(29 days)
EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples:
- · endovascular aortic aneurysm repair (AAA and TAA),
- · angioplasty,
- · stenting.
- · embolization in iliac arteries and corresponding veins.
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.
EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral).
EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices.
EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before endovascular procedure.
The provided document is a 510(k) summary for a modified medical device, EndoNaut, and focuses on demonstrating substantial equivalence to a predicate device (also named EndoNaut, K171829). It does not contain detailed acceptance criteria, device performance metrics, or study design information typically found in a clinical study report for proving device effectiveness.
The document primarily outlines minor changes in hardware components and software naming conventions, and reaffirms compliance with relevant standards. It explicitly states that "No new risks or possible errors were detected or identified. New clinical data were not necessary."
Therefore, I cannot provide detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you requested. The document does not describe such a study.
However, I can extract the information related to the device's validation and verification activities, which are general statements of compliance rather than specific performance metrics against pre-defined acceptance criteria.
Based on the provided document, here's what can be extracted regarding acceptance criteria and "study" (referring to verification and validation activities):
The document does not detail specific, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the modified device (EndoNaut, subject device) is substantially equivalent to the predicate device (EndoNaut, K171829) and continues to meet general safety and effectiveness requirements. The "study" in this context refers to the design verification and validation activities conducted as part of the quality assurance system.
1. A table of acceptance criteria and the reported device performance
No specific, quantitative acceptance criteria are provided in the document, nor are specific performance metrics reported against such criteria. The document states "These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended." The "acceptance criteria" are implied to be conformance with "design specification" and "performed as intended," as well as compliance with various standards.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Conforms to Design Specifications | Meets design specifications and performs as intended. |
| Safe and Effective | Deemed safe and effective (based on substantial equivalence). |
| ISO 14971 compliance | Applied |
| IEC 62304 compliance | Applied |
| IEC 62366 compliance | Applied |
| IEC 60601-1 compliance (Workstation) | Yes (for CENELEC countries) |
| ANSI AAMI ES60601-1 (Workstation) | Yes (for US deviations to IEC 60601-1) |
| IEC 60601-2 compliance (Workstation) | Yes |
| IEC 60601-1-6 compliance (Workstation) | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" and thus no sample size for such a set. The validation and verification activities are generally performed internally without a distinct "test set" from real patient data in the context of a 510(k) for minor modifications. The document does not provide a sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe a clinical study involving experts establishing ground truth. Therefore, this information is not available.
4. Adjudication method for the test set
Not applicable, as no external test set or adjudication process is described in the provided document.
5. 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
The document does not describe an MRMC study or any study evaluating human reader improvement with AI assistance. The device is described as an "imaging solution for intraoperative navigation and guidance tool," and the AI module mentioned pertains to 2D-3D fusion and semi-automatic registration, not diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state an "algorithm only" standalone performance study. The device is intended for "intraoperative navigation and guidance," implying human-in-the-loop use. The "Performance testing (Verification)" and "Simulated use testing (Validation)" would cover the device's functional integrity, but no details on standalone performance metrics are provided.
7. The type of ground truth used
The document does not mention specific "ground truth" data used for performance evaluation in the context of clinical accuracy (e.g., pathology, outcomes data). The verification and validation activities likely used internal reference standards and simulated use cases to confirm the device's functional performance and safety.
8. The sample size for the training set
Not applicable. The document is for a 510(k) submission for a modified device, primarily addressing hardware and software updates, and reaffirming substantial equivalence. It does not describe the development or training of an AI model, only mentions an "AI module" in the context of 2D-3D fusion and registration. Therefore, no training set size is provided.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
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August 31, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Therenva SAS % Cemil Göksu CEO 74F rue de Paris Rennes, 35000 FRANCE
Re: K212383
Trade/Device Name: EndoNaut Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: July 12, 2021 Received: August 2, 2021
Dear Cemil Göksu:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS)
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 medical devices and radiation-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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The document was signed on August 31, 2021 at 10:53:59 -04'00'.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212383
Device Name EndoNaut
Indications for Use (Describe)
EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples:
- · endovascular aortic aneurysm repair (AAA and TAA),
- · angioplasty,
- · stenting.
