(178 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and basic functionality of an injection catheter, with no mention of AI or ML capabilities.
No
The device is an injection catheter used to deliver substances (like dyes or treatments for varices) but does not itself provide a therapeutic effect; it is a tool for delivering therapy.
No
The device is described as an "Injection Catheter" used for injecting solutions for treatment (e.g., esophageal and gastric varices) and for submucosal dye marking, which are interventional procedures rather than diagnostic ones.
No
The device description clearly outlines physical components such as a stainless-steel needle, inner tube, injector head, catheter tube, and slider. It also details physical characteristics like needle gauge, length, and catheter length. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endoscopic injections within the GI tract, specifically for treating esophageal and gastric varices and for submucosal dye marking. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a catheter with a needle designed to deliver substances into tissue. This aligns with a therapeutic or procedural function, not the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on biocompatibility, physical/chemical safety, sterilization, and shelf life, which are typical for medical devices used in procedures, not IVDs.
In summary, the Clear-Jet Injection Catheter is a medical device used for delivering substances into tissue during endoscopic procedures. Its function is procedural and therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The Clear-Jet Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm.
There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys.
This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract, esophageal and gastric varies
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 . and ISO 10993-11:2006
- . Performance testing such as appearance and dimension
- Physical and Chemical Safety Testing such as color and transparent, pH, KMnO4 Consumption, . Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test
- EO Sterilization Testing according to ISO 11737-1:2006 and ISO 11737-2:2009
- Shelf Life Testing according to ASTM F1980 ●
The biocompatibility evaluation for Clear-Jet Injection Catheter was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). The following tests were completed: Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity.
Performance testing such as appearance and dimension and extractable testing such as color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, and heavy metal as lead were performed as per Finemedix's design control system.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.
December 21, 2018
Finemedix Co. Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, CA 92620
Re: K181690
Trade/Device Name: Clear-Jet Injection Catheter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: November 13, 2018 Received: November 20, 2018
Dear April Lee:
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 mav, 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 avare 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.
1
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel G. Walter Jr -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181690
Device Name Clear-Jet Injection Catheter
Indications for Use (Describe)
The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the logo for FINEMEDIX. The logo is in blue and has an orange circle above the letter 'E'. The text is in all caps and is a sans-serif font.
FINEMEDIX CO., LTD. 60, Maeyeo-ro, Dong-gu, Daegu, Republic of Korea (41065)
510(k) Summary
Submitter
FINEMEDIX CO., LTD. Hee Kyung Kwon 60, Maeyeo-ro, Dong-gu, Daegu 41065 South Korea Email: hkyung1230@finemedix.com Tel. +82-53-741-8388 Fax. +82-53-741-8168
Official Correspondent
Withus Group Inc April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: Clear-Jet Injection Catheter ●
- Common Name: Endoscopic Injection Needle ●
- Classification Name: Endoscopic injection needle, gastroenterology-urology ●
- . Product Code: FBK
- Panel: Gastroenterology/Urology
- Regulation Number: 21 CFR 876.1500 Endoscope and Accessories
- Device Class: Class II
- . Date Prepared: 06/20/2018
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
- K 150434, Injection Needle manufactured by Micro-Tech (Nanjing) Co., Ltd.
Indication for Use:
The Clear-Jet Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Device Description:
Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm.
There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys.
4
T
Image /page/4/Picture/1 description: The image shows the word "FINEMEDIX" in a bold, sans-serif font. The letters are a dark blue color. Above the letters "ME" is a small orange circle.
This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
Summary of Technological Characteristics:
| | | Subject Device | Primary Predicate | Substantial
Equivalence |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Company | | Finemedix Co., Ltd. | Micro-Tech Co., Ltd. | - |
| Device Name | | Clear-Jet Injection Catheter | Injection Needle | - |
| 510(k) Number | | NA | K150434 | - |
| Device
Classification Name | | Endoscopic injection needle,
gastroenterology-urology | Endoscopic injection needle,
gastroenterology-urology | me |
| Product Code | | FBK | FBK | Same |
| Regulation Number | | 876.1500 | 876.1500 | Same |
| Indications for Use | | The Clear-Jet Injection
Catheter is to be used in
conjunction with an
endoscope to perform
endoscopic injections, such as
the treatment of esophageal
submucosal dye marking in
the GI tract | The Injection Needle is to be
used in conjunction with an
endoscope to perform
endoscopic injections, such as
the treatment of esophageal
Sa
and gastric varies, and for
and gastric varies and for
submucosal dye marking in
the GI tract. | me |
| Material | Needle
Tube | Stainless-Steel
Thermoplastic-PTFE Polymer | Stainless-Steel
Thermoplastic-PTFE Polymer | Same
Same |
| Components | | Needle, Inner Tube, Catheter
Tube, Handle, Slider | Needle, Innersheath, outer
shell, outer sheath and luer
Simi | lar |
| Gauge size | | 21,23 Gauge | 19,22,25 Gauge | Within the range |
| Supplied Sterile | | Yes | Yes | Same |
| Outer Sheath
Diameter | 2.35mm | 2.3mm | Similar | |
| Working Length | 1800, 2300 mm | 1800, 2000, 2300 mm | Within the range | |
| Needle Length | 4, 6 mm | 4,5,6 mm | Within the range | |
| Packaging | Single-use EO Sterilized
Pouch with one device per
pouch | Single-use EO Sterilized
Pouch with one device per
pouch | Same | |
| Single Use | Yes | Yes | Same | |
| Similarities | Both subject and predicate device are substantially equivalent in the indications for use,
Material, Components, Design, sterility, outer sheath diameter, working length, needle length,
and packaging as charted. | | | |
| Differences | The differences between the subject and predicate devices are gauge size and outer sheath
diameter. The subject device has 21 and 23 gauge and the predicate device has 19,22,25 gauge.
But the subject device gauges are contained within the range of the predicate's gauges, so it
does not affect the safety and effectiveness.
The other difference is outer sheath diameter. The outer sheath diameter of the subject device is
2.35mm and the outer sheath diameter of the predicate device is 2.3mm. But this size difference
doesn't affect the safety and effectiveness during surgery.
Any differences in technology characteristics are accompanied by information that
demonstrated the device is substantially equivalent as the predicate and do not raise different
questions of safety and effectiveness than the predicate. | | | |
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Image /page/5/Picture/1 description: The image shows the word "FINEMEDIX" in a bold, sans-serif font. The letters are a dark blue color. Above the "E" in "FINEMEDIX" is a small orange circle.
FINEMEDIX CO., LTD.
60, Maeyeo-ro, Dong-gu, Daegu, Republic of Korea (41065)
6
Image /page/6/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in purple and has an orange circle above the letters 'ME'. The text is bold and sans-serif.
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 . and ISO 10993-11:2006
- . Performance testing such as appearance and dimension
- Physical and Chemical Safety Testing such as color and transparent, pH, KMnO4 Consumption, . Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test
- EO Sterilization Testing according to ISO 11737-1:2006 and ISO 11737-2:2009
- Shelf Life Testing according to ASTM F1980 ●
The biocompatibility evaluation for Clear-Jet Injection Catheter was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). The following tests were completed: Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity.
Performance testing such as appearance and dimension and extractable testing such as color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, and heavy metal as lead were performed as per Finemedix's design control system.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion:
Clear-Jet Injection Catheter constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Clear-Jet Injection Catheter and its predicate are substantially equivalent.