(259 days)
No
The device description focuses on mechanical operation and manual control, with no mention of automated decision-making, image analysis, or learning algorithms.
No.
The text states that the device is intended to "hold and position a rigid endoscope / exoscope," and it "allows the surgeon to work one-handed and/or two-handed." It contributes to the efficiency and stability of a surgical procedure but does not directly perform a therapeutic action on the patient.
No
The device is described as an arm for holding and positioning endoscopes during diagnostic and therapeutic procedures, which is a surgical device, not a diagnostic one itself.
No
The device description explicitly details a physical, manually operated surgical device with mechanical components (arm, controls, clamp, etc.) intended to hold and position an endoscope. It is not solely software.
Based on the provided information, the ENDOFIX EXO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ENDOFIX EXO Function: The ENDOFIX EXO is a surgical device designed to hold and position a rigid endoscope or exoscope during surgical procedures. It is a mechanical arm that assists the surgeon with visualization.
- Lack of Specimen Analysis: The device itself does not analyze any biological specimens. It is a tool used in conjunction with an endoscope/exoscope and camera system to provide visual information during a procedure.
The description clearly indicates its role as a surgical assist device for positioning and stabilizing an endoscope/exoscope, which is a function entirely separate from in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
Product codes
OCV
Device Description
The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.
lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.
An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.
Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.
On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.
To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.
During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all patients, who are suitable within the scope of indications for use.
Intended User / Care Setting
trained surgeon performing the operation / professional healthcare environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed:
- Lifetime test
- Lifetime test CONTROL
- Moving after fixation test
- Usability test
- Package drop test
Nonclinical performance tests of the substantial device are unknown. Therefore own nonclinical performance tests were successfully performed to demonstrate the safety and efficiency of the ENDOFIX EXO.
The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device. For the WalterLorenz Surgical Assist Arm there are unfortunately no which non-clinical performance tests have been performed. However, since the WalterLorenz Surgical Assist Arm is only a Class 1 device, it can be assumed that all non-clinical performance tests for the ENDOFIX EXO are sufficient to ensure at least equivalent safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2024
AKTORmed GmbH Hanna Kafurke Regulatory Affairs/Quality Management Neugablonzer Strasse 13 Neutraubling, BY 93073 Germany
Re: K232405
Trade/Device Name: Endofix Exo Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCV Dated: August 1, 2023 Received: August 10, 2023
Dear Hanna Kafurke:
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 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" (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).
1
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 reguires device manufacturers to review and approve changes to device design and production (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 (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 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.25 16:18:53
-04'00' Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
ENDOFIX EXO (171943)
Indications for Use (Describe)
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" in white, followed by the word "AKTORmed" in gray, and the words "ROBOTIC SURGERY" in a smaller font below. The letters "TM" are in the upper right corner of the word "AKTORmed".
Dokumentennummer / Document Number Q002-244988 Version / Version 00 Ersteller / Created by Erstellt Datum / Created Date 22.04.2024 Dokumentenname / Document name Ablageort / File
Hanna Kafurke 510(k) Summary 1DA9486B9E2CC68
freigegeben / released 22.04.2024
| Funktion | Name | Datum | Signatur | Vermerk |
|---|---|---|---|---|
| QM / Regulatory | ||||
| Affairs | Hanna Kafurke | 22.04.2024 | Hanna Kafurke | |
| Q102-244968-00 | erstellt/created | |||
| Geschäftsführer | ||||
| Managing Director | Robert Geiger | 22.04.2024 | 22.04.2024 15:20:27 | |
| Robert Geiger | ||||
| Q002-244988-00 | ||||
| 22.04.2024 15:20:36 | freigegeben/released |
| Version /
version | Änderung / Changes | Name /
name | Datum / Date |
|----------------------|----------------------|----------------|--------------|
| 00 | Erstellung / created | HK | 22.04.2024 |
510(k) Summary
Inhaltsverzeichnis / contents
| 1. | 510(k) Summary | |
|---|---|---|
| 2. | Contact Details | |
| 3. | Device Name | |
| 4. | Legally Marketed Predicate Devices | |
| 5. | Device Description Summary | |
| 6. | Intended use/Indications for Use | |
| 7. | Indications for Use Comparison | |
| 8. | Technological Comparison | |
| 9. Non-Clinical and/or Clinical Tests Summary & Conclusions |
4
Image /page/4/Picture/0 description: The image shows the logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" in white on the left side. To the right of the circle is the word "AKTORmed" in gray, with the words "ROBOTIC SURGERY" in a smaller font below it. The letters "TM" are in superscript to the right of the word "AKTORmed".
