ENDOFLATOR 40, ENDOFLATOR 50

K161554 · KARL STORZ Endoscopy-America, Inc. · HIF · Mar 2, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K161554
• Device Name: ENDOFLATOR 40, ENDOFLATOR 50
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

CO2 insufflators and their accessories are used to create and/or to distend a cavity during diagnostic or therapeutic endoscopic interventions.

Device Story

ENDOFLATOR 40 and 50 are microprocessor-controlled CO2 insufflators; used to create/distend cavities for diagnostic and therapeutic endoscopic procedures. Devices feature redundant pressure/flow monitoring, automatic pressure relief, and graphical user interface. ENDOFLATOR 50 includes integrated gas heater and user-saveable procedure settings. Operated by clinicians in clinical settings. Devices provide real-time display of pressure, flow rates, volume, and operating mode. Output informs clinician of cavity status; enables safe insufflation during procedures. Benefits include controlled, automated cavity distension for improved visualization and access during surgery.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including software verification/validation, electrical safety (IEC 60601-1), and performance testing (pressure/flow accuracy, overpressure safety, gas supply monitoring).

Technological Characteristics

Microprocessor-controlled CO2 insufflator. Features redundant pressure/flow sensors, automatic pressure relief valves, and graphical user interface. ENDOFLATOR 50 includes integrated gas heater. Connectivity: standalone. Software: major level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-18.

Indications for Use

Indicated for creating and/or distending a cavity in adult and pediatric patients during laparoscopy, endoscopy of the lower gastrointestinal tract (e.g., TEO, colonoscopy), and endoscopic vessel harvesting.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• World of Medicine's Insufflator 50L FM 134 (K153513)
• Olympus Medical Systems Corp's High Flow Insufflation Unit UHI-4 (K122180)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2017

Karl Storz Endoscopy-America, Inc. Nozomi Yagi, MAS, RAC Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K161554

Trade/Device Name: ENDOFLATOR 40 & 50 Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV, FCX Dated: January 26, 2017 Received: January 27, 2017

Dear Nozomi Yagi:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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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### Indications for Use

510(k) Number (if known) K161554

Device Name ENDOFLATOR 40&50

Indications for Use (Describe) The ENDOFLATOR 40 & 50 are used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions:

- · Laparoscopy
- · Pediatric Laparoscopy
- · Endoscopy of the Lower Gastrointestinal Tract (e.g., TEO, colonoscopy)
- · Endoscopic Vessel Harvesting

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

## 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. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Submitter: | KARL STORZ Endoscopy-America, Inc.<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of<br>Preparation: | February 28, 2017 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: ENDOFLATOR 40 and ENDOFLATOR 50<br>Classification Name: Insufflator, Laparoscopic (21 CFR Part<br>884.1730) |
| Regulatory<br>Class: | II |
| Product Code: | HIF (Insufflator, Laparoscopic),<br>OSV(Insufflator, Endoscopic Vessel Harvesting),<br>FCX(Insufflator, Automatic Carbon-Dioxide For Endoscope) |
| Guidance<br>Document: | Hysteroscopic and Laparoscopic Insufflators: Submission Guidance<br>for a 510(k) issued on August 1, 1995 for Product Code HIF |
| Predicate<br>Device(s): | Primary Predicate Device: World of Medicine's Insufflator 50L FM<br>134 (K153513)<br>Second Predicate Device: Olympus Medical Systems Corp's High<br>Flow Insufflation Unit UHI-4 (K122180) |
| Device<br>Description: | This submission includes two microprocessor controlled CO2<br>insufflators that have been developed in parallel: ENDOFLATOR 40<br>(Model Number: UI400) and ENDOFLATOR 50 (Model Number:<br>U1500), both of which come with HIGH FLOW and PEDIATRICS<br>modes. The HIGH FLOW mode has the pressure range of 1-30 mmHg<br>and the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50<br>LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure |

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Image /page/4/Picture/0 description: The image is a 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.

