(194 days)
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
The OTSC System Set is a single-use, pre-loaded mechanical clip and delivery system used for endoscopic clipping.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (OTSC System Set) |
|---|---|---|
| Functional Equivalence | Deployment: Ability to be deployed endoscopically to the target tissue in the correct location. | Deployment: "The test series resulted delivered identical results. Both devices can be accurately deployed to the target site." (Comparing OTSC with Resolution Hemostasis Clipping Device) |
| Dislodgement Force: Force required to dislodge the endoscopic clips from the tissue should be suitable for the intended use and comparable to the predicate device. | Dislodgement Force: "The dislodgement force of the Resolution Hemostasis Clip and the OTSC clip were comparable and suitable for the intended use." | |
| Biocompatibility | Conformance to ISO 10993-1 (Evaluation and testing within a risk management process), Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (FDA Blue Book Memorandum #G95-1), ISO 10993-3 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), ISO 10993-5 (Tests for in vitro cytotoxicity), ISO 10993-6 (Tests for local effects after implantation), ISO 10993-7 (Ethylene Oxide Sterilization Residuals), ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity), ISO 10993-12 (Sample preparation and reference materials). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO standards and FDA guidance documents under the "BIOCOMPATIBILITY" category. This implies conformance and successful testing against these criteria. |
| Packaging | Conformance to ISO 11607-1 (Packaging requirements), ISO 11607-2 (Validation requirements for packaging processes), EN 868-5 (Sealable Pouches and Reels requirements), ASTM F1980-02 (Accelerated Aging of Sterile Medical Device Packages), ASTM F1929-98 (Test Method for Detecting Seal Leaks). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO, EN, and ASTM standards under the "GENERAL HOSPITAL" and "STERILIZATION" categories related to packaging. This implies conformance and successful testing against these criteria. |
| Risk Management | Conformance to ISO 14971 (Application of Risk Management to Medical Devices). | The document states: "The OTSC System Set meets the following Performance Standards" and lists ISO 14971. This implies a risk management process was followed. |
| Sterilization | Conformance to ISO 11135 (Ethylene oxide sterilization), Updated 510(k) Sterility Review Guidance K90-1, ASTM F1980-02 (Accelerated Aging), ASTM F1929-98 (Seal Leaks). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ISO, and ASTM standards and FDA guidance documents under the "STERILIZATION" category. This implies conformance and successful testing against these criteria. |
| MRI Safety | Conformance to ASTM F2503-08 (Marking for Safety in MR Environment), ASTM F2063-05 (Wrought Nickel-Titanium Shape Memory Alloys), FDA Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the MR Environment, ASTM F2052-02 (Magnetically Induced Displacement Force), ASTM F2182-02a (Radio Frequency Induced Heating), ASTM F2213-04 (Magnetically Induced Torque), ASTM F2119-01 (MR Image Artifacts). | The document states: "The OTSC System Set meets the following Performance Standards" and lists all the aforementioned ASTM standards and FDA guidance documents under the "OTHER" category related to MRI safety. This implies conformance and successful testing against these criteria, indicating the device's compatibility with MRI. |
| Substantial Equivalence | Demonstrates overall performance equivalent to the predicate device (Resolution Hemostasis Clipping Device) for its intended uses. | "It can be concluded that the Resolution Hemostasis Clipping Device and the OTSC system set are substantial equivalent in overall performance." and "The OTSC system set is substantially equivalent to the predicate devices." (Based on comparison of technological characteristics and performance testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients for the performance testing. Instead, it refers to a "simulated deployment test" and a comparison of "dislodgement force."
- Data Provenance: The nature of the "simulated deployment test" and "dislodgement force" measurements implies laboratory or bench testing, not clinical data from specific countries. It's likely in vitro or ex vivo testing rather than in vivo human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The performance testing described (simulated deployment, dislodgement force) does not involve expert interpretation or ground truth establishment in the way clinical studies with image or physiological data would. These are engineering/mechanical performance tests.
4. Adjudication Method for the Test Set:
- Not applicable. The described tests are objective mechanical measurements (deployment confirmation, force measurement) and do not require expert adjudication.
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 device is a mechanical clipping system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a mechanical instrument used by a human endoscopist. There is no standalone "algorithm-only" performance for such a device. The device's performance is intrinsically tied to human operation.
7. The Type of Ground Truth Used:
- The "ground truth" for the functional tests was the objective measurement of mechanical performance:
- Simulated Deployment: Successful deployment to the target site.
- Dislodgement Force: Quantitative measurement of force.
- For the other acceptance criteria (biocompatibility, packaging, sterilization, MRI safety, risk management), the "ground truth" was conformance to established international and national standards (ISO, ASTM, EN, FDA guidances).
