(62 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 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 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
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.
The provided text describes a 510(k) submission for the "Endomat Select" device and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a specific study, nor does it present the results of a study designed to prove the device meets such criteria.
The document primarily focuses on establishing substantial equivalence through a comparison of the Endomat Select's indications for use, technological characteristics, and non-clinical performance data against two predicate devices (KARL STORZ Endomat Select (K180735) and KARL STORZ HAMOU Endomat (K936231)).
However, I can extract information related to the performance data and "acceptance criteria" in a general sense, as implied by the "Pass" status for various verification tests.
Here's the information based on the provided document, addressing your numbered points where possible, and indicating where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide explicit numeric acceptance criteria. Instead, it lists "Verification Tests" and indicates they "Pass," implying that the device met pre-defined internal specifications.
| Verification Test (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| 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 |
| Overall Conclusion: | Met all design specifications |
| Conclusion for Substantial Equivalence: | As safe and effective as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The tests are described as "bench testing," which implies laboratory or engineering testing, but the number of units or test runs is not mentioned.
- Data Provenance: Not specified, but generally, bench testing would originate from the manufacturer's R&D or testing facilities (Germany, given the applicant's address). The data is retrospective (i.e., conducted before the 510(k) submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This type of information (experts establishing ground truth) is typically relevant for studies involving subjective human interpretation, such as image analysis for diagnostic accuracy. The reported tests are objective performance verification tests for a medical device (a pump).
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, again, relevant to subjective assessments rather than objective device performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices." MRMC studies are clinical studies involving human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not a software algorithm device. The Endomat Select is a hardware device (a pump) with software control for pressure measurement and operation modes. The performance tests are for the physical device's function, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
- Objective Device Specifications/Design Requirements. For performance tests like flow rate and pressure, the "ground truth" would be the pre-defined target values and tolerances specified in the device's design and engineering documents. For safety and usability, it would involve adherence to relevant standards and risk analyses.
8. The Sample Size for the Training Set
- Not Applicable. This concept is relevant for machine learning algorithms. The Endomat Select is a electromechanical medical device; it does not "train" on a dataset in the way an AI algorithm does. Its software logic is programmed based on engineering principles and design specifications.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As noted above, there is no "training set" for this type of device. The functional specifications and safety parameters are established through engineering design, risk assessment, and compliance with medical device standards.
Summary of Device and Study:
The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump intended for various endoscopic surgical procedures. The substantial equivalence documentation highlights its expanded hysteroscopy suction mode compared to a primary predicate, while maintaining similarity to a secondary predicate's features.
The "study" to prove the device meets acceptance criteria was a series of non-clinical bench tests. These tests verified and validated that the Endomat Select met its design specifications for operating mode activation, software installation, flow rate performance, pressure performance, accessory compatibility, error detection, and usability. The results showed that all these tests passed, leading to the conclusion that the device is as safe and effective as its predicate devices, rendering clinical testing unnecessary for this 510(k) submission.
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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.
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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
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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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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. KGDr.-Karl-Storz-Straße 3478532 Tuttlingen, Germany |
|---|---|
| Contact: | Alexey DavidovManager Regulatory Affairs, US SubmissionsPhone: +49 (0)7461 708-7909Fax: +49 (0)7461 708-75095Email: Alexey.Davidov@karlstorz.com |
| Date ofPreparation: | July 21, 2020 |
| Type of 510(k)Submission: | Special |
| DeviceIdentification: | Trade Name: Endomat SelectCommon Name: Suction Irrigation PumpClassification Name: Hysteroscopic insufflator (21 CFR Part 884.1700) |
| Class: | II |
| Product Codes: | Primary: HIGSecondary: BTA, GWG, HRX, LJH, OCX, EOB |
| Regulation: | 884.1700 - Hysteroscopic insufflator |
| PredicateDevice: | 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. |