1. 510(k) Summary
510(k) Number: K232405
2. Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | AKTORmed GmbH |
|---|---|
| Applicant Address | Neugablonzer Strasse 13, Neutraubling, BY, 93073, Germany |
| Applicant Contact Telephone | +49 9401 9320 150 |
| Applicant Contact | Mrs. Hanna Kafurke |
| Applicant Contact Email | Hanna.kafurke@aktormed.com |
3. Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | ENDOFIX EXO (171943) |
|---|---|
| Common Name | Endoscope and accessories |
| Classification Name | Endoscope Holder |
| Regulation Number | 876.1500 |
| Product Code | OCV |
4. Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | K190576 |
|---|---|
| Predicate Trade Name | |
| (Primary Predicate is listed | |
| first) | WalterLorenz Surgical Assist Arm Scope Holder |
| Product Code | OCV |
5. Device Description Summary
21 CFR 807.92(a)(4)
The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.
lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.
An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.
Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.
On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.
To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.
| Dokumentennummer / document number | Q002-244988 |
|---|---|
| Version / version | 00 |
| Datum / date | 22.04.2024 |
| Seite / page | 2 / 4 |
5
Image /page/5/Picture/0 description: The image shows the logo for AKTORmed Robotic Surgery. The logo consists of a blue circle with the letters "am" in white inside of it. To the right of the circle is the word "AKTORmed" in gray, with the words "ROBOTIC SURGERY" in a smaller font below it.
During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.
6. Intended use/Indications for Use
21 CFR 807.92(a)(5)
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
7. Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are very similar for both devices have the same intended use, which is the fixation of an endoscope in a position. The ENDOFIX EXO is for use during general and neurological diagnostic and therapeutic procedures. The WalterLorenz Surgical Assist Arm can be used in general and neurological, diagnostic and therapeutic procedures. However, this does not create a new intended use, since the is identical for both devices. For WalterLorenz Surgical Assist Arm Scope Holder the user is a trained medical professional, for ENDOFIX EXO the user is defined as a trained surgeon performing the operation. Both statements mean the same thing, they are just worded differently. The Patient group for the ENDOFIX EXO is all patients, who are suitable within the scope of indications for use. There are no known patient limitations for the WalterLorenz Surgical Assist
Arm Scope Holder. Both devices should only be used in professional healthcare environment.
8. Technological Comparison
21 CFR 807.92(a)(6)
Both products have for the most part the same technological characteristics:
Both devices have a permanently installed unlock button, which releases all locks so that the arm can move freely. The unlock button of the ENDOFIX exo is called DEACTIVATION and is located at the distal end of the arm. In contrast, the button of the WalterLorenz Surgical Assist arm is located on the Control Box with User Interface Keypad. However, both devices have a second control panel with an unlock button that is connected to the base unit of the arm via a cable. The control unit of the WalterLorenz Surgical Assist Arm is a sterile, disposable accessory that is supplied separately and can be attached to the distal end of the arm as a release button. The CONTROL of the ENDOFIX EXO is slid over the magnetic bracket of the endoscope clamp and secured from slipping off by a magnetic attraction. When the status LED next to the DEACTIVATION PUSHBUTTON indicates, the CONTROL is ready to operate. This does not happen until the CONTROL is on the magnetic bracket of the endoscope clamp, because there is a sensor in the CONTROL that detects the magnet and only then activates the CONTROL. This increases safety for the patient, as the locks cannot be released if the CONTROL is not on the endoscope clamp. For both devices the Energy Source is Electricity and both do not emit energy. The control units are in the devices. The ENDOFIX exo as well as the WalterLorenz Surgical Assist Arm can be fixed on U.S. table rails. They have no software and do not include biologics, drugs, coatings and additives. For both devices, the sterilizable accessories can be sterilized by steam sterilization and cleaned by wiping disinfection. Regarding the power supply, both devices have the identical input voltage of 100-240 VAC; 50-60Hz and the operating mode is continuous.
