This submission includes two microprocessor controlled CO2 insufflators that have been developed in parallel: ENDOFLATOR 40 (Model Number: UI400) and ENDOFLATOR 50 (Model Number: U1500), both of which come with HIGH FLOW and PEDIATRICS modes. The HIGH FLOW mode has the pressure range of 1-30 mmHg and the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50 LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure range of 1-15 mmHg and the flow range of 0.1-15 LPM.
The ENDOFLATOR 40 &50 have redundant pressure and flow monitoring, automatic pressure relief, user control via graphical user interface and display of pressures/flow rates/ volume/operating mode.
The ENDOFLATOR 50 has three extra features not included in the ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2) the integrated gas heater, and (3) the ability for the user to save up to 30 procedure settings. Because the ENDOFLATOR 40 does not have the integrated gas heater, it can only be used with non-heated insufflation tubing set (Model Number: 031200-01). On the other hand, the ENDOFLATOR 50 (Model Number: UI500) can be used with either the non-heated insufflation tubing set (Model Number: 031200-01) or the heatable insufflation tubing set (Model Number: 031210-01).

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (ENDOFLATOR 40 & 50), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a statistical meets of performance. Therefore, many of the requested details about acceptance criteria for AI algorithms, such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, and detailed ground truth establishment, are not applicable to this type of regulatory submission and are not found in the document.

This document describes a physical medical device (laparoscopic insufflator), not an AI algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and functional performance tests for the insufflator itself, not measures of AI diagnostic accuracy.

However, I can extract the information that is present concerning the device's non-clinical performance data which serves as its "acceptance criteria" and "proof of meeting criteria."

Acceptance Criteria and Device Performance for ENDOFLATOR 40 & 50 (Non-Clinical Bench Testing)

The document details performance and safety criteria for the insufflator, verified through bench testing. The "acceptance criteria" for this device are defined by its ability to meet specified limits and functions during these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Verification Test	Acceptance Criteria	Reported Device Performance
Safety - Overpressure	The device informs user, if an unintended high cavity pressure is measured and activates appropriate valves if the activation threshold is exceeded.	Pass
Performance - Pressure	The difference between the measured and the set point pressures is within the specified limits.	Pass
Safety - Maximum pressure	The measured pressure shall not exceed the mode related specified limits.	Pass
Safety - Overpressure	The gas flow is stopped if a cavity pressure is measured is higher than mode related limits.	Pass
Performance - Gas supply	The device informs the user if the pressure gas supply falls under specified limits.	Pass
Performance - Flow	The difference between the measured and the set point flow is within the specified limits.	Pass
Safety - Pressure Controller	The pressure controller temperature shall stain within the specified limits.	Pass
Safety - Overtemperature	(ENDOFLATOR 50 only) The heater is switched off if the fault arises.	Pass
Performance - Heater connection symbol	(ENDOFLATOR 50 only) The heater connection symbol is correctly displayed.	Pass
Comparative - Adult and Pediatric Laparoscopy	To support laparoscopy indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Standard/Bariatric modes and the secondary predicate device's Normal Cavity mode. Similarly, to support Pediatric Laparoscopy indication of the subject device, the pressure control of Pediatrics mode must be substantially equivalent to the primary predicate device's Pediatric mode.	SE to predicate devices
Comparative - Lower Gastrointestinal Tract	In order to support lower gastrointestinal indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the secondary predicate device's Small Cavity mode.	SE to predicate devices
Comparative - Endoscopic Vessel Harvesting	In order to support Endoscopic Vessel Harvesting indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Vessel Harvesting mode and the secondary predicate device's Small Cavity mode.	SE to predicate devices

2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "bench testing" but does not specify the sample size of devices or the number of tests performed. It states "Software verification and validation testing were conducted," and "bench testing has been performed for following safety and performance requirements." Given this is a hardware device, "test set" here refers to the physical units undergoing testing, not a dataset in the AI sense.
Data provenance: Not explicitly stated beyond "bench testing." It is implied to be internal testing by the manufacturer (Karl Storz Endoscopy-America, Inc.) as part of their submission. It is a retrospective summary of performed tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth for a physical device's performance (e.g., pressure, flow rate accuracy) is established through engineering specifications, calibration standards, and direct measurement by instruments, not human experts.

