(188 days)
Not Found
No
The summary describes a mechanical needle device with a spring-loaded cap and provides performance data related to physical properties and material strength, with no mention of AI or ML.
No
The device is a needle intended for the administration of drugs, which is a delivery mechanism, not a therapeutic action itself.
No
Explanation: The device is described as "intended to provide a means of fluid delivery into the human body via body surface puncture" for "administration of drugs", which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a single lumen needle with a spring-loaded needle cap, and the performance studies focus on physical properties and mechanical testing, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the administration of drugs," which is a therapeutic purpose, not a diagnostic one.
- Device Description: The description focuses on fluid delivery into the human body, again indicating a therapeutic or administrative function.
- Lack of IVD Indicators: There is no mention of analyzing samples in vitro (outside the body), detecting specific substances, or providing information for diagnosis.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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.
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)
The following performance data were provided in support of the substantial equivalence.
- Needle Cap Sliding Force
- Twist Lock Release Force
- 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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym and the agency's full name are in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (760) 809-5178 Fax: (760) 290.3216 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
(K170768)- Primary
Predicate |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SteriCap™ Mini
Needle is intended for
use with a luer-tip
syringe for the
administration of
drugs. | The Mini Needle is
intended for use with a
luer-tip syringe for the
administration of drugs |
| Principle of Operation | SAMEas K170768 | Manual |
| Design/Construction | SAMEas K170768 | • Needle Assembly
(cannula, needle hub,
spring loaded needle
cap)
• Designed to fit standard
6% luer fittings |
| Materials | SAMEas K170768 | Cannula-Stainless steel
Lubricant-Silicone
Adhesive- polyacrylate
Hub-polypropylene
Needle Cap-
polypropylene
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
32G
30G
29G
27G
25G
23G | 33G
32G
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.