(88 days)
Not Found
Not Found
No
The summary describes a device for creating a pneumoperitoneum and preheating gas, with no mention of AI or ML capabilities.
No
The device is used to build a pneumoperitoneum for diagnostic or operative procedures, which is an ancillary function to the main procedure, not directly therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device "may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy." The presence of "diagnostic" in its intended use indicates it plays a role in diagnosis.
No
The device description clearly indicates a hardware device used for insufflation with CO2 gas, including a flow-therme for preheating. This is not a software-only device.
Based on the provided information, the WISAP Multi Hi-Flo Therme Pneu 45 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to build up a pneumoperitoneum with CO2 gas for diagnostic or operative Pelviscopy/Laparoscopy. This is a procedure performed in vivo (within the living body) to create space for surgical or diagnostic visualization.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The device's function is to prepare and deliver gas for a surgical/diagnostic procedure performed directly on the patient, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
Product codes
85 HIF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvis
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)
Not Found
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2003
Mr. Horst Semm General Manager WISAP Gesellschaft Fur Wissenschaft Rudolf-Diesel-Ring 20 Sauerlach, D-82054 GERMANY
Re: K031014 Trade/Device Name: HI-FLO Therme Pneu 45, #7083, 7083V Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: March 27, 2003 Received: March 31, 2003
Dear Mr. Semm:
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); 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.
1
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
Page 2
2
Page_1 of ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺪﻳﻤﺔ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HI-FLO Therme Pneu 45, WISAP #7083, 7083V
Indications For Use:
The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Odmil R. Segnon
(Division Sign-Off) Division of Reproduct and Radiological I 510(k) Num
(Optional Format 3-10-98)
Prescription Use