(30 days)
The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.
The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.
The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.
The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.
The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle 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 Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.
The provided text describes a 510(k) submission for several needle devices, primarily focusing on the addition of a "low dead space (LDS)" specification. The submission claims substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The primary new acceptance criterion mentioned is for "Low Dead Space (LDS)".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Low Dead Space (LDS) | ≤ 5µL (0.005 mL) |
| Biocompatibility (various endpoints) | Non-cytotoxic, Non-sensitizer, Non-irritant (Intracutaneous Reactivity, Ocular, Intravitreal Injection, Intraocular), Non-pyrogenic, Non-toxic, Non-hemolytic |
| Performance and Safety (general) | Dimensional and physical properties verified, bond and material strength verified, needle quality, color coding, luer connector, particulate testing, sharps injury prevention features |
| Sterilization | Validated based on ISO 11135, SAL: 10-6 |
| Residual Levels | Meet ISO 10993-7 requirements |
| LAL (Endotoxin) | ≤ 20 EU/device (for LDS Needle / SteriCap® LDS Safety Needle) |
| LAL (Endotoxin for intravitreal use) | ≤ 0.2 EU/device (for OcuSafe® LDS Needle / VitreJect® LDS Safety Needle) |
| Shelf-life | Validated to assure functional performance, packaging, and sterile barrier integrity for 5 years |
| Packaging Integrity | Validated using bubble leak test and seal strength |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Low Dead Space (LDS) Testing:
- Sample Size: 58 samples (for 95% confidence and 95% reliability)
- Data Provenance: Not specified (country/retrospective/prospective)
-
Other Testing (Biocompatibility, Performance, Sterilization, etc.): The specific sample sizes for each of these tests are not provided in the summary. The text implies these tests were conducted as part of the overall validation process, often following international standards (ISO, USP, AAMI, ASTM). No information about data provenance (country, retrospective/prospective) is given for these tests. The text states these characteristics "did not change from devices under the respective previously cleared 510(k)s," suggesting that much of this data might be carried over from previous submissions for very similar devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical needle, not an AI or imaging device that requires expert interpretation for a "ground truth" establishment in the traditional sense of clinical studies. The "ground truth" for the performance characteristics (e.g., dead space volume, material strength, biocompatibility endpoints) is established through standardized laboratory testing and measurement against pre-defined engineering and biological criteria outlined in the referenced ISO, USP, AAMI, and ASTM standards. The summary does not specify the number or qualifications of individuals conducting these laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of diagnoses or findings. The "test set" here refers to physical samples undergoing laboratory measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (needle) and does not involve AI assistance or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (needle) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for verifying the device's characteristics is based on:
- Direct Measurement/Quantitative Analysis: For specifications like low dead space volume (≤ 5µL), needle length, gauge.
- Standardized Laboratory Tests: For biocompatibility endpoints (e.g., cytotoxicity, endotoxin levels), material properties, sterilization efficacy, and packaging integrity. These tests compare results against established thresholds defined by international standards (ISO, USP, AAMI, ASTM).
- Engineering Specifications: For physical characteristics and design integrity.
8. The sample size for the training set
Not applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this summary.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2024
OcuJect, LLC % Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, Georgia 30004
Re: K242956
Trade/Device Name: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: QNS, FMI, QYM Dated: September 25, 2024 Received: September 25, 2024
Dear Julie Stephens:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Shruti N. Mistry -S
Shruti Mistry 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) K242956
Device Name
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
Indications for Use (Describe)
The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.
The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.
The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.
The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety 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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510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
Submitted By: OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 USA Phone: (678) 523-8977
Contact Person:
Julie Stephens, President/Consultant Regulatory Resources Group, Inc. Phone: (678) 513-0693
September 27, 2024 Date Prepared:
Device Name and Classification:
| Trade Name: | LDS NeedleOcuSafe® LDS NeedleVitreJect® LDS Safety NeedleSteriCap® LDS Safety Needle |
|---|---|
| Regulation Number: | 21 CFR 880.5570 |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Class: | II |
| Product Code(s): | QNS, FMI, QYM |
Legally Marketed Predicate Device:
Predicate Devices: SteriCap® Safety Needle / VitreJect® Safety Needle, 510(k) # K233343 VitreJect® Needle / OcuSafe® Needle, 510(k) # K230959 SteriCap™ Mini Needle and Standard Needles, 510(k) # K212805 Reference Predicate Device: EZ-Injec LDV Sterile Safety Needle, 510(k) # K210444
Device Description:
The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle 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 Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.
