The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

Device Description

The LAP-Pump PP110 is a suction and irrigation pump for use during laparoscopic procedures. The irrigation and suction functions are used to facilitate the removal of debris and fluids during laparoscopy. The pump consists of the following main components: : (1) a power supply, (2) a power switch, (3), a START/STOP button for the irrigation function, (4), a START/STOP button for the suction function, (5) a roller wheel, (6) a pump head, (7) suction pump and (8) a casing. The pump is a microprocessor controlled single roller pump that functions according to the peristaltic principle and is to be used with specially designed sterile, single use irrigation tube sets with or without hand piece, a sterile outflow tube set and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.

AI/ML Overview

This is a 510(k) premarket notification for the LAP-Pump PP110, a suction and irrigation pump for laparoscopic procedures. The document asserts substantial equivalence to predicate devices based on similar intended use, basic technological characteristics, and performance testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Test results demonstrate that the proposed device conforms to the above standards" and "Design verification testing of the LAP-Pump PP10 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness."

The "performance data" section focuses on compliance with various international standards for medical devices and sterility.

Here's a summary of the reported device performance in relation to the standards it aims to meet:

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Electrical Safety & EMC (AAMI ANSI ES60601-1, IEC60601-1-2)	Conforms to standards.
Software Life Cycle Processes (IEC 62304)	Developed, tested, and verified in accordance with the standard and FDA guidance.
Overall Performance (Design Verification)	Performs as intended; performance does not raise new questions of safety and effectiveness.
ETO Sterilization Validation (ISO 11135-1, ISO 14937, ISO 10993-7)	Residual EO < 4 mg and ECH < 5 mg after 10 days of aeration. Sterility assurance level (SAL) ≤ 10⁰.
Package and Product Integrity (ISO 11607-1, ASTM-F-1980)	Tested in accordance with standards.
Biocompatibility (ISO 10993-1, -5, -10, -11)	Tested in accordance with standards.
Flow Rate (Implicit comparison to predicate)	Flow rate of 3 l/min (same as predicate).

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

The document does not provide information on the sample size for any specific test sets. It mentions "Design verification testing," "ETO sterilization validation," "Package and product integrity" testing, and "Biocompatibility testing," but not the number of units or samples used for these tests.

The data provenance is implied to be prospective testing conducted by the manufacturer and independent laboratories to demonstrate compliance with standards for the specific device being submitted. There is no mention of country of origin of the data beyond the standards themselves being international.

There is no mention of any clinical study involving a "test set" of patients or data in the context of diagnostic accuracy or clinical outcomes. The performance data is focused on engineering, safety, and sterilization validation.

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

This information is not applicable and not provided in the document. The performance data presented relates to engineering and safety testing, not to the establishment of ground truth by clinical experts for diagnostic or treatment outcomes.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data, which are not described here.

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

There is no mention of an MRMC study, AI involvement, or human readers/assistants in the document. This is a submission for a physical medical device (pump for laparoscopy), not an AI-powered diagnostic or decision support system.

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

This is not applicable. The device is a physical pump, not an algorithm, so the concept of standalone algorithmic performance is irrelevant here.

7. The type of ground truth used

For the various engineering and safety tests, the "ground truth" implicitly refers to the specifications and requirements defined by the referenced international standards (e.g., AAMI ANSI ES60601-1 for electrical safety, ISO 11135-1 for sterilization). The device's performance is measured against these established engineering and safety benchmarks.

For the flow rate, the ground truth is simply the stated flow rate of 3 l/min, which is compared to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical pump, not a machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

This is not applicable for the same reason as point 8.

Summary

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

March 21, 2017

W.O.M. World of Medicine GmbH Dr. Soeren Markworth Head of Regulatory Affairs Salzufer 8 Berlin, 10587 Germany

Re: K163320

Trade/Device Name: LAP-Pump PP110 Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: Class II Product Code: HET Dated: March 7, 2017 Received: March 8, 2017

Dear Dr. Markworth:

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 of medical devicerelated 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.

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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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K163320

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163320

Device Name LAP-Pump PP110

Indications for Use (Describe)

The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

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 a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '163320'. The characters are displayed in a simple, sans-serif font and are evenly spaced.

Image /page/3/Picture/1 description: The image shows the logo for WOM, which is a medical device company. Below the logo is the text "LAP-Pump PP110" and "510(k) Premarket Notification". The LAP-Pump PP110 is a medical device that is used for laparoscopic surgery and the 510(k) Premarket Notification is a submission to the FDA that is required for medical devices that are similar to devices already on the market.

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(Content in accordance with 21 CFR §807.92)

1. General Information

Submitter:	W.O.M. WORLD OF MEDICINE GmbH
	Salufer 8
	10587 Berlin
	Germany
Registration Number:	3001556604
Contact Person:	Dr. Soeren MarkworthHead of Regulatory Affairs
	Phone: +4930-399 81-594Fax: +4930-399 81-593E-mail: soeren.markworth@womcorp.com
Date prepared:	7th of March, 2017

2. Proposed Device

Trade Name:	LAP-Pump PP110
Common Name:	Suction and Irrigation pump for Laparoscopy
Classification Name:	Gynecologic laparoscope and accessories
Regulation Number:	21 C.F.R. § 884.1720
Regulatory Class:	II
Product Code:	HET

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LAP-Pump PP110 510(k) Premarket Notification

3. Predicate Devices

Primary Predicate Device

Trade Name:	LAP-Wave 3000 (P07)
510(k) Number:	K990732
Classification Name	Gynecologic laparoscope and accessories
Regulation Numer	21 C.F.R. § 884.1720
Regulatory Class	II
Product Code	HET

Secondary Predicate Device

Trade Name:	KSEA UNIVERSAL LAPAROMAT LAPAROSCOPICSUCTION AND IRRIGATION PUMP
510(k) Number:	K010569
Classification Name	Laparoscope, General & Plastic Surgery
Regulation Numer	21 C.F.R. § 876.1500
Regulatory Class	II
Product Code (Classification)	GCJ
Product Code (Subsequent)	BTA

4. Device Description

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and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.

