Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device

K180689 · STERIS Corporation · PKL · Apr 12, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180689
• Device Name: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
• Applicant: STERIS Corporation
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Apr 12, 2018
• 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 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

Device Story

Padlock Clip is a single-use, radiopaque ligation clip for tissue approximation in the GI tract. Device mounts on the distal tip of a flexible endoscope; features a central 'tissue chamber' to pull target tissue into position. Deployment occurs via an independent hand control with a linking cable routed outside the endoscopic accessory channel. Compatible with endoscopes having distal tip diameters of 9.5mm to 14mm. Used by physicians during endoscopic procedures to achieve hemostasis or close perforations. Benefits include effective tissue approximation and defect closure. Modification involves alternate suppliers for stainless steel, PTFE-coated stainless steel, and black fluorocarbon components.

Clinical Evidence

Bench testing only. Verification activities included biocompatibility testing (ISO 10993-5, -10, -11) and functional performance testing (deployment, defect securing, tensile/compressive strength). All tests met acceptance criteria.

Technological Characteristics

Clip: superelastic shape memory alloy (Nitinol). Housing: Polypropylene. Components: Type 304, 302, 303, and 18-2 stainless steel; black fluorocarbon. Delivery system: flexible, endoscope-mounted with external hand control. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients undergoing flexible endoscopy requiring tissue compression in the GI tract for hemostasis or lesion treatment. Specific applications include endoscopic marking, hemostasis for mucosal/submucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula, and closure of GI luminal perforations <20mm.

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

• Aponos Medical, Padlock Clip (K120814)

Submission Summary (Full Text)

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April 12, 2018

STERIS Corporation Tony Piotrkowski Senior Regulatory Affairs Manager 5976 Heisley Road Mentor. OH 44060

Re: K180689

> Trade/Device Name: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: March 14, 2018 Received: March 15, 2018

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. 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.

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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K180689

### Device Name

Padlock Clip defect closure device Padlock Clip Pro-Select defect closure device

### 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)

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# 510(k) Summary For Padlock Clip Pro-Select™ defect closure device and Padlock Clip™ defect closure device

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Anthony Piotrkowski Contact: Senior Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Summary Date: April 11, 2018

Premarket Notification Number: K180689

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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## K180689 STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure devices

#### 1. Device Name

| Trade Name: | Padlock Clip defect closure device<br>Padlock Clip Pro-Select defect closure device |
|------------------------|-------------------------------------------------------------------------------------|
| 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

K120814 Aponos Medical, Padlock Clip

#### 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

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#### 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 stainless steel, PTFE-coated stainless steel and black fluorocarbon components of the device and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

