(157 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a manually-operated syringe, with no mention of AI or ML technologies.
No.
The device is described as an injection system intended for delivering fluids (specifically botulinum neurotoxin) into the body, which is a delivery mechanism, not a device that itself provides direct therapeutic effect to treat a disease or condition. Its purpose is to efficiently and precisely administer a therapeutic substance.
No
The device description clearly states its purpose is for "injection of fluids into the body," specifically botulinum neurotoxin. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, manually-operated syringe with mechanical components (piston, barrel, plunger, luer-lock connector, ratcheted mechanism) and is packaged as a kit with other hardware (needles, vial adapter). There is no mention of any software component.
Based on the provided information, the NavaClick Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "injection of fluids into the body," specifically "botulinum neurotoxin." This describes a device used for administering a substance into a living organism, which is an in vivo application.
- Device Description: The description details a syringe, needles, and a vial adapter – components used for preparing and delivering an injection. These are tools for in vivo procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This is the core function of an IVD.
Therefore, the NavaClick Injection System is a medical device intended for in vivo use, not an IVD.
N/A
Intended Use / Indications for Use
The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
Product codes
FMF, FMF, FMI, LHI
Device Description
The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections.
The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication.
The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
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
The NavaClick Injection System components described in this summary have been tested and demonstrated to be in conformance with the following FDA recognized standards:
- . ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications • - Part 7: Connectors for intravascular or hypodermic applications
- . ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
Biocompatibility testing of the predicate device was conducted per ISO 10993-1:2018 and the risk-based approach outlined in FDA quidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Sep 4, 2020. Based on the standard, the kit components were defined as externally communicating, limited exposure and either blood path indirect (syringe and adapter) or circulating blood (needle). The following testing was conducted on all kit components and no deviations were noted.
- . Cytotoxicity (ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity")
- Sensitization (ISO 10993-10:2021 "Biological evaluation of medical device Part 10: . Tests for skin sensitization")
- Irritation (ISO 10993-23:2021 "Biological evaluation of medical device – Part 23: Test for irritation")
- . Acute Systemic Toxicity (ISO 10993-11:2017 "Biological evaluation of medical device -Part 11: Tests for systemic toxicity")
- Hemolysis (ISO 10993-4:2017 "Biological evaluation of medical device – Part 4: Selection of tests for interactions with blood")
- Material Mediated Pyrogenicity (ISO 10993-11:2017 "Biological evaluation of medical . device - Part 11: Tests for systemic toxicity")
Evaluation of particulate in the fluid path per USP has been conducted on the NavaClick Injection System. Although there are no USP specifications for particulate matter found in or on medical devices, by comparison, the kit components met the specification for small volume parenteral fluids.
Results from the biocompatibility testing support the biocompatibility and safety of the subject device.
The sterilization method for the NavaClick Injection System is electron beam irradiation with a sterilization dose minimum of 25kGy. Acceptable test results from the sterilization validation demonstrated the ability of the electron beam process to consistently vield a sterility assurance level (SAL) of 10° for the NavaClick Injection System. Sterilization and endotoxin testing was completed in accordance with the following standards. No deviations were noted.
- ISO 11137-1: 2006/Amd 2:2019 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2: 2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
- ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
- AAMI TIR29:2012 (R2017) Guide For Process Characterization And Control In Radiation Sterilization Of Medical Devices
- USP Bacterial Endotoxin Test ●
Accelerated stability testing demonstrates the sterility and performance of the device to support the shelf-life of 1 year.
Product stability testing of the NavaClick Injection System was conducted after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Product performance testing of each component was conducted according to the relevant ISO standard as well as functional performance testing as a kit.
Package (sterile barrier) testing was performed on the subject device after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Package testing was also performed after simulated environmental conditioning (ASTM D4332-22) and distribution (ASTM D4169-22). Sterile barrier integrity testing was completed in accordance with the following standards. No deviations were noted.
- Visual inspection (ASTM F1886)
- Bubble Leak Test (ASTM 2096-11) ●
- Seal Strength (ASTM F88/F88M-21)
Key Metrics
Not Found
Predicate Device(s)
Merit Syringe K171362
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 30, 2023
Bradley Pliskow Director of R&D and Operations 620 NW Dixie Hwy Stuart, Florida 34994
Re: K231877
Trade/Device Name: NavaClick Injection System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, LHI Dated: September 22, 2023 Received: November 3, 2023
Dear Bradley Pliskow:
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).
1
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 QS 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.
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).
