Cannula- Stainless steel
Adhesive - epoxy
Lubricant- Silicone
Protector Cap- unknown
Hub- polypropylene |
| Needle Taper | None | None |
| Needle Length | 5.5mm | 9mm
13mm |
| Needle Gauge | 30G
32G
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
5
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.