(125 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and deployment mechanism of a physical stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a colonic stent used for palliative treatment of strictures, which falls under the scope of therapeutic intervention.
No
The device is a stent used for palliative treatment of colonic strictures, which is a therapeutic rather than a diagnostic function.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The Ultraflex™ Precision™ Colonic Stent is a physical device that is implanted into the body to treat colonic strictures. It is a therapeutic device, not a diagnostic one. It does not perform any tests on samples.
The information provided clearly describes a medical device used for treatment within the body, which is the opposite of an in vitro diagnostic.
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.
Product codes (comma separated list FDA assigned to the subject device)
78 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.
The proposed Ultraflex™ Precision™ Colonic Stent System is a Nitinol, self-expanding stent mounted on a delivery catheter. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colonic strictures in the 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)
Comparative performance testing was performed, where appropriate, between the proposed Ultraflex Precision Colonic Stent System and the Bard Memotherm Colorectal Stent System to establish substantial equivalence. Additional performance data, such as tensile strength, fatigue, and corrosion resistance testing was also performed.
In vivo testing of the proposed Ultraflex Precision Colonic Stent System demonstrates that the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
C.R. Bard Memotherm® Colorectal Stent
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO30769
JUL 1 4 2003
Microvasive Endoscopy Boston Sommi · Corporation One Boston Scientific Place Natick, MA J7769 1537 508-650-8000
SECTION 11 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Contact: Kathleen Morahan, RAC Regulatory Affairs Manager Date Prepared: March 10, 2003
2. Device:
Trade Name: Ultraflex™ Precision™ Colonic Stent System Common Name: Expandable, metallic colonic stent Classification Name: Not classified
3. Predicate Device:
C.R. Bard Memotherm® Colorectal Stent
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.
1
6. Technological Characteristics:
The proposed Ultraflex™ Precision™ Colonic Stent System is a Nitinol, self-expanding stent mounted on a delivery catheter. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm.
The Ultraflex™ Precision™ Colonic Stent System is substantially equivalent to C.R. Bard's Memotherm Colorectal Stent. The devices have intended use and are both self-expanding stents constructed of Nitinol. Both stents are mounted on a delivery catheter, however the delivery catheter designs differ. The proposed Ultraflex™ Precision™ Colonic stent is bound onto the delivery catheter shaft with braided nylon suture using a crochet stitch. The predicate Memotherm Colorectal stent delivery catheter utilizes a co-axial tube and the stent is constrained onto the delivery catheter shaft by the outer sheath.
7. Performance Data:
The use of self-expanding metal stents for palliation of malignant colorectal strictures is well documented in the literature.
Comparative performance testing was performed, where appropriate, between the proposed Ultraflex Precision Colonic Stent System and the Bard Memotherm Colorectal Stent System to establish substantial equivalence. Additional performance data, such as tensile strength, fatigue, and corrosion resistance testing was also performed.
In vivo testing of the proposed Ultraflex Precision Colonic Stent System demonstrates that the device is safe and effective for its intended use.
8. Conclusion:
BSC has demonstrated that Ultraflex Precision Colonic Stent System is substantially equivalent to C.R. Bard's currently marketed Memotherm® Colorectal Stent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. 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
JUL 1 4 2003
Ms. Kathleen Morahan Manager Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760
Re: K030769
Trade/Device Name: Ultraflex Precision Colonic Stent System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 78 MQR Dated: June 12, 2003 Received: June 16, 2003
Dear Ms. Morahan:
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. Drue, 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 (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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.
3
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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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SECTION 3 INDICATIONS FOR USE
510(k) Number:
To Be Determined
Ko30769
Device Name:
Ultraflex ™Precision™ Colonic Stent
Indication 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.1091) (Optional Format 1-2-96)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Daniel A. Jepson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K030769
Premarket Notification, Ultraflex™ Precision Colonic Stent System Proprietary and Confidential Information of Boston Scientific Corporation