(62 days)
No reference devices were used in this submission.
No
The description focuses on pressure control, fluid management, and user interface, with no mention of AI or ML technologies.
No
The device provides infusion and suction of fluids during diagnostic and operative endoscopic procedures, which are supportive functions for surgery rather than directly treating a disease or condition therapeutically.
No
The device is described as a multi-functional, pressure-controlled, combined irrigation and suction pump used during diagnostic and operative endoscopic procedures for fluid management, not for making a diagnosis.
No
The device description clearly states it is a "multi-functional, pressure-controlled, combined irrigation and suction pump" and mentions hardware components like a "roller pump" and "LCD display with touch screen user interface." While software is mentioned for control and safety features, the device itself is a physical pump system.
Based on the provided information, the Endomat Select is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Endomat Select Function: The Endomat Select is a pump used to irrigate and suction fluids during surgical procedures within the body. It is used to manage fluids within the surgical field, not to analyze specimens for diagnostic purposes.
- Intended Use: The intended use clearly describes its function in providing irrigation and suction during various endoscopic and surgical procedures. It does not mention any analysis of bodily fluids or tissues for diagnostic information.
- Device Description: The device description focuses on its mechanical function as a pump and its control systems. There is no mention of any components or processes related to analyzing biological samples.
Therefore, the Endomat Select falls under the category of a surgical device used for fluid management during procedures, not an IVD.
N/A
Intended Use / Indications for Use
Endomat Select is intended to:
· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
· provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures
· provide the infusion of the sterile irrigant solutions into organs and operating diagnostic and operative procedures in laparoscopic and open general surgery
· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery
· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery
Product codes (comma separated list FDA assigned to the subject device)
HIG, BTA, GWG, HRX, LJH, OCX, EOB
Device Description
The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) and Hysteroscopic (IBS) interventions. In addition, the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348].
The device protects the patient from overpressure via software means. The software- controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally, the device has high pressure alarms to alert the operating room staff of a high-pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.
The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and upper urinary tract, uterus, organs and operating fields, joint or intra-articular spaces, Functional Endoscopic Sinus Surgery, transnasal pituitary gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Data: Verification Test
Operating Mode Activation: Pass
Operating Mode/Software Installation: Pass
Performance – Flow Rate: Pass
Performance - Pressure: Pass
Accessory Compatibility: Pass
Safety – Error Detection: Pass
Safety - Usability: Pass
The bench testing performed verified and validated that the Endomat Select has met all its design specifications.
Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KARL STORZ Endomat Select (K180735), KARL STORZ HAMOU Endomat (K936231)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
July 22, 2020
Karl Storz SE & Co. KG Alexey Davidov Manager Regulatory Affairs, US Submissions Dr.-Karl-Storz-Strasse 34 Tuttlingen, Baden-Wurttemberg 78532 Germany
Re: K201355
Trade/Device Name: Endomat Select Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: HIG, BTA, GWG, HRX, LJH, OCX, EOB Dated: June 17, 2020 Received: June 22, 2020
Dear Alexey Davidov:
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.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
Jason R. Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Endomat Select
Indications for Use (Describe)
Endomat Select is intended to:
· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
· provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures
· provide the infusion of the sterile irrigant solutions into organs and operating diagnostic and operative procedures in laparoscopic and open general surgery
· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery
· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery
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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3
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Applicant: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alexey Davidov
Manager Regulatory Affairs, US Submissions
Phone: +49 (0)7461 708-7909
Fax: +49 (0)7461 708-75095
Email: Alexey.Davidov@karlstorz.com |
| Date of
Preparation: | July 21, 2020 |
| Type of 510(k)
Submission: | Special |
| Device
Identification: | Trade Name: Endomat Select
Common Name: Suction Irrigation Pump
Classification Name: Hysteroscopic insufflator (21 CFR Part 884.1700) |
| Class: | II |
| Product Codes: | Primary: HIG
Secondary: BTA, GWG, HRX, LJH, OCX, EOB |
| Regulation: | 884.1700 - Hysteroscopic insufflator |
| Predicate
Device: | Primary predicate device: KARL STORZ Endomat Select (K180735).
Secondary predicate device: KARL STORZ HAMOU Endomat (K936231).
Predicates have not been subjects of design-related recalls.
