45L CORE INSUFFLATOR, MODEL F114

K063367 · W.O.M. World of Medicine AG · HIF · May 23, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K063367
• Device Name: 45L CORE INSUFFLATOR, MODEL F114
• Applicant: W.O.M. World of Medicine AG
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 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.

Device Story

Microprocessor-controlled CO2 insufflator; inputs include CO2 gas supply and real-time pressure measurements from peritoneal/extraperitoneal cavities. Device features high flow, low flow, bariatric, and vessel harvesting modes. Operates via continuous and redundant discontinuous pressure measurement; software-controlled active pressure reduction maintains preset nominal pressure. Produces gas flow to distend cavities; alerts operator via alarms during overpressure events. Used in clinical settings (OR/endoscopy suites) by physicians. Healthcare providers monitor display elements and setting symbols to manage insufflation parameters. Benefits include controlled, safe cavity distension for laparoscopic and vessel harvesting procedures. Utilizes single-use heatable tubing sets for gas delivery and pressure sensing.

Clinical Evidence

Bench testing only. Performance data demonstrated safety and effectiveness of the F114, including validation of the bariatric mode and continuous pressure measurement functionality across all operating modes.

Technological Characteristics

Microprocessor-controlled CO2 insufflator. Features: casing, power supply, pressure reducers, venting system, fluid sensor, gas heater, display/setting interface. Connectivity: single-use tubing sets with integrated heating/pressure sensing. Sterilization: Ethylene Oxide (EN 550, SAL ≤ 10^-6). Biocompatibility: materials identical to predicate devices with established history of safe use.

Indications for Use

Indicated for diagnostic/therapeutic endoscopic procedures requiring cavity distension via CO2. Includes high flow, low flow (pediatric use), bariatric, and vessel harvesting applications (saphenous vein/radial artery).

Regulatory Classification

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.

Predicate Devices

• 40 L High Flow Insufflator F113 (K060723)
• HI-FLO Therme Pneu 45 (K031014)
• Stryker Heated Insufflator Tube Set (K003792)
• Surgiflator 20, Single-Use Heatable Tube Set (K950035)

Submission Summary (Full Text)

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K063367

## 510(k) SUMMARY

MAY 2 3 2007

| Submitter: | W.O.M. WORLD OF MEDICNE AG<br>Alte Poststraße 11<br>96337 Ludwigsstadt<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official<br>Correspondent: | Susanne Raab<br>Regulatory Consultant<br>1480 Cambridge Street<br>Cambridge, MA 02139<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Trade Name: | 45L CORE Insufflator F114 |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Endoscopic<br>Vessel Harvesting |
| Classification<br>Name: | Laparoscopic Insufflator, 21 C.F.R. 884.1730<br>Insufflator, Automatic Carbon Dioxide for Endoscope,<br>21 C.F.R. § 876.1500 |
| Regulatory Class: | II |
| Product Code: | HIF / GCJ |
| Predicate Devices: | 1. 40 L High Flow Insufflator F113, (K060723)<br>2. HI-FLO Therme Pneu 45, (K031014)<br>3. Stryker Heated Insufflator Tube Set, (K003792)<br>4. Surgiflator 20, Single-Use Heatable Tube Set,<br>(K950035) |
| Device Description: | The 45L CORE Insufflator F114 is a microprocessor<br>controlled CO2 insufflator designed with a high flow<br>application, a low flow application, a bariatric application<br>and a vessel harvesting application. The device incorporates<br>the 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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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.

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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 [phone] or [phone] 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

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