The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms.

The Medtronic InStent EsophaCoil Proximal and Distal Extensions are intended for extending previously placed esophageal stents exhibiting tumor overgrowth or tumor ingrowth on the upper or lower portion of the existing stent respectively.

The Medtronic InStent EsophaCoil Distal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the distal side of the stent.

The Medtronic InStent EsophaCoil Proximal Extension System is intended for use in extending previously implanted esophageal stents exhibiting turnor overgrowth on the proximal side of the stent.

Device Description

The Medtronic InStent EsophaCoil Esophageal Stent is a self-expanding, tightly wound spiral Nitinol wire coil which is flared at both ends to enhance fixation. The EsophaCoil Extension is identical to the EsophaCoil Esophageal Stent except that only one end is flared. The non-flared end of the EsophaCoil Extension is inserted into an implanted esophageal stent to extend the length of the stent. The delivery catheter is identical to the currently marketed device. The variable release handle utilizes three independently sliding levers located on the catheter 's proximal end that can release the stent in any sequence order; distal release, center release, or proximal release depending upon which of the sliding levers is pulled first, second, or third.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for a medical device, the Medtronic InStent EsophaCoil Esophageal Stent System and Extension Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive studies with acceptance criteria as one might expect for AI/ML devices or diagnostic tests.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this document as it describes a traditional medical device modification and extension, not an AI/ML diagnostic system or a comparative effectiveness study in the sense implied by the questions.

Here's a breakdown based on the provided text, while acknowledging the limitations for this type of device submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for substantial equivalence)	Reported Device Performance (as demonstrated for substantial equivalence)
Safety:
- Corrosion resistance	- Corrosion testing performed; no safety concerns identified.
Effectiveness/Functionality:
- Identical construction/materials to predicate	- Modified EsophaCoil Stent: identical to marketed, except for surface preparation.
- Similar design principles	- EsophaCoil Extension Systems: identical to marketed stent, but with only one flared end to extend existing stents.
- Similar intended use	- Intended use for esophageal obstructions from malignant neoplasms (stent) and extending existing stents (extensions).
Packaging and Sterilization:
- Consistent with predicate	- Packaging and sterilization methods are consistent, contributing to substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The submission states "Corrosion testing was performed to evaluate the safety of the device. No other testing was deemed necessary for the new or modified devices." This indicates bench testing for material properties, not a clinical study with a "test set" of patients in the context of diagnostic performance or clinical outcomes. No details on sample size for corrosion testing or data provenance are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This submission does not involve subjective diagnostic assessment or a "ground truth" established by experts in the context of algorithm performance. The evaluation is based on material properties and design changes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There was no "test set" requiring adjudication in the context of diagnostic interpretation or clinical outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the corrosion testing: The "ground truth" would be established by validated scientific methods and standards for evaluating material corrosion (e.g., electrochemical measurements, visual inspection for degradation), generally accepted as objective measures rather than expert consensus on a clinical diagnosis.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, and there was no "training set."

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device, and there was no "training set."

Study That Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Corrosion testing."

Type of Study: Benchtop material testing.
Purpose: To evaluate the safety of the device, specifically its resistance to corrosion.
Findings (implicit): The document concludes, "Based on the testing performed and the nature of the changes, it was concluded that the modified devices are substantially equivalent to the currently marketed device. The construction, materials packaging and sterilization methods were found to be equivalent." This implies that the corrosion testing results were acceptable and did not raise new safety concerns compared to the predicate device.
Rationale for Limited Testing: The submission states, "No other testing was deemed necessary for the new or modified devices." This is a common aspect of 510(k) submissions, where minor modifications to an already cleared device, or the introduction of a new model within an existing device family, may not require extensive new clinical or performance studies if the safety and effectiveness are established through substantial equivalence to the predicate. The changes (surface preparation, single vs. double flared end for extensions) were considered minor enough that only corrosion testing was required to affirm safety.

Summary

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JAN - 8 1988

K973584

510(k) NOTIFICATION SUMMARY

Medtronic InStent EsophaCoil Esophageal Stent System and EsophaCoil Proximal and Distal Extension Systems

General Provisions A.

Submitter's Name	Medtronic InStent
Submitter's Address	6271 Bury DriveEden Prairie, Minnesota 55346
Contact Person	John R. DalpeeSenior Quality Assurance/Regulatory AffairsManager
Classification Name:	Esophageal Endoprosthesis 21 CFR Part 878.3610
Common or Usual Name:	Esophageal Endoprosthesis
Proprietary Name:	EsophaCoil Esophageal Stent SystemEsophaCoil Proximal and Distal Extension Systems

Name of Predicate Device B.

These devices are considered substantially equivalent to the Medtronic InStent EsophaCoil Esophageal Stent System. (K944187 and K955041)

C. Device Description

D. Intended Use

The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms.

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Summary of Technological Characteristics E.

The modified EsophaCoil Esophageal Stent is identical to the currently marketed device with the exception of the surface preparation. The EsophaCoil Extension Systems are identical to the currently marketed device with the exception that the EsophaCoil Extension has only one flared end, rather than two flared ends as in the EsophaCoil Esophageal Stent.

F. Non-Clinical and Clinical Test Summary

Corrosion testing was performed to evaluate the safety of the device. No other testing was deemed necessary for the new or modified devices.

G. Conclusions

Based on the testing performed and the nature of the changes, it was concluded that the modified devices are substantially equivalent to the currently marketed device. The construction, materials packaging and sterilization methods

H. Other Information

No other information was deemed necessary for the determination of substantial equivalence of the EsophaCoil Esophageal Stent modifications or the new models, the EsophaCoil Distal and Proximal Extension Systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its wings, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

Mr. John R. Dalpee Senior Quality Assurance/Regulatory Affairs Manager Medtronic InStent 6271 Bury Drive Eden Prairie, Minnesota 55346

Re: K973584

Trade Name: Medtronic InStent EsophaCoil Esophageal Stent System and EsophaCoil Extension System Regulatory Class: III Product Code: EWZ Dated: September 19, 1997 Received: September 22, 1997

Dear Mr. Dalpee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions 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 Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations - Title 21, -----Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 action. 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

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Page 2 - Mr. John R. Dalpee

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour 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 advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from 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

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Page of of )

510(k) Number (if known):

Device Name: Medtronic InStent EsophaCoil Esophageal Stent System and EsophaCoil Extension System

Indications For Use:

The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms.

The Medtronic InStent EsophaCoil Distal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the distal side of the stent. 1

The Medtronic InStent EsophaCoil Proximal Extension System is intended for use in extending previously implanted esophageal stents exhibiting turnor overgrowth on the _ proximal side of the stent.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.”