(88 days)
Not Found
No
The document describes a microprocessor-controlled insufflator with standard control features and does not mention any AI or ML capabilities.
Yes
The device is intended for use during diagnostic and/or therapeutic endoscopic procedures, explicitly stating its therapeutic application.
Yes
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." This directly states its use in diagnostic procedures.
No
The device description clearly states it is a microprocessor-controlled CO2 insufflator consisting of multiple hardware components like a casing, power supply, pressure reducers, venting system, sensors, heater, and a touch screen GUI. While it has software, it is integral to the operation of the hardware.
Based on the provided information, the Insufflator 50L FM134 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas." This involves direct interaction with the patient's body during a medical procedure.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Insufflator 50L FM134 does not examine specimens from the body.
- Device Description: The description details a device that delivers gas into a body cavity. It does not mention any components or functions related to analyzing biological samples.
Therefore, the Insufflator 50L FM134 is a medical device used in vivo (within the living body) during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HIF, OSV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, saphenous vein, radial artery
Indicated Patient Age Range
pediatric (for Pediatric operating mode)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility testing was performed by independent laboratories in accordance with IEC 60601-1:2005 and IEC 60601-1-2:2007. Test results demonstrate that the proposed device conforms to these standards.
The software was developed, tested and verified in accordance with the FDA guidance document "Software Contained in Medical Devices" and IEC 62304:2006.
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.
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 l/min to 50 l/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 l/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, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2006. The insufflation tube set with heating wire was also tested in accordance with ISO 10993-18:2005.
ETO sterilization validation on the tube sets was performed in accordance with ISO 11135-1:2007, ISO 14937:2009, ISO 10993-7:2008, and AAMI TIR 28:2009. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO
§ 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.
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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
1
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 GmbH
Salzufer 8
10587 Berlin
Germany
Phone: +49 30 39981 594
Fax: +49 30 39981 593 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Registration Number: | 3001556604 |
| Contact Person: | Susanne Raab
Regulatory Consultant
1480 Cambridge Street
Cambridge, MA 02139
Phone: (617) 547-0628
Fax: (617) 547-0628
e-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 FM134
Carbon Dioxide Insufflator for Laparoscopic
and Vessel Harvesting
Insufflator, Laparoscopic
21 CFR 884.1730, Laparoscopic Insufflator
II
HIF, 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 F114
K063367
Insufflator, Laparoscopic
21 CFR 884.1730, Laparoscopic Insufflator
II
HIF |
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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:
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.
5) Intended Use:
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.
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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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Image /page/6/Picture/0 description: The image shows a logo with a circle and a design inside, followed by the letters "WOM". Below the logo, the text "Insufflator 50L FM134" is displayed, followed by "510(k) Premarket Notification". The text provides information about a medical device, specifically an insufflator, and its regulatory status.
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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Image /page/7/Picture/0 description: The image shows the WOM logo, which is a circle with a design inside and a red triangle at the bottom. Below the logo, the text "WOM" is written in a bold font. The text "Insufflator 50L FM134 510(k) Premarket Notification" is written below the logo.
- 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