What is the FDA product code for Padlock Clip defect closure system, Padlock Pro-Select defect closure device?

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 defect closure system, Padlock Pro-Select defect closure device?

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

Who can help prepare an FDA 510(k) submission like Padlock Clip defect closure system, Padlock Pro-Select defect closure device?

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 defect closure system, Padlock Pro-Select defect closure device

Q: Who is the manufacturer of Padlock Clip defect closure system, Padlock Pro-Select defect closure device?

STERIS Corporation filed the 510(k) submission for Padlock Clip defect closure system, Padlock Pro-Select defect closure device (K192722).

K192722 · STERIS Corporation · PKL · Oct 24, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K192722
Device Name	Padlock Clip defect closure system, Padlock Pro-Select defect closure device
Applicant	STERIS Corporation
Product Code	PKL · Gastroenterology, Urology
Decision Date	Oct 24, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: Endoscopic marking of lesions Hemostasis for: Mucosal/Submucosal defects Bleeding Ulcers Arteries <2mm Polyps <1.5cm in diameter Diverticula in the Colon Closure of GI tract luminal perforations <20mm that can be treated conservatively

Device Story

The Padlock Clip is a single-use, radiopaque, coin-sized ligation clip composed of superelastic shape memory alloy (Nitinol). It is mounted on the distal tip of a flexible endoscope via a delivery system featuring a central 'tissue chamber'. The device is operated by a physician during endoscopic procedures; an independent hand control deploys the clip. Tissue is pulled into the chamber to facilitate approximation of larger volumes than standard clips. The device is compatible with endoscopes having distal tip diameters of 9.5mm to 14mm. It provides mechanical tissue compression to achieve hemostasis or close perforations, aiding in lesion management and potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. Verification activities included biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, intramuscular implantation, genotoxicity, pyrogenicity) per ISO 10993 standards and corrosion susceptibility testing per ASTM F2129. Functional testing confirmed the device successfully deploys and secures defects.

Technological Characteristics

Materials: Nitinol (superelastic shape memory alloy), Polypropylene housing, Type 304/302/303/18-2 stainless steel, black fluorocarbon securing strap. Dimensions: Compatible with 9.5mm-14mm endoscope distal tips; clip opening 6-24mm. Principle: Mechanical tissue compression via shape memory alloy clip. Connectivity: None. Sterilization: Not specified. Standards: ISO 10993 (biocompatibility), ASTM F2129 (corrosion).

Indications for Use

Indicated for patients requiring endoscopic tissue compression in the GI tract for hemostasis (mucosal/submucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), lesion marking, or closure of GI luminal perforations <20mm treatable conservatively.

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

Padlock Clip defect closure device and Padlock Clip Pro-Select defect closure device (K180689)