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| Product Name | Description | Configurations |
|---|---|---|
| LDS Needle | Low Dead Space | 31G4mm |
| 33G8mm | ||
| 29G; 30G; 31G13mm | ||
| OcuSafe® LDS Needle | Low Dead SpaceIntravitreal | 31G4mm |
| 33G8mm | ||
| 29G; 30G; 31G13mm | ||
| VitreJect® LDS Safety Needle | SafetyLow Dead SpaceIntravitreal | 31G; 33G4mm |
| 30G; 31G; 33G5.5mm | ||
| 30G; 31G; 33G6mm | ||
| SteriCap® LDS Safety Needle | SafetyLow Dead Space | 31G; 33G4mm |
| 30G; 31G; 33G5.5mm | ||
| 30G; 31G; 33G6mm |
510(k) Summary
Indications for Use:
The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.
- The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.
- The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.
- The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.
Comparison of Indications of Use to the Predicate Device
The Indications for Use statement for the LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle [Proposed Devices] did not change from devices under the respective previously cleared 510(k)s [Predicate Devices]. The Low Dead Space (LDS) will be added to the trade name. labels and labeling of these needles going forward. The Low Dead Space (LDS) usage is stated in FDA's Product Classification Database within the 21 CFR 880.5570 regulation with Product Code QNS. The OcuSafe® LDS Needle and the VitreJect® LDS Safety Needle maintain "indicated for intravitreal use" in their Indications for Use. The QYM Product Code for Ophthalmic Needle within the 21 CFR 880.5570 regulation is added as an additional Subsequent Product Code.
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OcuJect LLC Page 3 of 6 LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle
510(k) Summary
| Proposed Device510(k) #: K242956 | Predicate Devices510(k) #: K233343;K230959; K212805 |
|---|---|
| LDS NeedleOcuSafe® LDS NeedleSteriCap® LDS Safety NeedleVitreJect® LDS Safety Needle | NeedleOcuSafe® NeedleSteriCap® Safety NeedleVitreJect® Safety Needle |
| The LDS Needle is intended for use with a luer-tip syringe for theadministration of drugs. | SameNo Changes |
| The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for theadministration of drugs. The OcuSafe® LDS Needle is indicated forintravitreal use. | |
| The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringefor the administration of drugs. The SteriCap Safety Needle has anintegrated passive needle cap/shield that covers the needle prior to useand automatically activates to cover the needle immediately after use. Alock mechanism can be manually activated to lock/unlock the needlecap. The locked needle cap minimizes risk of accidental needle stick. | |
| The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringefor the administration of drugs. The VitreJect® LDS Safety Needle hasan integrated passive needle cap/shield that covers the needle prior touse and automatically activates to cover the needle immediately afteruse. A lock mechanism can be manually activated to lock/unlock theneedle cap. The locked needle cap minimizes risk of accidental needlestick. The VitreJect® LDS Safety Needle is indicated for intravitreal use. |
Technological Characteristics:
The technological characteristics of the LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle [Proposed Devices] did not change from devices under the respective previously cleared 510(k)s [Predicate Devices]. The proposed devices and the predicate devices have the identical design, materials, manufacturing process, sterilization method, operation method, and packaging configuration.
A comparison of the technological characteristics between the Proposed Devices and Predicate Devices are illustrated in the following table:
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OcuJect LLC Page 4 of 6 LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle
510(k) Summary
Comparison of Technological Characteristics to the Predicate Device
| Characteristic | Proposed Device | Predicate Device | Associated Testing Standard | |
|---|---|---|---|---|
| Applicant | LDS NeedleOcuSafe® LDS NeedlesSteriCap® LDS Safety NeedlesVitreJect® LDS Safety Needles | NeedleOcuSafe® NeedlesSteriCap® Safety NeedlesVitreJect® Safety Needles | ||
| Trade Name(s) | OcuJect, LLC | Identical | - | |
| 510(k) Numbers | Needle, OcuSafe®; SteriCap®; VitreJect®K242956 | IdenticalK233343; K230959; K212805 | - | |
| Product Code;Regulation; Class | FMI, QNS, QYM; 21 CFR 880.5570;Class IIAdditional testing per standards to support QYM were performed within 510(k) K230959 and K233343 | FMI; 21 CFR 880.5570;Class II | ISO 10993-10ISO 10993-7USP <789>USP <85>ISO 7864ISO 9626ISO 80369-7 | |
| Intended Users andEnvironment | Health care professionals in a clinical setting | Identical | ||
| Principle ofOperation | Connects to a Luer type syringe to serve as a conduit for manual movement of fluid | Identical | ISO 80369-7,ISO 7864,ISO 9626 | |
| Device Components | Needle Assembly: needle, needle hub, spring-loaded needle cap (VitreJect and SteriCap)Designed to fit standard 6% Luer fittings | Identical | ISO 80369-7,ISO 7864,ISO 9626 | |
| Material | Needle | Stainless Steel | Identical | ISO 10993-1, |
| Needle hub | Polypropylene | ISO 10993-5, | ||
| Lubricant | Silicone | ISO 10993-7, | ||
