(197 days)
The 45L CORE Insufflator F114 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, the low flow application and the bariatric 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 F114 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 45L CORE Insufflator F114 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application, a bariatric application and a vessel harvesting application. The device incorporates the following major components and features: a casing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting symbols and display elements. The device is equipped with a continuous pressure measurement mode and redundant discontinuos pressure measurement mode that 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 45L CORE Insufflator F114 is designed with several alarms to inform the operator in case of an overpressure. The device is to be used with specially designed single-use tubing sets.
The 45L CORE Insufflator F114 is a medical device used for laparoscopic and endoscopic procedures. The information provided outlines its substantial equivalence to predicate devices rather than a detailed study with specific acceptance criteria and performance data in a tabular format. However, based on the text, we can infer the aspects that were evaluated for substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices (40 L High Flow Insufflator F113, HI-FLO Therme Pneu 45, Stryker Heated Insufflator Tube Set, Surgiflator 20). The "acceptance criteria" are implied to be that the new device does not raise new questions of safety and effectiveness compared to these predicates, and that its performance is equivalent or similar enough not to warrant additional concerns.
From the text, we can glean the following comparisons and performance claims:
| Acceptance Criteria (Implied) | Reported Device Performance (F114) |
|---|---|
| Overall Safety & Effectiveness | Substantially equivalent to predicate devices (F113, HI-FLO, Stryker/Surgiflator tube sets) and does not raise new questions of safety and effectiveness. |
| Functionality as CO2 Insufflator | Intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. Functions for high flow, low flow, bariatric, and vessel harvesting applications. |
| Peritoneal Cavity Distention | Effectively facilitates the use of a laparoscope by filling the peritoneal cavity with gas to distend it. |
| Pediatric Use (Low Flow) | Indicated for pediatric use. |
| Vessel Harvesting Application | Creates a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures. |
| Bariatric Mode Performance | Similar to the existing High Flow Mode of the F113 and identical with regard to the maximum flow performance to the High Flow Mode of the HI-FLO. Performance testing of the bariatric mode demonstrates no new questions of safety or effectiveness. |
| Maximum Gas Supply Pressure | Bariatric Mode: 70 mmHg. High Flow Mode: 65 mmHg. Veress Mode: 60 mmHg. These increases in pressure do not raise new questions of safety and effectiveness. |
| Pressure Measurement and Control | Equipped with continuous pressure measurement mode and redundant discontinuous pressure measurement mode. Software-controlled active pressure reduction ensures preset nominal pressure conforms to actual pressure in the cavity. Continuous pressure measurement in different modes demonstrates no new questions of safety or effectiveness. |
| Alarms | Several alarms to inform the operator in case of overpressure. |
| Tube Set Compatibility & Performance | To be used with specially designed single-use tubing sets. Proposed tube sets are substantially equivalent to Stryker Heated Insufflator Tube Set and Surgiflator 20's heatable tube sets. Major difference (connector design for combined connection of insufflation, pressure measurement, and heating) does not raise new safety/effectiveness questions. Technical characteristics are equivalent. |
| Sterilization (Tube Sets) | Sterilized according to EN 550, Method C (Ethylene Oxide). Residual ethylene oxide limit (250 ppm) not exceeded. Sterility assurance level (SAL) of ≤ 10-6 achieved (in accordance with DIN EN 14698-1 and EN1174, Part 1-3). |
| Biocompatibility (Tube Sets) | Components in short-term indirect contact with patient made of materials identical to predicate devices. Materials are well-characterized chemically and physically in published literature and have a long history of safe use regarding biocompatibility. |
| General Controls Compliance (Implied by FDA review acceptance) | Device subject to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. (This is a regulatory requirement, not a performance criterion in the same vein as those above, but it's an "acceptance criterion" for market clearance). |
2. Sample size used for the test set and the data provenance
The document states "Bench testing demonstrates the safety and effectiveness of the F114." It does not provide specific details on the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Typically, "bench testing" would imply laboratory-based tests on manufactured units, rather than human, animal, or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given that the submission focuses on substantial equivalence via bench testing and comparison to predicate devices, there's no mention of a ground truth established by experts in the context of clinical performance or diagnostic accuracy.
4. Adjudication method for the test set
This information is not provided. As above, for bench testing, an adjudication method for ground truth (which is relevant for perceptual or diagnostic tasks) would typically not be applicable.
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. This device is an insufflator, a mechanical device, not an imaging analysis or AI-driven diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an insufflator device. It is a piece of medical equipment used by a human operator, not an algorithm that performs a task autonomously.
7. The type of ground truth used
For the performance assessment, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, EN), and the established performance of the predicate devices. For example, for sterilization, the ground truth is a specific sterility assurance level (SAL) and residual gas limits. For pressure output, the ground truth would be the specified pressure ranges and stability. It's based on objective, measurable physical parameters.
