(207 days)
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No
The summary describes a disposable heating tube for a laparoscopic insufflator, which is a mechanical device for creating a pneumoperitoneum. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's function is to preheat insufflation gas for pneumoperitoneum during diagnostic-operative pelviscopy/laparoscopy, which is an accessory function for a diagnostic/surgical procedure, not a direct therapeutic intervention itself.
No
The text indicates the device is used for "building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy," and that "The insufflation gas is preheated to body temperature by the disposable tubing." This describes a supportive function for a diagnostic procedure, but the device itself does not perform diagnostics (e.g., analyze data, image, or provide a diagnosis).
No
The device description explicitly states it is a "Disposable Heating Tubing Set," which is a physical hardware component used with a laparoscopic insufflator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a laparoscopic accessory used in connection with an insufflator to build up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. This is a surgical procedure performed in vivo (within the living body).
- 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. This device does not perform any such tests on biological samples.
- Device Description: The description identifies it as a "Laparoscopic Insufflator: Disposable Heating Tubing Set," which aligns with its use in a surgical setting.
Therefore, the function and intended use of this device are entirely outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This device is restricted to use by authorized expert personnel/physicians. The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.
Product codes
85 HIF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
authorized expert personnel/physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. S. Grünwald Quality Management WISAP Gesellschaft für wissenschaftlichen Apparatebau mbH Rudolf-Diesel-Ring 20 D-82054 Sauerlach b. München GERMANY
Re: K990662
Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES Dated: September 1, 1999 Received: September 9, 1999 Requlatory Class: II 21 CFR §884.1730/Procode: 85 HIF
Dear Mr. Grünwald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): K990662
Disposable Heating Tubing Set #7642 HSES Device Name:
Indications For Use:
This device is restricted to use by authorized expert personnel/physicians.
The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .