(88 days)
Not Found
No
The device description focuses on mechanical components and a "slow release" mechanism, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for use in the "treatment of esophageal obstructions produced by malignant neoplasms," which is a therapeutic purpose.
No
This device is a stent system used for treating esophageal obstructions caused by malignant neoplasms, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components such as a self-expandable metal stent made of Nitinol, a delivery catheter made of thermoplastic material, and a slow release handle. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the treatment of esophageal obstructions produced by malignant neoplasms." This describes a therapeutic intervention performed directly on the patient's body to treat a condition.
- Device Description: The device is a "self-expandable metal stent" that is implanted into the esophagus. This is a medical device used for treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
Therefore, the Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release in indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
Product codes
ESW
Device Description
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandable metal stent which is mounted on a delivery catheter. The stent is manufactured from a nickel titanium (Nitinol) material and is comprised of a center stenting section of adjacent coils and two flared ends which enhance fixation. The delivery catheter is manufactured from a thermoplastic material with a tapered end and flexible tip. The stent is wound in a reduced diameter configuration and held in place by a restraining means. The restraining means in connected to the "slow release" handle on the proximal end of the catheter. The slow release allows the stent to be released from the catheter in a fixed and controlled speed manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal
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
Testing was performed to evaluate the safety and effectiveness of the slow release mechanism. No other testing was deemed necessary for the modification of this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
A.
510(k) NOTIFICATION AND SUMMARY
Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release
| General Provisions | |
|---|---|
| Submitter's Name | Medtronic InStent |
| Submitter's Address | 6271 Bury Drive |
| Eden Prairie, Minnesota 55346 | |
| Contact Person | Noel Messenger |
| Vice President, Regulatory Affairs | |
| Classification Name | Esophageal Endoprosthesis 21 CFR, Part 876.3610 |
| Common or Usual Name | Esophageal Endoprosthesis |
| Proprietary Name | EsophaCoil Esophageal Stent System with |
| Slow Release |
B. Name of Predicate Device
EsophaCoil Esophageal Stent System and Variable Release K941487 and K955041 respectively
C. Device Description
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandable metal stent which is mounted on a delivery catheter. The stent is manufactured from a nickel titanium (Nitinol) material and is comprised of a center stenting section of adjacent coils and two flared ends which enhance fixation. The delivery catheter is manufactured from a thermoplastic material with a tapered end and flexible tip. The stent is wound in a reduced diameter configuration and held in place by a restraining means. The restraining means in connected to the "slow release" handle on the proximal end of the catheter. The slow release allows the stent to be released from the catheter in a fixed and controlled speed manner.
D. Intended Use
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release in indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
E. Summary of Technological Characteristics
The modified EsophaCoil Stent System with Slow Release is identical to the currently marketed EsophaCoil Stent System with Variable Release with the exception of the slow release modification. The modified slow release handle allows a fixed, controlled (slower) release sequence, where the variable release allowed the stent to be released in which ever sequence was desired by the physician without the slower control mechanism.
1
Non-Clinical and Clinical Test Summary F.
Testing was performed to evaluate the safety and effectiveness of the slow release mechanism. No other testing was deemed necessary for the modification of this device.
G. Conclusions
Based on the testing performed and the nature of the change, it was concluded that the modified device is substantially equivalent to the currently marketed device.
Other H.
No other information was deemed necessary for the determination of substantial equivalence of the EsophaCoil Stent System with Slow Release.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. Noel Messenger Vice President Regulatory Affairs Medtronic InStent 6271 Bury Drive Eden Prairie, Minnesota 55346
K983297 Re:
K985277
Trade Name: EsophaCoil Esophageal Stent System with Slow Release Regulatory Class: II Product Code: ESW Dated: September 4, 1998 Received: September 21, 1998
Dear Mr. Messenger:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have levice your boomer be device is substantially equivalent (for the indications for above und we have dosure) to devices marketed in interstate commerce prior to use stated in the enactment date of the Medical Device Amendments, or to devices that May 20, 1770, the chasance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costicity for (Tree). "The general controls provisions of the Act include requirements for provisions of the Fea. Its ing 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 Approval), it may be subject to such additional controls. Existing major (1 remailed if for rollar)) was device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I was ood Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory sation. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Noel Messenger
This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will anow your to ough finding of substantial equivalence of your device to a premiured predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and Compilance at (301) 59 - e., please contact the Office of Compliance at (301) 594-4639. advertising of your as result from entitled, "Misbranding by reference to premarket Also, prease flow the regareral information on your responsibilities under the nother (21 OF CF CF CF Com the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Page
510(k) Number (if known):___
EsophaCoil Esophageal Stent Device Name: System with Slow Release
Indications For Use:
The EsophaCoil Slow Release esophageal prosthesis inc indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
୦୨
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
to coela to
(Division Fon-Off Division of General 510(k) Number