Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

K183590 · Olympus Medical Systems Corp. · PKL · Aug 1, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183590
• Device Name: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
• Applicant: Olympus Medical Systems Corp.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Aug 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries < 2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

Device Story

Device consists of reloadable clip applicator and clips used with endoscope; operated by physician in hospital/healthcare facility. Operator uses slider on applicator to open clip; pulling slider completely deploys clip and detaches it from applicator. Clip remains in tissue until natural excretion. Used for marking, hemostasis, and closure of GI perforations. Benefits include effective endoscopic tissue management and closure without surgery.

Clinical Evidence

No clinical study was performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), sterilization/shelf-life (ASTM F1980-16), and mechanical performance testing (insertability, rotatability, retention, MRI conditional status).

Technological Characteristics

Materials: Stainless steel, PTFE, silver solder (HX-810); Stainless steel, polyphthalamide, liquid crystal polymer (HX-610). Mechanical actuation via slider. Sterilization: EOG (HX-810) and Gamma radiation (HX-610). MRI conditional. Reloadable design.

Indications for Use

Indicated for adult patients for endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), and supplementary 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

• Resolution Clip (K142973)

Reference Devices

• Endoscopic Clipping Device HX-5LR-1, HX-6UR-1, Standard Clip HX-600-090/135, Long Clip HX-600-090L, Short Clip HX-600-090S/135S (K013066)
• HX-Y0003-L, HX-Y0003-U (K123601)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 1, 2019

Olympus Medical Systems Corp. Sheri L. Musgnung Manager, Regulatory Affairs Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K183590

> Trade/Device Name: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: July 2, 2019 Received: July 5, 2019

Dear Sheri Musgnung:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Martha W. Betz, Ph.D. Acting Assistant Division 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

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## Indications for Use

510(k) Number (if known)

K183590

Device Name

Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

Indications for Use (Describe)

The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects < 3 cm,

(b) Bleeding ulcers,

(c) Arteries < 2 mm,

(d) Polyps < 1.5 cm in diameter.

(e) Diverticula in the colon,

(3) As a supplementary method, closure of GI tract luminal perforations < 20 mm 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)

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Date Prepared: July 30, 2019

K183590 Page 1 of 7

# Section 5

## 510(k) Summary

#### 5.1 GENERAL INFORMATION

- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri L. Musgnung Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] Fax: [phone] Email: [e-mail]

#### 5.2 DEVICE IDENTIFICATION

| ■ Device Name | ■ Model Name |
|---------------------------------------|--------------------------|
| Single Use Reloadable Clip Applicator | HX-810LR, HX-810UR |
| Clip | HX-610-090, HX-610-135 |
| Long Clip | HX-610-090L, HX-610-135L |
| Short Clip | HX-610-090S, HX-610-135S |
| Super Short Clip | HX-610-135XS |

(Hereinafter, described collectively as "Single Use Reloadable Clip Applicators and Clips")

- Endoscopic Clipping Device ■ Common Name
- 21CFR 876.4400 ■ Regulation Number
- Regulation Name Hemorrhoidal ligator
- Regulatory Class II
- Product Code PKL
- Classification Panel Gastroenterology/Urology

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#### 5.3 PREDICATE DEVICE AND REFERENCE DEVICE

#### ■ Predicate device

| Device name | Applicant | 510(k) No. |
|-----------------|-------------------------------|------------|
| Resolution Clip | Boston Scientific Corporation | K142973 |

#### ■ Reference device

| Device name | Applicant | 510(k) No. |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------|
| Endoscopic Clipping Device<br>HX-5LR-1, HX-6UR-1<br>Standard Clip HX-600-090/135,<br>Long Clip HX-600-090L,<br>Short Clip HX-600-090S/135S | Olympus Optical Co., Ltd | K013066 |
| HX-Y0003-L, HX-Y0003-U | Olympus Medical Systems<br>Corp. | K123601 |

#### 5.4 DEVICE DESCRIPTION

#### ■ General Description of the subject device

The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of

(1) Endoscopic marking,

- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects < 3 cm,
- (b) Bleeding ulcers,
- (c) Arteries < 2 mm,
- (d) Polyps < 1.5 cm in diameter,
- (e) Diverticula in the colon,
- (3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

#### Principle of Operation

The subject devices are composed of the applicator and clip. The devices are used in a combined state. The clip that is attached to the applicator is controlled by the operator using the slider.

The clip opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the portion of the clip connector is broken. Upon completion,

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the clip and the applicator are no longer connected.

Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.

### 5.5 INDICATIONS FOR USE

The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of

- (1) Endoscopic marking,
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects < 3 cm,
- (b) Bleeding ulcers,
- (c) Arteries < 2 mm,
- (d) Polyps < 1.5 cm in diameter,
- (e) Diverticula in the colon,
- (3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

## 5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The Single Use Reloadable Clip Applicators and Clips have the same intended use and similar technological characteristics and design as the predicate device except for the following main differences:

(1) Dimension and material of delivery system (clip applicator) and clip

(2) Clip reloadability

(3) Sterilization method of clip

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

A side-by-side comparison of the subject devices and the predicate device is provided below.

