(178 days)
No
The device description explicitly states it is a manual syringe and there is no mention of AI, ML, or any computational processing.
No.
This device is a syringe used for fluid injection/aspiration, which is a medical instrument but not a therapeutic device itself. Its function is to administer or withdraw substances, not to provide therapy.
No
The device is described as a syringe intended for injecting or withdrawing fluids from the body, indicating it is an interventional or general-purpose medical tool, not a diagnostic one. Diagnostic devices are used to identify diseases or conditions.
No
The device description clearly outlines physical components (barrel, plunger, needle, etc.) and its operation is described as manual, indicating it is a hardware device.
Based on the provided information, the StaClear Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body." This is a direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe and needle, which are instruments for administering or collecting substances from a living organism.
- Anatomical Site: The specified anatomical site is "Intravitreal," which is within the eye of a living patient.
- Performance Studies: The performance studies focus on the physical characteristics and safety of the syringe and needle for injection/withdrawal, not on the analysis of biological samples.
- Predicate and Reference Devices: The predicate and reference devices are also syringes, which are not IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The StaClear Syringe's function is to interact directly with the body, not to analyze samples taken from it.
N/A
Intended Use / Indications for Use
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
Product codes (comma separated list FDA assigned to the subject device)
QLY, FMF, FMI
Device Description
The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
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
health care professionals
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)
Non-clinical Bench testing was performed to demonstrate the subject is as safe and effective as the proposed subject device. Performance testing was conducted according to TriboFilm's design control system. The following tests were completed:
ISO 7886-1: 2017
Cleanliness
Acidity and Alkalinity
Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device)
Lubricant
Tolerance on Graduations
Stopper Detachment
Dead Space
Air and Liquid Leakage Past Plunger
Plunger Force
Fit of Stopper
ISO 7864: 2016
Cleanliness
Acidity and Alkalinity
Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device)
Tolerance on Length
Tube Defects
Lubricant
Point Defects
Needle Penetration Force
Bond between Tube and Hub
Patency of Lumen
ISO 9626: 2016
Materials
Surface Finish
Cleanliness
Acidity and Alkalinity
Size designation
Dimensions
Stiffness
Resistance to Breakage
Resistance to Corrosion
Particulate Testing
USP Particulate Matter in Injections
USP Particulate Matter in Ophthalmic Solutions
StaClear Syringe is classified as an externally communicating device with prolonged (> 24 hours to 30 days) tissue contact. TriboFilm completed the following biological safety tests:
• Chemical Characterization
• Cytotoxicity
• Sensitization
• Irritation, Ocular
• Irritation, Intravitreal Injection
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity
• Hemolysis
The test article extract did not show evidence of causing cell lysis or toxicity, was not considered a sensitizer, was not considered an irritant to the ocular tissue of the rabbit, was not considered inflammatory to intraocular tissues of the rabbit, did not show evidence of erythema and edema, did not show evidence of mortality or systemic toxicity, was not considered pyrogenic, and was not considered hemolytic. A chemical characterization of the device was done to evaluate the subacute/subchronic and genotoxicity endpoints. The toxicological risk assessment demonstrated an acceptable level of risk of systemic exposure to the extractable compounds. Therefore, this biological safety testing demonstrates the subject device is biocompatible for its intended use.
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
§ 880.5860 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
July 27, 2020
TriboFilm Research, Inc. % Beryl Jeanne Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426
Re: K200242
Trade/Device Name: StaClear Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QLY, FMF, FMF, FMI Dated: June 24, 2020 Received: June 25, 2020
Dear Beryl Jeanne:
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,
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) K200242
Device Name StaClear Syringe
Indications for Use (Describe)
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe 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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Image /page/3/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is "Research, Inc." also in blue.
