(223 days)
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 irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
• provide liquid distention 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 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
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) 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 Endomat Select (Model Number: UP210) is a multi-functional pressure-controlled irrigation and suction pump. The device received FDA clearance K180735 on October 31, 2018.
Acceptance Criteria and Device Performance:
The device's performance was evaluated through a series of bench tests. The detailed acceptance criteria are implied by the "Pass" status for each performance and safety test. The reported device performance is that it Passed all these tests.
| Acceptance Criteria (Performance/Safety Test) | Reported Device Performance |
|---|---|
| Performance: Pressure Control | Pass |
| Performance: Flow Limitation | Pass |
| Performance: Flow Control | Pass |
| Performance: Pressure Limitation | Pass |
| Performance: Suction Control | Pass |
| Safety: Overpressure Warning (in pressure relevant GYN and URO interventions) | Pass |
| Safety: Overpressure Warning (in pressure relevant ARTHRO interventions) | Pass |
| Safety: Overpressure Alarm (in pressure relevant GYN and URO interventions) | Pass |
| Safety: Pressure Relief (in pressure relevant GYN and URO interventions) | Pass |
Study Details:
-
Sample size used for the test set and data provenance:
The document states that "Additional bench testing was performed to ensure the device met its design specifications." and "The bench testing performed verified and validated that the Endomat Select has met all its design specification and is substantially equivalent to its predicate devices." However, specific sample sizes for these bench tests are not provided in this document. The data provenance is also not explicitly stated beyond being "bench testing." It is implied to be from the manufacturer, Karl Storz SE & Co. KG, located in Germany. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the evaluation was based on non-clinical bench testing against design specifications and established standards, rather than expert-derived ground truth from a test set involving human interpretation. -
Adjudication method for the test set:
This information is not applicable as the evaluation was based on objective bench tests against pre-defined engineering and safety standards, rather than subjective interpretation requiring adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is a medical pump, not an algorithm or AI-powered system designed for diagnostic aid or similar tasks that would have standalone algorithm-only performance. Its performance is inherent in its mechanical and software functions. The "Performance" and "Safety" tests listed above can be considered standalone performance evaluations of the device's functional capabilities. -
The type of ground truth used:
The ground truth for the verification of the Endomat Select was based on design specifications and compliance with FDA recognized consensus standards and FDA Guidances. These include:- Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8)
- Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005)
- Summative Usability Testing (IEC 62366)
- Performance Testing for Hysteroscopic and Laparoscopic Insufflators (Submission Guidance For A 510(K), August 1, 1995 for Product Code HIG)
- Additional bench testing against design specifications.
-
The sample size for the training set:
This information is not applicable as the device is not an AI/ML product developed using a training set in the conventional sense. Its development involved engineering design, software development, and testing against specifications. -
How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows 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.
October 31, 2018
Karl Storz SE & Co. KG Nina Dusper Regulatory Affairs Manager Dr.-Karl-Storz-StraBe 34 Tuttlingen, 78532 Germany
Re: K180735
Trade/Device Name: Endomat Select (Model Number: UP210) Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG. BTA. LJH. OCX. HRX. GWG. EOB Dated: July 30, 2018 Received: August 2, 2018
Dear Nina Dusper:
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 mav, 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 avare 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon M. Andrews -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180735
Device Name
Endomat Select (Model Number: UP210)
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 irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
· provide liquid distention 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 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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See PRA Statement below.
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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 OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KARL STORZ`s knowledge.