Juliane C. Lessard -S Sincerely,
Juliane C. Lessard, 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 Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
NavaClick Injection System
Indications for Use (Describe)
The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
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
K231877 510(k) Summary
SUBMITTED BY:
| Company Name: | Lineage Biomedical. |
|---|---|
| Address: | 620 NW Dixie Hwy |
| Stuart, FL 34994 | |
| Telephone: | 1-772-539-9749 |
| Fax: | N/A |
| CONTACT PERSON: | Bradley Pliskow |
|---|---|
| DATE PREPARED: | Nov 27, 2023 |
| TRADE NAME: | NavaClick Injection System |
| COMMON and CLASSIFICATION NAME: | Piston Syringe |
| CLASSIFICATION REG/PANEL: | 21 CFR 880.5860/ General and Plastic Surgery |
| PROCODE: | FMF |
PREDICATE DEVICE:
Merit Syringe K171362
DEVICE DESCRIPTION:
The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections.
The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication.
The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
INDICATIONS FOR USE/INTENDED USE:
The NavaClick Injection System is intended for injection of fluids into the body and is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
The general intended use for injection of fluids into the body is identical to that of the predicate device; however, the subject device is not intended for withdrawal of fluids from the body. I In addition, the subject device is specifically used to inject botulinum neurotoxin per the neurotoxin product's intended use. This difference does not alter the general intended use of the subject
4
device for injection of fluids which is identical to a section of the predicate device's intended use statement and covered in 21 CFR 880.5860.
COMPARISON of TECHNOLOGICAL CHARACTERISTICS:
Results from testing based on "Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes" April 1993, support substantial equivalence of the NavaClick Injector to the predicate Merit Syringe cleared under K171362.
| Attribute | NavaClick Injection
System (Syringe) | Predicate Device:
Merit Syringe K171362 | Analysis |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Lineage Biomedical | Merit Medical Systems | |
| Design | Piston Syringe | Piston Syringe | Same |
| Device Class | II | II | Same |
| Procode | FMF | FMF | Same |
| Syringe Type | Piston Syringe | Piston Syringe | Same |
| Intended Use | Intended to inject fluids into
the body and is specifically
indicated for injection of
botulinum neurotoxin
consistent with the
neurotoxin's approved
labeling | Used to inject fluids into, or
withdraw fluids from, the
body | Different
The general intended use
for injection of fluids is the
same for both the subject
and predicate device and is
covered in 21 CFR
880.5860 (piston syringe).
No new questions of safety
or effectiveness. |
| Principle of
Operations | Manually operated by
advancing and withdrawing
the plunger within the barrel | Manually operated by
advancing and withdrawing
the plunger within the barrel | Same |
| Specific Drug
Use | Neurotoxin | Not specified | Different
Injection of botulinum toxin
(neurotoxin) is typically
achieved using any
conventional piston syringe;
a specific delivery device is
not required or identified in
published prescribing
information for common
botulinum toxin drugs.
Therefore, no new
questions of safety or
effectiveness for use of the
NavaClick piston syringe for
delivery of neurotoxin. |
| Design | Standard piston syringe
construction. The device
uses a two-piece molded
ratcheted plunger. Fitting
offered with male luer lock
connector. | Standard three-piece piston
syringe. The device uses a
single-piece molded
ratcheted plunger. Fitting
offered with male luer lock
connector | Different
The subject device has a
free mode (plunger
operates freely with no
feedback), and a feedback
mode (ratchet provides |
| Attribute | NavaClick Injection
System (Syringe) | Predicate Device:
Merit Syringe K171362 | Analysis |
| Materials | The barrel is constructed
using polypropylene, the
plunger from polypropylene,
and the seal from
polyisoprene | The barrel is constructed
using polypropylene, the
plunger from polypropylene,
and the seal from silicone. | Different
Both polyisoprene and
silicone are commonly used
plunger seal materials.
Testing confirms
performance and
biocompatibility of subject
device. No new questions
of safety or effectiveness. |
| Operational
Volume | Operational Volume of 1 mL | Operational volume of 10
mL | Different
Use of a plunger within the
syringe barrel to move fluid
into and out of the syringe
for operation of the syringe
is the same for both
devices. No new questions
of safety or effectiveness. |
| Graduation | Printed with accurate
graduation lines that are
compliant with ISO 7886-1 | Printed with accurate
graduation lines that are
compliant with ISO 7886-1 | Different
The subject device has a
graduation scale division of
0.1 mL and sub-division of
0.01 mL. Although volume
increments for the
graduation scale are
different, graduation for
both the subject and
predicate is in compliant
with ISO 7886-1. No new
questions of safety or
effectiveness. |
| Barrel
Transparency | Clear as required by ISO
7886-1 | Clear as required by ISO
7886-1 | Same |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Same |
| Performance
Testing | ISO 7886-1
ISO 80369-7 | ISO 7886-1
ISO 594-2 (withdrawn) | Same |
| Re-use | Single use only | Single use only | Same |
| Sterilization | Electron Beam | Ethylene Oxide | Different |
| Attribute | NavaClick Injection
System (Syringe) | Predicate Device:
Merit Syringe K171362 | Analysis |
| | | | Both the subject and
predicate devices are
sterilized using well-
established methods.
