(221 days)
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.
The endomina® system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract utilizing an endoscope. The system is comprised of a triangulation platform (endomina® platform) and an instrument for tissue piercing and approximation (TAPES). The endomina® system is sterile packaged and designed for single use and is manufactured from various thermoplastic, silicone, stainless steel materials, biocompatible 3D printing materials and other medical grade materials.
endomina® platform:
The endomina® platform can be assembled on a regular flexible endoscope inside the stomach. It includes a bendable therapeutic channel meant for the endoscopic tool TAPES. This channel can be deployed perpendicular to the axis of the endoscope, thereby ensuring the triangulation, leaving the channel of the endoscope free for other instruments.
TAPES:
TAPES is an instrument intended to be used with the endomina® platform and a flexible endoscope for tissue approximation in the gastrointestinal tract. TAPES is inserted in the bendable arm of endomina®'s platform. TAPES enables piercing and approximation of two, internal 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 provided document describes the 510(k) premarket notification for the endomina® system, an endoscopic tissue approximation device. It details the device's characteristics, intended use, and the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device.
However, the document does not contain the kind of information typically found in an FDA submission for an AI/ML-driven device, which would include specific acceptance criteria like precision, recall, or AUC, or details about the study design (e.g., sample size, expert consensus, MRMC study, ground truth establishment) for validating such an algorithm.
The endomina® system is a mechanical device for endoscopic suturing. Its performance evaluation focuses on physical attributes (dimensions, material properties, mechanical integrity, sterility, shelf-life, biocompatibility) and functional aspects like "suture delivery accuracy," "pull-off force," "force needed to approximate tissue," and "needle piercing force." The "Non-clinical Performance Data" section confirms "Appropriate product testing was performed on endomina® system to evaluate conformance with standard requirements and substantial equivalence to the predicate device."
Therefore, I cannot extract the specific information requested in the prompt (acceptance criteria for an AI/ML device, details of an AI/ML study, MRMC study, standalone performance, training set details) because the provided text pertains to a medical device, not an AI/ML algorithm.
The closest equivalent information regarding "acceptance criteria" and "proof" in this document is found under "Non-clinical Performance Data," which lists various bench tests and animal testing:
Relevant Information from the Document:
- Acceptance Criteria (implicit for a mechanical device): Conformance with standard requirements and substantial equivalence to the predicate device. This implies meeting pre-defined mechanical and functional specifications.
- Reported Device Performance (as described in the "Non-clinical Performance Data"):
- Bench testing included:
- Suture delivery accuracy
- Needle attachment
- Pull-off force to remove the distal tip from the endoscope
- Size of approximated tissue fold
- Force needed to approximate the tissue
- Ease of insertion into a patient gastrointestinal tract
- Suture strength
- Force needed to separate anchors and suture
- Needle piercing force
- Sterility: SAL 10-6 confirmed by sterilization validation according to EN ISO 11135:2014 /A1:2019.
- Packaging and Shelf-life: Packaging integrity confirmed by ASTM F1929-15 and ASTM F1886-16. Shelf-life claims confirmed by functional testing on aged products.
- Biocompatibility: Testing performed on all components per ISO 10993-1: 2018, including chemical characterization (ISO 10993-18: 2020), cytotoxicity (ISO 10993-5: 2009), sensitization (ISO 10993-10: 2010), irritation (ISO 10993-10: 2010), acute systemic toxicity (ISO 10993-11: 2017), material mediated pyrogenicity (USP <151>), and implantation (ISO 10993-6: 2016).
- Animal Testing: Performed to demonstrate substantial equivalence regarding ease of use, efficacy, and safety during endoscopic tissue approximation for suturing in a minipigs' stomach.
- Bench testing included:
Regarding the specific questions in the prompt, based on the provided text, the answers are:
-
A table of acceptance criteria and the reported device performance: This is not presented as a formal table with precise numerical criteria and outcomes, as one would expect for an AI/ML device's performance metrics. Instead, the "Non-clinical Performance Data" section lists the types of tests performed and the successful validation of these tests to establish conformance and substantial equivalence.
Acceptance Criteria (Implicit for non-AI device) Reported Device Performance (from "Non-clinical Performance Data") Conformance to standard requirements Bench testing (suture delivery accuracy, forces, etc.) performedSubstantial equivalence to predicate Animal testing demonstrated substantial equivalenceSterility (SAL 10-6) Confirmedby EN ISO 11135:2014 /A1:2019Packaging Integrity Confirmedby ASTM F1929-15 and ASTM F1886-16Shelf-life Confirmedby functional testing on aged productsBiocompatibility Performedas per ISO 10993 standards -
Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The document mentions "minipigs" for animal testing, which is a "sample" but not an AI test set. No country of origin for generic "data" is mentioned, and the nature is pre-market testing, not retrospective/prospective clinical data for an algorithm.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device's function is typically established through engineering specifications, physical measurements, and animal/cadaveric studies, not expert consensus on image interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to AI/ML ground truth adjudication.
