(60 days)
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 < 3 cm
- Arteries < 2 mm
- Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm)
- Lumen reduction
NOTE: The BARS Set is not indicated for stent fixation, For stent fixation, use the stentfix OTSC System Set.
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)
The provided text is a 510(k) Premarket Notification from the FDA for a device called the BARS Set. It describes the device, its indications for use, and a summary of non-clinical tests. However, the document explicitly states "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria from this document alone. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are all related to clinical or performance studies with human data/expert review, which were not submitted for this 510(k).
The document focuses on demonstrating substantial equivalence through bench testing and comparison to predicate and reference devices, rather than a new clinical study.
Here's what I can extract based on the provided text, primarily regarding the non-clinical bench testing:
Non-Clinical Bench Testing Summary (based on the device's substantial equivalence pathway):
-
Acceptance Criteria for Non-Clinical Bench Testing & Reported Device Performance: This information is not presented in a table with specific criteria and results. The document states:
- "Performance bench testing settings investigated key aspects of device safety and effectiveness."
- "The established precedent from these devices were met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing substantial equivalence."
- The tests mentioned for the subject device are:
- Functional capability and robustness
- Endoscope compatibility
- Clip application ring strength
- Space keeper balloon capability and robustness
- Usability
- MRI suitability
- However, specific quantitative acceptance criteria (e.g., "Clip application force > X N") and the numerical results the BARS Set achieved are not detailed in this public summary. The document only confirms that the device "met" these criteria or "the established precedent" set by reference devices.
-
Sample Size Used for the Test Set and Data Provenance:
- Not applicable as no clinical test set (i.e., human subject data for performance claims) was submitted. The tests mentioned were bench tests.
- The provenance of any data used for bench testing (e.g., whether conducted in the US, Germany, etc.) is not specified.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable as no clinical test set or expert-adjudicated ground truth was submitted for device performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and physical measurements.
-
Adjudication Method for the Test Set:
- Not applicable as no clinical test set requiring expert adjudication was submitted.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, explicitly stated: "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not an AI/algorithm.
-
The Type of Ground Truth Used:
- For the non-clinical bench tests, the "ground truth" would be the engineering specifications and physical properties of the device and its components, and comparison to the performance of legally marketed predicate/reference devices. This is not clinical ground truth (e.g., pathology, outcomes data).
-
The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" of the BARS Set to existing predicate and reference devices through non-clinical bench testing, without the need for new clinical data or human-in-the-loop performance studies like those typically conducted for AI/software devices. The document confirms that the device "met" acceptance criteria related to its physical and functional characteristics based on these bench tests.
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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 < 3 cm
- Arteries < 2 mm
- Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm)
- Lumen reduction
NOTE: The BARS Set is not indicated for stent fixation, For stent fixation, use the stentfix OTSC System Set.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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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 < 3 cm
-
Arteries < 2 mm
-
Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm)
-
Lumen reduction
NOTE: The BARS Set is not indicated for stent fixation, use the stentfix OTSC System Set.
Indications for Use Comparison
Indications for use differ slightly in specification. These are found to not raise different questions of safety and effectiveness (decision making flowchart point 4). Methods for investigating differences effectiveness are applied. Data from these methods support substantial equivalence.
Technological Comparison
Technological comparison shows that the subject device, as well as leveraged reference devices share common technological aspects. I.e., all are caps that are attached to an endoscope tip for the purpose of clip application in the gastrointestinal tract. In each case, a thread and hand wheel mechanism is application. For the subject device, an application ring is present which is not present in the predicate device. However, reference devices illustrate that presence of an application ring is established for these clip bearing cap device also provides additional working channels that have an established use in endoscopy of the GI-tract.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807-92(b)
The sponsor manufactures a number of devices similar to the subject device. Some are leveraged as reference devices. Performance bench testing settings investigated key aspects of device safety and effectiveness. As these performance bench testings were largely applied to the reference devices, these tests are considered to be acceptable (510(k) Flowchart decision 5a). Data from these acceptable methods support and demonstrate substantial equivalence (510(k) Flowchart decision 5b).
Device was tested for functional capability and robustness, endoscope compatibility, clip application ring strength, space keeper balloon capability and robustness, usability, and MRI suitability.
Not applicable - no clinical testing submitted for demonstration of substantial equivalence.
The subject device was subjected to performance bench testing previously applied to other devices that constitute a cap attached to an endoscope tip for astrointestinal clip application. The established precedent from these devices were met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing substantial equivalence.
21 CFR 807.92(a)(5)
plied. Data from these
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
§ 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.