(47 days)
The Lexion Medical Insuflow® device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.
The Insuflow® device is a single use device that attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation into the abdominal cavity. The Insuflow® device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system.
Gas from the insufflator flows into the Insuflow® device, through the in-line filter, continues along the tube to enter the Insuflow® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a trocar or insufflation needle, and finally flows into the patient's abdomen.
The provided text is a 510(k) summary for the Lexion Medical Insuflow® Device. This document is a premarket notification for a medical device and describes its equivalence to a previously marketed device (predicate device), rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria from an AI/ML perspective.
Therefore, the requested information, which pertains specifically to performance metrics, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data for AI/ML models, cannot be extracted from this document, as it is not relevant to the type of device and the submission presented.
The device described is a physical accessory to an insufflator that heats, humidifies, and filters gas for laparoscopic surgery. The studies mentioned are primarily focused on system performance (CO2 gas temperature and humidity characteristics), electrical safety, EMC testing, and biocompatibility. These are engineering and biological performance characteristics, not AI/ML model performance metrics.
Specifically, for each point requested:
- A table of acceptance criteria and the reported device performance: Not applicable. The document mentions "The Insuflow® device met all specified design and performance requirements" for electrical safety and EMC, and "All specified biocompatibility requirements were met." However, it does not provide a table of these specific criteria or quantitative performance results in a way that would be comparable to AI/ML model output (e.g., sensitivity, specificity, AUC).
- Sample sizes used for the test set and the data provenance: Not applicable. The studies mentioned (system performance, electrical safety, biocompatibility) are laboratory or bench tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance is not specified beyond being "verification testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's engineering and biocompatibility performance is typically established by engineering standards, chemical analysis, and certified test protocols, not expert consensus in the diagnostic sense.
- Adjudication method for the test set: Not applicable. There is no "test set" and thus no adjudication method as understood in AI/ML performance evaluation.
- 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. This device does not involve human "readers" or AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests performed would be established by engineering specifications, validated measurement equipment, and standardized biological assessments.
- The sample size for the training set: Not applicable. There is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided K063546 document for the Insuflow® device does not describe an AI/ML device and therefore the requested information fields related to AI/ML model performance and validation are not present.
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| Date Prepared: | November 22, 2006 |
|---|---|
| JAN 10 2007 | |
| Submitter: | Lexion Medical, LLC5000 Township ParkwaySt. Paul, MN 55110 |
| Contact Person: | Duane LloydResearch and DevelopmentLexion Medical, LLC5000 Township ParkwaySt. Paul, MN 55110Phone: 651-204-9951Fax: 651-635-0090E-mail: dlloyd@lexionmedical.com |
| Device Name: | Insuflow® Device, Filter Heater/Hydrator Insufflation GasConditioner |
| Classification Name: | Laparoscopic Insufflator |
| Product Code: | HIF |
| Device Class: | II |
| Regulation Number: | 884.1730 |
| Intended Use: | The Lexion Medical Insuflow® device is an accessory to aninsufflator intended to heat, humidify and filter a gas stream usedfor inflation during laparoscopic surgery. |
| Device Description: | The Insuflow® device is a single use device that attaches to theoutlet port of an insufflator and is designed to warm and humidifythe gas stream prior to insufflation into the abdominal cavity. TheInsuflow® device consists of a disposable filter heater/humidifiertubing set and a control module that houses the control and safetycircuits for the system.Gas from the insufflator flows into the Insuflow® device, throughthe in-line filter, continues along the tube to enter the Insuflow®device cassette that contains the heating element andhumidification media, through a tube that connects via a Luer lock |
:
510(k) Summary of Substantial Equivalence
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| connector to a trocar or insufflation needle, and finally flows intothe patient's abdomen. | |
|---|---|
| Predicate Device: | Insuflow® Filter Heater/Hydrator Insufflation Gas ConditionerK970866 Decision Date: January 23, 1998 |
| Summary of Studies: | Verification testing included system performance tests designed tomap the CO2 gas temperature and humidity characteristics emittedfrom the Insuflow® under a simulated run of varying flow rateswith sterile water and saline. |
| Electrical safety and EMC testing was performed using applicableguidelines of EN 60601-1-2, EN 55011, EN 61000-3 and EN61000-4. The Insuflow® device met all specified design andperformance requirements. | |
| Biocompatibility: | The Insuflow® device was assessed for biocompatibility accordingto guidelines of ISO 10993 - Biological Evaluation of MedicalDevices and FDA G95-1 guidelines. All specifiedbiocompatibility requirements were met. |
| Conclusion: | Through the data and information presented, Lexion Medical LLCconsiders the Insuflow® device to be substantially equivalent to thelegally marketed predicate device. |
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JAN 1 0 2007
Mr. Duane Lloyd Research and Development LEXION Medical, LLC 5000 Township Parkway ST. PAUL MN 55110
Re: K063546
Trade/Device Name: Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: December 28, 2006 Received: December 29, 2006
Dear Mr. Lloyd:
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 Coosn. 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 affective 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.
Image /page/2/Picture/9 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center in large letters, and "Centennial" below that. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.
Protecting and Promoting Public Health
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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.
This letter will allow you to begin marketing your device as described in your Section S10(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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
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): K063540
Device Name: Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner
Indications for Use:
The Lexion Medical Insuflow® device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
David A. Heggem
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063546
§ 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.