Who is the manufacturer of Endomat Select, IBS Shaver Software, License?

Karl Storz SE & CO. KG filed the 510(k) submission for Endomat Select, IBS Shaver Software, License (K201355).

What is the FDA product code for Endomat Select, IBS Shaver Software, License?

HIG. It is classified under 21 CFR 884.1700 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Endomat Select, IBS Shaver Software, License?

510(k) clearance (submission type: Special).

What are the predicate devices for Endomat Select, IBS Shaver Software, License?

KARL STORZ Endomat Select (K180735); KARL STORZ HAMOU Endomat (K936231).

Who can help prepare an FDA 510(k) submission like Endomat Select, IBS Shaver Software, License?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Endomat Select, IBS Shaver Software, License

K201355 · Karl Storz SE & CO. KG · HIG · Jul 22, 2020 · Obstetrics/Gynecology

Device Facts

Record ID	K201355
Device Name	Endomat Select, IBS Shaver Software, License
Applicant	Karl Storz SE & CO. KG
Product Code	HIG · Obstetrics/Gynecology
Decision Date	Jul 22, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 884.1700
Device Class	Class 2
Attributes	Therapeutic

Indications for 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.

Device Story

Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction roller pump. It accepts sterile irrigant solutions as input and provides controlled infusion and suction during endoscopic, laparoscopic, and open surgical procedures. Operated by OR staff via an LCD touch screen, the device uses encoded tubing sets to automatically select operating modes. It integrates with other Karl Storz equipment via the Storz Control Bus (SCB). The device features software-controlled pressure monitoring to prevent overpressure; it stops the roller pump and reverses direction if limits are exceeded, while providing high-pressure alarms. User confirmation is required for pressures exceeding 100mmHg. By maintaining fluid flow and lens clarity, the device assists surgeons in visualization and tissue management, potentially improving procedural outcomes and patient safety.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical bench testing, including verification of operating mode activation, software installation, flow rate and pressure performance, accessory compatibility, error detection, and usability.

Technological Characteristics

Multi-functional, pressure-controlled, combined irrigation and suction roller pump. Features LCD touch screen interface and proprietary Storz Control Bus (SCB) connectivity. Uses encoded single-use sterile tubing sets for automatic mode selection. Software-controlled pressure measurement system with automated pump reversal for overpressure protection. Class II device.

Indications for Use

Indicated for patients undergoing diagnostic and operative endoscopic urological, hysteroscopic, laparoscopic, and arthroscopic procedures, as well as endoscopically assisted Functional Endoscopic Sinus Surgery and transnasal pituitary gland surgery, requiring infusion of sterile irrigant solutions and suctioning of fluids, secretions, tissue, and gas.

Regulatory Classification

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.

Predicate Devices

KARL STORZ Endomat Select (K180735)
KARL STORZ HAMOU Endomat (K936231)

Submission Summary (Full Text)

{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) K201355 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {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 | | {5}------------------------------------------------ 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 | | |…

Endomat Select, IBS Shaver Software, License

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Endomat Select, IBS Shaver Software, License

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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