The manufacturer, Richard Wolf Medical Instruments Corp., relies on substantial equivalence to previously cleared devices to establish the safety and effectiveness of the Laparo CO₂ Pneu 2232. They state, "The differences [between this device and predicates] do not affect the safety or effectiveness of the device."

Therefore, for the information requested in your prompt, the answers derived from this document are as follows:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	No performance data generated or reported in this document.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable, as no test sets or performance studies were conducted.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable.

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laparoscopic insufflator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance Study: No, a standalone performance study was not done. This device is a hardware medical instrument, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable, as no performance studies were conducted.

8. The sample size for the training set

Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable.

Summary of Conclusions from the Device Submitter:

The manufacturer concluded that the "Laparo CO₂-Pneu 2232 was designed and tested to guarantee the safety and effectiveness during the expected lifetime of the device if it is used according to the instruction manual." This conclusion is based on design and internal testing, not on reported performance data or clinical trials in the provided 510(k) summary. The FDA's clearance is based on the determination of substantial equivalence to predicate devices already on the market.

Summary

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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488

SEP 1 0 1998

RICHARD V MEDICAL INSTRUMENTS CO

K981334

.510(k) Summary of Safety and Effectiveness

Company / Institution name:	Richard Wolf Medical Instruments Corp.	Date of Preparation:	April 8, 1998
Division name (if applicable):	N.A.	FDA establishment regulation number:	14 184 79
Street address:	353 Corporate Woods Parkway	Phone number (include area code):	(847) 913-1113
City:	Vernon Hills	FAX number (include area code):	(847) 913-0924
State/Province:	Illinois	ZIP/Postal Code:	60061
Country:	USA
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager

Product Information:

Trade name:	Laparo CO₂ Pneu	Model number:	2232.601, .611
Common name:	Automatic Laparoscopic CO₂ Insufflator	Classification Name:	Laparoscopic Insufflator

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or proprietary or model name	Manufacturer
1 K934884	1 2231 Laparoscopic Insufflator	1 Richard Wolf
2	2 System 4000	2 CABOT
3	3 Medicam 900	3 MP Video
4	4 26012C	4 Karl Storz

1.0 Description

The Laparo CO2-Pneu 2232 supplies CO2 gas from cylinders or central gas supplies to dilate the abdomen by CO2 gas insufflation.

2.0 Intended Use

The Laparo CO2-Pneu generates and maintains pneumoperitoneum CO2 gas and can be used in diagnostic and operative laparoscopy.

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Technological Characteristics 3.0

The pressure and flow values are checked by microprocessor control. A series of independent safety devices guarantee safe and problem-free insufflation.

The intra-abdominal pressure can be steplessly preselected between 5 mmHg and 25 mmHg. The pressure is reduced if the intra-abdominal pressure is higher than the preselected value.

The flow rate can be preselected between 1 1/min and 20 1/min in steps of 1 1/min.

The measured values can be displayed on-screen in order to document the pressure, flow and gas consumption values during intervention via video equipment.

Substantial Equivalence 4.0

The Laparo CO,-Pneu 2232 is substantially equivalent to existing 510(k) devices sold by Richard Wolf and to various existing laparoscopic insufflators from Cabot, MP Video, and Karl Storz.

The differences do not affect the safety or effectiveness of the device.

5.0 Performance Data

Performance data not generated.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

Laparo CO2-Pneu 2232 was designed and tested to guarantee the safety and effectiveness furing the expected lifetime of the device if it is used according to the instruction manual.

By: Robert J. Casana

Robert L. Casarsa Quality Assurance Manager

Date: Ape 1, 1998

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Image /page/2/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH" is arranged in a circular fashion around the left side of the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Mr. Robert L. Casarsa Manager of Quality Assurance RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Parkway Vernon Hills, IL 60061

Re: K981334

Laparo CO2 - Pneu 2232 (Laparoscopic Insufflator) Dated: June 26, 1998 Received: June 27, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to ievices 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, garket 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 III (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 531 through 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 (21 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/cdrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

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

Enclosure

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RICHARD WOLF QA DEPT.

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The Bank of the States of the States of the States of the States of the States of the States of the States of the States of the States of the States of the States of the S

Indications for Use

510(k) Number (if known):	K9813.34
Device Name:	Laparo CO, Pneu 2232

Intended Use:

The Laparo CO2-Pneu generates and maintains pneumoperitoneum CO3 gas and can be used in diagnostic and operative laparoscopy

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Vimit L. Sayan
(Division Sign-Off)

(Division Sign-Ort)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Use
Per 21 CFR 801.109 ✓

( )દર

Over-The Counter_

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.