| | range of 1-15 mmHg and the flow range of 0.1-15 LPM. | | | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|
| | The ENDOFLATOR 40 &50 have redundant pressure and flow<br>monitoring, automatic pressure relief, user control via graphical user<br>interface and display of pressures/flow rates/ volume/operating mode. | | | | |
| | The ENDOFLATOR 50 has three extra features not included in the<br>the integrated gas heater, it can only be used with non-heated<br>insufflation tubing set (Model Number: 031200-01). On the other<br>hand, the ENDOFLATOR 50 (Model Number: UI500) can be used<br>with either the non-heated insufflation tubing set (Model Number:<br>031200-01) or the heatable insufflation tubing set (Model Number:<br>031210-01). | | ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2)<br>the integrated gas heater, and (3) the ability for the user to save up to<br>30 procedure settings. Because the ENDOFLATOR 40 does not have | | |
| Intended Use: | CO2 insufflators and their accessories are used to create and/or to<br>distend a cavity during diagnostic or therapeutic endoscopic<br>interventions. | | | | |
| Indications For<br>Use, | Subject Device | Primary predicate<br>device, K153513 | Secondary predicate<br>device, K122180 | | |
| Comparison | ENDOFLATOR<br>40&50 | W.O.M. Insufflator<br>50L FM134 | Olympus High Flow<br>Insufflation Unit UHI-<br>4 | | |
| | Indication for Use | | | | |
| | The ENDOFLATOR<br>40&50 are used to create<br>and/or to distend a cavity<br>in the following diagnostic<br>and therapeutic<br>interventions: | The Standard, Pediatric<br>and Bariatric operating<br>modes of the device are<br>indicated to fill and<br>distend a peritoneal cavity<br>with gas during a<br>laparoscopic procedure. | This instrument is<br>intended to insufflate the<br>abdominal cavity and<br>provides automatic suction<br>and smoke evacuation to<br>facilitate laparoscopic<br>observation, diagnosis and | | |
| | Technological<br>Characteristics: | W.O.M. Insufflator 50L FM134 was chosen for having the Indication<br>for Use and Technological Characteristics most similar to the subject<br>device. The subject device differs from the primary predicate in that<br>an operation mode is not specific to indicated intervention; the subject<br>device has HIGH FLOW mode to cover laparoscopy, endoscopy of<br>lower GI tract, and endoscopic vessel harvesting indications and<br>PEDIATRICS mode to cover pediatric laparoscopy indication.<br>Olympus' High Flow Insufflation Unit UHI-4 was chosen as a<br>secondary predicate device to support the substantial equivalence of<br>the additional anatomical location of use (i.e., colon) that the primary<br>predicate does not include.<br>The subject device has the same Intended Use as both primary and<br>secondary predicate devices.<br>The subject and both primary and secondary predicate devices are CO2<br>insufflators that are used to create and maintain the cavity. There are<br>similarities and differences in the technological characteristics<br>including but not limited to the following: | | | |
| | | Subject Device | Primary predicate<br>device, K153513 | Secondary<br>predicate device,<br>K122180 | |
| | Distension<br>Medium | CO2 | Same as the subject<br>device | Same as the subject<br>device | |
| | Indicated<br>Population | Adult and Pediatric | Same as the subject<br>device | Adult | |
| | Modes | High Flow,<br>Pediatrics | Bariatric,<br>Standard,<br>Vessel Harvest,<br>Pediatric | Normal Cavity,<br>Small Cavity | |
| | Maximum<br>Flow Rate | 50 LPM | Same as the subject<br>device | 45 LPM | |
| | Maximum<br>Pressure | 30 mmHg | Same as the subject<br>device | 25 mmHg | |
| | Overpressure<br>Action | Visual and audible<br>alarms followed by<br>pressure relief after 5<br>seconds | Visual and audible<br>alarms followed by<br>pressure relief after 2-<br>5 seconds | Visual and audible<br>alarms followed by<br>pressure relief after 0<br>or 4.5 seconds | |
| | Gas Supply<br>Shortage<br>Action | When cylinder<br>pressure is below 1<br>bar, visual and<br>audible alarms will be<br>activated and<br>insufflation stops | At <15 bar, visual and<br>audible alarms will be<br>activated and<br>insufflation stops | When cylinder<br>pressure is below 0.1<br>MPa (1 bar), visual<br>and audible alarms<br>will be activated and<br>insufflation stops | |
| | Over<br>Temperature<br>Action | At >41°C,<br>Information signal<br>indicates that heating<br>is switched off | At >42°C, visual and<br>audible alarm | N/A, gas is not heated | |

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Image /page/5/Picture/0 description: The image is a 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.

