(69 days)
Not Found
No
The description focuses on microprocessor control, pressure regulation, and safety features, with no mention of AI or ML algorithms for decision-making, image analysis, or other functions.
Yes
The device is used in therapeutic endoscopic procedures and for creating a cavity during endoscopic vessel harvesting, which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic and/or therapeutic endoscopic procedures".
No
The device description explicitly lists multiple hardware components such as a housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, setting keys, and display elements. It is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to distend a cavity with gas during endoscopic procedures (diagnostic and therapeutic). This is a surgical/procedural function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and control aspects of delivering gas and monitoring pressure within a body cavity. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Keywords: There are no mentions of terms typically associated with IVD devices, such as "sample," "analyte," "reagent," "assay," "in vitro," "diagnostic test," etc.
The device is clearly intended for use during a medical procedure to facilitate visualization and access, which falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
Product codes
HIF, FCX
Device Description
The 40 L High Flow Insufflator F113 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application and a vessel harvesting application. The device incorporates the following major components and features: a housing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting keys and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 40 L High Flow Insufflator F113 is designed with several alarms to inform the operator in case of an overpressure. The device may be used with a heating tube and with an optional remote control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal or extraperitoneal cavity, saphenous vein and/or radial artery
Indicated Patient Age Range
pediatric (for low flow application)
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)
Performance testing and a clinical evaluation consisting of a summary of peer reviewed literature and information on questionnaire results regarding endoscopic vessel harvesting with the aid of CO2 insufflation demonstrate that these minor technical differences and the expansion of the device's indication for use do not raise new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030837, K030512, K981700, K031846
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
6723
510(k) SUMMARY
| Submitter: | W.O.M. WORLD OF MEDICNE AG
Alte Poststraße 11
96337 Ludwigsstadt
Germany
Phone: +49 9263 877 131
Fax: +49 9263 877 137 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent: | Susanne Raab
Regulatory Affairs Consultant
1480 Cambridge Street
Cambridge, MA 02139
Phone: 202 390 8227
e-mail: sbraab@comcast.net |
| Trade Name: | 40 L High Flow Insufflator F113 |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Endoscopic
Vessel Harvesting |
| Classification
Name: | Laparoscopic Insufflator, 21 C.F.R. 884.1730
Insufflator, Automatic Carbon Dioxide for Endoscope,
21 C.F.R. § 876.1500 |
| Regulatory Class: | II |
| Product Code: | HIF / FCX |
| Predicate Devices: | 40 L High Flow Insufflator F108 (K030837),
manufactured by W.O.M. WORLD OF MEDICINE AGGuidant VasoView Endoscopic Vessel Harvesting
System (K030512), manufactured by Guidant Corp.VasoView Dissection / Vessel Harvesting System
(K981700), manufactured by Guidant Corp.Cardiovations Optical Bipolar Device (K031846),
manufactured by Ethicon, Inc. |
| Device Description: | The 40 L High Flow Insufflator F113 is a microprocessor
controlled CO2 insufflator designed with a high flow
application, a low flow application and a vessel harvesting
application. The device incorporates the following major
components and features: a housing, a world power supply, |
MAY 25 2006
1
| | pressure reducers, a venting system, a fluid sensor, a gas
heater and various setting keys and display elements. A
continuous redundant pressure measurement controls the
conformity of the actual pressure in the peritoneal or
extraperitoneal cavity with the pre-set nominal pressure. In
addition, a software controlled active pressure reduction
ensures that the preset nominal pressure value conforms to
the actual pressure that is measured in the cavity. Finally,
the 40 L High Flow Insufflator F113 is designed with several
alarms to inform the operator in case of an overpressure.
The device may be used with a heating tube and with an
optional remote control. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indication for Use: | The 40 L High Flow Insufflator F113 is a CO2 insufflator
intended for use in diagnostic and/or therapeutic endoscopic
procedures to distend a cavity by filling it with gas. The
high flow application and the low flow application of the
device are each indicated for use in facilitating the use of a
laparoscope by filling the peritoneal cavity with gas to
distend it. The low flow application of the device is
indicated for pediatric use. The vessel harvesting application
of the F113 is indicated for use during endoscopic vessel
harvesting procedures to create a cavity along the saphenous
vein and/or radial artery during endoscopic vessel harvesting
procedures. |
| Substantial
Equivalence: | The 40 L High Flow Insufflator F113 is substantially
equivalent to the 40 L High Flow Insufflator F108
(K030837) manufactured by W.O.M. Specifically, the F113
and the F108 are both intended for use during diagnostic
and/or therapeutic endoscopic procedures to distend a cavity
by filling it with gas. In addition, the high flow application
and low flow application of both devices are indicated for
use in facilitating the use of a laparoscope by filling the
peritoneal cavity with gas to distend it. The minor
technological differences between the F113 and the F108 are
primarily related to the implementation of a special vessel
harvesting application similar to the existing low flow
application for pediatric use in laparoscopy, which allows for
the expansion of the indication for use of the F113 to include
use of the device during endoscopic vessel harvesting
procedures. Performance testing and a clinical evaluation
consisting of a summary of peer reviewed literature and
information on questionnaire results regarding endoscopic
vessel harvesting with the aid of CO2 insufflation
demonstrate that these minor technical differences and the |
・・ :
2
expansion of the device's indication for use do not raise new questions of safety or effectiveness.
Furthermore, with regards to its expanded indication for use the F113 is substantially equivalent to the Guidant VasoView Endoscopic Vessel Harvesting System (K030512), the VasoView Dissection / Vessel Harvesting System (K981700), and to the Cardiovations Optical Bipolar Device (K031846). Specifically, the F113 is substantially equivalent to the VasoView systems and to the Cardiovations Optical Bipolar Device as all three of these predicate devices are indicated to be used in conjunction with CO2 insufflation to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
March 13, 2006 Date Prepared:
3
Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
MAY 2 5 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
W. O.M. World of Medicine AG % Ms. Susanne Raab Regulatory Affairs Consultant 1490 Cambridge Street CANBRIDGE MA 02139
Re: K060723
Trade/Device Name: 40L High Flow Insufflator F113 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: HIF and GCJ Dated: March 13, 2006 Received: March 17, 2006
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have review a your books and have is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass success in 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 therefore, mainter are were 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 (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906 to 2006. The letters FDA are in the center of the logo in a stylized font. The word Centennial is written below the letters FDA.
wing Public 9
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
- Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K060723
Device Name: 40 L High Flow Insufflator F113
Indications for Use:
The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign Off) Division of Reproducti and Radiological Device 510(k) Number _
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