(163 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a manual needle for drug administration, with no mention of AI or ML.
No.
The device is a needle intended for drug administration, not for therapeutic effect itself.
No
Explanation: The device is described as a needle intended for administration of drugs (fluid injection and aspiration), not for diagnostic purposes.
No
The device description clearly outlines physical components (needles, caps) and mentions manufacturing processes (sterilization by ethylene oxide gas) and physical testing (dimensional, bond strength, etc.), indicating it is 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" via intravitreal injection. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of a needle for fluid injection and aspiration, which aligns with drug delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide information about a patient's health status, which is the core function of an IVD.
- Performance Studies: The performance studies focus on the physical properties, biocompatibility, and safety of the needle for injection, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is used to deliver a substance into the body for treatment.
N/A
Intended Use / Indications for Use
The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.
The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.
The VitreJect® Needle is offered in the following configurations:
30G x 5.5mm
30G x 6mm
31G x 4mm
31G x 5.5mm
31G x 6mm
33G x 4mm
33G x 5.5mm
33G x 6mm
The OcuSafe® Needle is offered in the following configurations:
29G x 13mm
30G x 13mm
31G x 4mm
31G x 13mm
33G x 8mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravitreal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals in a clinical setting
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 non-clinical testing was performed to confirm the safety and effectiveness of the VitreJect® and OcuSafe® Needles compared to the predicate devices. Performance testing was performed as per the design control system. The following tests were conducted:
- Dimensional and Physical Properties Verification
- Bond and Material Strength Verification
- Needle quality
- Color coding
- Luer connector
- Particulate testing
- Biocompatibility (ISO 10993-1)
VitreJect® and OcuSafe® Needles are categorized as externally communicating devices with limited ( (using both the light obscuration and microscopy test methods), and intraocular irritation testing and passed.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2023
OcuJect, LLC % Heidi Busz Senior Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426
Re: K230959
Trade/Device Name: VitreJect® Needle; OcuSafe® Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 9, 2023 Received: August 10, 2023
Dear Heidi Busz:
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.
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 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 mediation-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.
Image /page/1/Picture/6 description: The image shows the name Courtney Evans -S on the left side of the image. On the right side of the image, it says Digitally signed by Courtney Evans -S. The date is also listed as 2023.09.14 23:40:05 -04'00'.
For CAPT 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
2
Indications for Use
510(k) Number (if known) K230959
Device Name VitreJect® Needle OcuSafe® Needle
Indications for Use (Describe)
The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.
The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three interconnected hexagons in varying shades of blue on the left side. To the right of the hexagons, the company name "OcuJect" is written in a stylized, blue font, with "LLC" in smaller letters. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font, also in blue.
510(k) Summary
I. SUBMITTER
OcuJect, LLC 1441 Avocado Ave. Suite 204 Newport Beach, CA 92660 Phone: (949) 721.6716 Email: llerner@ocuject.com Primary Contact: Leonid Lerner, MD, PhD Date prepared: September 14, 2023
II. DEVICE
Name of Device: VitreJect® / OcuSafe® Needle Common or Usual Name: Needle, Hypodermic, Single Lumen Classification name: Hypodermic Single Lumen Needle (21 CFR 880.5570) Regulatory Class: 2 Product Code: FMI
III. PREDICATE DEVICE
SteriCap® Mini Needle and Standard Needle, K212805 The predicate devices have not been subject to a design-related recall.
IV. REFERENCE DEVICE
StaClear Syringe, K200242 Altaviz Needle Kit II, K231261
V. DEVICE DESCRIPTION
The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.
The VitreJect® Needle is offered in the following configurations:
| - | 30G x 5.5mm | 30G x 6mm |
|---|---|---|
| 31G x 4mm | 31G x 5.5mm | 31G x 6mm |
| 33G x 4mm | 33G x 5.5mm | 33G x 6mm |
4
Image /page/4/Picture/0 description: The image contains the logo for OcuJect LLC Advanced Drug Delivery. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name, "OcuJect LLC," in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.
The OcuSafe® Needle is offered in the following configurations:
| - | - | 29G x 13mm |
|---|---|---|
| - | - | 30G x 13mm |
| 31G x 4mm | - | 31G x 13mm |
| - | 33G x 8mm | - |
VI. INTENDED USE / INDICATIONS FOR USE
The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.
