(47 days)
Not Found
No
The description focuses on heating, humidifying, and filtering gas, with control and safety circuits. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an accessory to an insufflator, intended to heat, humidify, and filter a gas stream. Its function is to prepare the gas for insufflation, not to directly treat a disease or condition.
No
The device is described as an accessory to an insufflator designed to heat, humidify, and filter a gas stream for inflation during laparoscopic surgery. Its function is to modify the gas stream before it enters the patient's abdomen, not to diagnose any condition.
No
The device description explicitly states it is a "single use device that attaches to the outlet port of an insufflator" and "consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system." This indicates significant hardware components beyond just software.
Based on the provided information, the Lexion Medical Insuflow® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "heat, humidify and filter a gas stream used for inflation during laparoscopic surgery." This is a therapeutic and procedural function, not a diagnostic one.
- Device Description: The device description details how it modifies a gas stream for insufflation into the abdominal cavity. This is a direct interaction with the patient's body during a surgical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information for diagnosis. IVD devices are specifically designed for testing samples taken from the human body.
Therefore, the Insuflow® device is a medical device used in vivo (within the body) during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HIF
Device Description
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.
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
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)
Verification testing included system performance tests designed to map the CO2 gas temperature and humidity characteristics emitted from the Insuflow® under a simulated run of varying flow rates with sterile water and saline. Electrical safety and EMC testing was performed using applicable guidelines of EN 60601-1-2, EN 55011, EN 61000-3 and EN 61000-4. The Insuflow® device met all specified design and performance requirements.
The Insuflow® device was assessed for biocompatibility according to guidelines of ISO 10993 - Biological Evaluation of Medical Devices and FDA G95-1 guidelines. All specified biocompatibility requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| Date Prepared: | November 22, 2006 |
|---|---|
| JAN 10 2007 | |
| Submitter: | Lexion Medical, LLC |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Contact Person: | Duane Lloyd |
| Research and Development | |
| Lexion Medical, LLC | |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Phone: 651-204-9951 | |
| Fax: 651-635-0090 | |
| E-mail: dlloyd@lexionmedical.com | |
| Device Name: | Insuflow® Device, Filter Heater/Hydrator Insufflation Gas |
| Conditioner | |
| 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 an |
| insufflator intended to heat, humidify and filter a gas stream used | |
| for inflation during laparoscopic surgery. | |
| Device Description: | 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 |
:
510(k) Summary of Substantial Equivalence
1
| | connector to a trocar or insufflation needle, and finally flows into
the patient's abdomen. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner
K970866 Decision Date: January 23, 1998 |
| Summary of Studies: | Verification testing included system performance tests designed to
map the CO2 gas temperature and humidity characteristics emitted
from the Insuflow® under a simulated run of varying flow rates
with sterile water and saline. |
| | Electrical safety and EMC testing was performed using applicable
guidelines of EN 60601-1-2, EN 55011, EN 61000-3 and EN
61000-4. The Insuflow® device met all specified design and
performance requirements. |
| Biocompatibility: | The Insuflow® device was assessed for biocompatibility according
to guidelines of ISO 10993 - Biological Evaluation of Medical
Devices and FDA G95-1 guidelines. All specified
biocompatibility requirements were met. |
| Conclusion: | Through the data and information presented, Lexion Medical LLC
considers the Insuflow® device to be substantially equivalent to the
legally marketed predicate device. |
2
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
3
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
4
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