- · embolization in iliac arteries and corresponding veins.
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized symbol on the left and the company name on the right. The symbol is a teal-colored shape that resembles a sail or a stylized leaf, partially enclosed by a gray circle. The company name "Therenva" is written in gray, with the tagline "Share medical innovation" in a smaller font below the name.
Section 5 - EndoNaut Special 510(K) Summary
This Special 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
Therenva SAS hereby submits this Special 510(k) to provide a notification submission for a modified device EndoNaut and evidence of substantial equivalence to to the Predicate Medical Device EndoNaut (K171829).
The accessories are also subject to this Special 510(k).
1. Submitter information
| Manufacturer Name: | Therenva SAS74F, rue de Paris35000 RennesFrance |
|---|---|
| Contact Person: | Mrs Audrey Gallois, OA & RA LeaderPhone: +33 6 86 95 44 39E-mail: audrey.gallois@therenva.com |
| Establishment Registration Nº: | 3011240766 |
| Date prepared: | 12-Jul-21 |
2. Device Identification
| Trade Name: | EndoNaut |
|---|---|
| Regulation Name: | Interventional Fluoroscopic X-ray System |
| Regulatory Class: | Class II |
| Product Code: | OWB |
| Classification Regulation: | 21 CFR 892.1650 |
| Classification Panel: | Radiology |
| Accessories: | 1. Separate interventional tools workstation |
| 2. EndoSize Software |
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Image /page/4/Picture/1 description: The image shows the logo for Therenva. The logo consists of a stylized teal-colored shape resembling a leaf or wing, connected to a gray circle. To the right of the circle is the word "Therenva" in gray, block letters. Below "Therenva" is the tagline "Share medical innovation" in a smaller, lighter gray font.
3. Predicate device and accessories
- Predicate Medical Device Software: EndoNaut (K171829) ●
- Predicate Accessories:
4. Description of the device
EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral).
EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices.
EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before endovascular procedure. EndoSize is used by practitioners (in the preparation phase of the operating procedure) or by endoprosthesis manufacturers to visualize vascular structures and/or carry out an extract of the vascular structure from the preoperative CT scan. EndoSize is intended to be used for pre-operational planning and sizing. EndoSize is medical device software which obtained a substantial equivalence determination and FDA clearance through the CDRH premarket notification process (510(K)) (NºK160376).
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Image /page/5/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo features a stylized symbol on the left, consisting of a teal crescent shape intersecting with a gray circle. To the right of the symbol is the company name, "Therenva," in gray, block letters. Below the name is the tagline, "Share medical innovation," in a smaller, lighter gray font.
