(118 days)
Not Found
No
The summary describes a simple mechanical needle for drug administration and contains no mention of AI or ML technology.
No.
The device is intended for the administration of drugs, not for treatment itself. Its function is to facilitate fluid delivery, which is a method of introducing substances into the body rather than a therapeutic action in and of itself.
No
The device is intended for the administration of drugs into the body, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical needle with a spring-loaded cap, and the performance studies involve testing physical properties and materials, indicating it is a hardware device.
No, this device 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 (administering medication).
- Device Description: The description details a needle for "fluid delivery into the human body via body surface puncture." This further confirms its in vivo application.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not perform such testing.
The information provided clearly indicates this is a device for direct medical intervention within the body, not for laboratory testing of samples.
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 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.
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 (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 10993-1; ISO 10993-7)
- Sterilization Validation (ISO 11135)
- Packaging Validation
- Climatic Cycling & Transit Testing (ASTM D4169-16)
- 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.
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.
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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 |
| 1441 Avocado Ave, Suite 204 | |
| Newport Beach, CA 92660 | |
| (760) 809-5178 | |
| TRADE NAME: | Mini Needle |
| COMMON NAME: | Needle |
| CLASSIFICATION | |
| NAME: | Hypodermic single lumen needle |
| DEVICE | |
| 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
(K151571) |
|--------------|-----------------------------------------------|-----------------------------------------------|
| Intended Use | The Mini Needle is
intended for use with a | The Mini Needle is
intended for use with a |
4
| | Mini Needle | Mini Needle
(K151571) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | luer-tip syringe for the
administration of drugs
into the body. | luer-tip syringe for the
administration of drugs
into the body. |
| Principle of Operation | SAME | Manual |
| Design/Construction | • Needle Assembly
(cannula, needle hub, spring loaded needle cap)
• Designed to fit standard 6% luer fittings | • Needle Assembly
(cannula, needle hub, needle cap, clip)
• Designed to fit standard 6% luer fittings |
| 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 with
TPE tip, retaining ring
Clip- polypropylene |
| Needle Taper | SAME | None |
| Needle Length- total | SAME | 20 mm |
| Needle length- exposed | SAME | 5.5mm |
| Needle Gauge | SAME | 30G
32G
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
5
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.