(90 days)
To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
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 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 provided text is a 510(k) summary for a medical device called the SURGIFLATOR 30, a laparoscopic insufflator. This type of regulatory submission historically focused on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with detailed acceptance criteria and performance data as might be seen for novel devices today.
Therefore, the document does not contain the typical information requested regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement for ground truth, or an MRMC comparative effectiveness study. The basis for clearance is demonstrating substantial equivalence to existing devices.
Here's an analysis of what can be extracted or inferred based on the document's nature:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission from 1997, the "acceptance criteria" are broad and relate to demonstrating substantial equivalence to predicate devices already on the market. The primary "performance" reported is related to an increased flow rate.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device "Performance" |
|---|---|
| Equivalence in Intended Use: To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. | Met: Intended use is identical to predicate devices. |
| Similar Technological Characteristics: Design features similar to predicate. | Met: "incorporates the same design features as the W.O.M. Surgiflator 20-PIM." |
| Performance within established safety and effectiveness parameters for high-flow insufflators. | Achieved: Increased flow rate to max. 30 L/min (from 20 L/min in predicate). Also available as 25 L/min version. No optional simultaneous pressure monitoring (a difference noted, implying it doesn't negatively impact safety/effectiveness relative to predicates). |
| Safety profile consistent with predicate devices. | Achieved: Relies on the established safety and utility of laparoscopic techniques using high-flow insufflators as thoroughly reported in literature. |
Study Information (Based on 510(k) Context)
-
Sample size used for the test set and the data provenance:
- Not applicable / Not provided. A formal "test set" in the sense of a clinical study or performance study with a specific sample size is not described. The basis for safety and effectiveness relies on comparison to predicate devices and general medical literature.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment for a test set is not detailed as there isn't a described performance study with a test set. The "ground truth" for the device's utility and safety is implicitly drawn from established medical literature and the long history of laparoscopic procedures and insufflators.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None. No formal adjudication method is mentioned as there isn't a described test set needing ground truth adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device for laparoscopic insufflation, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant or described.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument (an insufflator), not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's safety and effectiveness relies on a combination of historical clinical experience and established medical literature regarding laparoscopic techniques and the use of high-flow insufflators. The document cites several medical textbooks to support the general safety and utility of such devices.
-
The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.
-
How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set is relevant to this device submission.
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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
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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:
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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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| 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)
§ 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.