5. Intended Use

The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and/or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

6. Comparison of Technological Characteristics

Primary Predicate Device

The predecessor product of the proposed device LAP-Pump PP110 is the LAP Wave 3000 (P07). The LAP-Wave 3000 (P07) was originally cleared under K990732 and is the primary predicate device for the LAP-Pump PP110. Both pumps are designed, developed and manufactured by W.O.M. WORLD of MEDICINE GmbH. They incorporate the same basic design. Specifically, both the LAP-Pump PP110 and the LAP-Wave 3000 (P07) are pump systems for use during laparoscopic procedures. They are microprocessor controlled single roller pumps that function according to the peristaltic principle and are to be used with specially designed tube sets.

The differences in the technological characteristics of both the proposed device LAP-Pump PP110 and the primary predicate device LAP-Wave 3000 (P07) are minor and do not raise new questions of safety and effectiveness. The main differences between the LAP-Pump PP110 and the LAP-Wave 3000 (P07) are the following:

The LAP-Pump PP110 incorporates a suction pump that is to be used with a nonsterile vacuum tube set. The LAP-Wave 3000 (P07) does not have a vacuum pump, which means a separate vacuum pump or the central vacuum connection of the hospital had to be used when needed.
The LAP-Pump PP110 is designed with a radio frequency identification (RFID) transponder technology tube set recognition function that controls the proper

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Image /page/6/Picture/1 description: The image shows the WOM logo, which is a circle with a stylized "W" inside. Below the logo, the text "LAP-Pump PP110" is displayed, followed by "510(k) Premarket Notification". The text indicates that the image is related to a medical device, specifically a LAP-Pump PP110, and its premarket notification under section 510(k) of the Food and Drug Administration regulations.

position of the Inflow Tube Set and eliminates accidental reuse of an Inflow Tube Set by invalidating the tube set after the irrigation process has been started.

. The LAP-Pump PP110 includes a greater variety of tube sets. For the LAP-Pump PP110 the following tube sets are available as accessories: standard irrigation tube set, high-flow suction-irrigation tube set with hand piece, suction tube set and vacuum tube set. The LAP-Wave 3000 (P07) featured only a standard irrigation tube set which can be connected to a standard hand piece.

Secondary Predicate Device

The KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (hereafter referred to as "Laparomat") was originally cleared under K010569 and is the secondary predicate device for the LAP-Pump PP110. Both pumps incorporate a similar basic design. Specifically, both the LAP-Pump PP110 and the Laparomat are pump systems for use during laparoscopic procedures. They are microprocessor controlled pumps that provide irrigation and suction functions and are to be used with specially designed tube sets.

The differences in the technological characteristics of both the proposed device LAP-Pump PP110 and the secondary predicate device Laparomat are minor and do not raise new questions of safety and effectiveness. The main differences between the LAP-Pump PP110 and the Laparomat are the following:

· The LAP-Pump PP110 is designed with a radio frequency identification (RFID) transponder technology tube set recognition function that controls the proper position of the Inflow Tube Set and eliminates accidental reuse of an Inflow Tube Set by invalidating the tube set after the irrigation process has been started.
. The LAP-Pump PP110 transports the irrigation fluid via the peristaltic principle using a roller wheel, while the Laparomat uses an impeller for irrigation fluid transportation.
. The irrigation tube sets of both devices have a different design with respect to the fluid transportation mechanism. The irrigation tube sets of the LAP-Pump PP110 feature a segment which is intended to be inserted around the roller wheel of the

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pump, while the irrigation tube sets of the Laparomat feature an impeller segment which is intended to be connected to the connection site of the pump.

7. Performance Data

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

AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC60601-1-2:2007 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:

. IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes.
Design verification testing of the LAP-Pump PP10 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.

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

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;

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Image /page/8/Picture/1 description: The image shows the logo for WOM, which is a circle with a design inside and a small red triangle at the bottom. Below the logo, the text "WOM" is written in a bold, sans-serif font. The text "LAP-Pump PP110 510(k) Premarket Notification" is written below the logo and the WOM text.

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.

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 remain 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.

Biocompatibility testing was performed on the tube sets in accordance with:

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

Finally, complete testing was performed to demonstrate safety and effectiveness of the proposed device LAP-Pump PP110. As the flow rate of 3 l/min as the main function of the predicate and the proposed device is the same, no comparative testing was performed. Instead, the performance and safety features of the proposed device are demonstrated.

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Image /page/9/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K163320'. The characters are presented in a clear, sans-serif font, making them easily readable. The arrangement is linear, with each character distinctly separated from the others.

Image /page/9/Picture/1 description: The image shows the WOM logo, which is a circle with a stylized heart shape inside. Below the logo, the text "WOM" is written in bold letters. The text "LAP-Pump PP110" and "510(k) Premarket Notification" are written below the WOM text.

8. Conclusion

Based on the similar intended use compared to the primary predicate device as well as the same intended use compared to the secondary predicate device, the same or similar basic technological characteristics and performance testing, the LAP-Pump PP110 is substantially equivalent to the predicate devices LAP-Wave 3000 (P07) (K990732) and Laparomat (K010569). The differences between the proposed device and the predicate devices do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.