Nevertheless, there are few differences of technological characteristics:
The first difference is the mechanism of the two devices. While the WalterLorenz Surgical Assist Arm uses electromechanical brakes in the axes, the ENDOFIX EXO uses electromagnetic brakes to lock movement in all axes. However, there are no safety or effectiveness implications or other safety issues arising from this difference, as the electromagnetic locks have been mechanically tested according to IEC 60601-1:2005 + A1:2012. In addition, the displacement after fixation of the arm has also been tested. From both tests, there are no risks regarding the safety of the arm.
| Dokumentennummer / document number | Q002-244988 |
|---|---|
| Version / version | 00 |
| Datum / date | 22.04.2024 |
| Seite / page | 3 / 4 |
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Image /page/6/Picture/0 description: The image shows the Aktormed logo. The logo consists of a blue circle with the letters "am" in white, followed by the word "AKTORmed" in gray. Below the word "AKTORmed" is the phrase "ROBOTIC SURGERY" in a smaller, gray font. The logo is clean and modern, and the colors are professional and trustworthy.
The ENDOFIX EXO is compatible with endoscopes. For the WalterLorenz Surgical Assist Arm Scope Holder, no exact specification of which scopes are compatible could be found. By specifying exactly which scopes are compatible, the ENDOFIX EXO has at least an equivalent level of safety in terms of compatibility with devices as the WalterLorenz Surgical Assist Arm Scope Holder.
The ENDOFIX EXO's safe working load is specified as 1kg, it was even tested with 5kg and no problems occurred. No defined safe working load was found for the WalterLorenz Surgical Assist Arm.
The WalterLorenz Surgical Assist Arm is battery powered. The ENDOFIX EXO, on the other hand, does not have a battery, which means that there is no risk of the battery failing during an operation and the safety of continuous power operation is ensured. However, this means that the ENDOFIX EXO can no longer be moved in the event of a power failure, but it has been assured that the arm will continue to hold the endoscope in a fixed position. In the event that power cannot be restored by reconnection, both the endoscope itself and the device can be safely and quickly removed from the patient using quick-release fasteners as described in the instructions for use.
The weights of the two devices differ significantly. The ENDOFIX EXO weighs 26.5lbs, the WalterLorenz Surgical Assist Arm without the Scope Holder 8lbs. However, the higher weight does not lead to an increased safety risk, as the ENDOFIX EXO is equipped with a counterbalance to compensate for the endoscope and the camera head. In addition, the ENDOFIX EXO is mounted to the operating table so that no weight has to be carried by one person. If the ENDOFIX EXO has to be transported over a long distance, it can be mounted on the trolley provided for this purpose and then only needs to be pushed. A usability test was also conducted with 15 American physicians, where weight was not mentioned negatively.
The output voltage of the two devices varies slightly. The ENDOFIX EXO has an output voltage of 24V DC and the WalterLorenz Surgical Assist Arm has an output voltage of 18V DC. However, the ENDOFIX EXO has been sufficiently tested according to IEC 60601-1 for electrical safety to state that it poses no danger to the user.
The last difference is that the distal unlock button of the WalterLorenz Surgical Assist Arm is a single-use product and comes sterile packed. The control unit of the ENDOFIX EXO, on the other hand, can be used more often, but must be cleaned and sterilized before the first use. The complete validation of the reprocessing and sterilization process confirms that there is no increased risk.
9. Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The following tests were performed:
-
- Lifetime test
-
- Lifetime test CONTROL
-
- Moving after fixation test
-
- Usability test
-
- Package drop test
Nonclinical performance tests of the substantial device are unknown. Therefore own nonclinical performance tests were successfully performed to demonstrate the safety and efficiency of the ENDOFIX EXO.
The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device. For the WalterLorenz Surgical Assist Arm there are unfortunately no which non-clinical performance tests have been performed. However, since the WalterLorenz Surgical Assist Arm is only a Class 1 device, it can be assumed that all non-clinical performance tests for the ENDOFIX EXO are sufficient to ensure at least equivalent safety.
| Dokumentennummer / document number | Q002-244988 |
|---|---|
| Version / version | 00 |
| Datum / date | 22.04.2024 |
| Seite / page | 4 / 4 |