(69 days)
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.
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.
The provided text describes the 40 L High Flow Insufflator F113 and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a detailed study of device performance against such criteria. The document is a 510(k) summary for a medical device and therefore focuses on establishing substantial equivalence rather than presenting an exhaustive performance study with acceptance criteria.
However, based on the information provided, we can infer some aspects related to performance and how "evidence" was presented for regulatory purposes.
Here's a breakdown of the requested information, with sections noted as "Not Provided" when the information is missing from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | The document states: "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." |
| Specifically, the 40 L High Flow Insufflator F113 performs substantially equivalently to the 40 L High Flow Insufflator F108 (K030837) for general insufflation and to Guidant VasoView Endoscopic Vessel Harvesting System (K030512), VasoView Dissection / Vessel Harvesting System (K981700), and Cardiovations Optical Bipolar Device (K031846) for endoscopic vessel harvesting. |
Note: The document focuses on demonstrating substantial equivalence, meaning the new device performs similarly and is as safe and effective as existing legally marketed devices. It does not provide specific quantitative acceptance criteria (e.g., "pressure maintained within X% of set point for Y time") or detailed results of performance testing against such criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not Provided. The document mentions "performance testing" and a "clinical evaluation," but no specific sample sizes for these tests are given.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not Provided. The clinical evaluation includes a "summary of peer reviewed literature and information on questionnaire results." The origin or nature (retrospective/prospective) of this data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Provided. The document mentions a "clinical evaluation" and "questionnaire results," but it does not specify the number or qualifications of experts involved in establishing ground truth for any test set. Given the nature of a CO2 insufflator, "ground truth" might pertain to objective measurements of pressure regulation or flow rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
- Not Provided. No mention of an adjudication method is included in the summary.
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
- No such study was done. This device (a CO2 insufflator) is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in a diagnostic context. Therefore, an MRMC study or AI-related effectiveness measure is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a hardware insufflator and does not involve algorithms for standalone diagnostic performance. Its function is to facilitate endoscopic procedures by distending cavities with gas.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in detail. For a CO2 insufflator, "ground truth" would likely involve objective physical measurements like pressure, flow rate, and CO2 concentration, as well as operational safety parameters. The "performance testing" mentioned generally refers to these kinds of engineering and functional tests. The "clinical evaluation" would likely focus on the intended use and safety in a surgical context, possibly drawing upon outcomes data from the peer-reviewed literature.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a hardware product, not a machine learning model, so there is no "training set" in the conventional sense of AI/ML. For hardware, "training" might refer to testing under various conditions, but no specific "training set" size for data used to optimize hardware design is provided or relevant in this context.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, this question is not relevant.
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6723
510(k) SUMMARY
| Submitter: | W.O.M. WORLD OF MEDICNE AGAlte Poststraße 1196337 LudwigsstadtGermanyPhone: +49 9263 877 131Fax: +49 9263 877 137 |
|---|---|
| OfficialCorrespondent: | Susanne RaabRegulatory Affairs Consultant1480 Cambridge StreetCambridge, MA 02139Phone: 202 390 8227e-mail: sbraab@comcast.net |
| Trade Name: | 40 L High Flow Insufflator F113 |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and EndoscopicVessel Harvesting |
| ClassificationName: | Laparoscopic Insufflator, 21 C.F.R. 884.1730Insufflator, 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 HarvestingSystem (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 microprocessorcontrolled CO2 insufflator designed with a high flowapplication, a low flow application and a vessel harvestingapplication. The device incorporates the following majorcomponents and features: a housing, a world power supply, |
MAY 25 2006
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| pressure reducers, a venting system, a fluid sensor, a gasheater and various setting keys and display elements. Acontinuous redundant pressure measurement controls theconformity of the actual pressure in the peritoneal orextraperitoneal cavity with the pre-set nominal pressure. Inaddition, a software controlled active pressure reductionensures that the preset nominal pressure value conforms tothe actual pressure that is measured in the cavity. Finally,the 40 L High Flow Insufflator F113 is designed with severalalarms to inform the operator in case of an overpressure.The device may be used with a heating tube and with anoptional remote control. | |
|---|---|
| Intended Use /Indication for Use: | The 40 L High Flow Insufflator F113 is a CO2 insufflatorintended for use in diagnostic and/or therapeutic endoscopicprocedures to distend a cavity by filling it with gas. Thehigh flow application and the low flow application of thedevice are each indicated for use in facilitating the use of alaparoscope by filling the peritoneal cavity with gas todistend it. The low flow application of the device isindicated for pediatric use. The vessel harvesting applicationof the F113 is indicated for use during endoscopic vesselharvesting procedures to create a cavity along the saphenousvein and/or radial artery during endoscopic vessel harvestingprocedures. |
| SubstantialEquivalence: | The 40 L High Flow Insufflator F113 is substantiallyequivalent to the 40 L High Flow Insufflator F108(K030837) manufactured by W.O.M. Specifically, the F113and the F108 are both intended for use during diagnosticand/or therapeutic endoscopic procedures to distend a cavityby filling it with gas. In addition, the high flow applicationand low flow application of both devices are indicated foruse in facilitating the use of a laparoscope by filling theperitoneal cavity with gas to distend it. The minortechnological differences between the F113 and the F108 areprimarily related to the implementation of a special vesselharvesting application similar to the existing low flowapplication for pediatric use in laparoscopy, which allows forthe expansion of the indication for use of the F113 to includeuse of the device during endoscopic vessel harvestingprocedures. Performance testing and a clinical evaluationconsisting of a summary of peer reviewed literature andinformation on questionnaire results regarding endoscopicvessel harvesting with the aid of CO2 insufflationdemonstrate that these minor technical differences and the |
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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:
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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
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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
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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 _
Page 1 of 1
§ 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.