(230 days)
The PADLOCK CLIP™ EFTR Device is a device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.
The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.
The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.
The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesson's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit. These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.
The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.
The provided document is a 510(k) summary for the PADLOCK CLIP EFTR Kit, which is a medical device for endoscopic full-thickness resection. The document outlines verification, validation, animal, and other testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Category | Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Simulated Use | Endoscope Detachment Force | Meets Design Requirements | Pass |
| Transparent Housing Verification | Meets Design Requirements | Pass | |
| Clip and Snare Deployment | Meets Design Requirements | Pass | |
| Over the Scope Attachment Verification | Meets Design Requirements | Pass | |
| Safety Cap Verification | Meets Design Requirements | Pass | |
| Handle Stay Visual Verification | Meets Design Requirements | Pass | |
| Safety Cap Visual Verification | Meets Design Requirements | Pass | |
| Snare Proximal to Clip Visual Verification | Meets Design Requirements | Pass | |
| Packaging Requirements | Peel Seal Strength Verification | Meets Design Requirements | Pass |
| Clip Deployment Force | Meets Design Requirements | Pass | |
| MAX Handle Snare Retraction Force | Meets Design Requirements | Pass | |
| Snare Continuity Test | Meets Design Requirements | Pass | |
| Pusher Compression Force | Meets Design Requirements | Pass | |
| Spool Compression Force | Meets Design Requirements | Pass | |
| Clip Pusher OD Measurement | Meets Design Requirements | Pass | |
| Device Working Length Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Depth Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Distal ID Measurement | Meets Design Requirements | Pass | |
| Component Force and Functional Requirements | Active Cord Detachment Force | Meets Design Requirements | Pass |
| Catheter (110302) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110052) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110303) to Pusher Force | Meets Design Requirements | Pass | |
| Drive Cable to Snare Loop Force | Meets Design Requirements | Pass | |
| Tissue Retention Force | Meets Design Requirements | Pass | |
| Clip Closure Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110302) Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110052) Force | Meets Design Requirements | Pass | |
| Drive Cable to Connector Force | Meets Design Requirements | Pass | |
| Scope Attachment to Housing Force | Meets Design Requirements | Pass | |
| Legibility of Markings | Meets Design Requirements | Pass | |
| Validation Testing | Clip Deployment and Snare Resection Validation | Meets Design Requirements | Pass |
| Straight and Articulated Endoscope Position Use Validation | Meets Design Requirements | Pass | |
| Visualization in the Lower GI Tract Validation | Meets Design Requirements | Pass | |
| Endoscope Compatibility Validation | Meets Design Requirements | Pass | |
| Safety Feature for Deployment of Clip Validation | Meets Design Requirements | Pass | |
| Animal Test - Design Validation | The PADLOCK CLIP™ EFTR Device Clip must facilitate healing after the removal of lesions up to 3cm in the GI tract | Meets Design Requirements | Pass |
| Additional Testing | MRI Testing | Meets the Requirements of ASTM F2052-21, ASTM F2182-19, ASTM F2119-2013 (17) | Pass |
| Electrical testing | Meets the Requirements of IEC 60601-1:2005 Ed.3 + A1; A2, IEC 60601-2-2:2017 Ed.6 and, IEC 60601-2-18:2009 Ed.3 | Pass | |
| Biocompatibility | Meets the requirements of ISO 10993-5:2009 Ed.3, 10993-12:2021 Ed.5, 10993-11:2017 Ed.3 & 10993-23:2021 Ed.1, 10993-1:2018, 10993-6 Ed. 3, 10993-18:2020 | Pass | |
| Human Factors | Meet Predetermined Critical Tasks | Pass | |
| EMC Testing | Meets the Requirements of 60601-1-2:2014+A1:2020 and 60601-4-2:2016; Meets the Requirements of EMC clauses 201.17/202 of ANSI AAMI IEC 60601-2-2:2017; Meets the Requirements of EMC clauses of 201.17/202 of IEC 60601-2-18 Ed. 3 2009-08 | Pass |
2. Sample Size Used for the Test Set and the Data Provenance:
The document summarizes the types of tests performed (Simulated Use, Packaging Requirements, Component Force and Functional Requirements, Validation Testing, Animal Test - Design Validation, MRI Testing, Electrical Testing, Biocompatibility, Human Factors, EMC Testing) and their outcomes ("Pass"). However, it does not provide details on the specific sample sizes used for each test set within these categories.
