(92 days)
No
The device description and intended use focus on a mechanical stent and delivery system, with no mention of AI/ML capabilities or related data analysis.
Yes
The device is indicated for "palliative treatment of colonic strictures... and to relieve large bowel obstruction", which are therapeutic actions.
No
The device is a stent used to treat colonic strictures, not to diagnose them. Its function is therapeutic, not diagnostic.
No
The device description clearly states that the device consists of a self-expanding metal stent and a delivery catheter, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the palliative treatment of colonic strictures and to relieve large bowel obstruction. This is a therapeutic intervention performed directly on the patient's anatomy.
- Device Description: The device is a self-expanding metal stent and a delivery catheter. This is a physical device implanted within the body.
- Lack of IVD Characteristics: An IVD device is 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 interact with or analyze such specimens.
Therefore, the Ultraflex™ Precision™ Colonic Stent is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Ultraflex™ Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Product codes
MOR, MQR
Device Description
The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending colon, sigmoid colon and rectum
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)
As this is a request for an additional indication and introduces no new materials or design changes the performance testing presented in K030769 was not repeated. Clinical data in support of the proposed indication has been collected and is presented within this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.”
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K060323
page 1 of 2
MAY 12 2006
SECTION 5 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4178 Fax: 508-683-5939
Contact: Jennifer A. Kimball, RAC Principal Regulatory Affairs Specialist Date Prepared: February 8, 2006
2. Device:
Trade Name: Ultraflex™ Precision™ Colonic Stent System Common Name: Expandable, metallic colonic stent Classification Name: Stent, colonic, metallic, expandable Regulation Number: 878.3610 Product Code: MOR Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K030769 Boston Scientific Corporation's Wallstent Enteral Stent, K000281 Both predicates are class II devices per 21 CFR 878.3610
4. Device Description:
The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch.
5. Intended Use:
The Ultraflex™ Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Image /page/0/Picture/15 description: The image shows a sequence of numbers. The numbers are all zeros except for a one in the fifth position and a zero in the last position. The sequence is "000010".
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6. Technological Characteristics:
The proposed Ultraflex Precision Colonic Stent has the identical technological characteristics (materials, construction, manufacturing processes) as the currently marketed Ultraflex Precision Colonic Stent.
7. Performance Data:
As this is a request for an additional indication and introduces no new materials or design changes the performance testing presented in K030769 was not repeated. Clinical data in support of the proposed indication has been collected and is presented within this submission.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Ultraflex™ Precision™ Colonic Stent is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and, in terms of the proposed indication to Boston Scientific Corporation's Wallstent Enteral Stent.
000071
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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 features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 12 2006
Ms. Jennifer Kimball Principal Regulatory Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K060323
Trade/Device Name: Ultraflex™ Precision™ Colonic Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: February 8, 2006 Received: February 13, 2006
Dear Ms. Kimball:
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. 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a logo with the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a circular border with the text "1906-2006" at the top and "In the Science of Public Health" at the bottom. The text "oting Ou" is at the bottom of the image.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of advanced 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated novice 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), please contact the Office of Compliance at one of the following numbers, 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 premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
Indications for Use:
510(k) Number (if known): To Be Determined K 0 (e 0322
Device Name: Ultraflex™ Precision™ Colonic Stent System
Indications For Use:
The Ultraflex™ Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
0000009
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Do
a
(Division Sign-Off)
Premarket Notification, Ultraflex™ Precision™ Colonic Stent System
proprietary and Confidential Information of Boston Scientific Corporation
ivision of Reproductive. Abdominal, and Radiological Devic
510(k) Number