Reference Devices

K120814

Related Devices

K120814 — PADLOCK CLIP-12 · Aponos Medical Corp. · Sep 6, 2012
K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device · STERIS Corporation · Apr 12, 2018
K201771 — Single Use Rotatable and Repositionable Hemoclip · Anrei Medical (Hangzhou) Co., Ltd. · Oct 19, 2020
K221124 — MANTIS Clip · Boston Scientific Corporation · Aug 4, 2022
K213338 — CORE-CLIP · Incore Co., Ltd. · Jun 23, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below. October 24, 2019 STERIS Corporation Tony Piotrkowski Regulatory Affairs Director 5960 Heisley Road Mentor, OH 44060 Re: K192722 > Trade/Device Name: Padlock Clip Pro-Select™ defect closure system, Padlock Pro-Select™ defect closure device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 26, 2019 Received: September 27, 2019 Dear Tony Piotrkowski: 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. 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 located 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/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. For Martha W. Betz, Ph.D. Acting 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 {2}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) K192722 ### Device Name Padlock Clip defect closure system Padlock Clip Pro-Select defect closure system ### Indications for Use (Describe) The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the gastrointestinal organs. The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - · Endoscopic marking of lesions - · Hemostasis for: - o Mucosal/Submucosal defects - o Bleeding Ulcers - o Arteries <2mm - o Polyps <1.5cm in diameter - o Diverticula in the Colon · Closure of GI tract luminal perforations <20mm that can be treated conservatively | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word STERIS in large, bold letters, with the registered trademark symbol next to it. Below the word STERIS is a graphic of several horizontal wavy lines stacked on top of each other. At the top of the image are the words "K192722" and "Page 1 of 5". # 510(k) Summary For Padlock Clip Pro-Select™ defect closure system and Padlock Clip™ defect closure system STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Contact: Anthony Piotrkowski Regulatory Affairs Director Tel: 440-392-7458 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com Summary Date: September 26, 2019 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ ## STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure systems #### 1. Device Name | Trade Name: | Padlock Clip defect closure system and Padlock Clip Pro-Select defect closure system | |------------------------|-----------------------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | Ligator clip | | Classification Name: | Hemorrhoidal ligator | | Classification Number: | 21 CFR 876.4400 | | Product Code: | PKL | #### 2. Predicate Device | K180689 | Padlock Clip defect closure device and Padlock Clip Pro-Select defect closure device | |---------|--------------------------------------------------------------------------------------| |---------|--------------------------------------------------------------------------------------| Originally cleared as: #### 3. Description of Device The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy for tissue approximation with opening sizes of 6 to 24mm on a flexible delivery system. #### 4. Intended Use The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - · Endoscopic marking of lesions - · Hemostasis for: - o Mucosal/Submucosal defects - o Bleeding Ulcers - o Arteries <2mm - o Polyps <1.5cm in diameter - o Diverticula in the Colon - · Closure of GI tract luminal perforations <20mm that can be treated conservatively {5}------------------------------------------------ #### 5. Description of Technological Similarities and Differences The Padlock Clip™ is identical to the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for the clip component of the device. It is the same raw material from the same source with only the supplier of the final, processed component changing and this proposed change raises no new concerns of safety and effectiveness when compared to the predicate device as evidenced through the testing summarized in this submission. ## Device Comparison Table | | Proposed Padlock Clip | K180689 Padlock Clip | Comparison | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Feature | | | | | Indications for Use | The Padlock ClipTM is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock ClipTM is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: Endoscopic marking of lesions Hemostasis for: Mucosal/Submucosal defects Bleeding Ulcers Arteries <2mm Polys <1.5cm in diameter Diverticula in the Colon Closure of GI tract luminal perforations <20mm that can be treated conservatively | The Padlock ClipTM is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock ClipTM is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: Endoscopic marking of lesions Hemostasis for: Mucosal/Submucosal defects Bleeding Ulcers Arteries <2mm Polys <1.5cm in diameter Diverticula in the Colon Closure of GI tract luminal perforations <20mm that can be treated conservatively | Identical | | Feature | Proposed Padlock Clip | K180689 Padlock Clip | Comparison | | Operating Principles/ Technology | The Padlock Clip™ defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock Clip™ is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock Clip™ delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope. Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock Clip™ delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm. | The Padlock Clip™ defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock Clip™ is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock Clip™ delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope. Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock Clip™ delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm. | Identical | | Clip | Radiopaque, single use, coin sized clip made of superelastic shape memory alloy (Nitinol®) | Radiopaque, single use, coin sized clip made of superelastic shape memory alloy (Nitinol®) | Identical - new source for processing to its final form | | Housing | Polypropylene | Polypropylene | Identical | | Stainless Steel | Type 304 Type 302 Type 303 Type 18-2 | Type 304 Type 302 Type 303 Type 18-2 | Identical | | Securing strap | Black fluorocarbon | Black fluorocarbon | Identical | ### Table 5-1. Padlock Device Comparison Table {6}------------------------------------------------ ## STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure systems Table 5-2 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the Padlock Clip defect closure system. All testing to {7}------------------------------------------------ ## STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure systems support this change was done following well established methods such as recognized consensus (i.e. ISO 10993 parts 3, 5, 6 10 and 11, ASTM F2129) standards, FDA guidance or using the same test methodology used to verify the predicate device design as noted in K180689 or K120814. | Test | Acceptance Criteria | Result | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------| | Cytotoxicity | Per ISO 10993-5 | Pass | | Sensitization | Per ISO 10993-10 | Pass | | Irritation | Per ISO 10993-10 | Pass | | 28-Day Systemic Toxicity | Per ISO 10993-11 | Pass | | 13-Week Intramuscular Implantation | Per ISO 10993-6 | Pass | | 1-Week Intramuscular Implantation | Per ISO 10993-6 | Pass | | Genotoxicity -Ames Assay and Mouse Lymphoma | Per ISO 10993-3 | Pass | | Pyrogenicity | Per ISO 10993-11 | Pass | | Corrosion Susceptibility per ASTM F2129 and Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol Draft Guidance for Industry and Food and Drug Administration Staff, April 19, 2019. | The breakdown potential of the test clip must be greater than or equal to the predicate clip | Pass | | Functional Testing | Deploys Secures defect | Pass | | | | | Table 5-2. Summary of verification activities. | | |--|--|--|------------------------------------------------|--| |--|--|--|------------------------------------------------|--| #### 6. Conclusion Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K180689), Class II (21 CFR 876.4400), product code PKL.