(27 days)
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
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.
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 provided document is a 510(k) premarket notification for a medical device called the "Padlock Clip Pro-Select™ defect closure system". The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K180689), specifically due to the addition of an alternate supplier for a component.
Therefore, the study described mainly focuses on non-clinical testing to ensure that the change in supplier does not affect the safety or effectiveness of the device. There are no clinical studies involving human patients or AI algorithms in this document.
As such, I cannot provide information on many of the requested points, such as sample size for test sets (as it's not applicable in the context of clinical data), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for training sets.
However, I can extract information related to the acceptance criteria and the performance results from the non-clinical testing performed.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing, not a clinical study involving a test set of human data. Therefore, "sample size for the test set" as it pertains to patient data is not applicable. The tests are performed on the device itself and its components. The provenance of the data is from the manufacturer's (STERIS Corporation) testing, presumably in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a non-clinical device performance study, not a study relying on expert human interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no human adjudication of medical data involved in this non-clinical study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a medical device (a clip system), not an AI algorithm, and does not involve human readers interpreting medical images with or without AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device evaluation is based on established scientific and regulatory standards for medical device biocompatibility and functional performance. It relies on:
- ISO 10993 series standards (parts 3, 5, 6, 10, 11): These are international standards for the biological evaluation of medical devices.
- ASTM F2129: An ASTM standard related to corrosion susceptibility.
- FDA guidance documents: Specifically, "Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol Draft Guidance for Industry and Food and Drug Administration Staff, April 19, 2019."
- Predicate device methodology: Using the same test methodology as used for the predicate device (K180689 or K120814).
8. The sample size for the training set
Not applicable. This is not an AI algorithm development or clinical study with a training set.
9. How the ground truth for the training set was established
Not applicable.
{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 andPadlock 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
| ProposedPadlock Clip | K180689Padlock Clip | Comparison | |
|---|---|---|---|
| Feature | |||
| Indicationsfor Use | The Padlock ClipTM isindicated for use in flexibleEndoscopy and for thecompression of tissue in thegastrointestinal tract, forhemostasis or for treatinglesions of the wall of thegastrointestinal organs.The Padlock ClipTM isindicated for clip placementwithin the gastrointestinal(GI) tract for the purpose of:Endoscopic marking oflesions Hemostasis for:Mucosal/Submucosaldefects Bleeding Ulcers Arteries <2mm Polys <1.5cm indiameter Diverticula in the Colon Closure of GI tractluminal perforations<20mm that can betreated conservatively | The Padlock ClipTM isindicated for use in flexibleEndoscopy and for thecompression of tissue in thegastrointestinal tract, forhemostasis or for treatinglesions of the wall of thegastrointestinal organs.The Padlock ClipTM isindicated for clip placementwithin the gastrointestinal(GI) tract for the purpose of:Endoscopic marking oflesions Hemostasis for:Mucosal/Submucosaldefects Bleeding Ulcers Arteries <2mm Polys <1.5cm indiameter Diverticula in the Colon Closure of GI tractluminal perforations<20mm that can be treatedconservatively | Identical |
| Feature | ProposedPadlock Clip | K180689Padlock Clip | Comparison |
| OperatingPrinciples/Technology | The Padlock Clip™ defectclosure device is mounted andsecured at the distal tip on theoutside surface of a flexibleendoscope. The PadlockClip™ is deployed using anindependent hand control.The linking cable to the handcontrol is not located withinthe endoscopic accessorychannel. The Padlock Clip™delivery system includes acentral "tissue chamber" thatresides on the distal tip of theendoscope. Clinicallyefficacious tissuemanipulation techniques maybe used to pull target tissueinto this "tissue chamber" toapproximate a larger volumeof tissue than wouldotherwise be approximated bydeploying the clip alone. ThePadlock Clip™ deliverysystem is compatible withflexible endoscopes withdistal tip outer diametersranging from 9.5mm to14mm. | The Padlock Clip™ defectclosure device is mounted andsecured at the distal tip on theoutside surface of a flexibleendoscope. The PadlockClip™ is deployed using anindependent hand control.The linking cable to the handcontrol is not located withinthe endoscopic accessorychannel. The Padlock Clip™delivery system includes acentral "tissue chamber" thatresides on the distal tip of theendoscope. Clinicallyefficacious tissuemanipulation techniques maybe used to pull target tissueinto this "tissue chamber" toapproximate a larger volumeof tissue than wouldotherwise be approximated bydeploying the clip alone. ThePadlock Clip™ deliverysystem is compatible withflexible endoscopes withdistal tip outer diametersranging from 9.5mm to14mm. | Identical |
| Clip | Radiopaque, single use, coinsized clip made ofsuperelastic shape memoryalloy (Nitinol®) | Radiopaque, single use, coinsized clip made ofsuperelastic shape memoryalloy (Nitinol®) | Identical -new sourceforprocessingto its finalform |
| Housing | Polypropylene | Polypropylene | Identical |
| StainlessSteel | Type 304Type 302Type 303Type 18-2 | Type 304Type 302Type 303Type 18-2 | Identical |
| Securingstrap | 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 | AcceptanceCriteria | 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 andTechnical Considerations for Non-ClinicalAssessment of Medical Devices containing NitinolDraft Guidance for Industry and Food and DrugAdministration Staff, April 19, 2019. | The breakdownpotential of the testclip must be greaterthan or equal to thepredicate clip | Pass |
| Functional Testing | DeploysSecures 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.
§ 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.