5. Comparison to the cleared (legacy) device and substantial equivalent discussion
| Medical Device Software Name | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
|---|---|---|---|
| Medical Device SoftwareTrade Name | EndoNaut | EndoNaut | Identical |
| Accessory 1 | Separate interventional toolsworkstation | EndoNaut Workstation | Different.Designation adjustmentonly.We have reclarified the qual-ification of hardware versussoftware. By definition,here, the hardware (Endo-Naut Workstation) is an ac-cessory to the software med-ical device. To better differ-entiate what is applicable toone and the other, we haveidentified the software by"EndoNaut Software" andthe hardware by "EndoNautWorkstation". The Endo-Naut Workstation alone isnot subject to any regulatorysubmission. It is integratedwith the System submittedfor FDA approval under thename, EndoNaut. |
| Accessory 1 Ref. | TS1CA2DS1-1 | TS1CA2DS1-2 | DifferentChange of the Panel PC, theControl Panel model and Ca-blings.Due to these changes, theProduct number"TS1CA2DS1-2" has beenchanged. New testings havebeen performed. |
| Accessory 2 | EndoSize Software(K160376) | EndoSize Software(K160376) | IdenticalEndoSize Software is an ac-cessory that is intended tosupplement the performanceof EndoNaut. |
| Identification and traceability | Name: EndoNautNo UDI | Trade name: EndoNautCommon name: EndoNautSystemUDI-DI: 3760262480046 | DifferentNo risk related to idenfica-tion between older andnewer EndoNaut device.EndoNaut is now referring tothe EndoNaut System whilethe EndoNaut Software isnamed EndoNaut Software |
| Medical Device Software | EndoNaut | EndoNaut | Comparable Properties an |
| Name | (Predicate Device) | (Subject Device) | Substantial |
| K171829 | Equivalence Discussion | ||
| No unit of the predicate device was sold in the USA. | |||
| Manufacturer | Therenva SAS | Therenva SAS | Identical |
| Product Code | OWB | OWB | Identical |
| Regulation Number | 892.1650 | 892.1650 | Identical |
| Regulation Name | Interventional FluoroscopicX-Ray System | Interventional FluoroscopicX-Ray System | Identical |
| Software Safety class (62304) | B | B | Identical |
| Level of concern | Moderate | Moderate | Identical |
| Intended use | Intended use and indicationsfor use were mixed.See below Indications foruse. | EndoNaut provides imageguidance by overlaying pre-operative 3D vessel anatomyonto live fluoroscopic im-ages in order to assist in thepositioning of the guide-wires, catheters and otherendovascular devices. | DifferentA distinction between "In-tended use" and "indicationsfor use" has been made basedon the recommendations ofthe FDA Guidance " The510(k) Program: EvaluatingSubstantial Equivalence inPremarketNotifications[510(k)]" (section IV, D, 1). |
| Indications for use | EndoNaut provides imageguidance by overlaying pre-operative 3D vessel anatomyonto live fluoroscopic im-ages in order to assist in thepositioning of the guide-wires, catheters and otherendovascular devices.EndoNaut is intended to as-sist endovascular proceduresin the thorax, abdomen,neck, pelvis and lower limbs.Suitable procedures include(but not limited to) endovas-cular aortic aneurysm repair(AAA and TAA), angio-plasty, stenting and emboli-zation in iliac arteries andcorresponding veins.EndoNaut is not intended foruse in the X-ray guided pro-cedures in the liver, kidneysor pelvic organs. | EndoNaut is indicated forthe treatment of patients withendovascular diseases andwho needs for example(without this list being re-strictive):endovascular aortic an-eurysm repair (AAAand TAA),angioplasty,stenting,embolization in iliac ar-teries and correspondingveins.EndoNaut is indicated forendovascular procedures inthe thorax, abdomen, pelvisand lower limbs. | DifferentA distinction between "In-tended use" and "indicationsfor use" has been made basedon the recommendations ofthe FDA Guidance " The510(k) Program: EvaluatingSubstantial Equivalence inPremarketNotifications[510(k)]" (section IV, D, 1). |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties andSubstantialEquivalence Discussion |