Similarly, the document does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the tests. The acceptance criteria are generally phrased as "Meets Design Requirements" or conformity to international standards, implying compliance with engineering specifications and regulatory benchmarks rather than a human-expert-derived ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method like 2+1 or 3+1. The tests listed are primarily performance-based and compliance-based, with results indicated as "Pass," suggesting a direct comparison to pre-defined specifications rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The PADLOCK CLIP EFTR Kit is a mechanical and electrosurgical device, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
This question is not applicable as the PADLOCK CLIP EFTR Kit is a physical medical device, not an algorithm or software requiring standalone performance testing in the typical sense of AI/software. Its performance is evaluated through a series of engineering, functional, and biological tests.
7. The Type of Ground Truth Used:
The ground truth for most of the tests appears to be engineering design requirements, predefined specifications, and compliance with established international standards (e.g., ASTM, IEC, ISO). For the animal study, the "ground truth" for success was the device's ability to "facilitate healing after the removal of lesions up to 3cm in the GI tract," which would be assessed by veterinary or pathology evaluation of the animal tissue post-procedure.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI models. Since the PADLOCK CLIP EFTR Kit is a physical medical device, there is no mention of a training set in this context. The non-clinical tests are verification and validation efforts, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
Again, as there is no "training set" in the context of this device, this question is not applicable. The ground truth for the device's performance is established through adherence to design specifications and regulatory standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
September 17, 2024
STERIS Corporation Jackie Oliver Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K240274
Trade/Device Name: PADLOCK CLIP EFTR Kit (00713229) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL, FDI, KNS, OCZ Dated: August 16, 2024 Received: August 16, 2024
Dear Jackie Oliver:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
PADLOCK CLIP EFTR Kit (00713229)
Indications for Use (Describe)
The PADLOCK CLIP™ EFTR Device is a device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.
The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.
The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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K240274 Page 1 of 7
Image /page/4/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is in a bold, sans-serif font, with the registered trademark symbol to the right. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.
510(k) Summary For the PADLOCK CLIP EFTR Kit
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Jackie Oliver Senior Regulatory Affairs Specialist
| Telephone: | (440) 358-6289 |
|---|---|
| Fax: | (440) 358-6259 |
| e-mail: | Jackie_Oliver@steris.com |
August 16, 2024 Summary Date:
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1. Device Identification
| Trade Name: | PADLOCK CLIP EFTR Kit (00713229) |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Endoscopic Full-Thickness Resection Device |
| Regulation Name: | Hemorrhoidal Ligator |
| Regulation Number: | 21 CFR 876.4400 |
| Product Code: | PKL |
| Associated Product Codes: | FDI, KNS, and OCZ |
2. Predicate Device
K170867 FTRD System
| FTRD System K170867 | PADLOCK CLIP EFTR Device | Comparison | |
|---|---|---|---|
| Features | (Predicate Device) | (Proposed Device) | |
| Intended Use | Instrument designed for flexibleendoscopy. Instrument isdesigned for diagnostic tissueacquisition and full-thicknessresection through the removal ofsuitable lesions in the colon andrectum.The FTRD System is indicatedfor the resection of lesions< 3 cm in the colon and rectum.Resection sizes may be less than3 cm due to targeted tissuethickness and degree of fibrosis. | The PADLOCK CLIP EFTRDevice is an electrosurgicaldevice that is designed forflexible endoscopy. It isintended for diagnostic tissueacquisition and full-thicknessresection through the removalof lesions in the colon andrectum.The PADLOCK CLIP EFTRDevice is indicated for theresection of lesions less than 3cm in the colon and rectum.Resection sizes may be lessthan 3 cm due to targetedtissue thickness and degree offibrosis. | Identical |