K200242 510(k) Summary
| 510(k) Number | K200242 | |
|---|---|---|
| Preparation Date | June 21, 2020 | |
| Submitter | TriboFilm Research, Inc. | |
| 625 Hutton Street, Suite 105 | ||
| Raleigh, NC 27606 | ||
| Phone: +1-919-838-2844 | ||
| Fax: +1-919-838-6787 | ||
| E-mail: info@tribofilmresearch.com | ||
| Primary Contact | Jackson Thornton, PhD | |
| Director of Research | ||
| TriboFilm Research, Inc. | ||
| 625 Hutton Street, Suite 105 | ||
| Raleigh, NC 27606 | ||
| Subject Device | Trade Name | StaClear Syringe |
| Common Name | Ophthalmic Syringe; | |
| Syringe, Piston; | ||
| Needle, Hypodermic, Single | ||
| Lumen | ||
| Regulation Name | Piston syringe; | |
| Hypodermic single lumen needle | ||
| Regulation Numbers | 21 CFR 880.5860; | |
| 21 CFR 880.5570 | ||
| Device Class | Class II | |
| Product Codes | QLY; FMF; FMI | |
| Regulation Medical Specialty | General Hospital | |
| 510(k) Review Panel | General Hospital | |
| Intended Use / | ||
| Indications for | ||
| Use | The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use. | |
| Device | ||
| Description | The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use. | |
| Predicate Device | Trade Name | Sterile Single-use Syringe with Needle |
| Applicant | JiangXi HongDa Medical | |
| Equipment Group Ltd. | ||
| 510(k) Number | K163161 |
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Image /page/4/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter 'T' with an orange arc around it, followed by the text 'riboFilm' in blue. Below 'riboFilm' is the text 'Research, Inc.' also in blue.
| Clearance Date | March 20, 2017 | |
|---|---|---|
| Common Name | Syringe, Piston; | |
| Needle, Hypodermic, Single | ||
| Lumen | ||
| Regulation Name | Piston syringe; | |
| Hypodermic single lumen needle | ||
| Regulation Numbers | 21 CFR 880.5860; | |
| 21 CFR 880.5570 | ||
| Device Class | Class II | |
| Product Codes | FMF; FMI | |
| Regulation Medical Specialty | General Hospital | |
| 510(k) Review Panel | General Hospital | |
| Reference Device | Trade Name | BD Insulin Syringe |
| Applicant | Becton, Dickinson & Company | |
| 510(k) Number | K024112 | |
| Clearance Date | 01/09/2003 | |
| Device | Syringe, Piston | |
| Regulation Numbers | 21 CFR 880.5860 | |
| Device Class | Class II | |
| Product Codes | FMF | |
| Regulation Medical Specialty | General Hospital | |
| 510(k) Review Panel | General Hospital | |
| Mechanism of Action | Manual operation |
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Image /page/5/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is "Research, Inc." also in blue. The logo is clean and professional, suggesting a company involved in research and development.
| Technological Characteristics | The technological characteristics of the subject device are substantially equivalent to the predicate device with only minor differences in the device materials, syringe volume, connector type, needle gauge, needle length, biocompatibility tests completed, and performance testing completed. Biocompatibility testing and performance testing demonstrate these differences do not raise questions of safety and effectiveness. Refer to Table 1 below for a comparison of technological characteristics between the subject and predicate devices. |
|---|---|
| ------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Characteristic | Subject Device | Predicate Device | Associated
Testing
Standard |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | StaClear Syringe | Sterile Single-Use
Syringe with Needle | - |
| Applicant | TriboFilm
Research, Inc. | JiangXi HongDa
Medical Equipment
Group Ltd. | - |
| 510(k) Number | K200242 | K163161 | - |
| Intended Use | The StaClear
Syringe is intended
to inject fluids into.
or withdraw fluids
from, the body. | Identical | All listed
Performance and
Biocompatibility
testing listing
within this 510(k)
Summary support
the safety and
effectiveness of
the device as
compared to the
predicate. |
| Indications for
Use | The StaClear
Syringe is
indicated for
intravitreal use. | Equivalent, the
predicate device does
not identify specific
indications for use. | ISO 10993-15,
Intravitreal
Injection
Irritation testing,
USP , USP
|
| Mechanism of
Action | Manual | Identical | ISO 7886-1 |
| Sterilization
information | Provided Sterile,
single-use
Sterilization
Method: Ethylene
Oxide
SAL: 10-6 | Identical | ISO 10993-7,
ISO 14937, TIR
56, ISO 11135,
ISO 11737-1,
ISO 11737-2 |
| Shelf Life | 1 year | Unknown
The predicate device's
shelf life is unknown.
