(60 days)
No
The summary describes a mechanical device for clip placement and does not mention any AI/ML components or functionalities.
Yes
The device is indicated for medical purposes such as hemostasis, treatment of luminal perforations, and lumen reduction within the GI tract, directly addressing medical conditions.
No
The device is described as an over-the-scope clip application device used for therapeutic purposes like hemostasis, treatment of perforations, and lumen reduction, which are interventional rather than diagnostic functions.
No
The device description explicitly lists physical components such as a memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, guide elements, and various endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire). This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The BARS Set is a mechanical device used within the body during flexible endoscopy in the GI tract. It physically applies a clip for hemostasis, perforation treatment, and lumen reduction. It does not analyze or test biological samples outside the body.
- Intended Use: The intended use clearly describes a therapeutic and procedural application within the GI tract, not the analysis of biological specimens.
Therefore, the BARS Set falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:
- 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.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it.
August 26, 2024
Ovesco Endoscopy AG % Amko Groeneveld Senior Consultant novineon CRO GmbH Friedrich-Miescher-Strasse 9 Tuebingen, 72076 Germany
Re: K241858
Trade/Device Name: BARS Set (100.60) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: June 27, 2024 Received: June 27, 2024
Dear Amko Groeneveld:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Anthony Lee -S
Anthony Lee, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn,
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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
Submission Number (if known)
Device Name
BARS Set (100.60)
Indications for Use (Describe)
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:
- Hemostasis for:
- Mucosal/submucosal defects Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| K241858 -- Page 1/2 | ||||
|---|---|---|---|---|
| 510(k) #: | 510(k) Summary | Prepared on: 2024-08-21 |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Ovesco Endoscopy AG |
| Applicant Address | Friedrich-Miescher-Strasse 9 Tuebingen 72076 Germany |
| Applicant Contact Telephone | +49707196528154 |
| Applicant Contact | Mr. Antonio Caputo |
| Applicant Contact Email | antonio.caputo@ovesco.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | BARS Set (100.60) |
| Common Name | Hemostatic Metal Clip for the GI Tract |
| Classification Name | Hemorrhoidal ligator |
| Regulation Number | 876.4400 |
| Product Code(s) | PKL |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K101428 | OTSC System Set | PKL |
Device Description Summary
21 CFR 807.92(a)(4)
Device Description - Explanation of how the device functions:
The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements)
- Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)
Scientific Concepts forming the basis for the device:
Established memory-shape alloy clips used for over-the-scope clip in flexible endoscopy in the gastrointestinal tract.
Significant Physical and Performance Characteristics: - Device Design:
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Device design is guided by compatibility with flexible endoscopes and device influence on endoscopic functions, e.g., vision and maneuverability.
- Material Used:
Materials used need to be sufficiently biocompatible considering the duration and nature of contact to the human body.
- Physical Properties:
Dimensions need to allow insertion via flexible endoscope into the gastrointestinal tract.
-Reference Devices: K200684: gastroduodenal FTRD Set K170867: FTRD System Set K183309: stentfix OTSC System Set
Intended Use/Indications for Use
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the Gl tract for the purpose of: - Hemostasis for:
- Mucosal/submucosal defects