(198 days)
Not Found
No
The description focuses on microprocessor control for gas flow and pressure regulation, with no mention of AI or ML terms or functionalities.
Yes
The device is described as being used during "diagnostic and/or therapeutic laparoscopic procedures," indicating its role in therapeutic interventions.
Yes
The text explicitly states that the device's intended use is "to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy."
No
The device description explicitly states it is a "microprocessor controlled device" designed to insufflate gas, indicating it is a hardware device with embedded software, not a software-only medical 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 "establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The device insufflates CO2 gas into the peritoneal cavities. This is a mechanical action within the body, not a diagnostic test on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used to facilitate a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavities
Indicated Patient Age Range
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image shows a stylized logo. The logo consists of a large, outlined letter 'H' with a circular design overlapping the top right portion of the 'H'. Inside the circle, there are abstract shapes that resemble letters or symbols, possibly 'f' and 'R'. The overall design is simple and monochromatic.
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
+49-8025-28668-0 +49-8025-28668-98 info@hippokratec.de
Establishment registration number: not yet available
Contact Person:
Christian Siedersberger, Am Windfeld 36 83714 Miesbach GERMANY
+49-8025-28668-0 Phone Fax +49-8025-28668-98 siedersberger@hippokratec.de 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
1
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 | |
| LAPAROSCOPIC | ||
| 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.
XI
2
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.
3
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
4
Page 2 -
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 (800) 638-2041 or (301) 796-7100 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
5
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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