The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.
VII. OF TECHNOLOGICAL CHARACTERISTICS COMPARISON WITH THE PREDICATE DEVICE
The intended use of the subject device is identical to the predicate device; designed and intended to inject fluids into, or withdraw fluids from, the body. The technological characteristics of the VitreJect® / OcuSafe® Needles are substantially equivalent to the predicate SteriCap® Mini Needle / Standard Needle (K212805). The subject device and the predicate device have identical design, material, manufacturing process, sterilization method, operation method, and packaging configuration. The OcuSafe® Needle introduces an additional configuration (31G x 4 mm) and there are minor differences in biocompatibility and performance testing and indications for use as the VitreJect® / OcuSafe® Needles are additionally indicated for intravitreal use.
A comparison of the technological characteristics between the subject and primary predicate devices is illustrated in the table below:
| Characteristic | Subject Device
VitreJect®/OcuSafe®
Needle | Predicate Device
SteriCap® Mini
Needle / Standard
Needle
(K212805) | Associated
Testing Standard |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | OcuJect, LLC | Identical | - |
| Proprietary
Name | VitreJect®
OcuSafe® | SteriCap® | - |
| Product Code | FMI | Identical | - |
| Intended Use | Intended to inject fluids*
into, or withdraw fluids
from, the body. | Identical | *Namely drugs
Supported by
referenced
performance and
biocompatibility |
| Characteristic | Subject Device
VitreJect®/OcuSafe®
Needle | Predicate Device
SteriCap® Mini
Needle / Standard
Needle
(K212805) | Associated
Testing Standard |
| Indications | The VitreJect® Needle is intended for use with a luer-tip syringe for the administration of drugs.
The VitreJect® Needle is indicated for intravitreal use.
The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs.
The OcuSafe® Needle is indicated for intravitreal use. | Equivalent, the predicate device does not identify specific clinical applications:
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. | testing
ISO 10993-1,
ISO 10993-7,
ISO 10993-10,
USP ,
USP |
| Intended Users
and Environment | Health care professionals in a clinical setting | Identical | - |
| Principle of
Operation | Connects to a luer type syringe to serve as a conduit for the manual advancement and withdrawal of fluid | Identical | ISO 80369-7,
ISO 7864,
ISO 9626 |
| Functional
Construct | Single lumen needle | Identical | ISO 7864,
ISO 9626 |
| Design/
Construction | Needle Assembly:
Cannula, needle hub, needle cap (spring loaded or removable)
Designed to fit standard 6% luer fittings | Identical | ISO 80369-7,
ISO 7864,
ISO 9626 |
| Device
Components and
Materials | Cannula: stainless steel
Lubricant: silicone
Adhesive: polyacrylate
Needle Cap: polypropylene
Hub: polypropylene
Spring (VitreJect®):
stainless steel | Identical
Stainless steel spring in SteriCap® model only | ISO 10993-1,
ISO 10993-2,
ISO 10993-4,
ASTM F756,
ISO 10993-5,
ISO 10993-7,
ISO 10993-10,
ISO 10993-11,
ISO 10993-12,
ISO 10993-17, |
| Characteristic | Subject Device
VitreJect®/OcuSafe®
Needle | Predicate Device
SteriCap® Mini
Needle / Standard
Needle
(K212805) | Associated
Testing Standard |
| Needle Length
(Exposed) | VitreJect®:
4 mm / 5.5 mm / 6 mm
OcuSafe®:
13 mm
8 mm
4 mm | Equivalent, the
predicate Standard
Needle is not offered
in 4 mm:
SteriCap®:
4 mm / 5.5 mm / 6 mm
Standard:
13 mm / 8 mm | ISO 7864,
ISO 9626 |
| Needle Gauge | VitreJect®: 30G, 31G and
33G.
OcuSafe®: 29G, 30G, 31G
and 33G. | Identical
SteriCap®: 30G, 31G
and 33G.
Standard Needle:
29G, 30G, 31G and
33G. | ISO 7864,
ISO 9626 |
| Cannula tip
configuration | Lancet bevel | Identical | ISO 7864,
ISO 9626 |
| Sterilization and
Shelf Life | Provided Sterile,
Single-Use
100 individual blister-packed
devices packaged into a shelf
carton
Sterilization Method: EO
SAL: 10-6
Shelf Life: 5 years
Ethylene oxide residual were
assessed per ISO 10993-7.
