The device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

Device Description

The Insufflator 50L FM134 is a microprocessor controlled CO2 insufflator that consists of the following major components and features: a casing, a world power supply, pressure reducers, a venting system, redundant pressure measurement, a fluid sensor, a gas heater, a software controlled graphical user interface (GUI) touch screen and various setting keys and display elements. The Insufflator 50L FM134 is not intended to enter the sterile field, and cannot be sterilized. The device is to be used with specially designed single-use tube sets that are delivered sterile. Specifically, the proposed device is to be used with a single-use tube set with heating wire and integrated filter or with a single-use tube set with integrated filter but without heating wire.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Insufflator 50L FM134. However, it does not detail specific acceptance criteria or an overarching study proving the device meets acceptance criteria in the way one might expect for a diagnostic or prognostic AI/ML device (e.g., sensitivity, specificity, AUC thresholds).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" can be inferred from the standards and comparisons performed.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device (CO2 insufflator) and not an AI/ML diagnostic, the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity but rather compliance with safety, performance, and biocompatibility standards, and comparability to predicate devices.

Acceptance Criterion (Inferred from tests performed)	Reported Device Performance (Summary from study)
Electrical Safety (IEC 60601-1:2005)	- Conforms to the standard.
Electromagnetic Compatibility (IEC 60601-1-2:2007)	- Conforms to the standard.
Software Development & Verification	- Developed, tested, and verified in accordance with "Software Contained in Medical Devices" guidance and IEC 62304:2006. - Design verification demonstrates the device performs as intended and does not raise new questions of safety and effectiveness.
Comparative Bench Testing (vs. 45L Core Insufflator F114)	- Reaching set pressure: Comparable to predicate. - Compensation of small and large leakages: Comparable to predicate. - Overpressure scenarios: Comparable to predicate. - Maximum flow rate (50 l/min vs. 45 l/min): Leads on average to a slightly better insufflation performance compared to the predicate device 45L Core Insufflator. Also substantially equivalent to Nebulae™ I 50 LPM Insufflator for this characteristic.
Biocompatibility (ISO 10993 series)	- Cytotoxicity: Conforms to ISO 10993-5:2009. - Irritation and Skin Sensitization: Conforms to ISO 10993-10:2010. - Systemic Toxicity: Conforms to ISO 10993-11:2006. - Chemical Characterization (for heated tube set): Conforms to ISO 10993 - 18:2005.
ETO Sterilization Validation (Tube Sets)	- EO & ECH Residuals: Limit of EO < 4 mg and ECH < 5 mg (after 10 days aeration) not exceeded. - Sterility Assurance Level (SAL): < 10^-6. - Conforms to: ISO 11135-1:2007, ISO 14937:2009, ISO 10993-7:2008, AAMI TIR 28:2009.
Package & Product Integrity (Tube Sets)	- Conforms to ISO 11607-1 and ASTM-F-1980:2002.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of patient data or case numbers for the performance tests. The tests performed are primarily laboratory-based bench tests (e.g., electrical safety, EMC, software verification, comparative performance of insufflation characteristics, biocompatibility of materials, sterilization validation).
Data Provenance: The tests were performed by "independent laboratories" (for electrical safety and EMC) and implicitly by the manufacturer or their designated testing facilities for others. The nature of the device (insufflator) means there wouldn't typically be "country of origin of the data" in the sense of clinical patient data, nor is it described as retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The "ground truth" for this device's evaluation is based on established engineering standards, physical performance measurements, and biological compatibility standards, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where there might be disagreement among experts. The tests performed for this insufflator are objective measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No. An MRMC study is not relevant for this type of medical device (an insufflator). This type of study is typically performed for AI/ML diagnostic tools where human readers (e.g., radiologists) interpret images with and without AI assistance.
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance

Was it done?: Yes, to the extent that an insufflator operates as a standalone device. The device's performance (e.g., flow rate, pressure regulation, leakage compensation) was tested independently against specifications and compared to predicate devices in bench testing. There is no "human-in-the-loop" performance as the device directly performs its function (insufflation).