| Spring | Stainless Steel (VitreJect and SteriCap) | ISO 10993-10, | ||
| Adhesive | Polyacrylate | ISO 10993-11, | ||
| Needle cap | Polypropylene | ISO 10993-12,ISO 7864,ISO 9626,ISO 6009,ISO 80369-7Internal Standards,ISO 23908 | ||
| Needle Length(Exposed) | VitreJect® LDS: 4 mm / 5.5 mm / 6 mmSteriCap® LDS: 4 mm / 5.5 mm / 6 mmOcuSafe® LDS: 13 mm / 8 mm / 4 mmLDS Needle: 13 mm / 8 mm / 4 mm | Identical | ISO 7864,ISO 9626 | |
| Needle Gauge | VitreJect® LDS: 30G, 31G and 33G.SteriCap® LDS: 30G, 31G and 33GOcuSafe® LDS: 29G, 30G, 31G and 33GLDS Needle: 29G, 30G, 31G and 33G | Identical | ISO 7864,ISO 9626 | |
| Connection | Luer-slipLuer-lock | Identical | ISO 7864,ISO 80369-7 | |
| Needle ColorCoding | Conforms to ISO 6009 | Identical | ISO 6009 | |
| Needle tipconfiguration | Lancet bevel | Identical | ISO 7864,ISO 9626 | |
| Sterilization andShelf Life | Provided Sterile, Single-Use100 individual blister packed devicespackaged into shelf cartonSterilization Method: EOSAL: 10-6Shelf Life: 5 years | Identical | AAMI TIR28,ISO 11135,ISO 10993-7,USP <85>,USP <161>,ANSI/AAMI ST72,ASTM F1980-16, | |
| Characteristic | Proposed DeviceLDS NeedleOcuSafe® LDS NeedlesSteriCap® LDS Safety NeedlesVitreJect® LDS Safety Needles | Predicate DeviceNeedleOcuSafe® NeedlesSteriCap® Safety NeedlesVitreJect® Safety Needles | AssociatedTesting Standard | |
| Biocompatibility perISO 10993-1 | Non-cytotoxic | Identical | ISO 10993-5 | |
| Non-sensitizer | Identical | ISO 10993-10 | ||
| Non-irritant, Intracutaneous Reactivity | Identical | ISO 10993-10 | ||
| Non-irritant, Ocular | Identical | ISO 10993-10 | ||
| Non-irritant, Intravitreal Injection | Identical | ISO 10993-10 | ||
| Non-irritant, Intraocular | Identical | ISO 10993-10 | ||
| Non-pyrogenic | Identical | ISO 10993-11,USP <151> | ||
| Non-toxic | Identical | ISO 10993-11 | ||
| Non-hemolytic | Identical | ISO 10993-4ASTM F756-17 |
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OcuJect LLC Page 5 of 6 LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle
510(k) Summary
The minor difference for the LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle is that a low dead space specification was established that is less than or equal to 5µL (≤ 0.005 mL)]. The "Low Dead Space (LDS)" specification was confirmed by testing using 58 samples for the 95% confidence and 95% reliability. The "Low Dead Space (LDS)" designation will be added to the trade name, labels and labeling of the LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle [Proposed Devices].
Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 biocompatibility categorized as an externally communicating device with limited (<24 hours) direct tissue and indirect blood path contact with the testing completed to demonstrate the needle devices are biocompatible for the intended use. Biocompatibility endpoints included Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Indirect hemolysis, Direct hemolysis, Particulates, Occular Irritation, and Intravitreal Injection Irritation. Performance and safety testing included dimensional and physical properties verification, bond and material strength verification, needle quality, color coding, luer connector, particulate testing, sharps injury prevention features. The ethylene oxide sterilization cycle was validated based on the principles of ISO 11135. The residual levels meet the requirements of ISO 10993-7. LAL testing for each lot ensures the devices meet the acceptance criteria of 20 EU/device (for LDS Needle / SteriCap® LDS Safety Needle) or ≤ 0.2 EU/device (for the OcuSafe® LDS Needle / VitreJect® LDS Safety Needle with the intravitreal indication for use). The shelf-life was validated using industry-standard accelerated aging technique and assured functional performance of the device as well as packaging and sterile barrier integrity. The shelflife validation included anticipated stress associated with transportation and handling. Packaging integrity was validated using the bubble leak test method and seal strength. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle IProposed Devices] did not change from devices under the respective previously cleared 510(k)s [Predicate Devices].
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OcuJect LLC Page 6 of 6 LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle
510(k) Summary
Substantial Equivalence Conclusions:
The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle [Proposed Devices] met the established safety and performance characteristics for a hypodermic single-lumen needle. The addition of the "low dead space (LDS)" specification to the trade name, labels and labeling did not raise any new or different questions of safety, performance or effectiveness when compared to the predicate device. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are as safe and effective as the respective predicate devices previously cleared under the 510(k)'s [Predicate Devices] and will perform as intended.
The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are substantially equivalent to the Needle / VitreJect® Safety Needle / SteriCap® Safety Needle previously cleared under 510(k) #: K233343; K239059; and K212805.
§ 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).