| Labelling | 1 label in the "about" sectionfor the Medical Device Soft-ware with the Trade Name"EndoNaut"+1 label for the Separate inter-ventional tools workstationwith the Trade Name "Endo-Naut" and Product Number= TS1CA2DS1-1 + uniqueSerial (production) Number | 1 label in the "about" sectionfor the Medical Device Soft-ware with the Trade Name"EndoNaut Software".+1 label on the workstationwith the Trade Name "Endo-Naut" (for the whole Sys-tem) and Workstation modelNumber = TS1CA2DS1-2 +unique Serial (production)Number (for the whole Sys-tem) | DifferentEach component of the En-doNaut System has itsproper labelling.Complete review of Label-ling design. Use of symbolsof ISO 15223-1.Addition of UDI.IdenticalThe system has a uniqueidentifier (S/N). |
| Directions for use (UserGuide(s)) | 1 User guide for EndoNaut | 1 User Guide for EndoNautSoftware1 User Guide for EndoNautWorkstation +1 addendum for informingabout the conditions govern-ing the marketing of Endo-Naut. | DifferentThe directions for use havebeen enhanced to clearly dis-tinguish the instructions spe-cific to the medical deviceSoftware, "EndoNaut SW"from the instructions specificto the EndoNaut Work-station, accessory to Endo-Naut SW. |
| Hardware compatibility | Software only product; runson a separate interventionaltools (imaging) workstation. | EndoNaut Software is theclass II medical device Soft-ware which runs on a sepa-rate interventional tools (im-aging) workstation, the so-named EndoNaut Work-station which is the acces-sory of the medical devicesoftware. | DifferentEndoNaut (legacy device)was intended to be sold withand installed on the separateinterventional tools work-station (ref: TS1CA2DS1-1)or installed on any hardwaremeeting the minimum re-quirements.The conditions for installingthe software on the work-station are identical.Only the model number ofthe workstation has changed(ref: TS1CA2DS1-2). |
| Software Operating System | Win Pro 7 SP1x64Win Pro 10 64bits | Win Pro 10 64bits | DifferentSupport for Windows 7ended on January 14, 2020. |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
| Software interoperability | EndoNaut software requiresthe use of EndoSize software(K160376) to prepare patientdata and perform preopera-tive sizing.Data imported from En-doSize include 3D volume,preoperative images, sizingreport (comments and meas-urements), and snapshotstaken during sizing. | EndoNaut requires the use ofEndoSizesoftware(K160376) to prepare patientdata and perform preopera-tive sizing.Data imported from En-doSize include 3D volume,preoperative images, sizingreport (comments and meas-urements), and snapshotstaken during sizing. | SimilarSome clarifications aremade.Preoperative data is a man-datory input for the use of AImodule, but it is not for thePAD module.Preoperative data includepre-op CT images and sizingreport (in case of AI moduleuse).The stent placement strategyand sizing are usually per-formed pre-operatively viathe use of software devicessuch as EndoSize.Alternatives to EndoSize ex-ist: other sizing or visualiza-tion software. In such cases,the data is then printed onpaper and used in the operat-ing room as is. |
| Data management | The user can import andmanage patient data withinthe software. Patient data in-clude pre-op CT images andsizing report. | The user can import andmanage patient data withinthe software. Patient data in-clude pre-op CT images andsizing report. | SimilarEndoNaut Software now en-ables import and export ofdata with a PACS. |
| Visualization | Intra-operative fluoroscopyor angiography, pre-opera-tive CT scan image, pre-op-erative 3D scanner volumereconstruction (if any in caseof PAD module).AI module only:Before and during the inter-vention, the user can accessinformation from pre-opera-tive sizing report such as pre-op CT images, measure-ments, comments, snap-shots and strategy. | Intra-operative fluoroscopyor angiography, pre-opera-tive CT scan image, pre-op-erative 3D scanner volumereconstruction (if any in caseof PAD module).AI module only:Before and during the inter-vention, the user can accessinformation from pre-opera-tive sizing report such as pre-op CT images, measurements,comments, snap-shots and strategy. | Identical |
