(28 days)
The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.
The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.
The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.
The provided text describes the submission of a medical device, the SteriCap™ Mini Needle and Standard Needles, for 510(k) premarket notification. The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain information about:
- A table of acceptance criteria and reported device performance related to an AI/ML or diagnostic imaging device.
- Sample sizes for test sets (beyond general mention of performance testing).
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods for test sets.
- Whether an MRMC comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The text focuses on the physical characteristics and performance testing of a hypodermic needle, demonstrating its substantial equivalence to a predicate device. The performance data mentioned relates to:
- Dimensional and Physical Properties Verification (ISO 9626:2016, ISO 7864:2016)
- Needle quality (ISO 9626:2016, ISO 7864:2016)
- Color coding (ISO 6009:2016, ISO 7864:2016)
- Biocompatibility (ISO 10993-1, cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity)
- Sterility/Shipping and Shelf-life (ISO 11135:2014, ISO 10993-7, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15)
These are standard tests for medical devices, particularly those involving materials, sterility, and physical properties, and are not related to AI/ML device performance or diagnostic accuracy.
Therefore, I cannot provide the requested information based on the given input, as it describes a physical medical device (hypodermic needle) and not an AI/ML-based diagnostic device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 30, 2021
OcuJect, LLC Rebecca Pine Official Correspondent 1441 Avocado Ave, Suite 204 Newport Beach, California 92660
Re: K212805
Trade/Device Name: SteriCapTM Mini Needle and Standard Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 31, 2021 Received: September 2, 2021
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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, if 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Alan Stevens Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212805
Device Name SteriCap™ Mini Needle and standard needles
Indications for Use (Describe)
The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip 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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K212805 510(k) Summary
DATE 9/30/2021
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 Email: beky@cox.net
II. DEVICE
Name of the device: SteriCap Mini Needle and Needles Common of usual name: Needle Classification name: Single lumen hypodermic needle Regulatory Class: 2 Product Code: FMI Regulation: 21 CFR 880.5570
III. PREDICATE DEVICE SteriCap Mini Needle (K183016)- primary predicate This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION
The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.
The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.
- V. INDICATIONS FOR USE The SteriCap Mini Needle and standard Needles are intended for use with a luertip syringe (e.g. luer- lock or slip-tip luer syringe) for the administration of drugs
- VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The technological characteristics of the modified SteriCap Mini Needle and Needles product family are highly analogous to the technological characteristics of the cleared SteriCap Mini Needle (K183016).
| Characteristics | SteriCap Mini NeedleK183016 | SteriCap Mini Needle and NeedleK212805 |
|---|---|---|
| Indications for Use | The SteriCap™ Mini Needle is a device intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip syringe) for administration of drugs | The SteriCap Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs. |
| Prescription Only or OTC | RX | RX |
The similarities and differences are illustrated in the tables below:
The indications for use statement for the subject device is identical to the predicate device.
| SteriCap Mini Needle(K183016) | SteriCap MiniNeedle and Needle(subject device) | Similarities/differences | |
|---|---|---|---|
| FunctionalConstruct | Single lumen needle | Single lumen needle | SAME |
| Principle ofOperation | Connects to a luer typesyringe to serve as a conduitfor the movement of fluid | Connects to a luertype syringe to serveas a conduit for themovement of fluid | SAME |
| Design/ Const. | Needle Assembly (cannula,needle hub, spring loadedneedle cap)Designed to fit standard 6%luer fittings | Needle Assembly(cannula, needle hub,spring loaded needlecap)Designed to fitstandard 6% luerfittings | SAME |
| Materials | Cannula- Stainless steelLubricant- SiliconeAdhesive- polyacrylateHub- polypropyleneNeedle Cap- polypropyleneSpring- stainless steel | Cannula- StainlesssteelLubricant- SiliconeAdhesive-polyacrylateHub- polypropyleneNeedle Cap-polypropyleneSpring- stainless steel(Mini Needle only) | SAME |
| Needle Taper | None | None | SAME |