| Applicant: | KARL STORZ SE & Co. KGDr.-Karl-Storz-Straße 3478532 TuttlingenBaden-Württemberg, GERMANY |
|---|---|
| Contact: | Nina DusperRegulatory Affairs Manager+49 (0) 7461 708-8399+49 (0) 7461 708-105 |
| Date of Preparation: | 1st February 2018 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: Endomat Select (Model Number: UP210)Common Name: Suction Irrigation Pump |
| Regulation: | 21 CFR 884.1700 (Hysteroscopic Insufflator) |
| Class: | II |
| Product Code: | HIG: Hysteroscopic Insufflator |
| Additional Product Codes: | BTA: Pump, Portable, Aspiration (Manual or Powered)LJH: System, Irrigation, UrologicalOCX: Endoscopic Irrigation/Suction SystemHRX: Arthroscope |
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| GWG: Endoscope, neurological | |
|---|---|
| EOB: Nasopharyngoscope (flexible or rigid) | |
| Predicate Device(s): | World of Medicine AQUILEX FLUID CONTROL SYSTEMH112 (K112624),Applied Medical EPIX (K122619),World of Medicine Uro Pro (K042457),Karl Storz Endomat LC (K031457),Atherex Dual Wave Arthroscopy Pump (K083707),Karl Storz ClearVision (K072410),Karl Storz Clear Vision (K013838)The above predicates have not been subject to any recall |
| Device Description: | The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can beused for irrigation and, where appropriate dilation, duringHysteroscopic (HYS), Arthroscopic (ART), Urological(URO) and General Surgical or Laparoscopic (SURG)interventions. The device can be used for suction duringUrological (URO) interventions. In addition the device canfunction in an oscillatory mode (ENT/Neuro) providing afluid means to maintain lens clarity during use in Transnasalprocedures. The device has a modern LCD display withtouch screen user interface. The tubing sets are encoded sothat they can be identified by the device, which selects theappropriate operating modes based on the tubing setconnected. The device can also be connected to other KarlStorz devices using the proprietary Storz Control Bus (SCB)[K994348].The device protects the patient from overpressure viasoftware means. The software controlled pressuremeasurement system can stop the actuator (roller pump)should the pressure rise beyond the pre-determined limit and |
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Image /page/5/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.
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, 5 1, sterilizable | 20300050 | Class II510(k) Exempt |
| Cap for suction bottle 20 300050, 5 1 sterilizable | 20300034 | Class II510(k) Exempt |
| Metal filter | 20300038 | Class II510(k) Exempt |
| Bottle stand for suction bottle,5 I | 20300032 | Class II510(k) Exempt |
| Bottle stand holder | 20300033 | Class II510(k) Exempt |
| Suction bottle, 0,5 I, sterilizable | 20300051 | Class II510(k) Exempt |
| Cap, for suction bottle | 20300039 | Class II510(k) Exempt |
| Bottle stand, for suction bottle | 20300231 | Class II510(k) Exempt |
| Control cable | 20701070 | Class IIK973251 |
| Single pedal footswitch | 20014130 | Class IIK072410 |
| SCB connecting cord, length 100cm | 20090170 | Class IIK994348 |
| Tubing Set, Irrigation, PC, forsingle use, sterile, package of 10 | 031523-10 | Class I |
| Tubing Set, Suction, BS, for | 031647-10 | Class I |
| single use, sterile, package of 10 | ||
| Tubing Set, Suction, OS, for single use, sterile, package of 10 | 030647-10 | Class I |
| Tubing Set, Irrigation, FC, for single use, sterile, package of 10 | 031524-10 | Class I |
| Tubing Set, Irrigation, CV, for single use, sterile, package of 10 | 031529-10 | Class I |
| 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 irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures• provide liquid distention 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 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 |
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Image /page/6/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters.
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| assisted transnasal pituitary gland surgery | |||
|---|---|---|---|
| ** The above Indications for Use represent a combination of theindications for the cited predicate devices and therefore there is no newintended use. ** | |||
| TechnologicalCharacteristics: | The proposed subject device is a multifunctional design thatincorporates the functionality of multiple predicate devices.The technological differences between each of the subjectdevice's functions and the respective predicate devices aresummarized in the Table 1.1. below, and they do not raiseany different issues of safety and effectiveness. | ||
| Non-ClinicalPerformance Data: | The Endomat Select follows the FDA recognized consensusstandards and is tested according to the following standardsand FDA Guidances:Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-1-8 Software Verification and Validation Testing Guidance for the Content of PremarketSubmissions for Software Contained inMedical Devices issued on May 11, 2005 Level of Concern: Major Summative Usability Testing IEC 62366 Performance Testing Hysteroscopic and Laparoscopic Insufflators:Submission Guidance For A 510(K) issued onAugust 1, 1995 for Product Code HIG Performance tests of pressure controlledirrigation mode |
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Image /page/8/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.
