The endomina® system, composed of a triangulation (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.
Device Story
Endomina system facilitates endoscopic tissue approximation; comprises triangulation platform (endomina platform) and tissue piercing/approximation instrument (TAPES). Platform attaches to flexible endoscope inside stomach; provides bendable therapeutic channel for TAPES, allowing perpendicular tissue access while keeping endoscope channel free. TAPES uses needle to pierce two internal tissues; releases anchors connected by braided suture to create interrupted stitches. Used by physicians in clinical settings. System enables tissue approximation via endoscopic guidance; benefits include minimally invasive approach to gastrointestinal suturing.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing (suture delivery accuracy, needle attachment, pull-off force, tissue approximation force, suture strength, piercing force) and animal study (minipig stomach) demonstrating safety and efficacy.
Technological Characteristics
System components: triangulation platform and TAPES instrument. Materials: ABS, stainless steel, Pellethane, Pebax, VisiJet Crystal/MED610, FEP, HDPE, PTFE, Nitinol, PEEK (Optima LT2). Sterilization: EO (SAL 10-6). Compatibility: single-channel endoscopes (8.5-11.0 mm diameter). Mechanical actuation via bendable arm and wire-based clamping mechanism. Non-implantable parts are single-use.
Indications for Use
Indicated for adult patients requiring endoscopic suture placement and soft tissue approximation within the gastrointestinal tract.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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December 7, 2021
Endo Tools Therapeutics S.A. Marine Rouyer International Regulatory Affairs Director Rue Auguste Piccard 48 Gosselies, 6041 BELGIUM
Re: K211309 Trade/Device Name: endomina system Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW Dated: October 25, 2021 Received: October 27, 2021
Dear Marine Rouyer:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Je Hi An, PhD Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K211309
Device Name
endomina® system
Indications for Use (Describe)
The endomina® system, composed of a triangulation (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.
Type of Use (Select one or both, as applicable)
网 Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter Name & Address | Endo Tools Therapeutics S.A.<br>Rue Auguste Piccard 48<br>6041 Gosselies<br>Belgium |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Marine ROUYER<br>International Regulatory Affairs Director<br>regulatory@endotools.be<br>Phone: +32 71 91 94 09 |
| Date: | 10 November 2021 |
| Name of Device: | endomina® system |
| Common or Usual Name: | Endoscopic Tissue Approximation Device |
| Classification Name: | Endoscope and Accessories |
| Regulatory Class: | Class II (21 CFR 876.1500) |
| Product Code: | OCW |
| Predicate Device: | K171886 – OverStitch™ Endoscopic Suturing System<br>(Apollo Endosurgery) |
| Device Description: | The endomina® system is intended for endoscopic<br>placement of suture(s) and approximation of soft tissue in<br>the gastrointestinal tract utilizing an endoscope. The<br>system is comprised of a triangulation platform (endomina®<br>platform) and an instrument for tissue piercing and<br>approximation (TAPES). The endomina® system is sterile<br>packaged and designed for single use and is manufactured<br>from various thermoplastic, silicone, stainless steel<br>materials, biocompatible 3D printing materials and other<br>medical grade materials. |
| | endomina® platform:<br>The endomina® platform can be assembled on a regular<br>flexible endoscope inside the stomach. It includes a<br>bendable therapeutic channel meant for the endoscopic<br>tool TAPES. This channel can be deployed perpendicular<br>to the axis of the endoscope, thereby ensuring the<br>triangulation, leaving the channel of the endoscope free for<br>other instruments. |
| | TAPES:<br>TAPES is an instrument intended to be used with the<br>endomina® platform and a flexible endoscope for tissue<br>approximation in the gastrointestinal tract. TAPES is |
inserted in the bendable arm of endomina®'s platform. TAPES enables piercing and approximation of two, internal
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tissues with a needle which are then linked by releasing anchors connected with suture. These anchors create a stitch that can then be tightened, generating interrupted stitches in the gastrointestinal tract.
The endomina® system, composed of a triangulation Indications for Use: platform (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.
