(178 days)
Not Found
None
No
The summary describes a device for lavage with preselected pressure and temperature, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as "solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity," indicating a therapeutic purpose.
No
The device is described as being used for "operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution." This indicates a therapeutic or interventional function (irrigating during surgery), not a diagnostic one (identifying or characterizing a disease).
No
The device description clearly indicates a physical device ("Aqua-Purator Biotherme 1608") used for lavage, which involves hardware components for heating and delivering saline solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution". This describes a surgical procedure and the use of a device to facilitate that procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations on specimens.
- Device Function: The device's function is to heat and deliver saline solution for irrigation during surgery. This is a therapeutic and procedural function, not a diagnostic one.
Therefore, the WISAP Aqua-Purator Biotherm 1608 is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is restricted to use by authorized expert personnel/physicians.
The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.
Product codes
85HET
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized expert personnel/physicians
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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
JAN 1 4 1999
Horst Semm WISAP Gesellschaft Fur Wissenshaftichen Apparatebau mbH Rudolf - Diesel - Ring 20 D-82054 Sauerlach b. Munchen GERMANY
Re: K982518/A1 Aqua Purator - Biotherm, WISAP Model #1608 Dated: October 20, 1998 Received: October 22, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85HET
Dear Mr. Semm:
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). 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 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 Register. 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please 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
Image /page/0/Picture/15 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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510(k) Number (if known): K982518
Device Name: Aqua-Purator Biotherme 1608
Indications For Use:
This device is restricted to use by authorized expert personnel/physicians.
The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.
(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)
Timid G. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number