(178 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a basic syringe, with no mention of AI or ML components or capabilities.
No
A syringe is used to deliver substances (like medication) or withdraw substances (like blood), but it does not inherently treat a condition or provide therapy itself. It is a tool for administration.
No
The device is described as a syringe used to facilitate injections or fluid withdrawal, which are therapeutic or procedural actions, not diagnostic ones. There is no mention of analysis, measurement, or interpretation of biological signals or samples for diagnosis.
No
The device description clearly outlines physical components (hollow barrel, plunger, male slip tip end) and the performance studies listed are related to the physical properties and function of a syringe, not software.
Based on the provided information, the MiniLoad Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to facilitate injections into or withdraw fluids from the body." This describes a device used on or in the body for therapeutic or diagnostic purposes, not a device used to examine specimens outside the body.
- Device Description: The description details a syringe for general fluid injection and aspiration, which is a common medical device used directly with a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or any other activity typically associated with in vitro diagnostics.
- Performance Studies: The performance studies listed are related to the physical and functional characteristics of the syringe itself (leakage, force, fit, etc.), not the analytical performance of a diagnostic test.
In summary, the MiniLoad Syringe is a general-purpose medical device for fluid handling in a clinical setting, not a device used for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The MiniLoad Syringe is a device intended to provide a means of general use fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component has a male slip tip end for the fitting of a compatible needle. The device is available in a 1ml volume.
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
Clinicians
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 are available in support of the substantial equivalence:
- Freedom from Extraneous Matter (ISO 7886-1)
- l Lubricant Quantification (ISO 7886-1)
- Plunger Stop Detachment (ISO 7886-1)
- I Barrel Flange to Plunger Distance (ISO 7886-1)
- Dead Space (ISO 7886-1)
- I Freedom from leakage (ISO 7886-1)
- I Piston operational force (ISO 7886-1)
- Plunger Fit (ISO 7886-1)
- I Packaging Validation (ISO 11607-1)
The subject device met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the MiniLoad Syringe was found to have a safety and effectiveness profile that is similar to the predicate device.
Biocompatibility testing was conducted in accordance with ISO 10993-1, classifying the needle as: Externally communicating, indirect blood path with limited contact duration (Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life:
The MiniLoad Syringe is sterilized utilizing ethylene oxide (EO). The sterilization cycle was validated per ISO 11135 Overkill (half-cycle) method, and the MiniLoad Syringe was adopted into the validated cycle utilizing AAMI TR28:2016. The ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals for the MiniLoad Syringe are gel clot method.
- Package integrity testing, after environmental conditioning and simulated . transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15 O
- Dye penetration ASTM F1929-15 O
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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.
NORM-JECT Syringe (K101547)
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 19, 2021
OcuJect, LLC Rebecca Pine Official Correspondent 1441 Avocado Ave, Suite 204 Newport Beach, California 92660
Re: K202432
Trade/Device Name: MiniLoad Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 19, 2021 Received: January 21, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Rumi Young Acting 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) K202432
Device Name MiniLoad Syringe
Indications for Use (Describe)
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
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
510(k) Summary
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: February 10, 2021
II. DEVICE
Name of the device: MiniLoad Syringe Common of usual name: Syringe Classification name: Syringe, Piston Regulatory Class: II Product Code: FMF Regulation: 21 CFR 880.5860
- III. PREDICATE DEVICE NORM-JECT Syringe (K101547)- primary predicate This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION
The MiniLoad Syringe is a device intended to provide a means of general use fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component has a male slip tip end for the fitting of a compatible needle. The device is available in a 1ml volume.
- V. INDICATIONS FOR USE The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
- VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the MiniLoad Syringe are highly analogous to the technological characteristics of the NORM-JECT Syringe (K101547).