## Technological Characteristics:
| Product Characteristics | | OverStitch™ Endoscopic<br>Suturing System<br>(needle driver, anchor exchange<br>and suture assembly (only its<br>anchor which serves also as a<br>needle)) | endomina® system<br>(endomina® platform and TAPES non-<br>implantable parts) | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Clearance | | K171886 | K211309 | |
| Single Use | | Yes | | |
| Sterilization | | Terminally sterilized to SAL 10-6 using a validated EO method | | |
| Shelf-Life Claim | | 3 years | 2 years | |
| Dimensions: | Device length Length of device extending from the tip of the endoscope Distance from the endoscope to the needle Diameter at the distal end closed Diameter at the distal end open | 130 cm 17.5 mm 13.1 mm 16.3 mm 23.3 mm | 108 cm 35 - 43 mm depending on the scope position inside the device 27.5 - 34.5 mm depending on the scope position inside the device 16.3 mm 14.4 mm + diameter of the endoscope | |
| | Compatible Scopes | | Dual channel endoscopes Olympus<br>GIF-2TH180 and GIF-2T160 | Single channel endoscopes that are<br>8.5 - 11.0 mm in diameter and no<br>restriction in working length |
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| Product Characteristics | OverStitch™ Endoscopic<br>Suturing System<br>(needle driver, anchor exchange<br>and suture assembly (only its<br>anchor which serves also as a<br>needle)) | endomina® system<br>(endomina® platform and TAPES non-<br>implantable parts) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Raw materials | ABS Stainless Steel | ABS Stainless Steel Pellethane Pebax VisiJet® Crystal or MED610 FEP HDPE PTFE (coating) Nitinol PEEK |
| Endcap + Scope Position | Capped onto the distal scope face<br>prior to insertion. The handle can<br>be attached to the scope. | Assembly of device with scope is done<br>inside the stomach. The handle is not<br>attached to the scope. |
| Endcap + Scope Attachment | Interference fit | 4 wires (Clamping mechanism) |
| Angle of the needle when<br>piercing | 90° (arc) | 90° (perpendicular to axis of vision) |
| Needle<br>- Diameter | 1.0 mm | 1.8 mm |
| - Raw materials | Stainless Steel 316L Cobalt Chromium MP35 | Stainless Steel 316L |
K211309
Page 3 of 6
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| Product Characteristics | | OverStitch™ Endoscopic<br>Suturing System<br>(cinch implantable part and<br>suture assembly) | endomina® system (TAPES<br>implantable parts) |
|-------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| 510(k) Clearance | | K171886 | K211309 |
| Single Use | | Yes | Yes |
| Sterilization | | Terminally sterilized to SAL 10-6 using a validated EO method | |
| Number of anchors | | 2 different anchors:<br>- one being the needle<br>itself<br>- one called cinch | 2 similar anchors |
| Anchors and suture | | Anchors are linked by<br>monofilament suture. | Anchors are linked by two,<br>braided sutures and a knot. |
| Dimensions: | Anchor length | 6.6 mm (needle) –<br>8.0 mm (cinch) | 10 mm |
| | Anchor diameter | 1.0 mm (needle) –<br>2.4 mm (cinch) | 1.1 mm |
| | Suture length | 185 mm | 80-100 mm |
| | Suture diameter | 1 wire of 0.3 mm* | 2 wires of 0.15 mm in parallel |
| Raw materials | Suture | Non-absorbable<br>monofilament<br>Polypropylene (synthetic<br>linear polyolefin) or long-<br>term absorbable<br>monofilament<br>polydioxanone | Non-absorbable<br>braided<br>polyester |
| | Anchors | VESTAKEEP PEEK<br>Cobalt Chromium MP35 | PEEK (Optima LT2) |
K211309 Page 4 of 6
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| Non-clinical Performance Data: | Appropriate product testing was performed on endomina®<br>system to evaluate conformance with standard requirements<br>and substantial equivalence to the predicate device.<br>Verification and validation for the proposed system was<br>conducted in accordance with protocols. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance testing:<br>Bench testing included suture delivery accuracy, needle<br>attachment, pull-off force to remove the distal tip from the<br>endoscope, the size of approximated tissue fold, the force<br>needed to approximate the tissue, the ease of insertion into<br>a patient gastrointestinal tract, the suture strength, the force<br>needed to separate anchors and suture and the needle<br>piercing force. |
| | Sterility:<br>Sterility claims (SAL 10-6) were confirmed by executing a<br>sterilization validation in accordance with EN ISO<br>11135:2014 /A1:2019. |
| | Packaging and Shelf-life:<br>Packaging integrity was confirmed by repeating testing in<br>accordance with ASTM F1929-15 and ASTM F1886-16.<br>Shelf-life claims were confirmed by functional testing on aged<br>products. |
| Biocompatibility: | Biocompatibility testing and toxicological assessments were<br>performed on all endomina® system components in<br>accordance with their risk category requirements, as defined<br>in ISO 10993-1: 2018. Testing included chemical<br>characterization in accordance with ISO 10993-18: 2020,<br>cytotoxicity in accordance with ISO 10993-5: 2009,<br>sensitization in accordance with ISO 10993-10: 2010.<br>irritation in accordance with ISO 10993-10: 2010, acute<br>systemic toxicity in accordance with ISO 10993-11: 2017,<br>material mediated pyrogenicity in accordance with USP<br><151> and implantation in accordance with ISO 10993-6:<br>2016. |
| Animal Testing: | Animal testing was performed to demonstrate the substantial<br>equivalence of endomina® system with its predicate in regard<br>to ease of use, efficacy and safety during an endoscopic<br>tissue approximation procedure for suturing in a minipigs'<br>stomach. |
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantial<br>equivalence. |
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## Basis of Substantial Equivalence:
The results of all studies confirmed substantial equivalence between the subject and predicate devices and that no new issues of safety nor efficacy were raised. Based on a comparison of indications for use and
technological characteristics, the proposed system has demonstrated substantial equivalence to its predicate.
