ALPHA DUO LAP INSUFFLATOR

K090652 · Hippokratec GmbH · HIF · Sep 25, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090652
• Device Name: ALPHA DUO LAP INSUFFLATOR
• Applicant: Hippokratec GmbH
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy.

Device Story

The ALPHA DUO LAP is a microprocessor-controlled laparoscopic insufflator used in clinical settings to establish and maintain pneumoperitoneum during diagnostic or therapeutic laparoscopic procedures. The device delivers medical CO2 gas into the peritoneal cavity at user-adjustable pressures (3-30 mmHg) and flow rates (16-45 lpm, model-dependent). It features integrated acoustic and visual alarms for overpressure and low gas supply conditions. Operated by healthcare professionals, the device provides automated gas delivery to facilitate surgical access. By maintaining a stable pneumoperitoneum, it enables visualization and instrumentation for the surgeon, potentially improving procedural efficiency and patient outcomes during minimally invasive surgery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and performance evaluations in conformance with harmonized device standards, alongside a review of professional literature regarding the safety and effectiveness of CO2 insufflators.

Technological Characteristics

Microprocessor-controlled CO2 insufflator. Flow rates: 16-45 lpm. Pressure range: 3-30 mmHg. Features acoustic and visual alarms for overpressure and low gas supply. Materials and design conform to international and FDA-recognized standards.

Indications for Use

Indicated for patients undergoing diagnostic or operative laparoscopic procedures requiring pneumoperitoneum established via CO2 gas insufflation.

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

• Multi HI-FLO Pneu 7080 (K011510)
• 40L High Flow Insufflator F108 (K030837)
• SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (K070783)

Submission Summary (Full Text)

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K090652

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### 510(k) SUMMARY · As required by Section 807.92(c)) Laparoscopic Insufflator

Applicant:

HIPPOKRATEC Gesellschaft für Medizintechnik mbH Am Windfeld 36 83714 Miesbach GERMANY

Phone: Fax: E-mail

[phone] [phone] [e-mail]

Establishment registration number: not yet available

## Contact Person:

Christian Siedersberger, Am Windfeld 36 83714 Miesbach GERMANY

[phone] Phone Fax [phone] [e-mail] E-mail

Date Prepared:

Product Information

Common:

E.T.

Trade Name

C.F.R. Section:

Classification Names:

•

Device Class

Product code

23rd February, 2009

Laparoscopic Insufflator

ALPHA DUO LAP Insufflator

Laparoscopic Insufflator

21 C.F.R. §884.1730

II

85 HIF

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## Predicate Devices

Predicate devices are produced by

| Company | Property/ Device Name | 510(k) No. |
|---------|------------------------------------------------|------------|
| WISAP | Multi HI-FLO Pneu 7080 | K011510 |
| W.O.M. | 40L High Flow Insufflator F108 | K030837 |
| SOPRO | SOPRO MODEL 640<br>LAPAROSCOPIC<br>INSUFFLATOR | K070783 |

Intended Use

The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy.

## Device Description

The Laparoscopic Insufflator ALPHA DUO LAP with the following model variants S.2916.00 II, S.2920.00 II, S.2925.00 II, S.2930.00 II, S.2945.00 II" is a microprocessor controlled device, designed to ínsufflate medical CO2 gas into peritoneal cavities during diagnostic and/or therapeutic laparoscopic procedures. The maximum flow delivery capability depends on the indexed ( performance ) type and ranges from 16 lpm to 45 lpm. The insufflation pressure is user adjustable between 3 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure and low gas supply.

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## Summary of Testing

All materials used in the composition of the laparoscopic insufflator and accessories were subject to performance and physical tests to evaluate safety, effectiveness and reliability of the devices. All results were in conformance with the cited harmonized device standards. From this it follows, that this device is substantial equivalent to other SE-devices.

## Information Bearing on the Safety and Effectiveness

Laparoscopic Insufflators of type ALPHA DUO LAP and accessories have the same intended use as predicate devices used in laparoscopy. They are made of the same material and produced to the same international and FDA-recognized standards. Modifications in design and dimensions do not adversely affect the safety and effectiveness of these devices.

In summary, the

- > intended use
- performance attributes Д
- > materials and
- > basic design

are identical/substantially equivalent to SE devices. Then it is judged that clinical data is not needed. A review of professional literature demonstrates the safety and effectiveness of CO2 insufflators.

The results of design validation raise no new issues of safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the edge. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or some other bird. The emblem is stylized with curved lines and shapes, giving it a modern and symbolic look.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Hippokratec GmbH % Mr. Stefan Preiss Responsible Third Party Manager TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

Re: K090652

Trade/Device Name: Laparoscopic Insufflator with the following device model variants: Alpha Duo Lap Insufflator (S.2916.00 II), (S.2920.00 II),

(S.2925.00 II), (S.2930.00 II), and (S.2945.00 II)

SEP 2 5 2009

Regulation Number: 21 CFR 884.1730

Regulation Name: Laparoscopic insufflator

Regulatory Class: II

Product Code: HIF

Dated: September 8, 2009

Received: September 11, 2009

## Dear Mr. Preiss:

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 (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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Laparoscopic Insufflator with the following device model variants:

Alpha Duo Lap Insufflator (S.2916.00 II), Alpha Duo Lap Insufflator (S.2920.00 II), Alpha Duo Lap Insufflator (S.2925.00 II), Alpha Duo Lap Insufflator (S.2930.00 II), Alpha Duo Lap Insufflator (S.2945.00 II)

Indications for Use

The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy.

Prescription Use X (Part 21 CFR 801 Subpart D)

## AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this Line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hul Reum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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