(44 days)
Not Found
No
The description focuses on the physical components and function of heating, humidifying, and filtering CO2 gas. There is no mention of AI/ML terms, image processing, or data-driven decision making.
No
The device is an accessory used to condition gas for insufflation, not directly treat a disease or condition in a therapeutic manner.
No
The device is described as a gas conditioner accessory device intended to heat, humidify, and filter a CO2 gas stream for insufflation of the surgical cavity. Its function is to modify the gas before it enters the patient, not to gather information about a patient's health condition.
No
The device description clearly outlines physical components including a disposable filter heater/humidifier tubing set and a control module housing control and safety circuits, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the VasoVapor™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity" during endoscopic vessel harvesting. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device description details how the device processes CO2 gas for direct delivery into the patient's surgical cavity. It does not mention analyzing any biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The VasoVapor™ is a device used during a surgical procedure to prepare a gas for insufflation into the patient's body. This falls under the category of a surgical accessory or device used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VasoVapor™is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
Product codes
HIF
Device Description
The VasoVapor™ 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 surgical cavity. The Vaso Vapor™ 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 VasoVapor™ device, through the in-line filter, continues along the tube to enter the VasoVapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical 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)
Extensive performance testing has been conducted to assure that the VasoVapor™ (i.e., Insuflow ) performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and K090456 are referenced in Section 5 for completeness.
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.
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K101 320
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SECTION 2. SUMMARY AND CERTIFICATION
JUN 2 4 2010
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for VasoVapor™
| 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: | 7 May 2010 |
1. Identification of device
Proprietary Name: VasoVapor™ Common Name: Laparoscopic Insufflator Gas Conditioner Classification Status: Class II per regulations 884.1730 Product Code: HIF
2. Equivalent devices
LEXION Medical believes that VasoVapor™ is substantially equivalent to the following devices:
Insuflow®, K063546
Insuflow®, K090456
Vaso Vapor™ is the same gas conditioner insufflator accessory device as cleared under 510(k) K063546 and K090456 and has a subset of the intended use of the predicate device cleared under 510(k) K090456.
3. Description of the Device
The VasoVapor™ 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 surgical cavity. The Vaso Vapor™ 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 VasoVapor™ device, through the in-line filter, continues along the tube to enter the VasoVapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
LEXION Medical VasoVapor™ 510k
Confidential
б
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4. Intended use
VasoVapor™is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
ડ. Technological characteristics, comparison to predicate device.
Technically, the VasoVapor™ is identical to the Insuflow cleared for market in 510(k) K063546 and K090456. The indications for use for the VasoVapor™ are patterned affer the predicate devices, being specific to the endoscopic vessel harvesting application.
6. Discussion of performance testing.
Extensive performance testing has been conducted to assure that the VasoVapor™ (i.e., Insuflow ) performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and K090456 are referenced in Section 5 for completeness.
7. Conclusion
Based on a comparison to the predicate devices, it is the conclusion of LEXION Medical that VasoVapor™ is substantially equivalent to devices already on the market being used for this application (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN 2 4 2010
Mr. Bernard (Bud) Horwath Regulatory Consultant LEXION Medical LLC 5000 Township Parkway ST PAUL MN 55110
Re: . K101320
Trade Name: VasoVapor™ Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: May 7, 2010 Received: May 11, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related
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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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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B. INDICATIONS FOR USE
510(k) Number K10 | 320
Device Name: VasoVapor™
Indications for Use:
VasoVapor™ is a gas conditioner accessory device for use in endoscopic vessel 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over the Counter Use X OR (Per 21 CFR 801.109) vision Sign=Off on of ReBroductive, Abdominal, and ales Devia LEXION Medical VasoVapor™ 510k
Confidential
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