| Performance tests of intrauterine pressure | |
|---|---|
| Additional bench testing was performed to ensure the device | |
| met its design specifications. | |
| Verification Test | Conclusion |
| Performance:Pressure Control | Pass |
| Performance:Flow Limitation | Pass |
| Performance:Flow Control | Pass |
| Performance:Pressure Limitation | Pass |
| Performance:Suction Control | Pass |
| Safety:Overpressure Warning (in pressure relevantGYN and URO interventions) | Pass |
| Safety:Overpressure Warning (in pressure relevantARTHRO interventions) | Pass |
| Safety:Overpressure Alarm(in pressure relevant GYN and UROinterventions) | Pass |
| Safety:Pressure Relief(in pressure relevant GYN and UROinterventions) | Pass |
| The bench testing performed verified and validated that theEndomat Select has met all its design specification and is | |
| substantially equivalent to its predicate devices. | |
| Clinical Performance Data: | Clinical testing was not required to demonstrate thesubstantial equivalence to the predicate devices. Non-clinicalbench testing was sufficient to assess safety and effectivenessand to establish the substantial equivalence. |
| Conclusion: | The non-clinical testing demonstrates that the device is assafe, as effective and performs as well as or better than thelegally marketed predicate devices. |
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Image /page/9/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
Table 1.1. Comparison of Technological Characteristics
| Subject Device | Predicate Devices by application | |||||||
|---|---|---|---|---|---|---|---|---|
| Karl Storz | Applied Medical | World of Medicine | World of Medicine | Karl Storz | Artherex | Karl Storz | Karl Storz | |
| Endomat Select | EPIX | AQUILEX FLUIDCONTROL SYSTEMH112 | Uro Pro | Endomat LC | Dual Wave ArthroscopyPump | Clearvision | ClearvisionLens Irrigation System | |
| Application | Multi | Surgery( Laparoscopy ) | Hysteroscopic | Urological | Urological Suction | Arthroscopic | Lens Cleaning | Lens Cleaning |
| Design | Microprocessorcontrolled, pressuremonitoring peristalticPump for irrigation orsuction. | Microprocessorcontrolled, peristalticpump for irrigationwith conduit forexternal suction. | Microprocessorcontrolled, pressuremonitoring peristalticpump for irrigationand/or suction. | Microprocessor controlled,pressure monitoringperistaltic pump forirrigation or suction. | Microprocessorcontrolled, peristalticpump for suction. | Microprocessorcontrolled, pressuremonitoring peristalticpump for irrigation andsuction. | Microprocessorcontrolled, oscillatoryperistaltic pump | Microprocessorcontrolled, oscillatoryperistaltic pump |
| Intended Use | Suction/irrigationpumps and theiraccessories are usedfor the introduction ofirrigation fluids intoorgans, joints andoperating fields as welas the suctioning off ofirrigation fluids andbodily fluids,secretions, tissue andgas during diagnosticor therapeuticinterventions. | The Epix® SuctionIrrigation System isintended as a generalpurpose suctionand/or irrigationdevice for use inlaparoscopic and opengeneral surgery,laparoscopic and opergynecological surgery,laparoscopic and openurologic surgery. Thisdevice delivers sterileirrigant solution andserves as a conduit forsuction. | Aquilex™ Fluid ControlSystem is intended toprovide liquiddistension of theuterus duringdiagnostic andoperativehysteroscopy, and tomonitor the volumedifferential betweenthe irrigation fluidflowing into and out ofthe uterus. | The URO Pro is an irrigationroller pump intended forthe infusion of sterilesolutions into the ureterand upper urinary tractduring diagnostic and/ortherapeutic endoscopicurologic procedures. It isindicated for the infusion ofsterile solutions through anendoscope into theurogenital tract to irrigatethe ureter or upper urinarytract in a controlledmanner and to improvevisibility of the surgicalfield during urologicprocedures. | Suction/irrigation pumpsand their accessories areused for the introductionof irrigation fluids intoorgans, joints andoperating fields as wellas the suctioning off ofirrigation fluids andbodily fluids, secretions,tissue and gas duringdiagnostic or therapeuticinterventions. | The AR-6480 is intendedto provide continuouspulse-free flow thatreacts immediately tochanges in the intra-articular pressure so thatjoint distention can besustained even underhigh shaver extractionvolumes or secondaryoutflow. | Irrigation pumps andtheir accessories areused for the introductionof irrigation fluids intoorgans and operatingfields during endoscopicinterventions. Theclearvision is a lensirrigation pump for thefields of ENT andNeurosurgery. | The KSEA Clearvision isa lens irrogation systemfor cleaning the lensand maintaining clearvisualization withoutremoving the scopefromthe surgical site duringsinus surgery. |
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Image /page/10/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.
