(315 days)
Not Found
No
The description focuses on the mechanical properties and deployment of a stent, with no mention of AI/ML terms or functionalities.
Yes.
The device is intended for maintaining luminal patency in esophageal structures caused by malignant tumors and to restore the structure and/or function of the esophagus, which are therapeutic purposes.
No
The device is a stent used to maintain patency in esophageal structures, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical, implantable stent made of Nitinol wire and includes a delivery system, 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 to maintain luminal patency in esophageal structures caused by malignant tumors. This is a therapeutic intervention performed in vivo (within the body) to treat a physical condition.
- Device Description: The device is a stent designed to be implanted in the esophagus. This is a medical device used for structural support and function restoration in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens or analysis performed outside the body.
Therefore, the Niti-S Esophageal Non-covered Stent & Introducer is a medical device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.
Product codes (comma separated list FDA assigned to the subject device)
ESW
Device Description
Niti-S Esophageal Non-covered Stent & Introducer is a rigid, flexible, and expandable tubular device made of a self-expanding Nickel Titanium alloy (Nitinol) wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes a device delivery system for deployment. Upon deployment, the stent imparts an outward radial force on the luminal surface of the lumen to establish patency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
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 Niti-S Esophageal Non-covered Stent & Introducer has been subjected to extensive safety, performance, and validations prior to release. Safety and performance tests have been further performed to ensure the devices comply with applicable industry and US regulations.
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
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
0
K041648, Puzz INC
510(k) Summary
Date: Jan 31, 2005
Company and Submission Correspondent making the submission: 1.
| Name | Taewoong Medical Co., Ltd.
610 Ilsan-Technotown
1141-1 Backsuk-doing
Ilsam-Ku, Koyang-si
Kyunggi-do
Korea | or | Correspondent (contract):
Delphi Consulting Group
11874 South Evelyn Circle
Houston, Texas 77071-3404 |
|-----------|--------------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------|
| Telephone | 82-31-811-9111 | | 832-285-9423 |
| Contact | J.H. Nam /Director | | J. Harvey Knauss |
2. Device:
| Proprietary Name: | Niti-S Esophageal Non-covered Stent & Introducer |
|---|---|
| Common Name: | Esophageal Stent |
| Classification Name: | Prosthesis, Esophageal |
| Classification: | 21 CFR 878.3610 |
| Product Code: | ESW |
Predicate Device: 3.
Ultraflex Esophageal NG Stent System, Boston scientific Corp, K032930
4. Description:
Niti-S Esophageal Non-covered Stent & Introducer is a rigid, flexible, and expandable tubular device made of a self-expanding Nickel Titanium alloy (Nitinol) wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes a device delivery system for deployment. Upon deployment, the stent imparts an outward radial force on the luminal surface of the lumen to establish patency.
1
ട്. Review:
The Niti-S Esophageal Non-covered Stent & Introducer has the similar device characteristics as the predicate device. Material, design and use concepts are similar.
The Niti-S Esophageal Non-covered Stent & Introducer has been subjected to extensive safety, performance, and validations prior to release. Safety and performance tests have been further performed to ensure the devices comply with applicable industry and US regulations.
Dimensions 6.
| Product | Art. No. | Stent | Head | Introducer | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Trunk Diameter (mm) | Trunk Length (mm) | Head Diameter (mm) | Head Length(mm) | Diameter (mm) | Usable Length (cm) | Total Length (cm) | ||||
| Niti-S | ||||||||||
| Esophageal | ||||||||||
| Non-covered | ||||||||||
| Stent | E01606 | 30±0.6 | 95±9.5 | |||||||
| E01608 | 50±1.0 | 98±9.8 | ||||||||
| E01610 | 16±0.32 | 70±1.4 | 24±0.48 | |||||||
| E01612 | 90±1.8 | 105±10.5 | ||||||||
| E01615 | 120±2.4 | 107±10.7 | ||||||||
| Niti-S | ||||||||||
| Esophageal | ||||||||||
| Non-covered | ||||||||||
| Stent | E01806 | 30±0.6 | 15±0.3 | 15±0.3 | 5.3±0.1 | |||||
| E01808 | 50±1.0 | 98±9.8 | ||||||||
| E01810 | 18±0.36 | 70±1.4 | 26±0.52 | 101±10.1 | ||||||
| E01812 | 90±1.8 | 105±10.5 | ||||||||
| E01815 | 120±2.4 | 107±10.7 |
2
Indications For Use: 7.
Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining Nit & Edophageal Nortested in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.
Conclusions: 8.
Niti-S Esophageal Non-covered Stent & Introducer is substantially equivalent fo Ultraflex Esophageal NG Stent System.
3
Image /page/3/Picture/2 description: The image is a black and white circular logo. The logo features a stylized bird in flight, with three curved lines representing its wings. The bird is facing to the left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is arranged along the upper half of the circle.
APR 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TaeWoong Medical Co., Ltd. c/o James Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071
K041648 Re:
Ko410+0
Trade/Device Name: Niti-S Esophageal Non-Covered Stent(s) & Introducer Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 28, 2005 Received: March 31, 2005
Dear Mr. Knauss:
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 do not require approvisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, it 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 I todo o a rison 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 I cacal statues and regulating, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017, good and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA midtig of sucstantial of a more of the promits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device of our habers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premaiket notification" (21 CFR Also, please fibe the regulation entitled, "Thereasons on your responsibilities under the Act from the 807.97). You may outain other general meetical and Consumer Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer del Idemalde Division of Small Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K04/648
page 10+1
Indications for Use
510(k) Number (if known): KO4 | 648
Niti-S Esophageal Non-covered Stent & Introducer Device Name:
Indications For Use: Niti-S Esophageal Non-covered Stent & Introducer is intended for Nill-J Esophageal No.1 Suminal patency in esophageal structures maintaining consic and/or extrinsic malignant tumors.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
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