(393 days)
The Memotherm colorectal stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon.
The Memotherm® Colorectal Stent comprised of two components - a self-expanding implantable metal stent and the delivery device. The stent is a nitinol grid-like cylinder with flared ends, available in 20 and 30mm diameters and 60, 80, and 100mm lengths. While mounted on the deployment system the stent is compressed. Upon release of the stent from the deployment system the nitinol cylinder expands. The coaxial deployment system consists of an inner catheter, an outer sheath and an ergonomically shaped handgrip. Female luer injection ports are included on the back of the handgrip and ratchet carriage. Two radiopaque markers are positioned on the deployment system to mark both ends of the stent.
The provided text describes the Memotherm® Colorectal Stent and details its submission for 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, or information related to AI/algorithm performance. It primarily focuses on demonstrating substantial equivalence to a predicate device through general comparative testing and literature review.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated but Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | |
| - Trackability (ability to be navigated to target site) | Within anticipated results |
| - Deployment (successful release of stent) | Within anticipated results |
| - Stent Expansion/Compression | Within anticipated results |
| - Tensile and Dimensional Verifications | Within anticipated results |
| - Corrosion Resistance (within anatomical environment) | Resistant |
| Safety and Effectiveness (Inferred from Predicate): | |
| - Palliative treatment of colonic strictures/obstruction | Demonstrated through relevant published literature for self-expanding metal stents in the colon. |
2. Sample size used for the test set and the data provenance
The document mentions "Comparative performance testing was done, where appropriate, between the Memotherm and WALLSTENT." However, it does not specify:
- The exact sample size for this comparative testing.
- The data provenance (e.g., country of origin, retrospective/prospective). It seems to refer to bench testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document relies on "relevant published, scientific, literature" for the general effectiveness of metal stents, and internal bench testing for comparative performance. There is no mention of expert-established ground truth for a test set in the context of a diagnostic or AI-assisted device.
4. Adjudication method for the test set
This information is not provided. Given the nature of the testing described (bench tests and literature review), adjudication methods for diagnostic performance are not relevant or described.
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
There is no mention of an MRMC study. This device is a physical medical device (stent), not an AI diagnostic or assistance system. Therefore, AI-related performance metrics and human reader improvement are not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical stent, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the effectiveness claim, the ground truth appears to be derived from:
- "relevant published, scientific, literature" demonstrating the effectiveness of self-expanding metal stents for palliative treatment of colon cancers.
- The established performance of the predicate device (WALLSTENT® Enteral Endoprosthesis).
For the performance testing (tensile, dimensional, trackability, deployment, expansion/compression), the ground truth would be the expected engineering specifications and functional outcomes.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
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MAR 1 6 2000
K 990504 1083
Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
BARD
VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.
- A. Submitter Information
| Submitter's Name: | Bard Interventional Products DivisionC.R. Bard, Inc. |
|---|---|
| Address: | 129 Concord Road, Bldg. #3Billerica, MA 01821 |
| Phone: | 978 - 262 - 4867 |
| Fax: | 978 - 262 - 4878 |
| Contact Person: | Marion Gordon, R.A.C. |
| Date of Preparation: | December 11, 1998 |
- B. Device Name
| Trade Name: | Memotherm® Colorectal Stent |
|---|---|
| Common/Usual Name: | Expandable, metallic colonic stent |
| Classification Name: | FDA has not classified to date |
- C. Predicate Device Name
Trade Name:
WALLSTENT® Enteral Endoprosthesis Schneider (USA), Inc.
- D. Device Description:
The Memotherm® Colorectal Stent comprised of two components - a self-expanding implantable metal stent and the delivery device. The stent is a nitinol grid-like cylinder with flared ends, available in 20 and 30mm
25
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diameters and 60, 80, and 100mm lengths. While mounted on the deployment system the stent is compressed. Upon release of the stent from the deployment system the nitinol cylinder expands. The coaxial deployment system consists of an inner catheter, an outer sheath and an ergonomically shaped handgrip. Female luer injection ports are included on the back of the handgrip and ratchet carriage. Two radiopaque markers are positioned on the deployment system to mark both ends of the stent.
-
Intended Use: ن
The proposed stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon. -
Technological Characteristics Summary: F.
The Memotherm® Colorectal Stent is a metal stent constructed of biocompatible nitinol. The self-expanding stent is packaged pre-mounted on a disposable delivery system that utilizes an uni-directional, pistol grip handle release mechanism.
The Memotherm® Colorectal Stent is substantially equivalent to the Schneider WALLSTENT® Enteral Endoprosthesis. Both devices are manufactured with a delivery system that implants a self-expanding metal stent over a guidewire using a coaxial, interfacing catheter/sheath (tubes). While each manufacturer's metal stents are made from different materials, both allow for self-expanding deployment using radial force to expand the inner colon lumen. The WALLSTENT can be placed via the colonoscope's working channel, while the Memotherm is positioned using fluoroscopy after the guidewire has been inserted using the colonoscope. Both manufacturers have the same intended use for the device and have stents within the same range of diameters and lengths.
- G. Performance Data
Safe and effective in vivo use of self-expanding, metal stents in the colon
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has been demonstrated in relevant published, scientific, literature. Metal stents have been shown to be effective, in palliative treatment of colon cancers, and give the patients relief from partial or complete obstructions caused by the disease.
Comparative performance testing was done, where appropriate, between the Memotherm and WALLSTENT. In addition to testing various tensile and dimensional verifications, other bench data included trackability, deployment and stent expansion/compression were completed. The stent is resistant to corrosion within the intended anatomical environment based on Bard's experience with other metal stents. All data was within the anticipated results.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
MAR 1 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg. #3 P.O. Box 7031 Billerica. MA 01821-7031
Re: K990504 Memotherm® Colorectal Stent
Dated: October 8, 1999 Received: October 12, 1999 Regulatory Class: III 21 CFR 878.3610/Procode: 78 MQR
Dear Ms. Gordon:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act indude 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 (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 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 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 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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | TBD K090504 |
|---|---|
| Device Name: | Memotherm Colorectal Stent |
| Indications For Use: | The Memotherm colorectal stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon. |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K990504/5002 |
|---|---|
| --------------- | -------------- |
01
:
§ 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.”