OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET

K101428 · Ovesco Endoscopy AG · PKL · Dec 1, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101428
• Device Name: OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
• Applicant: Ovesco Endoscopy AG
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Dec 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: Endoscopic marking Hemostasis for: Mucosal/submucosal defects < 3 cm Bleeding ulcers Arteries < 2 mm Polyps < 1.5 cm in diameter Diverticula in the colon Closure of G1 tract luminal perforations < 20 mm that can be treated conservatively

Device Story

OTSC System Set is a single-use, pre-loaded mechanical clip and delivery system for endoscopic use. Operated by physicians during flexible endoscopy; device delivers a clip to target tissue in the GI tract. Principle of operation involves mechanical compression of tissue to achieve hemostasis, mark lesions, or close perforations. Output is the physical placement of the clip on the target site. Benefits include effective management of GI bleeding, tissue defects, and perforations. Device is passive; no electronic or software components.

Clinical Evidence

Bench testing only. Simulated deployment tests compared OTSC system to Resolution Hemostasis Clipping Device, showing identical deployment accuracy. Dislodgement force measurements confirmed OTSC clip performance is comparable to predicate.

Technological Characteristics

Single-use mechanical clip and delivery system. Materials include wrought nickel-titanium shape memory alloy (ASTM F2063). Passive device; no energy source. Sterilized via ethylene oxide. Complies with ISO 10993 (biocompatibility), ISO 11607 (packaging), and ASTM standards for MR safety (F2503, F2052, F2182, F2213, F2119).

Indications for Use

Indicated for patients requiring endoscopic tissue compression in the GI tract for hemostasis, lesion marking, or treatment of wall lesions. Specific applications include mucosal/submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm, colonic diverticula, and GI luminal perforations < 20 mm 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

• Speedband Multiple Ligator (K981669 and K020824)
• Resolution Hemostasis Clipping Device (K040148)
• InScope Multi-Clip Applier (K051950)

Submission Summary (Full Text)

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KC1428
Page 1 of 7

## SECTION VII.

.DEC 1 _ 2010

## 510(k) Summary of Safety and Effectiveness Information

- A. Submitter Information:

| Applicant: | OVESCO Endoscopy AG<br>Dorfackerstrasse 26<br>72074 Tuebingen-Germany |
|----------------------|-----------------------------------------------------------------------|
| Phone Number: | +49 7071 - 770 45 - 14 |
| Fax Number: | +49 7071 - 76 35 - 74 |
| Contact Person: | Prof. Dr. Marc O. Schurr,<br>Member of the Executive Board |
| Date of Preparation: | May 17. 2010 |

ப் Device Name:

| Trade Name | OTSC™ (Over-The-Scope-Clip) System Set |
|---------------------|----------------------------------------|
| | Dorfackerstrasse 26 |
| | 72074 Tuebingen-Germany |
| Common/Usual Name: | Ligator, Hemorrhoidal |
| Classification Name | Ligator, Hemorrhoidal |
| | 876.4400; 876.1500; 876.5130 |

- C. Predicate Devices:

| Trade Name | Speedband Multiple Ligator (K981669 and<br>K020824) |
|------------|-----------------------------------------------------|
| Trade Name | Resolution Hemostasis Clipping Device<br>(K040148) |
| Trade Name | InScope Multi-Clip Applier (K051950) |

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K101428
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### D. Device Description:

The OTSC System Set is a single-use, pre-loaded mechanical clip and delivery system used for endoscopic clipping.

#### ப் Intended Use:

The OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.

The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon
- Closure of G1 tract luminal perforations < 20 mm that can be treated conservatively

F. Technological Characteristics Summary:

The OTSC system set is substantially equivalent to the predicates, as they have similar technological characteristics. The results of performance testing show no new issues of safety or effectiveness.

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K101K28
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### G. Performance Testing

The Resolution Hemostasis Clipping Device (predicate device) and the OTSC system set were compared during a simulated deployment test to ensure that the device can be deployed endoscopically to the target tissue in the correct location. The test series resulted delivered identical results. Both devices can be accurately deployed to the target site.

The force required to dislodge the endoscopic clips from the tissue was measured and compared for the Resolution Hemostasis Clipping Device and the OTSC clip. The dislodgement force of the Resolution Hemostasis Clip and the OTSC clip were comparable and suitable for the intended use.

It can be concluded that the Resolution Hemostasis Clipping Device and the OTSC system set are substantial equivalent in overall performance.

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OTSC" Over-The-Scope-Clipping System Set
including the OTSC" Reloader Traditional Premarket Notification [510(k)] Ovesco Endoscopy AG

#### H. Performance Standards

.

The OTSC System Set meets the following Performance Standards:

| FDA<br>'Recognition<br>Number | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date |
|-------------------------------|------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|
| | | | BIOCOMPATIBILITY: | | |
| 2-98 | 10993-1 | ISO | Biological evaluation of medical devices -- Part 1: Evaluation<br>and testing within a risk management process | 2009 | 2009 |
| - | - | - | Required Biocompatibility Training and Toxicology Profiles for<br>Evaluation of Medical Devices, May 1, 1995 (FDA Blue Book<br>Memorandum #G95-1) | 1995 | May 1, 1995 |
| 2-117 | 10993-3 | ISO | Tests for genotoxicity, carcinogenicity and reproductive toxicity | 2003 | 2003 |
| 2-153 | 10993-5 | ISO | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity | 2009 | 2009 |
| 2-120 | 10993-6 | ISO | Biological evaluation of medical devices -- Part 6: Tests for local<br>effects after implantation | 2007 | 2007 |
| 14-76 | 10993-7 | ISO | Biological evaluation of medical devices -- Part 7: Ethylene<br>Oxide Sterilization Residuals | 2008 | 2008 |
| 2-152 | 10993-10 | ISO | Tests for irritation and delayed-type hypersensitivity | 2007 | 2007 |
| 2-135 | 10993-12 | ISO | Sample preparation and reference materials | 2007 | 2007 |