| Features | FTRD System K170867(Predicate Device) | PADLOCK CLIP EFTRDevice (Proposed Device) | Comparison |
| Construction | A -Molded Handle(components consisting of:)1. Thumb Ring2. Handle Shaft3. Sliding HandleB -ConnectorC -Safety lockD -Endoscope sleeve &Linking wireE -Hand WheelF -System/Applicator CapG -ClipH -SnareI -ThreadN/A-Thread Retriever | A -Molded handle(components consisting of:)1. Thumb ring2. Handle shaft3. SpoolB -ConnectorC-Handle stayD-Linking wiresE -Clip actuatorF -Clip housing assemblyG -ClipH -SnareI -Drive CableN/A -Safety cap | Similar:Though the parts of these 2devices have differentnaming conventions they arevery similar devices, anydifferences not mentionedhere from the table to the leftare purely differences innaming convention. This hasno impact on safety,effectiveness or how thedevice is used.The proposed device uses 3Linking wires and thepredicate device uses oneLinking wire and anendoscope sleeve. Thesecomponents perform thesame function of connectingthe handle of the device tothe distal cap. There is noimpact on safety,effectiveness, or how thedevice is used.The proposed device usesstainless steel drive cablesand the predicate device usesthread.; to actuate the clip.There is no impact on safety,effectiveness, or how thedevice is used because bothcomponents perform thesame function.The proposed device doesnot require a thread retrieverbecause threads are not usedto deploy the device There isno impact to the safety andeffectiveness of the proposeddevice.The proposed device has asafety cap that protects theuser from inadvertentdeployment and injury. The |
| predicate device does nothave this safety feature. | |||
| Sterile/ Non-sterile | Sterile | Sterile | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| SterilizationAssuranceLevel | Not disclosed | 10-6 | Subject device conformswith EO sterilizationrequirements of ISO 11135 |
| Usage | Single-Use | Single-Use | Identical |
| Materials (bycomponent) | -Clip - Super Elastic Nitinol-Snare - Stainless Steel | -Molded handle (componentsconsisting of:)Thumb ring - ABS & ColorantHandle shaft- ABS & ColorantSpool – ABS & Colorant-Connector - ABS & Colorant,Stainless steel-Handle stay - ABS &Colorant-Linking wires - HDPE, PTFE& Stainless steel-Clip actuator - Stainless steel& PTFE Sandvik Glidefilmcoating-Clip housing assembly -Polycarbonate & TPE -Clip -Super Elastic Nitinol-Snare - Stainless Steel-Safety cap - ABS & Colorant | SimilarBoth devices have a nitinolclip, and both devices havestainless steel snares.The materials for othercomponents of the predicatedevice have not beendisclosed. |
| TargetPopulation | Patients who require fullthickness resection of lesionsin the rectum and colon. | Adult patients requiringdiagnostic tissue acquisitionand full-thickness resectionthrough the removal of lesionsin the colon and rectum. | Identical |
| EnergyUsed/Delivered | Monopolar High Frequency | Monopolar High Frequency | Identical |
| Device Specs: | Overall Length: 220cmCap outer diameter: 20mmCap inner diameter: 13mmCap depth: 23mm | Overall Length: 230cmCap outer diameter: 21mmCap inner diameter: 13.3mmCap depth: 23mm | Similar:The differences in size arenegligible |
| CompatibleEndoscopes | Suitable for endoscopes with adiameter of 11.5 - 13.2 mm | Suitable for endoscopes with adistal tip O.D. of 10.9mm -12.5mm, | Similar:The size of the compatiblescopes does not affect thesafety and effectiveness ofthe device as it performs itsintended use. |
| MRI safetystatus | MR Conditional | MR Conditional | Identical |
| Number ofDevices/Box | 1 | 1 | Identical |
Table 1. Device Comparison Table for proposed and Predicate devices
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Page 3 of 7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION PADLOCK CLIP EFTR Kit
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K240274 Page 4 of 7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION PADLOCK CLIP EFTR Kit
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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The proposed devices have the same intended use as the predicate with the same technological characteristics. Based on the testing in this submission, the minor physical differences do not impact safety, effectiveness, or how the devices are used.
3. Description of Device
The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.
The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesson's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit. These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.
The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.
4. Indications for Use
The PADLOCK CLIP™ EFTR Device is a device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.