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| Device Description: | The Endomat Select is a multi-functional, pressure-controlled, combined irrigationand suction pump. It can be used for irrigation and, where appropriate dilation,during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and GeneralSurgical or Laparoscopic (SURG) interventions. The device can be used for suctionduring Urological (URO) and Hysteroscopic (IBS) interventions. In addition, thedevice can function in an oscillatory mode (ENT/Neuro) providing a fluid means tomaintain lens clarity during use in Transnasal procedures. The device has a modernLCD display with touch screen user interface. The tubing sets are encoded so thatthey can be identified by the device, which selects the appropriate operating modesbased on the tubing set connected. 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 via software means. The software-controlled pressure measurement system can stop the actuator (roller pump) shouldthe pressure rise beyond the pre-determined limit and will immediately reverse thepump roller direction to depressurize the fluid system if required. Additionally, thedevice has high pressure alarms to alert the operating room staff of a high-pressuresituation. The device also requires positive action from the user to increasepressures above 100mmHg; the user is prompted to confirm their choice on the userinterface.The accessories for this device are provided separately. All of the accessories for usewith this device are already marketed in the U.S. and are either Class I, Class II510(k) exempt or Class II previously cleared devices. The generic tubing sets for usewith 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 forUse -Comparison toPredicateDevices | Primary Predicate Device (K180735) |
| Endomat Select is intended to: | |
| -provide the infusion of the sterile irrigant solutions into the ureter and upperurinary 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 fieldsduring diagnostic and operative procedures in laparoscopic and open generalsurgery | |
| -provide sustained liquid distension of the joint or intra-articular spaces during allphases of arthroscopic surgery | |
| -provide the infusion of the sterile irrigant solutions in order to enable the LensCleaning during endoscopically assisted Functional Endoscopic Sinus Surgery andendoscopically assisted Transnasal Pituitary Gland Surgery | |
| Secondary Predicate Device (K936231) | |
| The Karl Storz HAMOU Endomat is a dual purpose pump system for the controlledinfusion and aspiration of sterile solutions into body cavities, under control of thephysician, for laparoscopic and hysteroscopic procedures. In the laparoscopic modethe suction/irrigation pump is used to infuse and aspirate sterile irrigation solutioninto the peritoneal cavity for rinsing or removing carbon deposits, blood clots, orexcised tissue during laparoscopic and pelviscopic procedures. In the hysteroscopicmode the suction/ irrigation pump is used to infuse and aspirate sterile irrigationsolution 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 ofthe uterus during diagnostic and operative hysteroscopy. | |
| Comparison | |
| The subject device expands the indications of use of the primary predicate device toinclude suctioning off the irrigation fluids, bodily fluids, secretions, tissue and gasduring diagnostic and operative endoscopic hysteroscopic procedures. Thisexpanded indication for use is similar to that of the secondary predicate device;however, the secondary predicate device does not have indications for the othersurgical areas (i.e. urological, general surgery, arthroscopic, etc.) listed under thesubject device. | |
| The subject device does not represent a new intended use as compared to theprimary and secondary predicate devices. |
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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.
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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".
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Predicate Devices | |||
|---|---|---|---|---|
| Subject Device | Primary PredicateDevice K180785 | Secondary PredicateDeviceK936231 | ||
| Device Design | Endomat Select UP210 | Microprocessor controlled, pressuremonitoring peristaltic pump for irrigationand flow controlled peristaltic pump forsuction | HAMOU EndomatMicroprocessor controlled,pressure monitoringperistaltic pump forirrigation, pressuremonitoring vacuum pumpfor suction | |
| Device Type | Roller-pump | Suction: Vacuum-pump | ||
| OperatingModes(Irrigation) | General and Laparoscopic Surgery,Hysteroscopy, Urology, Arthroscopy, LensCleaning | LaparoscopyHysteroscopy | ||
| OperatingModes(Suction) | HysteroscopyUrology | Urology | LaparoscopyHysteroscopy | |
| Input/OutputDevices | LED touch screen | LED light bars with foilkeyboard | ||
| Suction FlowRate | Hyst: 100-300 ml/minUro: 100-1000 ml/min (RES mode) | 300-1000 ml/min (Calcusion mode) | n/a | |
| SuctionPressure | Hyst: max. -0.75bar (-562.5mmHg)Uro: max. -0.95bar(-712.5 mmHg) | Uro: max. -0.95 bar(-712.5 mmHg) | Lap: max. -0.8 bar (-600mmHg)Hyst: max. -0.5 bar (-375mmHg) | |
| The subject device features a hysteroscopy suction mode that is not present in theprimary predicate device; however, it is similar to a technological feature of thesecondary predicate device. Otherwise, the subject device and primary predicatedevice are identical.The differences in technological characteristics do not raise different questions ofsafety and effectiveness. | ||||
| Non-ClinicalPerformanceData: | 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 metall its design specifications. | ||||
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantial equivalence to thepredicate devices. |
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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 isas safe and effective as the predicate devices. |
§ 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.