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Image /page/6/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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

| | The differences do not raise different questions of safety and<br>effectiveness. | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Non-Clinical<br>Performance<br>Data: | The ENDOFLATOR 40 & 50 is tested according to the following<br>standards:<br>• IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + AM1<br>(2012)<br>• IEC 60601-1-2:2014<br>• IEC 60601-1-18:2006/AMD1:2012<br>Software verification and validation testing were conducted and<br>documentation was provided as recommended by FDA's Guidance for<br>Industry and FDA Staff titled Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Devices. The software<br>for this device was considered as a "major" level of concern, since a<br>failure or latent flaw in the software could directly result in serious<br>injury or death to the patient or operator.<br>In addition, the following bench testing has been performed for<br>following safety and performance requirements as well as for<br>comparative purposes: | | |
| | Bench Testing Summary<br>Verification Test<br>(Test#) | Acceptance Criteria | Conclusion |
| | Safety - Overpressure | The device informs user, if an unintended<br>high cavity pressure is measured and<br>activates appropriate valves if the<br>activation threshold is exceeded. | Pass |
| | Performance -- Pressure | The difference between the measured and<br>the set point pressures is within the<br>specified limits. | Pass |
| | Safety -Maximum pressure | The measured pressure shall not exceed the<br>mode related specified limits. | Pass |
| | Safety - Overpressure | The gas flow is stopped if a cavity pressure<br>is measured is higher than mode related<br>limits. | Pass |
| | Performance - Gas supply | The device informs the user if the pressure<br>gas supply falls under specified limits. | Pass |
| | Performance -- Flow | The difference between the measured and<br>the set point flow is within the specified<br>limits. | Pass |
| | Safety - Pressure Controller | The pressure controller temperature shall<br>stain within the specified limits. | Pass |
| | Safety - Overtemperature | (ENDOFLATOR 50 only)<br>The heater is switched off if the fault<br>arises. | Pass |
| | | | |
| | Performance - Heater<br>connection symbol | specified limits.<br>(ENDOFLATOR 50 only)<br>The heater connection symbol is correctly<br>displayed. | Pass |
| | Comparative -- Adult and<br>Pediatric Laparoscopy | To support laparoscopy indication of the<br>subject device, the pressure control of High<br>Flow mode must be substantially<br>equivalent to the primary predicate<br>device's Standard/Bariatric modes and the<br>secondary predicate device's Normal<br>Cavity mode.<br>Similarly, to support Pediatric Laparoscopy<br>indication of the subject device, the<br>pressure control of Pediatrics mode must be<br>substantially equivalent to the primary<br>predicate device's Pediatric mode. | SE to<br>predicate<br>devices |
| | Comparative - Lower<br>Gastrointestinal Tract | In order to support lower gastrointestinal<br>indication of the subject device, the<br>pressure control of High Flow mode must<br>be substantially equivalent to the secondary<br>predicate device's Small Cavity mode. | SE to<br>predicate<br>devices |
| | Comparative - Endoscopic<br>Vessel Harvesting | In order to support Endoscopic Vessel<br>Harvesting indication of the subject device,<br>the pressure control of High Flow mode<br>must be substantially equivalent to the<br>primary predicate device's Vessel<br>Harvesting mode and the secondary<br>predicate device's Small Cavity mode. | SE to<br>predicate<br>devices |
| Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate devices. Non-clinical bench testing was<br>sufficient to assess safety and effectiveness and to establish the<br>substantial equivalence of the modifications. | | |
| Conclusion: | The conclusions drawn from the nonclinical tests such as the software<br>data, the electrical safety and performance data, as well as the bench<br>top performance data, demonstrated the subject device is as safe as<br>and as effective as the primary and secondary predicate devices. As<br>such, we concluded that the substantial equivalence of the subject and<br>both predicate devices has been met. | | |

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Image /page/7/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.