The similarities and differences are illustrated in the table below:
4
| MiniLoad Syringe | NORM-JECT (K101547) | ||
|---|---|---|---|
| Proprietary Name | MiniLoad Syringe | NORM-JECT Syringe | |
| Product Code | FMF | FMF | |
| Indications for Use | The MiniLoad Syringe is | ||
| used to facilitate injections | |||
| into or withdraw fluids | |||
| from the body | The HSW NORM-JECT | ||
| syringes are intended to be | |||
| used to inject into, or | |||
| withdraw fluids from the | |||
| body. The 1 ml syringe with | |||
| a purple plunger, labeled with | |||
| BOTOX® is exclusively | |||
| produced for use with | |||
| BOTOX® Cosmetic | |||
| (onabotulinumtoxinA) | |||
| Intended Users | SAME | Clinicians | |
| Principle of operation | SAME | Manual advancement and | |
| withdrawal of the plunger | |||
| within the barrel | |||
| Device components | SAME | Barrel | |
| Plunger | |||
| Materials | Barrel | Polypropylene | Unknown |
| Plunger | Polyethylene | Unknown | |
| Lubricant | Oleamide | Unknown | |
| Barrel Size Volume (ml) | SAME | 1ml | |
| Barrel length | ~ 85mm | Unknown | |
| Barrel outside diameter | ~ 6.4mm | Unknown | |
| Barrel inside diameter | ~ 4.6mm | Unknown | |
| Barrel color | Transparent | Unknown | |
| Barrel printing | Black ink | Unknown | |
| Plunger length | 93.4 mm | Unknown | |
| Plunger color | Blue | Purple | |
| Graduation | Printed, ISO 7886-1 | ||
| compliant | Unknown | ||
| Tip type | Slip tip | Unknown | |
| Sterilization method | EO | Unknown | |
| SAL | 10-6 | Unknown | |
| Sterilization Validation | SAME | ISO 11135-1 | |
| Standard | |||
| Biocompatibility | ISO 10993-1 (Biological | ||
| Evaluation) | |||
| ISO 10993-4 | |||
| (Hemocompatibilty) | |||
| ISO 10993-5 (cytotoxicity) | |||
| ISO 10993-7 (EO | |||
| residuals) | |||
| ISO 10993-10 ( | |||
| Sensitization) | |||
| ISO 10993-10 (Irritation) | |||
| Acute Systemic Toxicity | |||
| (ISO 10993-11) | |||
| Materials Mediated | |||
| Pyrogenicity (ISO 10993- |
- | ISO 10993-1 (Biological
Evaluation)
ISO 10993-4
(Hemocompatibilty)
ISO 10993-5 (cytotoxicity)
ISO 10993-7 (EO residuals)
ISO 10993-10 (
Sensitization)
ISO 10993-10 (Irritation)
Acute Systemic Toxicity (ISO
10993-11) | |
| Performance Data | SAME | ISO 7886-1 | |
5
The MiniLoad Syringe and the NORM-JECT Syringe both have a barrel component which provides a holding area for liquid and a plunger for the expulsion of the liquid from the barrel.
All device barrels are fabricated from polymers demonstrated to be biocompatible. The plunger of the MiniLoad syringe is blue and the NORM-JECT plunger is purple. Any material, lubricant or color differences do not raise any safety concerns because the device complies with biocompatibility requirements per ISO 10993-1. Both the MiniLoad and the NORM-JECT syringes are available in a 1 ml capacity.
Both the MiniLoad Syringe and the NORM-JECT syringe are in conformance with the requirements of ISO 7886-1.
PERFORMANCE DATA VII.
The following performance data are available in support of the substantial equivalence.
- Freedom from Extraneous Matter (ISO 7886-1) ■
- l Lubricant Quantification (ISO 7886-1)
- Plunger Stop Detachment (ISO 7886-1)
- I Barrel Flange to Plunger Distance (ISO 7886-1)
- Dead Space (ISO 7886-1)
- I Freedom from leakage (ISO 7886-1)
- I Piston operational force (ISO 7886-1)
- Plunger Fit (ISO 7886-1)
- I Packaging Validation (ISO 11607-1)
The subject device met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the MiniLoad Syringe was found to have a safety and effectiveness profile that is similar to the predicate device.
Biocompatibility
In accordance with ISO 10993-1, the needle is classified as: Externally communicating, indirect blood path with limited contact duration (Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life
The MiniLoad Syringe is sterilized utilizing ethylene oxide (EO). The sterilization cycle was validated per ISO 11135 Overkill (half-cycle) method, and the MiniLoad Syringe was adopted into the validated cycle utilizing AAMI TR28:2016. The ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals for the MiniLoad Syringe are gel clot method.
- Package integrity testing, after environmental conditioning and simulated . transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device: ●
- Seal strength ASTM F88/F88-15 O
- Dye penetration ASTM F1929-15 O
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
VIII. CONCLUSIONS
The design testing performed for the MiniLoad Syringe demonstrated that the performance of the device is equal to the legally marketed predicate device NORM-JECT (K101547).