(184 days)
Not Found
No
The description focuses on the physical components and function of heating, humidifying, and filtering CO2 gas, with no mention of AI or ML algorithms for control, analysis, or decision-making.
No.
The device is a gas conditioner accessory device that heats, humidifies, and filters a CO2 gas stream for insufflation during minimally invasive surgery. It does not treat or cure a disease or condition, which is the function of a therapeutic device.
No
The device is an accessory that conditions CO2 gas for insufflation during surgery, not a device used to diagnose medical conditions.
No
The device description clearly outlines hardware components including a disposable filter heater/humidifier tubing set and a control module housing control and safety circuits. It is a physical accessory device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity." This is a therapeutic or surgical support function, not a diagnostic one.
- Device Description: The description details how the device prepares CO2 gas for introduction into the body during surgery. It does not mention any interaction with biological samples (blood, urine, tissue, etc.) for the purpose of diagnosis.
- Lack of Diagnostic Purpose: The core function of an IVD is to provide information about a patient's health status through the examination of biological samples. This device does not perform any such examination or provide diagnostic information.
The device is an accessory used during surgical procedures to improve the conditions within the surgical cavity, which is a therapeutic/surgical support function.
N/A
Intended Use / Indications for Use
Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
Product codes (comma separated list FDA assigned to the subject device)
HIF
Device Description
The Insuflow device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the cardiothoracic, vascular or abdominal surgical 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.
Regulated CO2 gas 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 anno a insufflation needle/trocar and finally flows into the patient's surgical cayity over and finally
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiothoracic, vascular or abdominal surgical cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive surgery
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)
Extensive performance testing has been conducted to assure that the Insuflow performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
AUG 2 6 2009
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for Insuflow
| SUBMITTER'S NAME: | LEXION Medical LLC |
|---|---|
| ADDRESS: | 5000 Township Parkway |
| St. Paul, MN 55110 | |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 18 February 2009 |
1. Identification of device
Proprietary Name: Insuflow® Common Name: Laparoscopic Insufflator Gas Conditioner Classification Status: Class II per regulations 884.1730 Product Code: HIF
2. Equivalent devices
LEXION Medical believes that Insuflow® is substantially equivalent to the following devices:
Insuflow®, K063546 CarbonAid, K052125
Insuflow is the same gas conditioner insufflator accessory device as cleared under 510(k) K063546 and has essentially the same intended use as the predicate devices.
3. Description of the Device
The Insuflow device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the cardiothoracic, vascular or abdominal surgical 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.
Regulated CO2 gas 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 anno a insufflation needle/trocar and finally flows into the patient's surgical cayity over and finally
LEXION Medical Insuflow® 510k
Confidential
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4. Intended use
Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
న. Technological characteristics, comparison to predicate device.
Technically, the Insuflow is identical to the Insuflow® cleared for market in 510(k) K063546 and essentially equivalent to the other predicate. The indications for use for the Insuflow are patterned after the predicate devices and supported by an extensive collection of literature references.
6. Discussion of performance testing.
Extensive performance testing has been conducted to assure that the Insuflow performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5.
7. Conclusion
Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that Insuflow is substantially equivalent to devices already on the market being used for these applications (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
LEXION Medical Insuflow® 510k
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Confidential
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Insuflow®
(1) Gas Conditioning Device (1) 10mL Luer Lock Syringe
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Intended Use: Insuflow® is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician.
Image /page/2/Picture/5 description: The image contains two symbols. The first symbol is a circle with a number 2 inside, and a diagonal line crossing out the number. The second symbol is a triangle with the text 'ST' inside.
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Patent 5,411,474 and Patent 6,068,609
Exic
LEXION Medical 5000 Township Pkwy St. Paul, MN 55110 USA Toll Free Customer Service: (877) 9-LEXION Email: customerservice@lexionmedical.com
P/N: #### (rev. A)
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Image /page/3/Picture/0 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 a stylized image of an eagle or bird-like figure with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Bernard Horwath Regulatory Consultant LEXION Medical, LLC 5000 Township Parkway ST PAUL MN 55110
Re: K090456
AUG 2 6 2009
Trade/Device Name: Insuflow® Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: August 5, 2009 Received: August 6, 2009
Dear Mr. Horwath:
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 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); medical device reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/cdrh/industry/support/index.html.
Sincerely yours,
Lamme M. Mouk
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
A. INDICATIONS FOR USE
K090456 510(k) Number
Device Name: Insuflow®
Indications for Use:
Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
(Please do not write below this line - continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Over the Counter Use on J sa.
10 300 2017 11/11/2017 10:00 2016 300 2017 17 000 2017 11/07 1
LEXION Medical
Insuflow® 510k
Prescription Use
(Per 21 CFR 801,109)
のお気になるのですが、お店は
Confidential