| Export | Take and export snapshots.Export panoramas in case ofPAD module. | Take and export snapshots.Export panoramas in case ofPAD module. | Identical |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
| 3D-2D / 2D-2D Registration | AI module:Display 2D-3D fusion: 3Dvolume pre-op overlay onper-op 2D fluoroscopy.Semi-automatic registration(automatic or manual initial-ization, automatic computa-tion and manual validation). | AI module:Display 2D-3D fusion: 3Dvolume pre-op overlay onper-op 2D fluoroscopy.Semi-automatic registration(automatic or manual initial-ization, automatic computa-tion and manual validation). | Identical |
| Lower limbs module:Panorama creation: Acquisi-tion and save of fluoroscopyand angiography stage bystage keeping the same C-Arm orientation.Display 2D-2D fusion: 2Dpre-op angiographic overlayon per-op 2D fluoroscopy.Synchronization betweencurrent per-op 2D fluoros-copy and 2D fluoroscopyfrom recorded panorama. | PAD (lower limbs) module:Panorama creation: Acquisi-tion and save of fluoroscopyand angiography stage bystage keeping the same C-Arm orientation.Display 2D-2D fusion: 2Dpre-op angiographic overlayon per-op 2D fluoroscopy.Synchronization betweencurrent per-op 2D fluoros-copy and 2D fluoroscopyfrom recorded panorama. | ||
| Dynamic update on C-arm /table / patient motion | Automatic motiondetection; registration isupdated manually. | Automatic motion detectionRegistration: auto-matic/manual initializationand manual user validation. | DifferentImprovement of semi-auto-matic registration (alreadyexisting requirement). Thechange does not significantlyaffect the use of the device.No new risks or possible er-rors were detected or identi-fied. New clinical data werenot necessary. V&V activi-ties were performed and suc-cessful. No additional ques-tions raised for safety and ef-fectiveness. |
| Tools | AI module:Draw markers on intra-oper-ative images, locate/trackpoints between per-op andpre-op images, and takemeasurements on pre-op CTscan images and fusionview.Lower limbs module:Draw lesions markers onpanorama (stenosis and | AI module:Draw markers on intra-oper-ative images, locate/trackpoints between per-op andpre-op images, and takemeasurements on pre-op CTscan images and fusionview.PAD (lower limbs) module:Draw lesions markers onpanorama (stenosis and | Identical |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
| thrombosis), calibrate thelength of previous markedlesions due to inserted mate-rial, draw markers, create acontrol panorama. | thrombosis), calibrate thelength of previous markedlesions due to inserted mate-rial, draw markers, create acontrol panorama. | ||
| Patient contacting | No | No | Identical |
| Energy emitted or absorbed | No | No | Identical |
| Workstation main display &computer | Panel PC Baaske, model e-medic Silence TP 4Rated AC 100-240V, 2.3-0.8A 50-60Hz | Panel PC ACL OR-PC27LPRated AC 100-240V, 1.5-0.6A ~47 – 63 Hz | DifferentNo new risks or possible er-rors were detected or identi-fied. V&V activities wereperformed and successful.No additional questionsraised for safety and effec-tiveness. |
| Monitor size: 24" LCDBrigthness: 250 cd/ m2 typi-calResolution: 1920 x 1080Cooling Fanless (no mainte-nance) | Monitor size: 27" LCDBrightness: 300 cd/m2Resolution: 1920 x 1080Cooling Fanless (no mainte-nance) | ||
| Workstation secondary dis-play (touch screen) | One Touch monitor ELO,model 1519LM,rated AC 100-240V 1.2-0.63A 60/50HzMonitor size: 15.6" LCDResolution: 1366 x 768Brightness: 225 cd/m2Touch technology: PCAP | One Touch monitor ELOmodel 1502L,rated AC 100-240 VInput frequency: 50-60 HzMonitor size: 15.6" LCDResolution: 1920 x 1080Brightness: 270 cd/m2Touch technology: PCAP | SimilarNew monitor providesmore effective visual imageresolution.No new risks or possible er-rors were detected or identi-fied. |
| Workstation cart | One mobile frame holderITD, including one isolatingtransformer, rated AC 115V/ 230V 50/60Hz 1240VA. | One mobile frame holderITD, including one isolatingtransformer, rated AC 115V/ 230V 50/60Hz 1240VA. | Identical |
| Workstation dimensions | Height: 1742 mmWidth (footprint): 661 (640)mmDepth (footprint): 950 (660)mmWeight: 71 kg | Height: 1740 mmWidth (footprint): 661 (640)mmDepth (footprint): 950 (660)mmWeight: 70 kg | SimilarMinor dimensional andweight changes do not resultin additional risks. |
| Connectors | Digital video input: DVI-Dor DVI-I*Analog video input: BNCVideo output: DisplayPortNetwork:10/100/1000 MbpsEthernet (RJ45)USB interface USB 3.0(x2) | Digital video input: DVI-Dor DVI-I*Video output: HDMINetwork: 10/100/1000 MbpsEthernet (RJ45)USB interface USB 3.0(x2) | SimilarSimply a new more commonvideo interface is now used. |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
| Power supply | Input voltage:100 – 230 VAC / 50 – 60 Hz | Input voltage:100 – 230 VAC / 50 – 60 Hz | Identical |
| Workstation cablings | Connection BoxFront cable RJ45DVI front cableBNC front cableUSB 3.0 front cable 1m(x2)Power suppliesPower supply extension jack2.5mm 3m IEC extensioncable 1m (red)IEC extension cable 0.5m(blue)External power sup-ply ELO TOUCH1519LMExternal power sup-ply BaaskeVideo cabling: DVI 5mOther cables:DisplayPort DVI ca-ble 1.5mUSB 3.0 A/B 1mUSB 2.0 2m | Connection BoxFront cable RJ45DVI front cableUSB 3.0 front cable1m (x2)Power suppliesPower supply extension IECC7-C14Power supply extension jack2.5mm 3mIEC extension cable 1m(red)IEC extension cable 0.5m(blue)External power supply XPPOWER (for ELO TOUCH1502L)External power supplyBICKER (for ACL ORPC-27LP) BET-1012MVideo cabling: DVI 5mOther cables:HDMI cable 1.5mHDMI/DP adapterUSB 3.0 A/B 1mUSB 2.0 2mEquipotential 1,5m | DifferentNo new risks or possible er-rors were detected or identi-fied. V&V activities wereperformed and successful.No additional questionsraised for safety and effec-tiveness. |
| IEC 62304 | Applied | Applied | Identical |
| IEC 62366 | Applied | Applied | Identical |
| ISO 14971 | Applied | Applied | Identical |
| DICOM Standard parts 1-20 | Applied | Applied | SimilarA newer DICOM Conform-ance Statement has beenwritten for EndoNaut Sys-tem Software and is pro-vided in Appendix 2. |
| Conformity to IEC 60601-1of the separate interventionaltools workstation | YesFor CENELEC countries | YesFor CENELEC countries | IdenticalIEC 60601-1 is not a FDArecognized standard versionbut is applied and included inV&V protocol and results. |
| Medical Device SoftwareName | EndoNaut(Predicate Device)K171829 | EndoNaut(Subject Device) | Comparable Properties anSubstantialEquivalence Discussion |
| Conformity to ANSI AAMIES60601-1:2005/(R)2012andA1:2012,C1:2009/(R)2012andA2:2010/(R)2012 (Consoli-dated Text) of the separateinterventional tools work-station | No | Yes | DifferentUS deviations to IEC 60601-1 are taken into account forthe new model of separateinterventional tools work-station (TS1CA2DS1-2). |
| Conformity to IEC 60601-2of the separate interventionaltools workstation | Yes | Yes | IdenticalIEC 60601-2 FDA recog-nized standard version is ap-plied and included in V&Vprotocol and results. |
| Conformity to IEC 60601-1-6 of the separate interven-tional tools workstation | Yes | Yes | IdenticalIEC 60601-1-6 FDA recog-nized standard version is ap-plied and included in V&Vprotocol and results. |
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Image /page/6/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized teal and gray icon on the left, followed by the company name in gray, and the tagline "Share medical innovation" in a smaller font below the name. The icon appears to be a combination of a curved teal shape and a gray circle.
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Image /page/7/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal-colored, curved shape that resembles a leaf or wing, partially overlapping a gray circle. To the right of the graphic is the word "Therenva" in gray, block letters. Below "Therenva" is the tagline "Share medical innovation" in a smaller, lighter gray font.
