(323 days)
Not Found
No
The device description focuses on the physical properties and materials of a bare stent, and there is no mention of AI or ML in the provided text.
Yes.
The device is indicated for "palliation of malignant strictures in the biliary tree," which is a therapeutic intervention to alleviate symptoms and improve quality of life.
No
Explanation: The device is a stent, an implantable medical device used to palliate malignant strictures in the biliary tree. Its purpose is therapeutic (to open and maintain patency of the stricture), not diagnostic (to identify or characterize a disease).
No
The device description clearly details a physical, implantable stent made of Nitinol wire with gold-plated tungsten markers. It undergoes bench testing for physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "palliation of malignant strictures in the biliary tree." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a "Single bare stent" made of Nitinol wire, designed to be implanted in the bile duct. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The EGIS Biliary Single Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
Single bare stent has straight and round cylinder form made of a Nitinol wire. It is woven twice in V-hook type by one wire. The cell size is approximately 2 mm. The end of wire is tied by the both wires. No bonding material is used. Single bare Stent is manufactured by continuous works, V and Twist structure manufacturing process. From these processes, design of Single bare stent has the 12 bends and 2mm cell size. 2mm cell size has the merit to prolong the time that tissue grows up into the stent. In addition, Single Bare Stent designed to have the Radial force, Flexibility and conformability. Single Bare Stent has 6 markers in diameter 6, 7, and 8mm in size and 8 markers in diameter 10mm in size; 2 or 3 markers at both sides and 2 markers at the center. Markers are made of Gold-plated Tungsten wire. They are intended to identify the location of the loaded stent through X-ray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
biliary tree / Bile duct
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
Non-clinical Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Shelf-Life Test
- ISO 10993-3- Genotocixity (Ames test) & Genotocixity (chromosomal aberration)
- ISO 10993-4- Haemolysis
- ISO 10993-5- Cytotoxicity
- ISO 10993-6- Implantation
- ISO 10993-10 Sensitization & Intracutatneous Reactivity
- ISO 10993-11 Acute systemic toxicity & Subchronic Toxicity & Pyrogens
- Other bench testing- Foreshortening, Stent integrity, Dimensional Verification, Radial Compression Force, Radial Outward Force, Pitting Corrosion, Corrosion, Crossin Profile, Deployment, Catheter Bond Strength, Radiopacity, MR
Bench test results allowed to conclude that EGIS Biliary Single Bare Stent is substantially equivalent to the predicate devices for its intended use.
Clinical Test Conclusion: Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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 symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
September 21, 2023
S&G Biotech Inc. Mr. Dave Kim Official Correspondent 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K223354
Trade/Device Name: EGIS Biliary Single Bare Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: August 18, 2023 Received: August 18, 2023
Dear Mr. Dave Kim:
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 and the limitations described below. 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.
The OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section
1
2
513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system has not been established.
Furthermore, the indication for biliary use use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-regulatoryinformation/postmarketing-safety-reporting-combination-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/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products. including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
2
specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/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,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K223354
Device Name
EGIS Biliary Single Bare Stent
Indications for Use (Describe)
The EGIS Biliary Single Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.
| 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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4
510(k) Summary K223354
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92;
- 5.1 Submitter: S&G BIOTECH INC. Address: 82, Bugok-ro, Pogok-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, REPUBLIC OF KOREA (17023) Phone No. +82-31-748-6625 Fax No. +82-31-748-6620 Contact Person: Mr. Dave Kim 7505 Fannin St. Suite 610, Houston, TX 77054 (Official Correspondent) Tel: 713-467-2607 Email: davekim@mtech-inc.net Date Prepared: December 28, 2022
5.2 Device Identification
| Device Trade Name | EGIS Biliary Single Bare Stent |
|---|---|
| Common Name | Biliary catheter and accessories |
| Classification Name, Number | Biliary catheter and accessories (21 CFR 876.5010) |
| Device Classification | II |
| Product Code | FGE |
5.3 Predicated or legally marketed devices which are substantially equivalent
Predicated device: K111149, "HANAROSTENT Biliary (NNN)", manufactured by "M.I.Tech"
5.4 Device Description
Single bare stent has straight and round cylinder form made of a Nitinol wire. It is woven twice in V-hook type by one wire. The cell size is approximately 2 mm. The end of wire is tied by the both wires. No bonding material is used. Single bare Stent is manufactured by continuous works, V and Twist structure manufacturing process. From these processes, design of Single bare stent has the 12 bends and 2mm cell size. 2mm cell size has the merit to prolong the time that tissue grows up into the stent. In addition, Single Bare Stent designed to have the Radial force, Flexibility and conformability. Single Bare Stent has 6 markers in diameter 6, 7, and 8mm in size and 8 markers in diameter 10mm in size; 2 or 3 markers at both sides and 2 markers at the center. Markers are made of Gold-plated Tungsten wire. They are intended to identify the location of the loaded stent through X-ray.
5.5 Statement of Indication for use
The EGIS Biliary Single Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.
5.6 Non-clinical Test Conclusion
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- · Shelf- Life Test
5
- ISO 10993-3- Genotocixity (Ames test) & Genotocixity (chromosomal aberration)
- ISO 10993-4- Haemolysis
- ISO 10993-5- Cytotoxicity
- ISO 10993-6- Implantation
- ISO 10993-10 Sensitization & Intracutatneous Reactivity
- · ISO 10993-11 Acute systemic toxicity & Subchronic Toxicity & Pyrogens
• Other bench testing- Foreshortening, Stent integrity, Dimensional Verification, Radial Compression Force, Radial Outward Force, Pitting Corrosion, Corrosion, Crossin Profile, Deployment, Catheter Bond Strength, Radiopacity, MR
Bench test results allowed to conclude that EGIS Biliary Single Bare Stent is substantially equivalent to the predicate devices for its intended use.
