(102 days)
This device is 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.
The Disposable Hemostasis Clip is a sterile, single use device that consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Disposable Hemostasis Clip is 230 cm long. The deployed clip portion of the Disposable Hemostasis Clip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.
The provided text describes a 510(k) summary for a medical device called the "Disposable Hemostasis Clip" by Wilson-Cook Medical, Inc. / Cook Endoscopy. Based on the provided information, I will answer your questions.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in the provided document beyond the general statement that the device met "performance requirements to fulfill the intended use." The document indicates the device's performance through non-clinical bench testing, demonstrating its substantial equivalence to predicate devices for its intended use.
| Acceptance Criteria (Inferred from regulatory context and intended use) | Reported Device Performance |
|---|---|
| Ability to fulfill intended use for endoscopic clip placement. | Met performance requirements through non-clinical bench testing to fulfill intended use. |
| Hemostasis for mucosal/submucosal defects less than 3 cm. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for bleeding ulcers. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for arteries less than 2 mm. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for polyps less than 1.5 cm in diameter. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Compatibility with endoscopes with a minimum accessory channel of 2.8 mm. | Device description states compatibility. |
| Device length of 230 cm. | Device description states length. |
| MR Conditional per ASMT F2503. | The deployed clip portion of the device is MR Conditional per ASMT F2503. |
| Detachment of metal clip from introducer. | Device description states "consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis." |
| Maintenance of tissue approximation. | Device description states "consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis." |
| Sterile, single-use. | Device description states "sterile, single use device." |
| Not intended for repair of GI tract lumenal perforations. | This is a limitation of the device's intended use and not a performance criterion to be met, but rather a boundary of its application. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states "Performance testing consisting of non-clinical bench testing demonstrates that the Disposable Hemostasis Clip met the performance requirements to fulfill the intended use of the device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying laboratory or simulated environments rather than human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not provided in the document. The performance testing was non-clinical bench testing, which typically does not involve human expert adjudication for ground truth in the same way clinical studies with medical images or diagnoses might.
4. Adjudication Method for the Test Set
As the performance testing was non-clinical bench testing, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable and therefore not mentioned in this document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi Reader Multi Case (MRMC) comparative effectiveness study is not mentioned in the document. This device is a mechanical hemostasis clip, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable as the device is a medical instrument (hemostasis clip), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies to this device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Given that the testing was "non-clinical bench testing," the ground truth likely involved physical measurements and objective criteria based on pre-defined engineering specifications and intended functionality (e.g., clip strength, deployment success, tissue approximation force against a simulated target). Clinical ground truth (like pathology or patient outcomes) would not be generated in non-clinical bench testing.
8. The Sample Size for the Training Set
This information is not provided and is not relevant for this type of medical device's performance testing described. Training sets are typically associated with machine learning or AI models, which is not the case here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set or machine learning in the context of this device's regulatory review.
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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a black background. The word "COOK" is on the top line, and the word "MEDICAL" is on the second line.
of 2 COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHOHE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
. ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
AUG 3 1 2012
121505
5. 510(k) Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station RoadWinston-Salem, North Carolina 27105 |
| Phone: | (336)744-0157 |
| Fax: | (336)201-5994 |
| Contact: | Scottie Fariole, Global Regulatory Affairs Specialist |
| Date: | May 18, 2012 |
| Trade Name: | Disposable Hemostasis Clip |
| Common Name: | Hemostasis Clip |
| Classification Name: | Hemorrhoidal ligator, Gastroenterology-Urology (21 CFR 876.4400,Product Code MND) |
| Legally Marketed Devices: | Wilson-Cook Endoscopic Clipping Device (K023903) |
| Description of the Device: | The Disposable Hemostasis Clip is a sterile, single use device thatconsists of a metal clip that detaches from the introducer tomaintain approximation of tissue to achieve hemostasis in thegastrointestinal tract. The device is compatible with endoscopeswith a minimum accessory channel of 2.8 mm. The DisposableHemostasis Clip is 230 cm long. The deployed clip portion of theDisposable Hemostasis Clip is stainless steel and nitinol while theintroducer is nylon, stainless steel and nitinol. |
| Intended Use: | This device is used for endoscopic clip placement within thegastrointestinal tract for the purpose of endoscopic marking,hemostasis for mucosal/submucosal defects less than 3 cm in theupper GI tract, bleeding ulcers, arteries less than 2 mm, andpolyps less than 1.5 cm in diameter in the GI tract. This device isnot intended for the repair of GI tract lumenal perforations. |
| Technological Characteristics: | The Disposable Hemostasis Clip has similar technologicalcharacteristics to the Wilson-Cook Endoscopic Clipping Device(K023903) in terms of general design and function but differs interms of materials, dimensions, clip geometry and handleoperation. Additionally, the deployed clip portion of the device isMR Conditional per ASMT F2503. |
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Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates that the Disposable Hemostasis Clip met the performance requirements to fulfill the intended use of the device. The device is substantially equivalent to currently cleared predicate devices.
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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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Wilson-Cook Medical, Inc. / Cook Endoscopy Scottie Fariole Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K121505
Trade/Device Name: Disposable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): August 21, 2012 Received (Date on orig SE ltr): August 22, 2012
Dear Scottie Fariole,
This letter corrects our substantially equivalent letter of August 31, 2012.
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
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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
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4. Indications for Use
510(k) Number (if known): K121505
Device Name: _ Disposable Hemostasis Clip
Indications for Use:
This device is 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.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard Leuu
inn Sidne tive, Gastro-Renal, and S10/k) Numr
Page __ of 1
§ 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.