No reference devices were used in this submission. |
4
| Device Description: | The Endomat Select is a multi-functional, pressure-controlled, combined irrigation
and suction pump. It can be used for irrigation and, where appropriate dilation,
during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General
Surgical or Laparoscopic (SURG) interventions. The device can be used for suction
during Urological (URO) and Hysteroscopic (IBS) interventions. In addition, the
device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to
maintain lens clarity during use in Transnasal procedures. The device has a modern
LCD display with touch screen user interface. The tubing sets are encoded so that
they can be identified by the device, which selects the appropriate operating modes
based on the tubing set connected. The device can also be connected to other Karl
Storz devices using the proprietary Storz Control Bus (SCB) [K994348].
The device protects the patient from overpressure via software means. The software-
controlled pressure measurement system can stop the actuator (roller pump) should
the pressure rise beyond the pre-determined limit and will immediately reverse the
pump roller direction to depressurize the fluid system if required. Additionally, the
device has high pressure alarms to alert the operating room staff of a high-pressure
situation. The device also requires positive action from the user to increase
pressures above 100mmHg; the user is prompted to confirm their choice on the user
interface.
The accessories for this device are provided separately. All of the accessories for use
with this device are already marketed in the U.S. and are either Class I, Class II
510(k) exempt or Class II previously cleared devices. The generic tubing sets for use
with this device are single use, sterile Class I accessories. | | |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|
| Accessory description | Part number | Marketing Status | |
| Suction bottle, 5l, sterilizable | 20300050 | Class II, Exempt | |
| Cap for suction bottle 20300050, 5l sterilizable | 20300034 | Class II, Exempt | |
| Metal filter | 20300038 | Class II, Exempt | |
| Bottle stand for suction bottle, 5l | 20300032 | Class II, Exempt | |
| Bottle stand holder | 20300033 | Class II, Exempt | |
| Suction bottle, 0,5l, sterilizable | 20300051 | Class II, Exempt | |
| Cap, for suction bottle | 20300039 | Class II, Exempt | |
| Bottle stand, for suction bottle | 20300231 | Class II, Exempt | |
| Control cable | 20701070 | Class II, K973251 | |
| Single pedal footswitch | 20014130 | Class II, K072410 | |
| SCB connecting cord, length 100cm | 20090170 | Class II, K994348 | |
| Tubing Set, Irrigation, PC, for single use,
sterile, package of 10 | 031523-10 | Class I, Exempt | |
| Tubing Set, Suction, BS, for single use,
sterile, package of 10 | 031647-10 | Class I, Exempt | |
| Tubing Set, Suction, DS, for single use,
sterile, package of 10 | 030647-10 | Class I, Exempt | |
| Tubing Set, Irrigation, FC, for single use,
sterile, package of 10 | 031524-10 | Class I, Exempt | |
| Tubing Set, Irrigation, CV, for single use,
sterile, package of 10 | 031529-10 | Class I, Exempt | |
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Image /page/5/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Intended Use: | Suction/irrigation pumps and their accessories are used for the introduction of irrigation fluids into organs, joints and operating fields as well as the suctioning off of irrigation fluids and bodily fluids, secretions, tissue and gas during diagnostic or therapeutic interventions. |
|---|---|
| Indications for Use: | Endomat Select is intended to: |
| ✓ provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures | |
| ✓ provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures | |
| ✓ provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery | |
| ✓ provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery | |
| ✓ provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery | |
| Indications for | |
| Use - | |
| Comparison to | |
| Predicate | |
| Devices | Primary Predicate Device (K180735) |
| Endomat Select is intended to: | |
| -provide the infusion of the sterile irrigant solutions into the ureter and upper | |
| urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, | |
| tissue and gas during diagnostic and operative endoscopic urological procedures | |
| -provide liquid distension of the uterus for diagnostic and operative hysteroscopy | |
| -provide the infusion of the sterile irrigant solutions into organs and operating fields | |
| during diagnostic and operative procedures in laparoscopic and open general | |
| surgery | |
| -provide sustained liquid distension of the joint or intra-articular spaces during all | |
| phases of arthroscopic surgery | |
| -provide the infusion of the sterile irrigant solutions in order to enable the Lens | |
| Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and | |
| endoscopically assisted Transnasal Pituitary Gland Surgery | |
| Secondary Predicate Device (K936231) | |
| The Karl Storz HAMOU Endomat is a dual purpose pump system for the controlled | |
| infusion and aspiration of sterile solutions into body cavities, under control of the | |
| physician, for laparoscopic and hysteroscopic procedures. In the laparoscopic mode | |
| the suction/irrigation pump is used to infuse and aspirate sterile irrigation solution | |
| into the peritoneal cavity for rinsing or removing carbon deposits, blood clots, or | |
| excised tissue during laparoscopic and pelviscopic procedures. In the hysteroscopic | |
| mode the suction/ irrigation pump is used to infuse and aspirate sterile irrigation | |
| solution into the uterine cavity for rinsing or removing carbon deposits, blood clots, | |
| or excised tissue and provides a continuous flow of sterile liquid for the distention of | |
| the uterus during diagnostic and operative hysteroscopy. | |
| Comparison | |
| The subject device expands the indications of use of the primary predicate device to | |
| include suctioning off the irrigation fluids, bodily fluids, secretions, tissue and gas | |
| during diagnostic and operative endoscopic hysteroscopic procedures. This | |
| expanded indication for use is similar to that of the secondary predicate device; | |
| however, the secondary predicate device does not have indications for the other | |
| surgical areas (i.e. urological, general surgery, arthroscopic, etc.) listed under the | |
| subject device. | |
| The subject device does not represent a new intended use as compared to the | |
| primary and secondary predicate devices. |
6
Image /page/6/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
7
Image /page/7/Picture/1 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is "KARL STORZ - ENDOSKOPE".
