(90 days)
Not Found
No
The summary describes a mechanical device for endoscopic clipping and does not mention any AI or ML components or functions.
Yes
The device is used for hemostasis, which is a therapeutic intervention to stop bleeding.
No
Explanation: The device is used for endoscopic clip placement for purposes like marking and hemostasis, which are treatment or procedural actions, not diagnostic.
No
The device description clearly states it is comprised of an introducer and a pre-loaded clip, which are physical hardware components.
Based on the provided information, 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.
- Device Function: The description clearly states the device is used for endoscopic clip placement within the gastrointestinal tract for purposes like marking and hemostasis. It is a therapeutic and procedural device, not a diagnostic one that analyzes samples.
- Lack of Diagnostic Testing: There is no mention of analyzing biological samples or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a therapeutic or procedural medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.
Product codes (comma separated list FDA assigned to the subject device)
MCH, PKL
Device Description
The Wilson-Cook Endoscopic Clipping Device is comprised of an introducer with a locking handle and one (1) pre-loaded clip. The introducer is used to deploy the clip and is not left in the patient. The clip is left in the patient to accomplish hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, upper GI tract
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)
The Wilson-Cook Endoscopic Clipping Device underwent simulated use testing and biocompatibility testing. Test results provide reasonable assurance the device will perform in accordance with 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.
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
RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
N 023903
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 1.
pg 1 of 2
FEB 2 0 2003
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Endoscopic Clipping Device is comprised of an introducer with a locking handle and one (1) pre-loaded clip. The introducer is used to deploy the clip and is not left in the patient. The clip is left in the patient to accomplish hemostasis.
| Trade Name: | Wilson-Cook Endoscopic Clipping Device |
|---|---|
| Common/Usual Name: | Endoscopic Clipping Device |
| Classification Name/Code: | Clip, Hemostatic / MCH |
| Classification: | FDA has classified similar devices as Class II. 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 for endoscopic clip placement within the |
| gastrointestinal tract for the purpose of endoscopic | |
| marking, hemostasis for mucosal/submucosal defects | |
| less than 3 cm in the upper GI tract, bleeding ulcers, | |
| arteries less than 2 mm, and polyps less than 1.5 cm in | |
| diameter in the GI tract. This device is not intended for | |
| the repair of GI tract lumenal perforations. |
Predicate Device:
| PREDICATE
DEVICE | MANUFACTURER | DOCUMENT
CONTROL
NUMBER |
|---------------------------------------|----------------------|-------------------------------|
| Olympus Endoscopic
Clipping Device | Olympus America, Inc | K990687 |
Substantial Equivalence:
The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.
1
K023903 Py202
NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC RE: PREMARKET CLIPPING DEVICE
| DEVICE
CHARACTERISTIC | Wilson-Cook
Endoscopic Clipping
Device
[Subject of 510(K)] | Olympus
Endoscopic Clipping
Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not assigned | K990687 |
| Intended Use | Used for endoscopic clip
placement within the
gastrointestinal tract for the
purpose of endoscopic
marking, hemostasis for
mucosal/ submucosal
defects less than 3 cm in
the upper GI tract, bleeding
ulcers, arteries less than 2
mm, and polyps less than
1.5 cm in diameter in the
GI tract. This device is not
intended for the repair of
GI tract lumenal
perforations. | Used for endoscopic clip
placement within the
gastrointestinal (GI) tract
for the purpose of
endoscopic marking,
hemostasis in the upper GI
tract for
mucosal/submucosal defects
Trade/Device Name: Wilson-Cook Endoscopic Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): November 16, 2002 Received (Date on orig SE ltr): November 22, 2002
Dear Margaret J. Posner,
This letter corrects our substantially equivalent letter of February 20, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ 19_ of _ 19
510(k) Number (if known): _K ○ノろイクフ
Device Name: __ Wilson-Cook Endoscopic Clipping Device
Indications for Use:
Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/ submucosal defects less than 3 cm in the upper Gl tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter (Optional Format 1-2-96
David A. Syverson
(Division Sign-Off) Division of Reproductive, I and Radiological Devices 510(k) Number