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| | Subject Device (SD) | Predicate Device (PD) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | HX-810, HX-610 | Resolution Clip (K142973) |
| Indications<br>for Use | The Single Use Reloadable Clip<br>Applicators and Clips have been<br>designed to be used with an<br>Olympus endoscope for<br>endoscopic Clip placement within<br>the gastrointestinal (GI) tract in<br>adult patients only for the purpose<br>of.<br>(1) Endoscopic marking,<br>(2) Hemostasis for<br>(a) Mucosal/sub-mucosal<br>defects < 3 cm,<br>(b) Bleeding ulcers,<br>(c) Arteries < 2 mm,<br>(d) Polyps < 1.5 cm in diameter,<br>(e) Diverticula in the colon,<br>(3) As a supplementary method,<br>closure of GI tract luminal<br>perforations < 20 mm that can be<br>treated conservatively. | The Resolution™ Hemostasis<br>Clipping Device is indicated for<br>clip placement within the<br>gastrointestinal (GI) tract for the<br>purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for:<br>Mucosal/sub-mucosal defects<br>< 3 cm<br>Bleeding ulcers<br>Arteries < 2 mm<br>Polyps < 1.5 cm in diameter<br>Diverticula in the colon<br>Prophylactic clipping to<br>reduce the risk of delayed<br>bleeding post lesion resection<br>3. Anchoring to affix jejunal<br>feeding tubes to the wall of the<br>small bowel; and Anchoring to<br>affix fully covered esophageal<br>selfexpanding metal stents to the<br>wall of the esophagus<br>4. As a supplemental closure<br>method of luminal perforations <<br>20 mm that can be treated<br>conservatively. |
| Model name | HX-810LR, HX-810UR,<br>HX-610-090, HX-610-135<br>HX-610-090L, HX-610-135L,<br>HX-610-090S, HX-610-135S<br>HX-610-135XS | M00522600, M00522601,<br>M00522602, M00522610,<br>M00522611, M00522612 |
| Common<br>name | Endoscopic Clipping Device | Endoscopic Clipping Device |
| Regulation<br>Number | 21CFR 876.4400 | 21CFR 876.4400 |
| Regulation<br>Name | Hemorrhoidal ligator | Hemorrhoidal ligator |
| Regulatory<br>Class | II | II |
| Product Code | PKI | PKI |
| Item | Subject Device (SD)<br>HX-810, HX-610 | Predicate Device (PD)<br>Resolution Clip (K142973) |
| Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Sterilization | HX-810:EOG<br>(Marketed as a sterilized device)<br>HX-610:Gamma radiation<br>Marketed as a sterilized device | EOG |
| Reprocessing | Unknown | Unknown |
| Single-Use/<br>Reusable | HX-810: Single Use<br>(multiple clipping to one patient)<br>HX-610: Single Use | Single use |
| Reloadability | Yes | No |
| Material<br>composition<br>of patient-<br>contact parts | [HX-810]<br>Stainless steel<br>Polytetrafluoroethylene<br>Silver solder<br>[HX-610]<br>Stainless steel<br>Polyphthalamide<br>Liquid Crystal Polymer | Unknown |
| Duration and<br>type of<br>contact | [HX-810]<br>Surface-contacting device in<br>contact with mucosal membranes.<br>The contact duration is limited<br>exposure (<24 hours).<br>[HX-610]<br>Surface-contacting device in<br>contact with mucous membrane<br>and breached or compromised<br>surfaces.<br>The contact duration is prolonged<br>exposure (>24 hours to 30 days) | Unknown |

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K183590 Page 6 of 7

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Traditional 510(k) Notification Single Use Reloadable Clip Applicators / Clips HX-810 / HX-610

#### 5.7 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

- (1) Sterilization/Shelf life testing
Sterilization/shelf life testing for the Single Use Reloadable Clip Applicators and Clips were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the Single Use Reloadable Clip Applicators and Clips was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.

#### (2) Biocompatibility testing

Biocompatibility testing for the Single Use Reloadable Clip Applicators and Clips were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

#### [HX-810]

- Cytotoxicity Study Using the Colony Assay ।
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test ।
- । Systemic Toxicity Study in Mice
- Material-Mediated Pyrogenicity ।

#### [HX-610]

- । Cytotoxicity Study Using the Colony Assay
- Intracutaneous Study in Rabbits ı
- Guinea Pig Maximization Sensitization Test ।
- Systemic Toxicity Study in Mice ।
- Material-Mediated Pyrogenicity ।
- Bacterial Reverse mutation Test ।
- In Vitro Chromosomal Aberration Assay ।
- Muscle Implantation Test ।
- Subchronic Toxicity Test
- Chemical characterization

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K183590 Page 7 of 7

# OLYMP

Traditional 510(k) Notification Single Use Reloadable Clip Applicators / Clips HX-810 / HX-610

#### (3) Performance testing - Bench

Bench testing for the Single Use Reloadable Clip Applicators and Clips as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.

- Insertability
- Clip opening width
- Clip rotatability
- Clip capability
- Withdrawal from endoscope
- Applicator repetition
- Endoscope compatibility
- Clip tail length
- Retention capability
- MRI testing*
- Package integrity testing
- Mechanical testing

*MRI testing was conducted in accordance with various applicable ASTM standards, which demonstrated the device to be MRI conditional.

- (4) Performance testing Animal
No animal study was performed to demonstrate substantial equivalence.

- (5) Performance testing Clinical
No clinical study was performed to demonstrate substantial equivalence.

- (6) Risk analysis
Risk analysis for the Single Use Reloadable Clip Applicators and Clips was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

### 5.8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Single Use Reloadable Clip Applicators and Clips raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.