(90 days)
K 955791
Not Found
No
The summary describes a high-flow insufflator for laparoscopic procedures, focusing on gas flow rate and pressure monitoring. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device facilitates the use of a laparoscope by distending the peritoneal cavity with gas, which is a procedural aid and not a direct therapeutic intervention.
No
This device is an insufflator used to distend the peritoneal cavity with gas for laparoscopic procedures. Its function is to create space for surgical access, not to diagnose medical conditions by analyzing data or images.
No
The device description clearly states it is a laparoscopic high flow insufflator, which is a hardware device used to fill the peritoneal cavity with gas. It describes physical characteristics like flow rate and comparison to a predicate hardware 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 "facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it." This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description confirms its use in a surgical context for insufflation during laparoscopy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the Surgiflator-30 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the use of the laparoscope by filling To factitate the abo on one and and it.
Product codes
85 HIF
Device Description
The Surgiflator-30 is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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)
K 955791, KSEA Thermoflator, Model 26 4320 20
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PI92
Summary of Safety and Effectiveness - 510(k) Summary ાનં.
W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Pascalstr. 11 D-10587 Berlin Germany.
DEC - 9 1997
Proprietary Name: SURGIFLATOR 30 Common Name: Laparoscopic Insufflator
The Surgiflator-30 is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
The Surgiflator-30 described in this notification is substantially equivalent to the W.O.M. Surgiflator 20-PIM. K 955791, and the KSEA Thermoflator, Model 26 4320 20, by Kan Storz Endoscopy - America, Inc.
- · The Surgifiator-30 incorporates the same design features as the W.O.M. Surgifiator 20-PIM. The only differences lie in the following:
Surgiflator-30 offers an increased flow rate of max. 30 Vmin. The device will also be available as a 25 Vmin version.
The Surgifiator-30 does not offer optional simultaneous pressure monitoring.
- · The utility and safety of laparoscopic techniques using modern electronic high flow insufflators is thoroughly reported in the literature with the advantages and the risks well articulated.
- · A comprehensive discussion of the use of insufflation methods is presented in the book "Operative Laparoscopy" (1): 9-15, by M .- A. Bruhat, 1992, which observes that Laparoscopy, along with the entire concept of minimally invasive surgery through edoscopically guided intra-abdominal surgerv. has become a mainstay in gynecologic surgery. The review of instrumentation in this field includes comments on the use of modern high flow insufflators, the establishment of the pneumoperitoneum, use of instrumentation and use of CO2-lasers.
- · A detailed description of the use of different insufflator types is given in the book "Laparoscopy in gynecology, surgery and pediatrics," by H. Frongenheim. Requirements for insufflation apparatus and for the sterilization of instruments are described (2): 8-26, 39-A3
1
K973432 12022
Summary of Safety and Effectiveness - 510(k) Summary ાં
W.O.M. GmbH Pascalstr. 11 D-10587 Berlin Germany.
Page -2- / -2-
Background information and experiences with the use of laparoscopic techniques including video endoscopy are presented in the book "Minimal Invasive Surgery" (3): 57ff, 216-218, 291-295 by John G. Hunter, M.D. and Jonathan M. Sackier, M.D., McGraw-Hill, Inc., 3-6 and 216, 291. New technologies are discussed as well as advantages and disadvantages of minimally invasive surgery. The importance of effective, well-maintained instrumentation, i.e. insufflators and other instrumentation like light sources, television screens, and energy sources, is discussed.
REFERENCES
- Maurice-Antoine Bruhat. "Operative Laparoscopy". New York: McGraw-Hill, 1992, 1 . 226 pages.
-
- H. Frongenheim. "Laparoscopy in Gynecology, Surgery and Pediatry" Shuttgart: Georg Thieme Verlag, 1977, 214 pages.
-
- John G., Hunter. "Minimally Invasive Surgery". New York: McGraw Hill, 1993, 358 pages.
Signed:
03 September 1987 Michael McGrail
Manager, Regulatory Affairs
M. McOuil
Date:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure.
DEC - 9 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.O.M. GmbH c/o Robert P. Reznick Hughes Hubbard & Reed 1300 I Street, N.W. Suite 900 West Washington, D.C. 20005-3306 Re: K973432 Surgiflator-30 Dated: September 9, 1997 Received: September 10, 1997 Regulatory Class: II 21 CFR §884.1730/Product Code: 85 HIF
Dear Mr. Reznick:
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 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, 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 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 predication 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 (2) CFR Part 801 and additionally 809.10 for in vito 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 respensibilities 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/dsmamain.html".
Sincerely yours,
William Yin
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| Number (if known): | |
|---|---|
| Name: | Surgiflator-30 |
CONFIDENTIAL
Indications For Use:
510(k)
Device
:
To facilitate the use of the laparoscope by filling To factitate the abo on one and and it. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973432
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)