This information is not
provided in the
K163161 510(k) | ASTM F1980-16,
ISO 7886-1, ISO
7864, USP |
| Device Materials | Barrel -
Polypropylene
Plunger -
Polyethylene
Plunger Stopper -
Polyisoprene
(Nipol IR2200,
Zeon Chemicals)
Needle - ASTM
304 Stainless Steel
Needle Shield -
Polyethylene
Plunger Cap -
Polyethylene
Barrel Lubricant -
Silicone Oil,
crosslinked with
inert argon gas
plasma | Equivalent. Both the
subject and predicate
devices use stainless
steel for the needles.
Both the subject and
predicate devices use
polypropylene and
polyisoprene for the
syringes.
The predicate device
additionally uses
polyethylene for the
syringe's plunger,
needle shield, and
plunger cap. These
components are non-
patient contacting.
The subject device
uses a silicone oil
crosslinked with inert
argon gas plasma for
the lubricant. The
predicate device uses
standard silicone oil as
the lubricant. | ISO 10993-1,
ISO 10993-2,
ISO 10993-4,
ISO 10993-5,
ISO 10993-10,
ISO 10993-11,
ISO 10993-12,
ISO 10993-17,
ISO 10993-18,
ASTM F756 |
| Syringe Volume | 0.25 mL | Equivalent. The
subject device's 0.25
mL syringe volume is
smaller than the
predicate device's
syringe volume range
of 1 mL to 60 mL. | ISO 7886-1 |
| Connector Type | Attached needle | Equivalent. The
subject device has the
needle permanently
attached to the syringe
body whereas the
predicate uses a luer
slip and luer lock
connector. | ISO 7886-1, ISO
7864, ISO 9626 |
| Needle Gauge | 31 G | Equivalent. The
subject device's 31G
needle is smaller than
the predicate device's
needle range of 18G to
30G. | ISO 7864 and
ISO 9626 |
| Needle Length | 5/16 in. | Equivalent. The
subject device's 5/16
in. needle length is
shorter than the
predicate device's
needle length range of
1/8 in. to 1 1/8 in. | ISO 7864 and
ISO 9626 |
| Cytotoxicity | | | |
| Cytotoxicity | No evidence of causing cell lysis or toxicity | Identical | ISO 10993-5 |
| Sensitization | No skin sensitization | Identical | ISO 10993-10 |
| Irritation or
Intracutaneous
Reactivity | Intracutaneous
Reactivity: No
intracutaneous
reactivity | Identical | ISO 10993-15,
Intravitreal
Injection
Irritation testing |
| Irritation or
Intracutaneous
Reactivity | Irritation, Ocular:
Not considered
irritants to the
ocular tissue
Irritation,
Intravitreal
Injection: Not
considered
inflammatory to
intraocular tissues | N/A. Ocular Irritation
and Intravitreal
Injection Irritation
testing not performed
on predicated device. | ISO 10993-15,
Intravitreal
Injection
Irritation testing |
| Acute Systemic
Toxicity | No mortality or
evidence of
systemic toxicity | Identical | ISO 10993-11 |
| Pyrogenicity | Not pyrogenic | Identical | ISO 10993-11 |
| Hemolysis | Not hemolytic | Identical | ASTM F756, ISO
10993-4 |
Table 1: Comparison of Technological Characteristics
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Image /page/6/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized "T" with an orange arc around it, followed by the text "riboFilm" in blue. Below that, the text "Research, Inc." is also written in blue.
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Image /page/7/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is the word "Research, Inc." also in blue. The logo is clean and professional, with a focus on the company's name and branding.
Substantial Equivalence Discussion:
The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics.