## Device Comparison Table

| Feature | Proposed<br>Padlock Clip | K120814<br>Aponos Padlock Clip | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Padlock Clip™ is<br>indicated for use in flexible<br>Endoscopy and for the<br>compression of tissue in the<br>gastrointestinal tract, for<br>hemostasis or for treating<br>lesions of the wall of the<br>gastrointestinal organs.<br><br>The Padlock Clip™ is<br>indicated for clip placement<br>within the gastrointestinal<br>(GI) tract for the purpose of:<br>Endoscopic marking of<br>lesions Hemostasis for: Mucosal/Submucosal<br>defects Bleeding Ulcers Arteries <2mm Polyps <1.5cm in<br>diameter Diverticula in the Colon Closure of GI tract<br>luminal perforations<br><20mm that can be<br>treated conservatively | The Aponos Medical<br>Padlock Clip™ is indicated<br>for use in flexible Endoscopy<br>and for the compression of<br>tissue in the gastrointestinal<br>tract, for hemostasis or for<br>treating lesions of the wall of<br>the gastrointestinal organs.<br><br>The Padlock Clip™ is<br>indicated for clip placement<br>within the gastrointestinal<br>(GI) tract for the purpose of:<br>Endoscopic marking of<br>lesions Hemostasis for: Mucosal/Submucosal<br>defects Bleeding Ulcers Arteries <2mm Polyps <1.5cm in<br>diameter Diverticula in the Colon Closure of GI tract<br>luminal perforations<br><20mm that can be<br>treated conservatively | Identical<br><br>Removed<br>Aponos<br>Medical<br>from the<br>Indications<br>since the<br>device was<br>purchased<br>by STERIS<br>Corporation |
| Feature | Proposed<br>Padlock Clip | K120814<br>Aponos Padlock Clip | Comparison |
| Operating<br>Principles/<br>Technology | The Padlock ClipTM defect<br>closure device is mounted and<br>secured at the distal tip on the<br>outside surface of a flexible<br>endoscope. The Padlock ClipTM<br>is deployed using an<br>independent hand control. The<br>linking cable to the hand control<br>is not located within the<br>endoscopic accessory channel.<br>The Padlock ClipTM delivery<br>system includes a central "tissue<br>chamber" that resides on the<br>distal tip of the endoscope.<br>Clinically efficacious tissue<br>manipulation techniques may be<br>used to pull target tissue into this<br>"tissue chamber" to approximate<br>a larger volume of tissue than<br>would otherwise be<br>approximated by deploying the<br>clip alone. The Padlock ClipTM<br>delivery system is compatible<br>with flexible endoscopes with<br>distal tip outer diameters ranging<br>from 9.5mm to 14mm. | The Padlock ClipTM defect<br>closure device is mounted and<br>secured at the distal tip on the<br>outside surface of a flexible<br>endoscope. The Padlock ClipTM<br>is deployed using an<br>independent hand control. The<br>linking cable to the hand control<br>is not located within the<br>endoscopic accessory channel.<br>The Padlock ClipTM delivery<br>system includes a central "tissue<br>chamber" that resides on the<br>distal tip of the endoscope.<br>Clinically efficacious tissue<br>manipulation techniques may be<br>used to pull target tissue into this<br>"tissue chamber" to approximate<br>a larger volume of tissue than<br>would otherwise be<br>approximated by deploying the<br>clip alone. The Padlock ClipTM<br>delivery system is compatible<br>with flexible endoscopes with<br>distal tip outer diameters ranging<br>from 9.5mm to 14mm. | Identical |
| Clip | Radiopaque, single use, coin<br>sized clip made of<br>superelastic shape memory<br>alloy (Nitinol®) | Radiopaque, single use, coin<br>sized clip made of<br>superelastic shape memory<br>alloy (Nitinol®) | Identical |
| Housing | Polypropylene | Polypropylene | Identical |
| Stainless<br>Steel | Type 304<br>Type 302<br>Type 303<br>Type 18-2 | Type 304<br>Type 302<br>Type 303<br>Type 18-2 | Same grade<br>of steel<br>different<br>supplier |
| Securing<br>strap | Black fluorocarbon | Black fluorocarbon | Same<br>material<br>different<br>supplier |
| Usage | Single Use | Single Use | Identical |
| Sterility | EO Sterilization | EO Sterilization | Identical |
| Shelf Life | 2 years | 2 years | Identical |

Table 5-1. Processor Device Comparison Table

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## K180689 STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure devices

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 device.

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## K180689 STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure devices

| Test | Acceptance Criteria | Result |
|--------------------------------|---------------------|--------|
| Cytotoxicity | Per ISO 10993-5 | Pass |
| Sensitization | Per ISO 10993-10 | Pass |
| Irritation | Per ISO 10993-10 | Pass |
| Acute Systemic Toxicity | Per ISO 10993-11 | Pass |
| Pyrogenicity | Per ISO 10993-11 | Pass |
| Functional Testing | Deploys | Pass |
| | Secures defect | Pass |
| Component Tensile Strength | Meets specification | Pass |
| Component Compressive Strength | Meets specification | 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 (K120814), Class II (21 CFR 876.4400), product code PKL.