The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

AI/ML Overview

The provided text is a 510(k) summary for the SURGIFLATOR-20 ECU, a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device (Surgiflator 20-PIM) and does not contain the kind of detailed study data, acceptance criteria, or performance metrics typically found in clinical trial reports or academic papers for devices that rely on complex algorithms or diagnostic capabilities.

Instead, the submission leverages existing literature and the substantial equivalence pathway for a modified version of an already cleared device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document.

Here's how the provided information relates to your request:

A table of acceptance criteria and the reported device performance:
- Not available. The document states the device "incorporates the same design features" as the predicate and the "only difference" is a modification to a function adjustment feature (serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center). This suggests that the acceptance criteria for performance would implicitly be the same as the predicate, but these are not explicitly stated or quantified in this 510(k) summary. No specific performance data for the modified device is reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. There is no mention of a dedicated test set or clinical study for the SURGIFLATOR-20 ECU in this document. The submission relies on existing literature and the equivalence to a previously cleared device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not available. No ground truth establishment is described as there's no test set or clinical study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. No test set or related adjudication process is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laparoscopic insufflator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; no standalone algorithm performance is relevant or described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not available. No ground truth is described. The safety and effectiveness are supported by referencing existing literature on laparoscopic techniques and the substantial equivalence to a predicate device.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.

Summary of Device Rationale provided in the document:

The argument for safety and effectiveness is based on:

Substantial Equivalence: The SURGIFLATOR-20 ECU is a modified version of the SURGIFLATOR 20-PIM (K955791), with the only difference being a modified function adjustment feature (serial interface to allow surgeon selection of device settings utilizing the HERMES Operating Room Control Center).
Existing Literature: The submission references several books detailing the utility and safety of laparoscopic techniques and the use of high-flow insufflators. This literature serves as general background and support for the established safety and efficacy of the procedure and device type, rather than presenting specific study data for the new device. The provided references are:
- "Operative Laparoscopy" by M.-A. Bruhat, 1992.
- "Laparoscopy in gynecology, surgery and pediatrics" by H. Frongenheim, 1977.
- "Minimal Invasive Surgery" by John G. Hunter and Jonathan M. Sackier, 1993.

In conclusion, this 510(k) summary uses the substantial equivalence pathway and reliance on established medical literature for the device type, rather than presenting a de novo study with specific acceptance criteria, performance metrics, or ground truth data for the modified device itself.

Summary

{0}------------------------------------------------

JUN 26 1998

J.

Summary of Safety and Effectiveness - 510(k) Summary

K98F859

P192

W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.

SURGIFLATOR-20 ECU Proprietary Name: Laparoscopic Insufflator Common Name:

The Surgiflator-20 ECU is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH.

The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

· The utility and safety of laparoscopic techniques using modern electronic high flow insufflators is thoroughly reported in the literature with the advantages and the risks well articulated.
· A comprehensive discussion of the use of insufflation methods is presented in the book "Operative Laparoscopy" (1): 9-15, by M.-A. Bruhat, 1992, which observes that Laparoscopy, along with the entire concept of minimally invasive surgery through edoscopically guided intraabdominal surgery, has become a mainstay in gynecologic surgery. The review of instrumentation in this field includes comments on the use of modern high flow insufflators, the establishment of the pneumoperitoneum, use of instrumentation and use of CO2-lasers.
· A detailed description of the use of different insufflator types is given in the book "Laparoscopy in gynecology, surgery and pediatrics," by H. Frongenheim. Requirements for insufflation apparatus and for the sterilization of instruments are described (2): 8-26, 39-A3

Background information and experiences with the use of laparoscopic techniques including videoendoscopy are presented in the book "Minimal Invasive Surgery" (3): 57ff, 216-218, 291-295 by John G. Hunter, M.D. and Jonathan M. Sackier, M.D., McGraw-Hill, Inc., 3-6 and 216, 291. New technologies are discussed as well as advantages of minimally invasive surgery. The importance of effective, well-maintained instrumentation, i.e. insufflators and other instrumentation like light sources, television screens, and energy sources, is discussed.

{1}------------------------------------------------

Summary of Safety and Effectiveness - 510(k) Summary J.

K981859
p292

W.O.M. GmbH Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.

Page -2- / -2-

REFERENCES

Maurice-Antoine Bruhat. "Operative Laparoscopy". New York: McGraw-Hill, 1992, 1. 226 pages.
H. Frongenheim. "Laparoscopy in Gynecology, Surgery and Pediatry" Stuttgart: Georg 2. Thieme Verlag, 1977, 214 pages.
John G., Hunter. "Minimally Invasive Surgery". New York: McGraw Hill, 1993, 3. 358 pages.

Signed:

M. McDaid

Michael McGrail Manager, Regulatory Affairs

13 May 1998
Date:

Date:

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

W.O.M. GmbH c/o Mr. Robert P. Reznick Hughes, Hubbard and Reed, L.L.P. 1775 I Street. N.W. Washington, D.C. 20006-2041

Re: K981859

SURGIFLATOR-20 ECU, Laparoscopic Insufflator, for (optional) use with the Hermes Operating Room Control Center Dated: May 26, 1998 Received: May 27, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Reznick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the I vice is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaln.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K981859

Device Name: SURGIFLATOR-20 ECU, Laparoscopic Insufflator, for use with the HERMES Operating Room Control Center

Indications For Use:

intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Rottinghaus

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.