5.7 Clinical Test Conclusion
Clinical testing was not required for this submission.
5.8 Technical Characteristics and Substantial Equivalence
The EGIS Biliary Single Bare Stent is substantially equivalent to HANAROSTENT Biliary (NNN) (K111149). The following comparison table is presented to demonstrate substantial equivalence. The EGIS Biliary Single Bare Stent does not have a new intended use. It shows equivalent specifications with the predicate devices in most of the parameters. However, there are no significant differences in some parameters [Stent's Diameter, Stent's Length, Deployment System's Diameter, Deployment System's Usable Length, Delivery Deployment and withdrawal, Radial Outward Force, Compression Force(Radial Compression Force), Dimensional Verification, Corrosion, Pitting corrosion, Catheter Bond strength, Foreshortening] between the EGIS Biliary Single Bare Stent and Predicate Device[HANAROSTENT Biliary (NNN) (K111149)].
| | Candidate Device | Predicate Device | Substantial
Equivalence
Analysis |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k)
Number | K223354 | K111149 | - |
| Device Name | EGIS Biliary Single Bare Stent | HANAROSTENT Biliary (NNN) | - |
| Common Name | Biliary catheter and accessories | Biliary catheter and accessories | - |
| Manufacturer | S&G BIOTECH INC. | M.I.Tech | - |
| Indication for
Use | The EGIS Biliary Single Bare
Stent s indicated for the
palliation of malignant strictures
in the biliary tree | The HANAROSTENT® Biliary
(NNN) is indicated for the
palliation of malignant strictures
in the biliary tree | Same as predicate |
| Stent's Type | Uncovered Type | Uncovered Type | Same as predicate |
| Stent's
Diameter | 6mm & 7mm & 8 mm & 10 mm | 8mm & 10mm | No significant
difference |
| Stent's Length | 30mm & 40 mm & 50 mm & 60
mm & 70 mm & 80 mm & 90 mm
& 100 mm & 120 mm | 40 mm & 50 mm & 60 mm & 70
mm & 80 mm & 90 mm & 100
mm & 120 mm | No significant
difference |
| Deployment
System's
Diameter | 2mm(6F), 2.7 mm (8Fr) | 2.36mm | No significant
difference |
| Deployment
System's
Usable Length | 500 mm & 1800 mm | 600mm & 1800mm | No significant
difference |
| Single use | Yes | Yes | Same as predicate |
| Radiopaque
Markers | Yes | Yes | Same as predicate |
| Lasso | No | No | Same as predicate |
| Delivery,
Deployment,
and
Withdrawal | Deploy force: 8.6 ~ 18.8N
Distance: 0.13 ~ 1.95mm | Deploy force: 6.3 ~ 14.2 N
Distance: 0.36 ~ 4.37mm | No significant
difference |
| Radial
Outward Force | 1.04 ~ 1.28 N | 0.64 ~ 1.01 N | No significant
difference |
| Compression
Force
(Radial
Compression
Force) | 1.03 ~ 1.27 N | 0.66 ~ 1.05 N | No significant
difference |
| Dimensional
Verification | 1.39 ~ 2.46 % | 0.98 ~ 2.93% | No significant
difference |
| Corrosion | 0.95 ~ 1.29 N | 0.67 ~ 1.05 N | No significant
difference |
| Pitting
corrosion | 1.00 ~ 1.03 N | 0.75 ~ 0.80 N | No significant
difference |
| Catheter bond
strength | Sheath hub & tube (A) : 52.5 ~
68.9 N
Peek tube & Olive Tip (B): 20.7 ~
38.5 N
Pusher hub & tube (C): 168.9 ~
520.0 N
Stainless steel & PP tube (D):
24.2 ~ 77.7 N | Sheath hub & tube (A) : 51.3 ~
65.8 N
Peek tube & Olive Tip (B): 14.5 ~
20.6 N
Pusher hub & tube (C): more
than 500 N
Stainless steel & PP tube (D):
32.2 ~ 39.3 N | No significant
difference |
| Foreshortening | 31.4 ~ 36.9 % | 17.6~ 21.5% | No significant
difference |
| Target
Population | Patients in need of treatment of
malignant biliary strictures | Patients in need of treatment of
malignant biliary strictures | Same as predicate |
| Anatomical
Site | Bile duct | Bile duct | Same as predicate |
| Sterilization
Method | EO Gas Sterilization | EO gas sterilization | Same as predicate |
| Packaging
Material | Tyvek, Manila paper | Tyvek, paper box | Same as predicate |
| Bio-
compatibility | All user directly contacting
materials are compliance with
ISO10993 requirements. | All user directly contacting
materials are compliance with
ISO10993 requirements. | Same as predicate |
Table 1. General Device Characteristics Comparison Table
6
Although the subject device and predicate device are no significant differences in some parameters, the differences do not affect the substantial equivalence of the subject device when compared to the predicate device.
5.9 Conclusion
Based on the testing results, S&G BIOTECH INC. concludes that the subject device is substantially equivalent to the predicate device.