(86 days)
Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.
The Vessel Vapor™ 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 Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ 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.
This document is a 510(k) summary for the Vessel Vapor™ device, a laparoscopic insufflator gas conditioner. It does not contain information about a clinical study with acceptance criteria and device performance. The document focuses on demonstrating substantial equivalence to predicate devices (Vessel Guardian® K102136 and Insuflow® K090456) based on technological characteristics and intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set information.
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NOV 1 0 2011
SECTION 1. SUMMARY AND CERTIFICATION
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 Vessel VaporTM
| SUBMITTER'S NAME: | LEXION Medical LLC |
|---|---|
| ADDRESS: | 545 Atwater CircleSt. Paul, MN 55103 |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 12 August 2011 |
Identification of device 1.
Proprietary Name: Vessel Vapor™ Common Name: Laparoscopic Insufflator Gas Conditioner Classification Status: Class II per regulations 884.1730 Product Code: HIF
2. Equivalent devices
LEXION Medical believes that Vessel Vapor™ is substantially equivalent to the following devices:
Vessel Guardian®, K102136 Insuflow®, K090456
Vessel Vapor™ is the same gas conditioner insufflator accessory device and has the same intended use as the predicate devices cleared under 510(k) K102136 and K090456.
3. Description of the Device
The Vessel Vapor™ 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 Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system.
Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ 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.
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4. Intended use
. . .
Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular. thoracoscopic, and vessel harvesting surgical procedures.
The indications for use for the Vessel Vapor™ are patterned after the predicate devices: however, they have been expanded to include minimally invasive cardiovascular surgical procedures. The addition of this specific indication does not affect the safety and effectiveness of the device when used as labeled.
ડ. Technological characteristics, comparison to predicate device.
Technically, the Vessel Vapor™ is identical to the Vessel Guardian® and Insuflow devices cleared for market in 510(k) K102136 and K090456, respectively.
Conclusion 6.
Based on a comparison to the predicate devices, it is the conclusion of LEXION Medical that Vessel Vapor™ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Mr. Bernard Horwath Regulatory Consultant LEXION Medical LLC 545 Atwater Circle ST PAUL MN 55103
Re: K112357 Trade/Device Name: Vessel Vapor™ Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF. OSV Dated: August 12, 2011 Received: August 16, 2011
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/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,
Hubert H. Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K112357 510(k) Number
Device Name: Vessel Vapor™
Indications for Use:
Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures. ・・
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X OR Over the Counter Use (Per 21 CFR 801.109) vision Signoductive, Gastro-Renal, and
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§ 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.