(90 days)
K944220/A
Not Found
No
The device description and performance studies focus on mechanical ligation and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is used to ligate (tie off) esophageal varices or hemorrhoids, which are medical procedures to treat a pathological condition.
No
The device is described as a ligator used to treat conditions (ligate esophageal varices or internal hemorrhoids), not to diagnose them.
No
The device description explicitly details physical components like a friction fit adapter, barrel, trigger cord, handle, irrigation adapter, and loading catheter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically ligate esophageal varices... or to ligate internal hemorrhoids." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a mechanical tool used to physically apply bands to tissue. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used on the body to treat a condition.
N/A
Intended Use / Indications for Use
Used to endoscopically ligate esophageal varices at or above the gastroesophagel junction or to ligate internal hemorrhoids.
Product codes (comma separated list FDA assigned to the subject device)
78 FHN, 78 MND
Device Description
The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal varices at or above the gastroesophagel junction, internal hemorrhoids
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)
Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results. This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension.
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.
K944220/A
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
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 。
中国中
JAN 20 1998
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
| Trade Name: | Wilson-Cook Ten Shot Multi-Band Ligator |
|---|---|
| Common/Usual Name: | Band Ligator |
| Classification Name/Code: | Ligator, Hemorrhodial, 78 FHN |
| Ligator, Esophageal 78 MND | |
| Classification: | FDA has classified similar devices as Class II, as per 21 |
| CFR § 876.4400. This device falls within the purview of | |
| the Gastroenterology and Urology Device Panel. | |
| Performance Standards: | To the best of our knowledge, performance standards for |
| this device do not exist. | |
| Intended Use: | Used to endoscopically ligate esophageal varices at or above the |
| gastroesophagel junction or to ligate internal hemorrhoids. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL
NUMBER |
|--------------------------------------------|--------------------------|----------------------------|
| Wilson-Cook Six Shot
Multi-Band Ligator | Wilson-Cook Medical Inc. | K944220/A |
Substantial Equivalence:
The Wilson-Cook 10 Shot Multi-Band Ligator is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.
1
PREMARKET NOTIFICATION
PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) 。
上一篇:
| DEVICE
CHARACTERISTIC | Wilson-Cook
10 Shot Multi-Band Ligator
[Subject of 510(K)] | Wilson-Cook
Multi-Band Ligator
(K944220/A) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to endoscopically ligate
esophageal varices at or above
the gastroesopahgeal junction
or to ligate internal
hemorrhoids. | Used to endoscopically ligate
esophageal varices at or above
the gastroesopahgeal junction
or to ligate internal
hemorrhoids. |
| Components | 1) Non-Patient Contacting
Loading Catheter
2) Irrigation Adapter
3) Barrel with 10 Ligation
Bands
4) Trigger Cord
5) Deployment Handle | 1) Non-Patient Contacting
Loading Catheter
2) Irrigation Adapter
3) Barrel with 6 Ligation
Bands
4) Trigger Cord
5) Deployment Handle |
| Patient Contacting Materials | Friction Fit Adapter:
Polyurethane
Barrel: Polycarbonate
Trigger Cord: Vectran
Bands: Latex Rubber | Friction Fit Adapter:
Polyurethane
Barrel: Polycarbonate
Trigger Cord: Vectran
Bands: Latex Rubber |
| Method of Use | Friction Fit adapter and barrel
with ligation bands mounted to
the distal tip of the endoscope.
Band release from the barrel
accomplished by trigger cord
and deployment handle. | Friction Fit adapter and barrel
with ligation bands mounted to
the distal tip of the endoscope.
Band release from the barrel
accomplished by trigger cord
and deployment handle. |
| Bands | Multiple bands can perform
serial ligations without
removal of the endoscope for
reloading of bands. | Multiple bands can perform
serial ligations without
removal of the endoscope for
reloading of bands. |
Testing:
Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results. This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension.
2
Image /page/2/Picture/0 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1998
Ms. Paula Joyce Regulatory Affairs Manager Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K974018
Wilson-Cook 10 Shot Multi-band Ligator Dated: October 17, 1997 Received: October 22, 1997 Regulatory Class: II 21 CFR 876.4400/Procode: 78 FHN, 78 MND
Dear Ms. Joyce:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 misbranion.
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 requirement, 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 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 marked 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 yitro 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 of titled, "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,
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 14 of 14
510(k) Number (if known): INITIAL 510(k) SUBMISSION UNKNOWN
WILSON-COOK TEN SHOT MULTI-BAND LIGATOR Device Name:
Indications For Use:
Used to endoscopically ligate esophageal varices at or above the gastroesophagea1 junction or to ligate internal hemorrhoids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Riker D. Sitting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K97 4018 510(k) Number _
Prescription Use I (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)