Endotoxins were tested as
recommended in FDA
guidance Endotoxin Testing
Recommendations for
Single-Use Intraocular
Ophthalmic Devices. | Identical
Reduced residual and
endotoxin limits for
ophthalmic use not
applicable. | AAMI TIR28,
ISO 11135-1,
ISO 10993-7,
USP ,
USP ,
ANSI/AAMI
ST72,
ASTM F1980-16,
ISO 7864,
ISO 9626,
ISO 80369-7,
ASTM F88/F88-
15,
ASTM F1929-15,
ASTM D4169-16 |
| Characteristic | Subject Device
VitreJect®/OcuSafe®
Needle | Predicate Device
SteriCap® Mini
Needle / Standard
Needle
(K212805) | Associated
Testing Standard |
| Biocompatibility
per ISO 10993-1 | Non-cytotoxic | Identical | ISO 10993-5 |
| | Non-sensitizer | Identical | ISO 10993-10 |
| | Non-irritant, Intracutaneous | Identical | ISO 10993-23 |
| | Non-irritant, Ocular | Equivalent, Ocular, | ISO 10993-10 |
| | Non-irritant, Intravitreal
Injection | Intravitreal Injection
and Intraocular | ISO 13485 |
| | Non-irritant, Intraocular | Irritation testing not
performed on the
predicate device. | ISO 13485 |
| | Non-pyrogenic | Identical | USP , ISO
10993-11 |
| | Non-toxic | Identical | ISO 10993-11 |
| | Non-hemolytic | Identical | ISO 10993-4,
ASTM F756
ISO 10993-3 |
Page 2 Traditional 510(k)
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Image /page/5/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons of different shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC", in a stylized blue font. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.
OcuJect, LLC
VitreJect® / OcuSafe® Needle
Page 3 Page 3
Traditional 510(k)
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Image /page/6/Picture/0 description: The image shows the logo for OcuJect LLC. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name "OcuJect LLC" in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.
7
Image /page/7/Picture/0 description: The image shows the logo for OcuJect LLC. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name, "OcuJect LLC", in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.
VIII. PERFORMANCE DATA
The following non-clinical testing was performed to confirm the safety and effectiveness of the VitreJect® and OcuSafe® Needles compared to the predicate devices. Performance testing was performed as per the design control system. The following tests were conducted:
- Dimensional and Physical Properties Verification ●
- o ISO 7864, ISO 80369-7
- . Bond and Material Strength Verification
- o ISO 7864, ISO 80369-7
- Needle quality
- o ISO 9626, ISO 7864
- Color coding
●
- o ISO 6009, ISO 7864
- Luer connector
- o ISO 80369-7
- Particulate testing
- o USP , USP
- Biocompatibility (ISO 10993-1) ●
VitreJect® and OcuSafe® Needles are categorized as externally communicating devices with limited ( (using both the light obscuration and microscopy test methods), and intraocular irritation testing and passed.
- Biocompatibility testing and performance testing demonstrate the additional configuration/size offering and additional indication do not raise new or different questions of safety and effectiveness.
The biocompatibility testing data and particulate test data in conjunction with the performance test data demonstrating compliance with ISO 7864, ISO 9626, and ISO 80369-7 demonstrate that the VitreJect® and OcuSafe® Needles meet the established safety and performance characteristics of the device and demonstrate substantial equivalence.
X. CONCLUSIONS
The VitreJect® and OcuSafe® Needles met the established safety and performance characteristics
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Image /page/9/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons of varying shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC," in a stylized blue font. Below the company name is the tagline "ADVANCED DRUG DELIVERY," also in blue.
for a hypodermic single-lumen needle. Suitability of the subject devices for the additional configuration/size offering and additional indication of intravitreal use was evaluated through biocompatibility and performance testing. These differences do not raise any new or different questions of safety or effectiveness. Testing demonstrates the VitreJect® and OcuSafe® Needles are as safe and effective as the predicate device and will perform as intended.
The Vitrelect® and OcuSafe® Needles are biocompatible for the intended use and demonstrate equivalent performance to the predicate device. The VitreJect® and OcuSafe® Needles are substantially equivalent to the SteriCap® Mini Needle and Standard Needles cleared under K212805.