Who is the manufacturer of PADLOCK CLIP EFTR Kit (00713229)?

STERIS Corporation filed the 510(k) submission for PADLOCK CLIP EFTR Kit (00713229) (K240274).

What is the FDA product code for PADLOCK CLIP EFTR Kit (00713229)?

PKL. It is classified under 21 CFR 876.4400 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PADLOCK CLIP EFTR Kit (00713229)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PADLOCK CLIP EFTR Kit (00713229)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PADLOCK CLIP EFTR Kit (00713229)

K240274 · STERIS Corporation · PKL · Sep 17, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K240274
Device Name	PADLOCK CLIP EFTR Kit (00713229)
Applicant	STERIS Corporation
Product Code	PKL · Gastroenterology, Urology
Decision Date	Sep 17, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

The PADLOCK CLIP EFTR Kit is an electrosurgical, single-use system for endoscopic full-thickness resection. The device mounts over the distal tip of a flexible endoscope; it includes a tissue chamber, a radiopaque super-elastic Nitinol clip, and a stainless steel snare. The kit includes a TOUCHSOFT Coagulator for marking/ablating lesion perimeters and a RAPTOR Grasping Device for tissue retraction. During procedures, a physician uses the grasping device to pull the target lesion into the tissue chamber; the snare is then used for resection, and the clip is deployed to close the tissue. The device is used in clinical settings by trained physicians. The system provides a mechanical and electrosurgical solution for colorectal lesions not resectable by standard polypectomy, potentially benefiting patients by enabling full-thickness resection.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing (simulated use, mechanical force, packaging, and component testing), animal design validation (confirming clip facilitates healing after resection of lesions up to 3cm), and additional testing including MRI safety (ASTM F2052-21, F2182-19, F2119-2013), electrical safety (IEC 60601-1, 60601-2-2, 60601-2-18), biocompatibility (ISO 10993 series), and human factors validation.

Technological Characteristics

Materials: Nitinol (clip), stainless steel (snare, drive cables, connector), ABS (handle, spool, safety cap), HDPE/PTFE (linking wires), Polycarbonate/TPE (scope attachment). Energy: Monopolar high frequency. Form factor: 230cm length, 21mm outer diameter cap. Connectivity: Standalone. Sterilization: Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for adult patients requiring diagnostic tissue acquisition and full-thickness resection of lesions <3cm in the colon and rectum.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

FTRD System (K170867)

Related Devices

K250842 — PADLOCK CLIP EFTR Kit (00713229) · STERIS Corporation · Apr 18, 2025
K170867 — FTRD System Set · Ovesco Endoscopy AG · Jul 25, 2017
K131700 — SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES · Boston Scientific Corp · Nov 4, 2013
K221713 — Polypectomy Snare · Hangzhou AGS MedTech Co., Ltd. · Mar 3, 2023
K955650 — OLYMPUS SD SERIES SNARES · Olympus America, Inc. · Mar 29, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K240274 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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: {5}------------------------------------------------ ### 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 flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis. | The PADLOCK CLIP EFTR Device is an electrosurgical device that is designed for flexible endoscopy. 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 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis. | Identical | | Features | FTRD System K170867 (Predicate Device) | PADLOCK CLIP EFTR Device (Proposed Device) | Comparison | | Construction | A -Molded Handle (components consisting of:) 1. Thumb Ring 2. Handle Shaft 3. Sliding Handle B -Connector C -Safety lock D -Endoscope sleeve & Linking wire E -Hand Wheel F -System/Applicator Cap G -Clip H -Snare I -Thread N/A-Thread Retriever | A -Molded handle (components consisting of:) 1. Thumb ring 2. Handle shaft 3. Spool B -Connector C-Handle stay D-Linking wires E -Clip actuator F -Clip housing assembly G -Clip H -Snare I -Drive Cable N/A -Safety cap | Similar: Though the parts of these 2 devices have different naming conventions they are very similar devices, any differences not mentioned here from the table to the left are purely differences in naming convention. This has no impact on safety, effectiveness or how the device is used. The proposed device uses 3 Linking wires and the predicate device uses one Linking wire and an endoscope sleeve. These components perform the same function of connecting the handle of the device to the distal cap. There is no impact on safety, effectiveness, or how the device is used. The proposed device uses stainless steel drive cables and the predicate device uses thread.; to actuate the clip. There is no impact on safety, effectiveness, or how the device is used because both components perform the same function. The proposed device does not require a thread retriever because threads are not used to deploy the device There is no impact to the safety and effectiveness of the proposed device. The proposed device has a safety cap that protects the user from inadvertent deployment and injury. The | | | | | predicate device does not have this safety feature. | | Sterile/ Non- sterile | Sterile | Sterile | Identical | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Sterilization Assurance Level | Not disclosed | 10-6 | Subject device conforms with EO sterilization requirements of ISO 11135 | | Usage | Single-Use | Single-Use | Identical | | Materials (by component) | -Clip - Super Elastic Nitinol -Snare - Stainless Steel | -Molded handle (components consisting of:) Thumb ring - ABS & Colorant Handle shaft- ABS & Colorant Spool – ABS & Colorant -Connector - ABS & Colorant, Stainless steel -Handle stay - ABS & Colorant -Linking wires - HDPE, PTFE & Stainless steel -Clip actuator - Stainless steel & PTFE Sandvik Glidefilm coating -Clip housing assembly - Polycarbonate & TPE -Clip - Super Elastic Nitinol -Snare - Stainless Steel -Safety cap - ABS & Colorant | Similar Both devices have a nitinol clip, and both devices have stainless steel snares. The materials for other components of the predicate device have not been disclosed. | | Target Population | Patients who require full thickness resection of lesions in the rectum and colon. | Adult patients requiring diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum. | Identical | | Energy Used/Delivered | Monopolar High Frequency | Monopolar High Frequency | Identical | | Device Specs: | Overall Length: 220cm Cap outer diameter: 20mm Cap inner diameter: 13mm Cap depth: 23mm | Overall Length: 230cm Cap outer diameter: 21mm Cap inner diameter: 13.3mm Cap depth: 23mm | Similar: The differences in size are negligible | | Compatible Endoscopes | Suitable for endoscopes with a diameter of 11.5 - 13.2 mm | Suitable for endoscopes with a distal tip O.D. of 10.9mm - 12.5mm, | Similar: The size of the compatible scopes does not affect the safety and effectiveness of the device as it performs its intended use. | | MRI safety status | MR Conditional | MR Conditional | Identical | | Number of Devices/Box | 1 | 1 | Identical | ### Table 1. Device Comparison Table for proposed and Predicate devices {6}------------------------------------------------ K240274 ### Page 3 of 7 # STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION PADLOCK CLIP EFTR Kit {7}------------------------------------------------ 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 {8}------------------------------------------------ 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: {9}------------------------------------------------ ## 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 | | 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 | {10}------------------------------------------------ #### 6. Summary of Validation Testing | Category | Testing | Acceptance Criteria | Result | |-----------------------|---------------------------------------------------------------|---------------------------|--------| | 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 | #### 7. Summary of Animal Test - Design Validation | Testing | Acceptance Criteria | Result | |----------------------------------------------------------------------------------------------------------------------|---------------------------|--------| | 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 | #### 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 60601-2-2:2017 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 | #### 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.