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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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 AGDorfackerstrasse 2672074 Tuebingen-Germany |
|---|---|
| Phone Number: | +49 7071 - 770 45 - 14 |
| Fax Number: | +49 7071 - 76 35 - 74 |
| Contact Person: | Prof. Dr. Marc O. Schurr,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 andK020824) |
|---|---|
| Trade Name | Resolution Hemostasis Clipping Device(K040148) |
| Trade Name | InScope Multi-Clip Applier (K051950) |
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K101428
Page 2 of 7
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
Page 3 of 7
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.
{3}------------------------------------------------
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'RecognitionNumber | StandardsNo. | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|---|
| BIOCOMPATIBILITY: | |||||
| 2-98 | 10993-1 | ISO | Biological evaluation of medical devices -- Part 1: Evaluationand testing within a risk management process | 2009 | 2009 |
| - | - | - | Required Biocompatibility Training and Toxicology Profiles forEvaluation of Medical Devices, May 1, 1995 (FDA Blue BookMemorandum #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 invitro cytotoxicity | 2009 | 2009 |
| 2-120 | 10993-6 | ISO | Biological evaluation of medical devices -- Part 6: Tests for localeffects after implantation | 2007 | 2007 |
| 14-76 | 10993-7 | ISO | Biological evaluation of medical devices -- Part 7: EthyleneOxide 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
' 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
| FDARecognitionNumber | StandardsNo. | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|---|
| GENERAL HOSPITAL: | |||||
| 14-193 | 11607-1 | ISO | Packaging of terminally sterilized medical devices-Part 1:Requirements for materials, sterile barrier systems andpackaging-First edition | 2006 | 2006 |
| 14-194 | 11607-2 | ISO | Packaging of terminally sterilized medical devices-Part 2:Validation requirements for forming, sealing and assemblyprocesses | 2006 | 2006 |
| - | 868-5 | EN | Packaging For Terminally Sterilized Medical Devices - Part 5:Sealable Pouches And Reels Of Porous Materials And PlasticFilm Construction - Requirements And Test Methods | 2002 | 2002 |
| 5-40 | 14971 | ISO | Medical devices - Application of Risk Management to MedicalDevices + ISO14971:2000/Amd 1:2003 | 2007 | 2007 |
| STERILIZATION: | |||||
| 14-228 | 11135 | ISO | Medical Devices - Validation and routine control of ethyleneoxide sterilization ISO 11135:1994/Cor 1:1994 | 2007 | 2007 |
| - | - | Updated 510(k) Sterility Review Guidance K90-1; FinalGuidance for Industry and FDA | 2002 | August 30,2002 | |
| 14-229 | F 1980-02 | ASTM | Standard Guide for Accelerated Aging of Sterile Medical DevicePackages Sterilization of health care products - Requirementsof validation and routine control - Radiation sterilization | 2007 | 2007 |
| 14-64 | F 1929-98 | ASTM | Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration | 2004 | 2004 |
K101628
Laps 5
Pool 7
{5}------------------------------------------------
OTSC" Over-The-Scope-Clipping System Set
including the OTSC" Reloader
Traditional Premarket Notification [510(k)] Ovesco Endoscopy AG
| FDARecognitionNumber | StandardsNo. | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|---|
| - | - | - | OTHER: | - | - |
| 8-176 | F2503-08 | ASTM | Standard Practice for Marking Medical Devices and Other Itemsfor Safety in the Magnetic Resonace Enviroment. (Materials) | 2008 | 2008 |
| - | F2063 - 05 | ASTM | Standard Specification for Wrought Nickel-Titanium ShapeMemory Alloys for Medical Devices and Surgical Implants | 2005 | 2005 |
| - | - | - | Guidance for Industry and FDA Staff Establishing Safety andCompatibility of Passive Implants in the Magnetic Resonance(MR) Environment | 2008 | August 21,2008 |
| 8-124 | F2052-02 | ASTM | Standard Test Method or Measurement of Magnetically InducedDisplacement Force on Medical Devices in the MagneticResonance Environment | 2002 | 2002 |
| 8-71 | F2182-02a | ASTM | Standard Test Method for Measurement of Radio FrequencyInduced Heating Near Implants DuringMagnetic Resonance Imaging | 2002 | 2002 |
| 8-128 | F2213-04 | ASTM | Standard Test Method for Measurement of Magnetically InducedTorque on Medical Devices in the Magnetic ResonanceEnvironment | 2004 | 2004 |
| 8-153 | F2119-01 | ASTM | Standard Test Method for Evaluation of MR Image Artifacts fromPassive Implants | 2001 | 2001 |
K101428
Page 6 of 7
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KIC/1828
Page 7 of 7
- 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.
{7}------------------------------------------------
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
{8}------------------------------------------------
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{9}------------------------------------------------
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 |
|---|---|
| --------------- | --------- |
§ 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.