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Image /page/8/Picture/1 description: The image shows the logo for Therenva, a company that shares medical innovation. The logo consists of a stylized symbol on the left, resembling a teal sail or leaf intersecting with a gray circle. To the right of the symbol is the company name, "Therenva," in gray, block letters. Below the name, in a smaller font, is the tagline "Share medical innovation".
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Image /page/9/Picture/1 description: The image shows the logo for Therenva, a company that shares medical innovations. The logo consists of a teal abstract shape and a gray circle on the left, followed by the company name "Therenva" in gray, and the tagline "Share medical innovation" in a smaller font size below the name. The logo is clean and modern, with a focus on innovation and medical technology.
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Image /page/10/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized symbol on the left and the company name on the right. The symbol is a combination of a circle and a teal-colored shape that resembles a sail or a wing. The company name is written in gray, with the tagline "Share medical innovation" below it in a smaller font.
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Image /page/11/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo consists of a teal-colored abstract shape that resembles a sail or a leaf, next to a gray circle. To the right of the circle is the company name, "Therenva," in gray, with the tagline "Share medical innovation" in a smaller font below.
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Image /page/12/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape and a gray circle on the left, followed by the word "Therenva" in gray. Below the word "Therenva" is the phrase "Share medical innovation" in a smaller, lighter gray font.
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Image /page/13/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape that looks like a sail, a gray circle, and the word "Therenva" in gray. Below the word "Therenva" is the phrase "Share medical innovation" in a smaller, lighter gray font.
6. Summary of the technical characteristics
EndoNaut (Subject Device) has identical intended users, indications for use, anatomical location, limitations, patient population, environment of use than the predicate device, EndoNaut (Legacy Device).
EndoNaut (Subject Device) has similar HW and SW compatibilities, principle of operation and technical characteristics as the predicate device, EndoNaut.
EndoNaut workstation TS1CA2DS1-2 has similar material characteristics (design, power, principle of operation) than the predicate accessory, the separate intervention tools workstation TS1CA2DS1-1.
The differences between the new modified device and accessories to their predicates do not raise any question with respect to the safety and effectiveness of the subject device and accessory.
7. Performance Data
The predicate device (K171829) and the new modified subject device and their respective accessories, the separate interventional tools workstation and EndoSize Software, have been subject to the same Therenva quality assurance system during their design and development:
- Risk assessment ●
- Usability File Reviews ●
- Requirement Reviews ●
- Design Reviews ●
- Clinical Evaluation Report Reviews ●
- . Directions for use Reviews
- Testing on unit level (Module verification)
- . Integration testing (EndoNaut Software embedded on the EndoNaut Workstation accessory and tests on several operating systems)
- Interoperability testing (with EndoSize Software) ●
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The same design verification testing including electrical safety, EMC, functional and mechanical testing's were carried out on the new EndoNaut Workstation TS1CA2DS1-2 as it its predicate TS1CA2DS1-1 by the COFRAC accredited testing laboratory. These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended.
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Image /page/14/Picture/1 description: The image is a logo for Therenva. The logo consists of a teal and gray abstract shape on the left, followed by the word "Therenva" in gray. Below the word "Therenva" is the phrase "Share medical innovation" in a smaller, lighter gray font.
They also demonstrated compliance with the same following standards:
- ISO 14971 medical devices Application of risk management to medical devices ●
- . IEC 62304 - medical devices Software - Software life-cycle processes
- . IEC 62366 - medical devices - Application of usability engineering to medical devices
Specific to the Workstation:
- IEC 60601-1 Medical electrical equipment Electrical safety ●
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text)
- IEC 60601-2 - Medical electrical equipment - EMC disturbances
- IEC 60601-1-6 Medical electrical equipment Usability ●
8. Statement of substantial equivalence
Based on the information supplied in this Special 510(k), Therenva SAS concludes that the EndoNaut (Subject device) and accessories
-
are substantially equivalent to the predicate devices and accessories .
and -
are safe and effective. ●
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.