-
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, as this is a mechanical device, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, ground truth would be based on engineering specifications, physical measurements, and histological/observational results from animal studies concerning tissue approximation, rather than expert interpretation of a dataset.
-
The sample size for the training set: Not applicable, as there is no AI/ML algorithm requiring a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm requiring a training set.
In summary, the provided document describes the regulatory clearance of a mechanical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, ground truth, and training data cannot be answered from the given text.
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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.Rue Auguste Piccard 486041 GosseliesBelgium |
|---|---|
| Contact Person | Marine ROUYERInternational Regulatory Affairs Directorregulatory@endotools.bePhone: +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(Apollo Endosurgery) |
| Device Description: | The endomina® system is intended for endoscopicplacement of suture(s) and approximation of soft tissue inthe gastrointestinal tract utilizing an endoscope. Thesystem is comprised of a triangulation platform (endomina®platform) and an instrument for tissue piercing andapproximation (TAPES). The endomina® system is sterilepackaged and designed for single use and is manufacturedfrom various thermoplastic, silicone, stainless steelmaterials, biocompatible 3D printing materials and othermedical grade materials. |
| endomina® platform:The endomina® platform can be assembled on a regularflexible endoscope inside the stomach. It includes abendable therapeutic channel meant for the endoscopictool TAPES. This channel can be deployed perpendicularto the axis of the endoscope, thereby ensuring thetriangulation, leaving the channel of the endoscope free forother instruments. | |
| TAPES:TAPES is an instrument intended to be used with theendomina® platform and a flexible endoscope for tissueapproximation 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™ EndoscopicSuturing System(needle driver, anchor exchangeand suture assembly (only itsanchor which serves also as aneedle)) | endomina® system(endomina® platform and TAPES non-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 OlympusGIF-2TH180 and GIF-2T160 | Single channel endoscopes that are8.5 - 11.0 mm in diameter and norestriction in working length |
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| Product Characteristics | OverStitch™ EndoscopicSuturing System(needle driver, anchor exchangeand suture assembly (only itsanchor which serves also as aneedle)) | endomina® system(endomina® platform and TAPES non-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 faceprior to insertion. The handle canbe attached to the scope. | Assembly of device with scope is doneinside the stomach. The handle is notattached to the scope. |
| Endcap + Scope Attachment | Interference fit | 4 wires (Clamping mechanism) |
| Angle of the needle whenpiercing | 90° (arc) | 90° (perpendicular to axis of vision) |
| Needle- 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™ EndoscopicSuturing System(cinch implantable part andsuture assembly) | endomina® system (TAPESimplantable 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:- one being the needleitself- one called cinch | 2 similar anchors | |
| Anchors and suture | Anchors are linked bymonofilament suture. | Anchors are linked by two,braided sutures and a knot. | |
| Dimensions: | Anchor length | 6.6 mm (needle) –8.0 mm (cinch) | 10 mm |
| Anchor diameter | 1.0 mm (needle) –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-absorbablemonofilamentPolypropylene (syntheticlinear polyolefin) or long-term absorbablemonofilamentpolydioxanone | Non-absorbablebraidedpolyester |
| Anchors | VESTAKEEP PEEKCobalt 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®system to evaluate conformance with standard requirementsand substantial equivalence to the predicate device.Verification and validation for the proposed system wasconducted in accordance with protocols. |
|---|---|
| Performance testing:Bench testing included suture delivery accuracy, needleattachment, pull-off force to remove the distal tip from theendoscope, the size of approximated tissue fold, the forceneeded to approximate the tissue, the ease of insertion intoa patient gastrointestinal tract, the suture strength, the forceneeded to separate anchors and suture and the needlepiercing force. | |
| Sterility:Sterility claims (SAL 10-6) were confirmed by executing asterilization validation in accordance with EN ISO11135:2014 /A1:2019. | |
| Packaging and Shelf-life:Packaging integrity was confirmed by repeating testing inaccordance with ASTM F1929-15 and ASTM F1886-16.Shelf-life claims were confirmed by functional testing on agedproducts. | |
| Biocompatibility: | Biocompatibility testing and toxicological assessments wereperformed on all endomina® system components inaccordance with their risk category requirements, as definedin ISO 10993-1: 2018. Testing included chemicalcharacterization in accordance with ISO 10993-18: 2020,cytotoxicity in accordance with ISO 10993-5: 2009,sensitization in accordance with ISO 10993-10: 2010.irritation in accordance with ISO 10993-10: 2010, acutesystemic toxicity in accordance with ISO 10993-11: 2017,material mediated pyrogenicity in accordance with USP<151> and implantation in accordance with ISO 10993-6:2016. |
| Animal Testing: | Animal testing was performed to demonstrate the substantialequivalence of endomina® system with its predicate in regardto ease of use, efficacy and safety during an endoscopictissue approximation procedure for suturing in a minipigs'stomach. |
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantialequivalence. |
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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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.