(92 days)
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.
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.
This document describes a 510(k) submission for the Ultraflex™ Precision™ Colonic Stent System. It is an application for an expanded indication for a device that is already on the market. Therefore, the information provided focuses on the substantial equivalence to predicate devices and clinical data for the new indication, rather than detailed performance studies for the device itself.
Here's an analysis based on the provided text, addressing the requested information points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a tabular format. The submission relies on demonstrating substantial equivalence to existing predicate devices for its technological characteristics and presenting clinical data to support the new indication.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided text. The document mentions "Clinical data in support of the proposed indication has been collected and is presented within this submission." However, the exact number of patients or cases is not detailed here.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given text.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not mentioned or implied. The submission focuses on device performance and clinical effectiveness for a palliative indication, not on the improvement of human reader performance with AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (stent system), not an AI algorithm. The performance data refers to the device's functional characteristics and clinical outcomes.
7. Type of Ground Truth Used
- Given the context of a colonic stent for malignant strictures, the "ground truth" for the clinical data would likely be based on clinical observation, patient outcomes, medical diagnoses (e.g., confirmed malignant neoplasms), and potentially imaging or endoscopic confirmation of stricture palliation. The text itself does not explicitly define the "type of ground truth," but these are standard for such medical devices.
8. Sample Size for the Training Set
- This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
Summary based on the document:
The submission for the Ultraflex™ Precision™ Colonic Stent System asserts substantial equivalence based on:
- Technological Characteristics: The proposed device has identical materials, construction, and manufacturing processes as the currently marketed Ultraflex Precision Colonic Stent (K030769).
- Performance Data: For the new indication, "Clinical data in support of the proposed indication has been collected and is presented within this submission." The document explicitly states that performance testing from the prior K030769 submission was not repeated because there are no new materials or design changes.
The focus is on demonstrating that the new indication is safe and effective and that the device is substantially equivalent to legally marketed predicate devices (K030769 and K000281). Detailed breakdowns of clinical study methodology (sample sizes, expert qualifications, adjudication, specific metrics) are not provided in this summary document.
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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.
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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.
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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
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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)
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(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
§ 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.”