| SteriCap Mini Needle(K183016) | SteriCap MiniNeedle and Needle(subject device) | Similarities/differences | |
| Needle Length-total | 20 mm | SteriCap Mini Needle19.5mm20 mm21.5mmNeedle16mm20.5mm | Different (seeComment 1) |
| Needle Length-Exposed | 5.5mm | SteriCap Mini Needle5.5mm6 mm4 mmNeedle13 mm8 mm | Different (seeComment 1) |
| Needle Gauge | 33G32G30G29G27G25G23G | SteriCap Mini Needle33G x 5.5mm32G x 5.5mm30G x 5.5mm29G x 5.5mm27G x 5.5mm25G x 5.5mm23G x 5.5mm30G x 6mm31G x 6mm33G x 6mm31G x 4mm33G x 4mmNeedle29G x 13mm30G x 13mm31G x 13mm33G x 8mm | Different (seeComment 2) |
| TipConfiguration | Lancet Bevel | Lancet Bevel | SAME |
| Wall Type | Std wall | Std wall | SAME |
| Sterilization | Ethylene oxide | Ethylene oxide | SAME |
| How provided | Sterile, single use | Sterile, single use | SAME |
| Sterile barrier | Blister pouch | Blister pouch | SAME |
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Comment 1: The additional exposed needle lengths for the product family, namely 4mm, 6mm, 8mm and 13mm are consistent with other commercially available hypodermic needles. The 4mm and 6mm lengths are highly similar to the existing Mini Needle length (e.g. 5.5mm). The 8mm and 13mm lengths are highly similar to other standard hypodermic needle lengths. The overall length of the needle have been modified based on the new exposed lengths. In the case of the 19.5mm and 21.5mm
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overall lengths, these lengths are highly similar to the existing Mini Needle overall length of 20mm. The addition of the 16mm and 20.5mm are highly similar to other standard hypodermic needle lengths. Performance testing per ISO 9626:2016, ISO 7864:2016 verified the substantial equivalence of the new lengths.
Comment 2: The new needle gauges, specifically the 31G is within the established needle gauge range (23G-33G) for the Mini Needle product family. Performance testing per ISO 9626:2016, ISO 7864:2016, ISO 6009:2016 verified the substantial equivalence of the new gauges.
The performance test data demonstrating compliance with ISO 9626:2016- Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. ISO 7864:2016- Sterile hypodermic needles for single use- Requirements and test methods and ISO 6009:2016- Hypodermic needles for single use- color coding for identification demonstrate that the additional needle configurations have no adverse effect on the established safety and performance characteristics of the device and demonstrate substantial equivalence.
The technological characteristics of the modified SteriCap Mini Needle and Needles are similar to the technological characteristics of the SteriCap Mini Needle previously cleared (K183016) version of the device. The fundamental difference is the additional needle lengths.
At a high level, the subject and predicate devices are based on the following same technological elements:
- . all intended for use with a luer-tip syringe for the administration of drugs into the body
- All are fabricated from the same materials
- all have a lancet bevel tip configuration ●
- all SteriCap Mini Needles 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 lengths have been incorporated into the product family, namely 4mm, 6mm, 8mm and 13mm
An additional needle gauge has been incorporated into the product family, namely 31G
VII. PERFORMANCE DATA The following performance data are available in support of the substantial equivalence.
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- Dimensional and Physical Properties Verification (ISO 9626:2016, ISO l 7864:2016)
- Needle quality (ISO 9626:2016, ISO 7864:2016)
- Color coding (ISO 6009:2016, ISO 7864:2016)
Biocompatibility
In accordance with ISO 10993-1, the needle is classified as: Externally communicating Device, Blood Path Indirect, Limited contact (<24 hours). The previous testing performed, namely cytotoxicity, sensitization, irritation, acute systemic toxicity and materials mediated pyrogenicity remains applicable to the product family.
Sterility/Shipping and Shelf-life
The Mini Needle and Needles are sterilized using ethylene oxide. The sterilization cycle was validated based on the principles of ISO 11135:2014. The residual levels meet the requirements of ISO 10993-7 with EO < 4mg and ECH < 9mg. LAL testing for each lot of devices ensures the devices meet the acceptance criteria of < 20 EU/device.
The shelf-life was validated using industry-standard accelerated aging techniques (ASTM F1980-16), and assured functional performance of the device as well as packaging and sterile barrier integrity. The shelf-life validation included anticipated stress associated with transportation and handling, per ASTM D4169-16. Packaging integrity was validated using the bubble leak test method (ASTM F2096-11). The seal strength was verified per ASTM F88/F88M-15.
VIII. CONCLUSIONS
The subject device met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the additions to the SteriCap® Mini Needle and Needles were found to have a safety and effectiveness profile that is similar to the predicate device.
§ 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).