KARL STORZ Premarket Notification
Endomat Select
Summary of Safety and Effectiveness
| HIG, BTA, LJH, OCX,HRX, GWG, EOB | BTA | HIG | LJH | OCX | HRX | GWG | EOB | |
|---|---|---|---|---|---|---|---|---|
| Procode | ||||||||
| Pressuremeasurementlocation and | Yes, dual pressuresensors at the pumphead | No pressuremeasurement | Yes, single transducerat the pump head | Yes, dual pressure sensorsat the pump head | No pressuremeasurement | Yes, dual sensor | No pressuremeasurement | No pressuremeasurement |
| Userinterface/Selectionof Application | LCD touch screen | Digital flowrate displayand membranebuttons | Digital display and button | Digital display andmembrane buttons | Digital flowrate displayand membrane buttons | LCD touch screen | On/Off | On/Off |
| OverpressureSafety | Yes, using softwareand roll pump reversal | No | Yes, using softwareand roll pump reversal | Yes, using software and rollpump reversal | N/A | Software controlledpump stops at>300mmHg (IFUrecommends manual | N/A | N/A |
| Features | ||||||||
| IndicatesOperating | Yes | No | Intrauterine | Yes | No | Yes | No | No |
| Alarm for overPressure | Yes | No | Yes | Yes | No | Yes | No | No |
| Volume differencemonitor | No | No | Yes | No | No | No | No | No |
| IndicatesOperating FluidFlow | Yes | Yes | No | Yes, nominal set point | No | No | No | No |
| Alarm for overFluid Flow | Yes | No | Yes | Yes | No | No | No | No |
| IndicatesMaximum SuctionPressure | No | No | No | No | No | No | No | No |
| Alarm for overSuction Pressure | No | No | No | No | No | No | No | No |
| Accessories | ||||||||
| Foot Switch | Yes | No | No | No | Yes | Yes | Yes | Yes |
| Tubing Sets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| External pressuresensor (optional) | No | No | No | No | No | No | No | No |
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Image /page/11/Picture/0 description: The image shows the logo for STORZ. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE", also written in blue. The logo is simple and professional.
Summary of Safety and Effectiveness
| Performance | ||||||||
|---|---|---|---|---|---|---|---|---|
| Irrigation Pressure | ||||||||
| Lap/Surgical | 100,300 and 500mmHg | Not Given | ||||||
| Hysteroscopic | 20-150mmHg | 40-150 mmHg | ||||||
| Urological | 20-150mmHg | 15-150 mmHg | ||||||
| Urological suction | N/A | N/A | ||||||
| Arthroscopy | 20-150mmHg | 10-120 mmHg | ||||||
| Clearvision | N/A | N/A | ||||||
| Clearvision | N/A | N/A | ||||||
| Irrigation Flow | ||||||||
| Lap/Surgical | 100-3500ml/min | 2, 3 or 4 L/min | ||||||
| Hysteroscopic | 200, 400, 600ml/min | 0-800ml/min | ||||||
| Urological | 200, 400, 600ml/min | 0-500ml/min | ||||||
| Urological suction | N/A | N/A | ||||||
| Arthroscopy | 1500,2000,2500ml/min | 0 - >1,500ml/min | ||||||
| Clearvision | 50,65,80,95,110,130ml/min | 85 ml/min | ||||||
| Clearvision | 50,65,80,95,110,130ml/min | 40 ml/min | ||||||
| Suction Pressure | ||||||||
| Lap/Surgical | N/A | N/A | ||||||
| Hysteroscopic | N/A | - 500 mmHg | ||||||
| Urological | N/A | N/A | ||||||
| Urological suction | -0.95 Bar (-712.5mmHg) | -0.95 Bar (-712.5mmHg) | ||||||
| Arthroscopy | N/A | Not Given | ||||||
| Clearvision | N/A | N/A | ||||||
| Clearvision | N/A | N/A | ||||||
| Suction Flow | ||||||||
| Lap/Surgical | N/A | N/A | ||||||
| Hysteroscopic | N/A | N/A | ||||||
| Urological Resection | 0-1000ml/min | N/A | ||||||
| Urological suction | 300-1000ml/min | 0-1000 ml/min | ||||||
| Arthroscopy | N/A | N/A | ||||||
| Clearvision | N/A | N/A | ||||||
| Clearvision | N/A | N/A |
§ 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.