(230 days)
Not Found
No
The summary describes a mechanical and electrosurgical device for tissue resection, with no mention of AI or ML capabilities in its function, intended use, or description.
Yes
The device is described as "an electrosurgical, single use tissue resection system" intended for "resection of lesions" and "monopolar therapeutic hemostasis and tissue ablation," which are therapeutic actions.
No
The device is primarily intended for therapeutic tissue resection and hemostasis, not solely for diagnosis. While it acquires tissue, this acquisition is for removal/resection rather than purely diagnostic purposes. The "Intended Use" section clearly states "therapeutic hemostasis and tissue ablation" and "full-thickness resection through the removal of lesions."
No
The device description clearly outlines multiple hardware components including a clip, snare, handle components, drive wires, catheter, and scope attachment assembly. It also describes the use of additional hardware devices (TOUCHSOFT Coagulator and RAPTOR Grasping Device) within the kit.
Based on the provided information, the PADLOCK CLIP™ EFTR Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- PADLOCK CLIP™ EFTR Device Function: The PADLOCK CLIP™ EFTR Device is used within the body (in vivo) during an endoscopic procedure. Its primary function is to physically acquire tissue and perform full-thickness resection of lesions in the colon and rectum. While the acquired tissue may be sent for subsequent in vitro diagnostic testing (like histology), the device itself is not performing the diagnostic test.
- Intended Use: The intended use clearly states "diagnostic tissue acquisition and full-thickness resection through the removal of lesions." This describes a surgical/interventional procedure, not an in vitro diagnostic test.
- Device Description: The description details a mechanical and electrosurgical system for tissue removal, not a system for analyzing biological specimens.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, such as reagents, assays, or analytical platforms typically associated with IVDs.
In summary, the PADLOCK CLIP™ EFTR Device is a surgical/interventional device used for tissue removal during an endoscopic procedure. It facilitates the acquisition of tissue that could be used for subsequent IVD testing, but the device itself is not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PKL, FDI, KNS, OCZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon and rectum
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
trained physician or clinician
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)
Non-clinical testing consisted of the following: Simulated Use (Endoscope Detachment Force, Transparent Housing Verification, Clip and Snare Deployment, Over the Scope Attachment Verification, Safety Cap Verification, Handle Stay Visual Verification, Safety Cap Visual Verification, Snare Proximal to Clip Visual Verification), Packaging Requirements (Peel Seal Strength Verification, Clip Deployment Force, MAX Handle Snare Retraction Force, Snare Continuity Test, Pusher Compression Force, Spool Compression Force, Clip Pusher OD Measurement, Device Working Length Measurement, Tissue Chamber Depth Measurement, Tissue Chamber Distal ID Measurement), Component Force and Functional Requirements (Active Cord Detachment Force, Catheter (110302) to Housing Force, Catheter (110052) to Housing Force, Catheter (110303) to Pusher Force, Drive Cable to Snare Loop Force, Tissue Retention Force, Clip Closure Force, Actuator to Catheter (110302) Force, Actuator to Catheter (110052) Force, Drive Cable to Connector Force, Scope Attachment to Housing Force, Legibility of Markings). All tests met design requirements and passed.
Validation Testing: Clip Deployment and Snare Resection Validation, Straight and Articulated Endoscope Position Use Validation, Visualization in the Lower GI Tract Validation, Endoscope Compatibility Validation, Safety Feature for Deployment of Clip Validation. All tests met design requirements and passed.
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. Met design requirements and passed.
Additional testing included: MRI Testing (Met the Requirements of ASTM F2052-21, ASTM F2182-19, ASTM F2119-2013 (17)), Electrical testing (Met 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), Biocompatibility (Met 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), Human Factors (Met Predetermined Critical Tasks), EMC Testing (Met the Requirements of 60601-1-2:2014+A1:2020 and 60601-4-2:2016, Met the Requirements of EMC clauses 201.17/202 of ANSI AAMI IEC 60601-2-2:2017, Met the Requirements of EMC clauses of 201.17/202 of IEC 60601-2-18 Ed. 3 2009-08). All passed.
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.
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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
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
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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
3
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 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 |