Electron Beam sterilization
of the subject device is
compliant with ISO 11137-
1, ISO 11137-2 and ISO
11137-3. No new questions
of safety or effectiveness. |
| Accessories | Packaged as a kit | Not a kit configuration | Different
The NavaClick syringe is
packaged with needles and
a vial adapter for
convenience of the user.
The kit components are
previously 510k cleared
devices to be utilized per
the cleared indications. No
new questions of safety of
effectiveness. |
5
6
The NavaClick Injector has the same intended use, materials of construction, and principle of operations as the predicate device. There are minor differences between the subject and predicate devices. Although they are both 3-part piston syringes consisting of a barrel, plunger and tip, the Nava device also has grips to enhance control. Both devices have ratcheted plungers; however, the mechanism to produce an audible clicking and tactile feedback is different. The Nava device allows the feedback mechanism to engage by twisting the thumb rest 90 degrees. These differences are not significant with regard to the function of the syringe to inject fluids; these minor differences do not raise different questions of safety and effectiveness.
Performance Testing
The NavaClick Injection System components described in this summary have been tested and demonstrated to be in conformance with the following FDA recognized standards:
- . ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications • - Part 7: Connectors for intravascular or hypodermic applications
- . ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
7
Biocompatibility Testing
Biocompatibility testing of the predicate device was conducted per ISO 10993-1:2018 and the risk-based approach outlined in FDA quidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Sep 4, 2020. Based on the standard, the kit components were defined as externally communicating, limited exposure and either blood path indirect (syringe and adapter) or circulating blood (needle). The following testing was conducted on all kit components and no deviations were noted.
- . Cytotoxicity (ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity")
- Sensitization (ISO 10993-10:2021 "Biological evaluation of medical device Part 10: . Tests for skin sensitization")
- Irritation (ISO 10993-23:2021 "Biological evaluation of medical device – Part 23: Test for irritation")
- . Acute Systemic Toxicity (ISO 10993-11:2017 "Biological evaluation of medical device -Part 11: Tests for systemic toxicity")
- Hemolysis (ISO 10993-4:2017 "Biological evaluation of medical device – Part 4: Selection of tests for interactions with blood")
- Material Mediated Pyrogenicity (ISO 10993-11:2017 "Biological evaluation of medical . device - Part 11: Tests for systemic toxicity")
Evaluation of particulate in the fluid path per USP has been conducted on the NavaClick Injection System. Although there are no USP specifications for particulate matter found in or on medical devices, by comparison, the kit components met the specification for small volume parenteral fluids.
Results from the biocompatibility testing support the biocompatibility and safety of the subject device.
Sterility and Shelf Life
The sterilization method for the NavaClick Injection System is electron beam irradiation with a sterilization dose minimum of 25kGy. Acceptable test results from the sterilization validation demonstrated the ability of the electron beam process to consistently vield a sterility assurance level (SAL) of 10° for the NavaClick Injection System. Sterilization and endotoxin testing was completed in accordance with the following standards. No deviations were noted.
- ISO 11137-1: 2006/Amd 2:2019 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2: 2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
8
- ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
- AAMI TIR29:2012 (R2017) Guide For Process Characterization And Control In Radiation Sterilization Of Medical Devices
- USP Bacterial Endotoxin Test ●
Accelerated stability testing demonstrates the sterility and performance of the device to support the shelf-life of 1 year.
Product stability testing of the NavaClick Injection System was conducted after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Product performance testing of each component was conducted according to the relevant ISO standard as well as functional performance testing as a kit.
Package (sterile barrier) testing was performed on the subject device after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Package testing was also performed after simulated environmental conditioning (ASTM D4332-22) and distribution (ASTM D4169-22). Sterile barrier integrity testing was completed in accordance with the following standards. No deviations were noted.
- Visual inspection (ASTM F1886)
- Bubble Leak Test (ASTM 2096-11) ●
- Seal Strength (ASTM F88/F88M-21)
Conclusion
Based on the intended use, technological characteristics, performance testing, and biocompatibility studies, the NavaClick Injection System meets the requirements that are considered essential for its intended use. The technological differences between the predicate (K171362) Merit Syringe and the subject device do not raise any new questions of safety or effectiveness. The NavaClick Injection System is considered substantially equivalent to the predicate device.