(325 days)
The 40L High Flow Insufflator F108 with low flow mode is a device intended to facilitate the use of the laparosoope by filling the peritoneal cavity with gas to distend it. The low flow application of this device is indicated for pediatric use.
The 40 L High Flow Insufflator F108 is a microprocessor controlled device designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and therapeutic laparoscopic procedures. The 40 L High Flow Insufflator F108 consists of the following main components: a housing, power supply, pressure reducers, a venting system, a fluid sensor, a gas heater, various setting kevs and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the abdomen with the pre-set nominal pressure. The device is to be used with a specially designed heating tube and with an optional remote control.
The 40 L High Flow Insufflator F108 is a medical device and therefore does not have acceptance criteria or performance metrics directly comparable to AI/ML software. The provided text describes its regulatory submission (510(k)) and substantial equivalence to a predicate device, rather than a study with acceptance criteria for device performance in the way an AI model would be evaluated.
Here's a breakdown of the specific points you requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
This information is not applicable in the context of this medical device submission. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing new acceptance criteria for novel performance metrics with a quantitative study design.
However, the document states:
- Acceptance Criteria (Implicit): Substantial equivalence to the predicate device, Surgiflator 40 (K001533), in intended use, design, and technological characteristics. The main difference, a new software logarithm for accurate flow measurements (0.1 V/min to 1 V/min) and a Low Flow Mode, was deemed not to raise new questions of safety and effectiveness.
- Reported Device Performance: "Bench tests demonstrate the safety and effectiveness of the 40 L High Flow Insufflator F108 when used in the Low Flow Mode to insufflate small abdominal cavities." No specific quantitative performance metrics are provided in the summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or data provenance is mentioned as this is a medical device for which bench testing was performed, not a data-driven AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No experts are mentioned in the context of establishing ground truth for a test set. Bench tests were performed to demonstrate safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as no test set requiring human adjudication was utilized.
5. 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
Not applicable. No MRMC comparative effectiveness study was performed or mentioned. This is a hardware medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a standalone hardware product. The mention of "software logarithm" refers to an internal control system for accurate flow measurements, not an AI algorithm for diagnostic interpretation or decision-making. Its performance is its standalone performance without a human in the loop for its primary function of insufflation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the sense of a data-driven model. The "ground truth" for this device's safety and effectiveness was established through bench tests and a comparison to the predicate device's known performance record and literature review on CO2 insufflators.
8. The sample size for the training set
Not applicable. No training set is mentioned. This device does not use machine learning in the conventional sense that would require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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510(k) SUMMARY 40L High Flow Insufflator F108
I. Applicant:
W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany
Phone number: 011 49 9263 877 0 FAX number: 011 49 9263 877 128
Establishment registration number:
8043980
| Contact name: | Marc Engelhardt |
|---|---|
| Contact title: | Regulatory Affairs Manager |
| Phone number: | 011 49 30 399 81 610 |
| FAX number: | 011 49 30 399 81 593 |
| Contact e-mail address: | marc.engelhardt@womcorp.com |
II. Submission Correspondent:
Susanne Raab 368 St. North Asaph Street Alexandria, VA 22314
| Contact title: | Regulatory Counsultant |
|---|---|
| Phone number: | 703-299-0523 |
| FAX number: | 703-299-0523 |
| Contact e-mail address: | sbraab@comcast.netsoraab@aol.com |
III. Date Summary was Prepared: March 13, 2003
IV. Product Information:
| Classification name: | Laparoscopic Insufflator |
|---|---|
| ---------------------- | -------------------------- |
Common name: Laparoscopic Insufflator
Trade name:
40 L High Flow Insufflator F108
V. Product Classification:
| Product code: | 85 HIF |
|---|---|
| C.F.R. Section: | 21 C.F.R. § 884.1730 |
| Device Class : | II |
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VI. Predicate Devices:
- Surgiflator 40 (K001533) manufactured by W.O.M. WORLD OF . MEDICINE AG
VII. Intended Use:
The 40 L High Flow Insufflator F108 is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
VIII. Device Description:
The 40 L High Flow Insufflator F108 is a microprocessor controlled device designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and therapeutic laparoscopic procedures. The 40 L High Flow Insufflator F108 consists of the following main components: a housing, power supply, pressure reducers, a venting system, a fluid sensor, a gas heater, various setting kevs and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the abdomen with the pre-set nominal pressure. The device is to be used with a specially designed heating tube and with an optional remote control.
IX. Substantial Equivalence:
The device described in this notification is similar in intended use. design and technological characteristics to the Sugiflator 40 (K001533) manufactured by W.O.M. WORLD OF MEDICINE AG.
Both the 40 L High Flow Insufflator F108 and the Surgiflator 40 (K001533) are intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. In addition, both devices are similar in design and technical characteristics. In particular, the pressure reduction concept, the venting system and the maximum flow and pressure ranges are identical.
Unlike the predicate device, the 40 L High Flow Insufflator F108 is designed with a new software logarithm which allows for accurate flow measurements in the range of 0.1 Vmin and 1 Vmin and for the integration of a Low Flow Modc to ensure the safe and effective performance of the device when insufflating small abdominal cavities.
The differences between the 40 L High Flow Insufflator F108 and the predicate device are minor and raise no new questions of safety and effectiveness. Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the 40 L High Flow Insufflator F108 is substantially equivalent to the predicate device.
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X. Performance Data:
Bench tests demonstrate the safety and effectiveness of the 40 L High Flow Insufflator F108 when used in the Low Flow Mode to insufflate small abdominal cavities.
XI. Clinical Data:
No clinical tests were performed. A review of professional literature demonstrates the safety and effectiveness of CO2 insufflators in pediatric laparoscopy.
XII. Voluntary Standards:
The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). In addition, the device meets the requirements of the Underwriter Laboratories Standard UL 2601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
W.O.M. World of Medicinc AG % Ms. Susanne Raab Regulatory Consultant 368 St. North Asaph Street ALEXANDRIA VA 22314
Re: K030837 Trade/Device Name: 40 L High Flow Insufflator F108 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: November 7, 2003 Received: November 7, 2003
Dear Ms. Raab:
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 such 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,
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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. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K030837
40L High Flow Insufflator F108 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
"The 40L High Flow Insufflator F108 with low flow mode is a device intended to facilitate the use of the laparosoope by filling the peritoneal cavity with gas to distend it. The low flow application of this device is indicated for pediatric use."
ﮐﯽ ﺍ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _
§ 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.