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on a combination of:

International Standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 series, ISO 11135-1, ISO 14937, ISO 11607-1, ASTM-F-1980.
Predicate Device Performance: The characteristics of the legally marketed predicate devices (45L Core Insufflator F114 and Nebulae™ I 50 LPM Insufflator) served as a benchmark for comparison to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is an electro-mechanical insufflator, not an AI/ML system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable.

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 an abstract symbol that resembles a stylized caduceus or a series of human profiles.

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

March 4, 2016

W.O.M World of Medicine Gmbh Susanne Raab Regulatory Consultant 1480 Cambridge Street Cambridge, MA 02139

Re: K153513 Trade/Device Name: Insufflator 50L FM134 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF, OSV Dated: November 25, 2015 Received: December 7, 2015

Dear Susanne Raab,

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153513

Device Name Insufflator 50L FM134

Indications for Use (Describe)

The device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

Type of Use (Select one or both, as applicable)
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 WOM, which is a medical device company. The logo consists of a circle with a stylized "W" inside, and the text "WOM" is written below the logo. Below the logo and name is the text "Insufflator 50L FM134" and "510(k) Premarket Notification".

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1) General Information:

Product Code:

Submitter:	W.O.M. WORLD OF MEDICINE GmbHSalzufer 810587 BerlinGermanyPhone: +49 30 39981 594Fax: +49 30 39981 593
FDA Registration Number:	3001556604
Contact Person:	Susanne RaabRegulatory Consultant1480 Cambridge StreetCambridge, MA 02139Phone: (617) 547-0628Fax: (617) 547-0628e-mail: sbraab@comcast.net
Date Prepared:	November 24, 2015
2) Proposed Device
Trade Name:Common Name:Classification Name:Regulation Number and Name:Regulatory Class:Product Code:	Insufflator 50L FM134Carbon Dioxide Insufflator for Laparoscopicand Vessel HarvestingInsufflator, Laparoscopic21 CFR 884.1730, Laparoscopic InsufflatorIIHIF, OSV
3) Predicate Devices:
Primary Predicate Device:Trade Name:510(k) Number:Classification Name:Regulation Number and Name:Regulatory Class:Product Code:	45L Core Insufflator F114K063367Insufflator, Laparoscopic21 CFR 884.1730, Laparoscopic InsufflatorIIHIF

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Image /page/4/Picture/0 description: The image shows the WOM logo, which includes a circle with a stylized figure inside and a red triangle at the bottom. Below the logo, the text "WOM" is displayed. Further down, the text "Insufflator 50L FM134" and "510(k) Premarket Notification" are written.

Secondary Predicate Device:

Trade Name: 510(k) Number: Classification Name: Regulation Number and Name: Regulatory Class: Product Code:

Nebulae™ I 50 LPM Insufflator K120151 Insufflator, Laparoscopic 21 CFR 884.1730, Laparoscopic Insufflator II HIF, FCX, OSV

4) Device Description:

5) Intended Use:

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Image /page/5/Picture/0 description: The image shows a logo with a circle and a design inside, followed by the text "WOM". Below this, the text "Insufflator 50L FM134" is displayed, followed by "510(k) Premarket Notification". The logo and text appear to be related to a medical device or product, possibly an insufflator.

6) Comparison of Technological Characteristics:

The Insufflator 50L FM134 is substantially equivalent to the 45L Core Insufflator F114 (K063367). Both the proposed device and the predicate device F114 have the same intended use and are used for the same indications. Specifically, the Insufflator 50L FM134 and the predicate device 45L Core Insufflator F114 are CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. In addition, both the proposed device and the predicate device are designed with Standard, Pediatric and Bariatric operating modes that are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. Finally, both the proposed device and the predicate device incorporate a Vessel Harvesting operating mode that is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

Furthermore, the Insufflator 50L FM134 and the predicate device 45L Core Insufflator F114 use the same basic operating principles and incorporate the same basic design. Both the proposed device Insufflator 50L FM134 and the predicate device 45L Core Insufflator F114 are microprocessor controlled CO2 insufflators that consist of the same major components and incorporate the same features. In addition, both the proposed device and the predicate device 45L Core Insufflator F114 are to be used with specially designed sterile, single-use tube sets. The technical differences between the proposed device and the predicate device 45L Core Insufflator F114 consist of the following:

. The casing of the proposed device is slightly larger in dimensions and higher in weight.
. The maximum flow rate in the Bariatric operating mode has been

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increased from 45 1/min to 50 1/min.