K101428
Page 7 of 7

^&#x27; http://www.accessdata.fda.gov/scripts/cdrh/cidocs/cfStandards/search.cfm

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## OTSC" Over-The-Scope-Clipping System Set
Including the OTSC" Reloader
Traditional Premarket Notification [510(k)] Ovesco Endoscopy AG

| FDA<br>Recognition<br>Number | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date |
|------------------------------|------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------|
| | | | GENERAL HOSPITAL: | | |
| 14-193 | 11607-1 | ISO | Packaging of terminally sterilized medical devices-Part 1:<br>Requirements for materials, sterile barrier systems and<br>packaging-First edition | 2006 | 2006 |
| 14-194 | 11607-2 | ISO | Packaging of terminally sterilized medical devices-Part 2:<br>Validation requirements for forming, sealing and assembly<br>processes | 2006 | 2006 |
| - | 868-5 | EN | Packaging For Terminally Sterilized Medical Devices - Part 5:<br>Sealable Pouches And Reels Of Porous Materials And Plastic<br>Film Construction - Requirements And Test Methods | 2002 | 2002 |
| 5-40 | 14971 | ISO | Medical devices - Application of Risk Management to Medical<br>Devices + ISO14971:2000/Amd 1:2003 | 2007 | 2007 |
| | | | STERILIZATION: | | |
| 14-228 | 11135 | ISO | Medical Devices - Validation and routine control of ethylene<br>oxide sterilization ISO 11135:1994/Cor 1:1994 | 2007 | 2007 |
| - | | - | Updated 510(k) Sterility Review Guidance K90-1; Final<br>Guidance for Industry and FDA | 2002 | August 30,<br>2002 |
| 14-229 | F 1980-02 | ASTM | Standard Guide for Accelerated Aging of Sterile Medical Device<br>Packages Sterilization of health care products - Requirements<br>of validation and routine control - Radiation sterilization | 2007 | 2007 |
| 14-64 | F 1929-98 | ASTM | Test Method for Detecting Seal Leaks in Porous Medical<br>Packaging by Dye Penetration | 2004 | 2004 |

K101628
Laps 5
Pool 7

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## OTSC" Over-The-Scope-Clipping System Set
including the OTSC" Reloader
Traditional Premarket Notification [510(k)] Ovesco Endoscopy AG

| FDA<br>Recognition<br>Number | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date |
|------------------------------|------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------|
| - | - | - | OTHER: | - | - |
| 8-176 | F2503-08 | ASTM | Standard Practice for Marking Medical Devices and Other Items<br>for Safety in the Magnetic Resonace Enviroment. (Materials) | 2008 | 2008 |
| - | F2063 - 05 | ASTM | Standard Specification for Wrought Nickel-Titanium Shape<br>Memory Alloys for Medical Devices and Surgical Implants | 2005 | 2005 |
| - | - | - | Guidance for Industry and FDA Staff Establishing Safety and<br>Compatibility of Passive Implants in the Magnetic Resonance<br>(MR) Environment | 2008 | August 21,<br>2008 |
| 8-124 | F2052-02 | ASTM | Standard Test Method or Measurement of Magnetically Induced<br>Displacement Force on Medical Devices in the Magnetic<br>Resonance Environment | 2002 | 2002 |
| 8-71 | F2182-02a | ASTM | Standard Test Method for Measurement of Radio Frequency<br>Induced Heating Near Implants During<br>Magnetic Resonance Imaging | 2002 | 2002 |
| 8-128 | F2213-04 | ASTM | Standard Test Method for Measurement of Magnetically Induced<br>Torque on Medical Devices in the Magnetic Resonance<br>Environment | 2004 | 2004 |
| 8-153 | F2119-01 | ASTM | Standard Test Method for Evaluation of MR Image Artifacts from<br>Passive Implants | 2001 | 2001 |

K101428
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KIC/1828
Page 7 of 7

1. Substantial Equivalence:

FDA's "Guidance for the Content of Premarket Notifications", and the results of technological characteristics and functional testing support the determination of substantial equivalence for the new device when compared to the predicate devices. The OTSC system set is substantially equivalent to the predicate devices.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

VISAMED GmbH Arne Briest CEO Kastellstr, 8 D-76227 Karlsruhe Germany

K101428 Re: Trade/Device Name: OTSCTM (Over-The-Scope-Clip) System Set Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE Itr): October 22, 2010 Received (Date on orig SE ltr): October 25, 2010

Dear Arne Briest,

This letter corrects our substantially equivalent letter of December 1, 2010.

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

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### Page 2 -

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. 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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for

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

Enclosure

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## SECTION I-E.

### Statement of Indications for Use

510(k) Number: K101428

OTSC™ (Over-The-Scope-Clip) System Set Device Name:

Indications for Use:

The OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.

The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

- Endoscopic marking .
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon

- Closure of GI tract luminal perforations < 20 mm that can be treated conservatively

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and

Urological Devices

| 510(k) Number | K101428 |
|---------------|---------|
|---------------|---------|