- There are no differences between the subject device and the predicate device with respect to intended use.
- The subject device is additionally indicated for intravitreal use. . This additional indication was evaluated through ocular and intravitreal injection irritation testing, demonstrating that the device is biocompatible for intravitreal use. This difference in indications for use between the subject and predicate device does not raise new or different questions of safety and effectiveness.
- The technological characteristics of the subject device are substantially equivalent to the predicate device with only minor differences in the device materials, syringe volume, connector type, needle gauge, needle length.
- . TriboFilm completed performance testing according to the following standards: ISO 7886-1, ISO 7864, and ISO 9626. The StaClear Syringe met the applicable requirements of all three standards. These three standards were utilized by predicate device JiangXi Sterile Single-use Syringe with Needle (K163161) to demonstrate performance. Additionally, TriboFilm completed particulate testing according to the following standards and
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Image /page/8/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below "riboFilm" is the text "Research, Inc." also in blue.
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Image /page/9/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized "T" with an orange circle around it, followed by the text "riboFilm" in blue. Below the text is the phrase "Research, Inc." also in blue.
Non-clinical Bench testing was performed to demonstrate the subject is as safe and Testing: effective as the proposed subject device. Performance testing was conducted according to TriboFilm's design control system. The following tests were completed: ISO 7886-1: 2017 ● Cleanliness Acidity and Alkalinity ● ● Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device) ● Lubricant ● Tolerance on Graduations Stopper Detachment ● Dead Space ● ● Air and Liquid Leakage Past Plunger ● Plunger Force Fit of Stopper ● ISO 7864: 2016 Cleanliness ● ● Acidity and Alkalinity ● Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device) ● Tolerance on Length ● Tube Defects ● Lubricant Point Defects ● Needle Penetration Force ● Bond between Tube and Hub ● . Patency of Lumen ISO 9626: 2016 Materials ● ● Surface Finish ● Cleanliness Acidity and Alkalinity ● ● Size designation Dimensions ● Stiffness ● ● Resistance to Breakage Resistance to Corrosion ● Particulate Testing USP Particulate Matter in Injections ● USP Particulate Matter in Ophthalmic Solutions ●
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Image /page/10/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is the phrase "Research, Inc." also in blue.
| Non-Clinical
Testing
(Biocompatibility
) | StaClear Syringe is classified as an externally communicating device with
prolonged (> 24 hours to 30 days) tissue contact. TriboFilm completed the
following biological safety tests:
• Chemical Characterization
• Cytotoxicity
• Sensitization
• Irritation, Ocular
• Irritation, Intravitreal Injection
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity
• Hemolysis |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The test article extract did not show evidence of causing cell lysis or
toxicity, was not considered a sensitizer, was not considered an irritant to
the ocular tissue of the rabbit, was not considered inflammatory to
intraocular tissues of the rabbit, did not show evidence of erythema and
edema, did not show evidence of mortality or systemic toxicity, was not
considered pyrogenic, and was not considered hemolytic. A chemical
characterization of the device was done to evaluate the subacute/subchronic
and genotoxicity endpoints. The toxicological risk assessment
demonstrated an acceptable level of risk of systemic exposure to the
extractable compounds. Therefore, this biological safety testing
demonstrates the subject device is biocompatible for its intended use. |
| Clinical Testing: | Not Applicable |
| Conclusion: | In conclusion, the StaClear Syringe is biocompatible for its intended use,
demonstrates equivalent performance as the predicate device, and
demonstrates better performance than the reference device. TriboFilm
Research, Inc. respectfully requests FDA clearance to legally market the
StaClear Syringe in the U.S.
The modifications to design, dimensions, and materials met the
requirements of the standards. The suitability of the device for intravitreal
injections was evaluated through biocompatibility and particulate testing.
The differences between the predicate and the subject device do not raise
any new or different questions of safety or effectiveness. The StaClear
Syringe is substantially equivalent to the Sterile Single-use Syringe with
Needle cleared under K163161 with respect to the intended use, target
populations, treatment method, and technological characteristics. |