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate Devices | |||
|---|---|---|---|---|
| Subject Device | Primary Predicate | |||
| Device K180785 | Secondary Predicate | |||
| Device | ||||
| K936231 | ||||
| Device Design | Endomat Select UP210 | Microprocessor controlled, pressure | ||
| monitoring peristaltic pump for irrigation | ||||
| and flow controlled peristaltic pump for | ||||
| suction | HAMOU Endomat | |||
| Microprocessor controlled, | ||||
| pressure monitoring | ||||
| peristaltic pump for | ||||
| irrigation, pressure | ||||
| monitoring vacuum pump | ||||
| for suction | ||||
| Device Type | Roller-pump | Suction: Vacuum-pump | ||
| Operating | ||||
| Modes | ||||
| (Irrigation) | General and Laparoscopic Surgery, | |||
| Hysteroscopy, Urology, Arthroscopy, Lens | ||||
| Cleaning | Laparoscopy | |||
| Hysteroscopy | ||||
| Operating | ||||
| Modes | ||||
| (Suction) | Hysteroscopy | |||
| Urology | Urology | Laparoscopy | ||
| Hysteroscopy | ||||
| Input/Output | ||||
| Devices | LED touch screen | LED light bars with foil | ||
| keyboard | ||||
| Suction Flow | ||||
| Rate | Hyst: 100-300 ml/min | |||
| Uro: 100-1000 ml/min (RES mode) | 300-1000 ml/min (Calcusion mode) | n/a | ||
| Suction | ||||
| Pressure | Hyst: max. -0.75 | |||
| bar (-562.5 | ||||
| mmHg) | ||||
| Uro: max. -0.95 | ||||
| bar | ||||
| (-712.5 mmHg) | Uro: max. -0.95 bar | |||
| (-712.5 mmHg) | Lap: max. -0.8 bar (-600 | |||
| mmHg) | ||||
| Hyst: max. -0.5 bar (-375 | ||||
| mmHg) | ||||
| The subject device features a hysteroscopy suction mode that is not present in the | ||||
| primary predicate device; however, it is similar to a technological feature of the | ||||
| secondary predicate device. Otherwise, the subject device and primary predicate | ||||
| device are identical. | ||||
| The differences in technological characteristics do not raise different questions of | ||||
| safety and effectiveness. | ||||
| Non-Clinical | ||||
| Performance | ||||
| Data: | Verification Test | Conclusion | ||
| Operating Mode Activation | Pass | |||
| Operating Mode/Software Installation | Pass | |||
| Performance – Flow Rate | Pass | |||
| Performance - Pressure | Pass | |||
| Accessory Compatibility | Pass | |||
| Safety – Error Detection | Pass | |||
| Safety - Usability | Pass | |||
| The bench testing performed verified and validated that the Endomat Select has met | ||||
| all its design specifications. | ||||
| Clinical | ||||
| Performance | ||||
| Data: | Clinical testing was not required to demonstrate the substantial equivalence to the | |||
| predicate devices. |
8
Image /page/8/Picture/1 description: The image displays the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters with a circle in place of the letter "O". Below this, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters. The logo is simple and professional, likely representing a medical or technological company.
| Conclusion: | The Endomat Select is substantially equivalent to its predicate devices. |
|---|---|
| The conclusions drawn from the non-clinical tests demonstrate that the subject device is | |
| as safe and effective as the predicate devices. |