The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis. The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
న్. Summary of Verification Testing
The proposed and predicate devices have the same intended use and similar technological characteristics. The minor design differences do not raise different questions of safety and effectiveness as compared to the predicate device. Non-clinical testing consisted of the following:
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION PADLOCK CLIP EFTR Kit
| Category | Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Simulated Use | Endoscope Detachment Force | Meets Design Requirements | Pass |
| Transparent Housing Verification | Meets Design Requirements | Pass | |
| Clip and Snare Deployment | Meets Design Requirements | Pass | |
| Over the Scope Attachment Verification | Meets Design Requirements | Pass | |
| Safety Cap Verification | Meets Design Requirements | Pass | |
| Handle Stay Visual Verification | Meets Design Requirements | Pass | |
| Safety Cap Visual Verification | Meets Design Requirements | Pass | |
| Snare Proximal to Clip Visual Verification | Meets Design Requirements | Pass | |
| PackagingRequirements | Peel Seal Strength Verification | Meets Design Requirements | Pass |
| Clip Deployment Force | Meets Design Requirements | Pass | |
| MAX Handle Snare Retraction Force | Meets Design Requirements | Pass | |
| Snare Continuity Test | Meets Design Requirements | Pass | |
| Pusher Compression Force | Meets Design Requirements | Pass | |
| Spool Compression Force | Meets Design Requirements | Pass | |
| Clip Pusher OD Measurement | Meets Design Requirements | Pass | |
| Device Working Length Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Depth Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Distal ID Measurement | Meets Design Requirements | Pass | |
| ComponentForce andFunctionalRequirements | Active Cord Detachment Force | Meets Design Requirements | Pass |
| Catheter (110302) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110052) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110303) to Pusher Force | Meets Design Requirements | Pass | |
| Drive Cable to Snare Loop Force | Meets Design Requirements | Pass | |
| Tissue Retention Force | Meets Design Requirements | Pass | |
| Clip Closure Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110302) Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110052) Force | Meets Design Requirements | Pass | |
| Drive Cable to Connector Force | Meets Design Requirements | Pass | |
| Scope Attachment to Housing Force | Meets Design Requirements | Pass | |
| Legibility of Markings | Meets Design Requirements | Pass |
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6. Summary of Validation Testing
| Category | Testing | Acceptance Criteria | Result |
|---|---|---|---|
| ValidationTesting | Clip Deployment and Snare Resection Validation | Meets Design Requirements | Pass |
| Straight and Articulated Endoscope Position UseValidation | Meets Design Requirements | Pass | |
| Visualization in the Lower GI Tract Validation | Meets Design Requirements | Pass | |
| Endoscope Compatibility Validation | Meets Design Requirements | Pass | |
| Safety Feature for Deployment of Clip Validation | Meets Design Requirements | Pass |
7. Summary of Animal Test - Design Validation
| Testing | Acceptance Criteria | Result |
|---|---|---|
| The PADLOCK CLIP™ EFTR Device Clip must facilitate healingafter the removal of lesions up to 3cm in the GI tract | Meets Design Requirements | Pass |
8. Summary of additional testing
| Testing | Acceptance Criteria | Result |
|---|---|---|
| MRI Testing | Meets the Requirements of ASTM F2052-21, ASTM F2182-19, ASTM F2119-2013(17) | Pass |
| Electrical testing | Meets the Requirements of IEC 60601-1:2005 Ed.3 + A1; A2, IEC 60601-2-2:2017Ed.6 and, IEC 60601-2-18:2009 Ed.3 | Pass |
| Biocompatibility | Meets the requirements of ISO 10993-5:2009 Ed.3, 10993-12:2021 Ed.5, 10993-11:2017 Ed.3 & 10993-23:2021 Ed.1, 10993-1:2018, 10993-6 Ed. 3, 10993-18:2020 | Pass |
| Human Factors | Meet Predetermined Critical Tasks | Pass |
| EMC Testing | Meets the Requirements of 60601-1-2:2014+A1:2020 and 60601-4-2:2016Meets the Requirements of EMC clauses 201.17/202 of ANSI AAMI IEC 60601-2-2:2017Meets the Requirements of EMC clauses of 201.17/202 of IEC 60601-2-18 Ed. 32009-08 | Pass |
9. Conclusion
Based on the intended uses, technological characteristics, non-clinical performance data, and additional testing, the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device K170867, Class II (21 CFR 876.4400), product code PKL and associated codes FDI, KNS, and OCZ.
§ 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.