8. The sample size for the training set
This information is not provided and is not applicable in the context of a purely hardware device like an insufflator. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
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510(k) SUMMARY
MAY 2 3 2007
| Submitter: | W.O.M. WORLD OF MEDICNE AGAlte Poststraße 1196337 LudwigsstadtGermanyPhone: +49 9263 877 131Fax: +49 9263 877 137 |
|---|---|
| OfficialCorrespondent: | Susanne RaabRegulatory Consultant1480 Cambridge StreetCambridge, MA 02139Phone: 617 547 0628Fax: 617 520 2136e-mail: sbraab@comcast.net |
| Trade Name: | 45L CORE Insufflator F114 |
| 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 / GCJ |
| Predicate Devices: | 1. 40 L High Flow Insufflator F113, (K060723)2. HI-FLO Therme Pneu 45, (K031014)3. Stryker Heated Insufflator Tube Set, (K003792)4. Surgiflator 20, Single-Use Heatable Tube Set,(K950035) |
| Device Description: | The 45L CORE Insufflator F114 is a microprocessorcontrolled CO2 insufflator designed with a high flowapplication, a low flow application, a bariatric applicationand a vessel harvesting application. The device incorporatesthe following major components and features: a casing, a |
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world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting symbols and display elements. The device is equipped with a continuous pressure measurement mode and redundant discontinuos pressure measurement mode that 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 45L CORE Insufflator F114 is designed with several alarms to inform the operator in case of an overpressure. The device is to be used with specially designed single-use tubing sets.
The 45L CORE Insufflator F114 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, the low flow application and the bariatric 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 45L CORE Insufflator F114 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 45L CORE Insufflator F114 (the "F114") is substantially equivalent to the 40 L High Flow Insufflator F113 (the "F113") and to HI-FLO Therme Pneu 45 (the "HI-FLO"). Specifically, both the F114 and the predicate devices F113 and HI-FLO are CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. In addition, all three devices are indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The technical characteristics of the F114 are equivalent to those of the predicate devices. The minor technological differences between the F114 and the predicate devices are primarily related to the implementation of a special Bariatric Mode similar to the existing High Flow Mode of the F113 and identical with regard to the maximum flow performance to the High Flow Mode of the HI-FLO. In addition, the increase of the maximum gas supply pressure in the Bariatric Mode to 70 mmHg and in the High Flow Mode
Intended Use / Indication for Use:
Substantial Equivalence:
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to 65 mmHg and 60 mmHg (Veress Mode) does not raise new questions of safety and effectiveness. Performance testing of the bariatric mode and continuous pressure measurement in the different modes demonstrate that the minor technical differences between the F114 and the predicate devices do not raise new questions of safety or effectiveness.
In addition, the tube sets to be used in conjunction with the F114 are substantially equivalent to the Stryker Heated Insufflator Tube Set and the single-use heatable tube sets for use in conjunction with the Surgiflator 20. Both the proposed tube sets and the predicate devices are used during endosopic procedures to provide a path for the insufflation gas from the insufflation device to the patient. In addition. the technical characteristics of the proposed tube sets are equivalent to those of the predicate devices. The major difference between the proposed tube sets and the predicate devices consists of the design of the connector of the proposed tube sets, which enables the connection of the insufflation tubing and the tubing for continuous pressure measurement and the heating function in one step. The minor differences between the tube sets to be used in conjunction with the F114 and the predicate devices Stryker Heated Insufflator Tube Set and the single-use heatable tube sets for use in conjunction with the Surgiflator 20 do not raise new questions of safety and effectiveness.
The insufflation tube sets to be used in conjunction with the Sterilization: F114 will be sterilized in accordance with EN 550 "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization" method C. Residual ethylene oxide data shows that the limit of residual gas (250 ppm) will not be exceeded. In accordance with the European Standard DIN EN 14698-1 and EN1174, Part 1-3 the used sterility assurance level (SAL) to detect the quantity of bioburden was ≤ 10-6.
Biocompatibility: The components of insufflation tube sets that come into short term indirect contact with the patient consist of materials that are identical to those used in the predicate devices. In addition, all used materials have been well characterized chemically and physically in the published literature and have a long history of safe use in regards to biocompatibility.
45L CORE Insufflator F114 W.O.M. WORLD OF MEDICNE AG Page 3 of 3
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Performance Data: Bench testing demonstrates the safety and effectiveness of the F114.
November 3, 2006 Date Prepared:
45L CORE Insufflator F114 W.O.M. WORLD OF MEDICNE AG :
:
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2-3 2007
W.O.M. World of Medicine AG c/o Ms. Susanne Raab Regulatory Consultant 1480 Cambridge Street CAMBRIDGE MA 02139
Re: K063367
Trade/Device Name: 45L Core Insufflator F114 Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: May 10, 2007 Received: May 14, 2007
Dear Ms. 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.
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/4/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" at the top. The logo is circular and contains three stars below the word "Centennial". The text is arranged in a circular fashion around the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the FDA.
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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 promated 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 11 you abon 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): K063367
Device Name: 45L CORE Insufflator F114
Indications for Use:
The 45L CORE Insufflator F114 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, the low flow application and the bariatric 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 F114 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 Broadon
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices
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.