4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-expert consensus in AI ground truth establishment. For a physical device, performance is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI-assisted device, nor a diagnostic imaging device requiring human reader studies. The "comparative" tests listed were to show "substantial equivalence" of the device's technical specifications and intended use to existing predicate devices, not improvement of human reader performance with AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in the sense that the device's performance was tested independently of human operation. The tests mentioned are for the device itself (e.g., pressure control, flow rate, safety mechanisms) and determine its inherent operational characteristics.

7. The Type of Ground Truth Used:
Technical specifications and direct objective measurements against calibrated instruments and pre-defined engineering limits. For example, "The difference between the measured and the set point pressures is within the specified limits."

8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for a machine learning model. Software validation and verification (mentioned as IEC 60601-1-18 relevant and a "major" level of concern) refer to traditional software development and testing, not AI model training.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED:

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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.2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Nozomi YagiRegulatory Affairs SpecialistPhone: (424) 218-8351Fax: (424) 218-8519
Date ofPreparation:	February 28, 2017
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: ENDOFLATOR 40 and ENDOFLATOR 50Classification Name: Insufflator, Laparoscopic (21 CFR Part884.1730)
RegulatoryClass:	II
Product Code:	HIF (Insufflator, Laparoscopic),OSV(Insufflator, Endoscopic Vessel Harvesting),FCX(Insufflator, Automatic Carbon-Dioxide For Endoscope)
GuidanceDocument:	Hysteroscopic and Laparoscopic Insufflators: Submission Guidancefor a 510(k) issued on August 1, 1995 for Product Code HIF
PredicateDevice(s):	Primary Predicate Device: World of Medicine's Insufflator 50L FM134 (K153513)Second Predicate Device: Olympus Medical Systems Corp's HighFlow Insufflation Unit UHI-4 (K122180)
DeviceDescription:	This submission includes two microprocessor controlled CO2insufflators that have been developed in parallel: ENDOFLATOR 40(Model Number: UI400) and ENDOFLATOR 50 (Model Number:U1500), both of which come with HIGH FLOW and PEDIATRICSmodes. The HIGH FLOW mode has the pressure range of 1-30 mmHgand the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure

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	range of 1-15 mmHg and the flow range of 0.1-15 LPM.
	The ENDOFLATOR 40 &50 have redundant pressure and flowmonitoring, automatic pressure relief, user control via graphical userinterface and display of pressures/flow rates/ volume/operating mode.
	The ENDOFLATOR 50 has three extra features not included in thethe integrated gas heater, it can only be used with non-heatedinsufflation tubing set (Model Number: 031200-01). On the otherhand, the ENDOFLATOR 50 (Model Number: UI500) can be usedwith either the non-heated insufflation tubing set (Model Number:031200-01) or the heatable insufflation tubing set (Model Number:031210-01).		ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2)the integrated gas heater, and (3) the ability for the user to save up to30 procedure settings. Because the ENDOFLATOR 40 does not have
Intended Use:	CO2 insufflators and their accessories are used to create and/or todistend a cavity during diagnostic or therapeutic endoscopicinterventions.
Indications ForUse,	Subject Device	Primary predicatedevice, K153513	Secondary predicatedevice, K122180
Comparison	ENDOFLATOR40&50	W.O.M. Insufflator50L FM134	Olympus High FlowInsufflation Unit UHI-4
	Indication for Use
	The ENDOFLATOR40&50 are used to createand/or to distend a cavityin the following diagnosticand therapeuticinterventions:	The Standard, Pediatricand Bariatric operatingmodes of the device areindicated to fill anddistend a peritoneal cavitywith gas during alaparoscopic procedure.	This instrument isintended to insufflate theabdominal cavity andprovides automatic suctionand smoke evacuation tofacilitate laparoscopicobservation, diagnosis and
	TechnologicalCharacteristics:	W.O.M. Insufflator 50L FM134 was chosen for having the Indicationfor Use and Technological Characteristics most similar to the subjectdevice. The subject device differs from the primary predicate in thatan operation mode is not specific to indicated intervention; the subjectdevice has HIGH FLOW mode to cover laparoscopy, endoscopy oflower GI tract, and endoscopic vessel harvesting indications andPEDIATRICS mode to cover pediatric laparoscopy indication.Olympus' High Flow Insufflation Unit UHI-4 was chosen as asecondary predicate device to support the substantial equivalence ofthe additional anatomical location of use (i.e., colon) that the primarypredicate does not include.The subject device has the same Intended Use as both primary andsecondary predicate devices.The subject and both primary and secondary predicate devices are CO2insufflators that are used to create and maintain the cavity. There aresimilarities and differences in the technological characteristicsincluding but not limited to the following:
		Subject Device	Primary predicatedevice, K153513	Secondarypredicate device,K122180
	DistensionMedium	CO2	Same as the subjectdevice	Same as the subjectdevice
	IndicatedPopulation	Adult and Pediatric	Same as the subjectdevice	Adult
	Modes	High Flow,Pediatrics	Bariatric,Standard,Vessel Harvest,Pediatric	Normal Cavity,Small Cavity
	MaximumFlow Rate	50 LPM	Same as the subjectdevice	45 LPM
	MaximumPressure	30 mmHg	Same as the subjectdevice	25 mmHg
	OverpressureAction	Visual and audiblealarms followed bypressure relief after 5seconds	Visual and audiblealarms followed bypressure relief after 2-5 seconds	Visual and audiblealarms followed bypressure relief after 0or 4.5 seconds
	Gas SupplyShortageAction	When cylinderpressure is below 1bar, visual andaudible alarms will beactivated andinsufflation stops	At <15 bar, visual andaudible alarms will beactivated andinsufflation stops	When cylinderpressure is below 0.1MPa (1 bar), visualand audible alarmswill be activated andinsufflation stops
	OverTemperatureAction	At >41°C,Information signalindicates that heatingis switched off	At >42°C, visual andaudible alarm	N/A, gas is not heated