The proposed device does not incorporate an optional continuous . pressure measurement feature.
. The proposed device is not equipped with an optional Sidne control system interface.
The proposed device is not designed with a proprietary connection for the tube sets but instead incorporates an ISO 15/22 mm connector.
The proposed device is designed with separate connections for gas insufflation and for gas heating.

The differences in the technological characteristics of both the proposed device Insufflator 50L FM134 and the predicate device F114 do not raise new questions of safety and effectiveness. Moreover, with regards to the increase of the maximum flow rate to 50 l/min, the Insufflator 50L FM134 is substantially equivalent to the predicate device Nebulae™ I 50 LPM Insufflator (K120151).

7) Performance Data:

Electrical safety and electromagnetic compatibility testing was performed by independent laboratories in accordance with the following standards:

IEC 60601-1:2005 Medical Electrical Equipment Part 1: General ● Requirements for Basic Safety and Essential Performance; and
IEC 60601-1-2:2007 Medical Electrical Equipment Part 1 -2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

Test results demonstrate that the proposed device conforms to the above standards.

The software was developed, tested and verified in accordance with the FDA guidance document Software Contained in Medical Devices" and in accordance with the following standard:

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IEC 62304:2006 Medical Device Software Software Life Cycle . Processes.
Design verification testing of the Insufflator 50L FM134 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.

In addition, comparative bench testing was performed to demonstrate that the performance of the Insufflator 50L FM134 in the Bariatric operating mode is substantially equivalent to that of the predicate device 45L Core Insufflator F114. The comparative bench test included comparison of both devices with regards to reaching the set pressure, compensation of small and large leakages, overpressure scenarios and increase of the maximum flow rate from 45 1/min to 50 1/min. The test results demonstrate that the performance of the proposed device related to reaching the set pressure, compensation of small and large leakages and overpressure scenarios are comparable to the performance of the predicate device 45L Core Insufflator F114. In addition, the test results demonstrate that a maximum flow rate of 50 1/min leads on average to a slightly better insufflation performance of the proposed device compared to the predicate device 45L Core Insufflator.

Biocompatibility testing was performed on the insufflation tube sets of the proposed device Insufflator 50L FM134 in accordance with:

ISO 10993-1:2009 Biological evaluation of medical devices- Evaluation and testing within a risk management system;
· ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity;
· ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization; and
· ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

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Image /page/8/Picture/0 description: The image shows a logo with a circle and a design inside, followed by the text "WOM". Below this, the text "Insufflator 50L FM134" is displayed, followed by "510(k) Premarket Notification". The logo and text appear to be related to a medical device or product, possibly an insufflator.

In addition, the insufflation tube set with heating wire of the proposed device FM134 was tested in accordance with ISO 10993 - 18:2005, Chemical characterization of materials.

ETO sterilization validation on the tube sets was performed in accordance with the below standards:

. ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
ISO 14937:2009 Sterilization of health care products General criteria for ● characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
AAMI TIR 28:2009, Product adoption and process equivalency for ethylene ● oxide sterilization

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 10 days of aeration (gas release) that remains on the tube set will not be exceeded. The sterility assurance level (SAL) was < 10 . Package and product integrity of the tube sets were tested in accordance with ISO 11607-1 - Packaging for terminally sterilized medical devices and ASTM-F-1980:2002 - Standard for accelerated aging of sterile medical device packages.

8) Conclusion:

Based on the same intended use, the same basic technological characteristics and performance testing, the Insufflator 50L FM134 is substantially equivalent to the predicate devices 45L Core Insufflator F114 and to the Nebulae™ I 50 LPM Insufflator. The differences between the proposed device and the predicate devices

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do not raise new questions of safety and effectiveness.

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.