(194 days)
Not Found
No
The description focuses on a mechanical clipping system and its performance in simulated deployment and dislodgement force tests, with no mention of AI or ML capabilities.
Yes.
The device is used for therapeutic purposes such as hemostasis, treating lesions, and closure of GI tract luminal perforations.
No
Explanation: The device is used for therapeutic purposes like hemostasis, tissue compression, and closure of perforations, and for marking lesions, none of which are diagnostic functions.
No
The device description explicitly states it is a "single-use, pre-loaded mechanical clip and delivery system," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The OTSC system set is a mechanical device used within the gastrointestinal tract during flexible endoscopy. It physically interacts with tissue for purposes like compression, hemostasis, and marking.
- Intended Use: The intended use clearly describes a procedure performed inside the body, not a test on a sample taken from the body.
Therefore, the OTSC system set falls under the category of a medical device used for therapeutic and procedural purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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
§ 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.
0
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
Dorfackerstrasse 26
72074 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 and
K020824) |
|------------|-----------------------------------------------------|
| Trade Name | Resolution Hemostasis Clipping Device
(K040148) |
| Trade Name | InScope Multi-Clip Applier (K051950) |
1
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 ' http://www.accessdata.fda.gov/scripts/cdrh/cidocs/cfStandards/search.cfm
4
OTSC" Over-The-Scope-Clipping System Set
Including the OTSC" Reloader
Traditional Premarket Notification [510(k)] Ovesco Endoscopy AG
| FDA
Recognition
Number | Standards
No. | Standards
Organization | 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 and
packaging-First edition | 2006 | 2006 |
| 14-194 | 11607-2 | ISO | Packaging of terminally sterilized medical devices-Part 2:
Validation requirements for forming, sealing and assembly
processes | 2006 | 2006 |
| - | 868-5 | EN | Packaging For Terminally Sterilized Medical Devices - Part 5:
Sealable Pouches And Reels Of Porous Materials And Plastic
Film Construction - Requirements And Test Methods | 2002 | 2002 |
| 5-40 | 14971 | ISO | Medical devices - Application of Risk Management to Medical
Devices + ISO14971:2000/Amd 1:2003 | 2007 | 2007 |
| | | | STERILIZATION: | | |
| 14-228 | 11135 | ISO | Medical Devices - Validation and routine control of ethylene
oxide sterilization ISO 11135:1994/Cor 1:1994 | 2007 | 2007 |
| - | | - | Updated 510(k) Sterility Review Guidance K90-1; Final
Guidance for Industry and FDA | 2002 | August 30,
2002 |
| 14-229 | F 1980-02 | ASTM | Standard Guide for Accelerated Aging of Sterile Medical Device
Packages Sterilization of health care products - Requirements
of validation and routine control - Radiation sterilization | 2007 | 2007 |
| 14-64 | F 1929-98 | ASTM | Test Method for Detecting Seal Leaks in Porous Medical
Packaging 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
| FDA
Recognition
Number | Standards
No. | Standards
Organization | Standards Title | Version | Date |
|------------------------------|------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------|
| - | - | - | OTHER: | - | - |
| 8-176 | F2503-08 | ASTM | Standard Practice for Marking Medical Devices and Other Items
for Safety in the Magnetic Resonace Enviroment. (Materials) | 2008 | 2008 |
| - | F2063 - 05 | ASTM | Standard Specification for Wrought Nickel-Titanium Shape
Memory Alloys for Medical Devices and Surgical Implants | 2005 | 2005 |
| - | - | - | Guidance for Industry and FDA Staff Establishing Safety and
Compatibility 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 Induced
Displacement Force on Medical Devices in the Magnetic
Resonance Environment | 2002 | 2002 |
| 8-71 | F2182-02a | ASTM | Standard Test Method for Measurement of Radio Frequency
Induced Heating Near Implants During
Magnetic Resonance Imaging | 2002 | 2002 |
| 8-128 | F2213-04 | ASTM | Standard Test Method for Measurement of Magnetically Induced
Torque on Medical Devices in the Magnetic Resonance
Environment | 2004 | 2004 |
| 8-153 | F2119-01 | ASTM | Standard Test Method for Evaluation of MR Image Artifacts from
Passive Implants | 2001 | 2001 |
K101428
Page 6 of 7
6
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