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	The differences do not raise different questions of safety andeffectiveness.
Non-ClinicalPerformanceData:	The ENDOFLATOR 40 & 50 is tested according to the followingstandards:• IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + AM1(2012)• IEC 60601-1-2:2014• IEC 60601-1-18:2006/AMD1:2012Software verification and validation testing were conducted anddocumentation was provided as recommended by FDA's Guidance forIndustry and FDA Staff titled Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices. The softwarefor this device was considered as a "major" level of concern, since afailure or latent flaw in the software could directly result in seriousinjury or death to the patient or operator.In addition, the following bench testing has been performed forfollowing safety and performance requirements as well as forcomparative purposes:
	Bench Testing SummaryVerification Test(Test#)	Acceptance Criteria	Conclusion
	Safety - Overpressure	The device informs user, if an unintendedhigh cavity pressure is measured andactivates appropriate valves if theactivation threshold is exceeded.	Pass
	Performance -- Pressure	The difference between the measured andthe set point pressures is within thespecified limits.	Pass
	Safety -Maximum pressure	The measured pressure shall not exceed themode related specified limits.	Pass
	Safety - Overpressure	The gas flow is stopped if a cavity pressureis measured is higher than mode relatedlimits.	Pass
	Performance - Gas supply	The device informs the user if the pressuregas supply falls under specified limits.	Pass
	Performance -- Flow	The difference between the measured andthe set point flow is within the specifiedlimits.	Pass
	Safety - Pressure Controller	The pressure controller temperature shallstain within the specified limits.	Pass
	Safety - Overtemperature	(ENDOFLATOR 50 only)The heater is switched off if the faultarises.	Pass

	Performance - Heaterconnection symbol	specified limits.(ENDOFLATOR 50 only)The heater connection symbol is correctlydisplayed.	Pass
	Comparative -- Adult andPediatric Laparoscopy	To support laparoscopy indication of thesubject device, the pressure control of HighFlow mode must be substantiallyequivalent to the primary predicatedevice's Standard/Bariatric modes and thesecondary predicate device's NormalCavity mode.Similarly, to support Pediatric Laparoscopyindication of the subject device, thepressure control of Pediatrics mode must besubstantially equivalent to the primarypredicate device's Pediatric mode.	SE topredicatedevices
	Comparative - LowerGastrointestinal Tract	In order to support lower gastrointestinalindication of the subject device, thepressure control of High Flow mode mustbe substantially equivalent to the secondarypredicate device's Small Cavity mode.	SE topredicatedevices
	Comparative - EndoscopicVessel Harvesting	In order to support Endoscopic VesselHarvesting indication of the subject device,the pressure control of High Flow modemust be substantially equivalent to theprimary predicate device's VesselHarvesting mode and the secondarypredicate device's Small Cavity mode.	SE topredicatedevices
ClinicalPerformanceData:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to assess safety and effectiveness and to establish thesubstantial equivalence of the modifications.
Conclusion:	The conclusions drawn from the nonclinical tests such as the softwaredata, the electrical safety and performance data, as well as the benchtop performance data, demonstrated the subject device is as safe asand as effective as the primary and secondary predicate devices. Assuch, we concluded that the substantial equivalence of the subject andboth predicate devices has been met.

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Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.