(118 days)
Not Found
No
The summary describes a standard suction and irrigation pump with microprocessor control, but there is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on electrical safety, software validation according to standard medical device software guidelines, sterilization, packaging, and biocompatibility, not on the performance of an AI/ML algorithm.
No
The device is used for suction and irrigation to remove fluids and debris during laparoscopic procedures, which supports diagnostic or therapeutic procedures but does not directly provide a therapeutic effect itself.
Yes
The intended use explicitly states "intended for use during diagnostic and or therapeutic laparoscopic procedures".
No
The device description explicitly lists multiple hardware components (power supply, pump head, suction pump, casing, etc.) and the performance studies include testing related to electrical safety, electromagnetic compatibility, and sterilization of physical tube sets, indicating it is a hardware device with embedded software.
Based on the provided information, the LAP-Pump PP110 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "irrigate fluid into and remove fluid from the abdominal cavity" during laparoscopic procedures. This is a surgical/therapeutic function, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a pump for fluid management during surgery. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on the fluid removed. The focus is purely on the mechanical action of irrigation and suction.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The LAP-Pump PP110 does not perform this function.
N/A
Intended Use / Indications for 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.
Product codes
HET
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 words "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 connecting them.
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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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)
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 Markworth |
| Head of Regulatory Affairs | |
| Phone: +4930-399 81-594 | |
| Fax: +4930-399 81-593 | |
| E-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 LAPAROSCOPIC
SUCTION 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
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
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Image /page/5/Picture/1 description: The image shows the logo for WOM, which is a circle with a stylized figure-8 shape inside and a small red triangle at the bottom. Below the logo, the text "WOM" is printed in a sans-serif font. Below that, the text "LAP-Pump PP110 510(k) Premarket Notification" is printed in a smaller font.
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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Image /page/7/Picture/1 description: The image shows the WOM logo, which is a circle with a stylized "W" inside. Below the logo is the text "WOM LAP-Pump PP110 510(k) Premarket Notification". The text is centered below the logo and is in a simple, sans-serif font. The logo is in black and white, with a small red triangle at the bottom of the "W".
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