(118 days)
No
The description focuses on the physical components and function of heating, humidifying, and filtering CO2 gas, with no mention of AI or ML technologies.
Yes
The device is used in cardiovascular surgical procedures to condition a CO2 gas stream for introduction into the surgical cavity, with the purpose of improving visibility and reducing the risk of air embolism, which are therapeutic benefits.
No
The device is described as a "Blower/Mister Gas conditioner device" intended to heat, humidify, and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism. Its function is to modify a gas stream, not to diagnose a condition.
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.
Based on the provided information, the Insuflow® DewHeart™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Insuflow® DewHeart™ is used to condition and introduce CO2 gas directly into a patient's surgical cavity during cardiovascular procedures. It does not analyze or test any biological samples.
- The intended use is for surgical procedures to improve visibility and reduce the risk of air embolism. This is a therapeutic and procedural application, not a diagnostic one.
- The device description focuses on gas conditioning and delivery. It describes the process of heating, humidifying, and filtering CO2 gas for direct patient use.
Therefore, the Insuflow® DewHeart™ falls under the category of a surgical device used during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.
Product codes (comma separated list FDA assigned to the subject device)
FOH, HIF
Device Description
The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ 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® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry 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
cardiovascular 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 Insuflow DewHeart™ performs in accordance with its specifications and applicable standards. Details of the Insuflow 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)
Reference Device(s)
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.
0
SEP - 3 2009
1091366
SECTION 2. 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 Insuflow® DewHeart™
| 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: | 1 May 2009 |
1. Identification of device
Proprietary Name: Insuflow DewHeart™ Common Name: Blower/Mister Gas Conditioner Classification Status: Class II per regulations 880.5475 Product Code FOH
Class II per regulations 884.1730 Product Code HIF
2. Equivalent devices
LEXION Medical believes that Insuflow® DewHeart™ is substantially equivalent to the following devices:
Insuflow®, K063546
CarbonAid, K052125
CTS Blower Mister, K983135
Insuflow® DewHeart™ is technically the same device as the Insuflow® gas conditioner insufflator accessory device cleared under 510(k) K063546 and has essentially the same intended use as the predicate devices.
Description of the Device 3.
The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ 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® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry into the patient's surgical cavity of C ( ) gas strem home ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham
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4. Intended use
The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.
Technological characteristics, comparison to predicate device. ನೆ.
Technically, the Insuflow® DewHeart™ is the same as the Insuflow® cleared for market in 510(k) K063546 and essentially equivalent to the other two predicates. The indications for use for the Insuflow® DewHeart™ 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 DewHeart™ performs in accordance with its specifications and applicable standards. Details of the Insuflow 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® DewHeart™ 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.
Confidential
S Pricede of the reading starter of the comments of the many the submit and the subject of the subject of
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Image /page/2/Picture/0 description: The image shows a partial view of a logo and the beginning of a word. The logo is a circular emblem with an abstract design resembling a bird or a stylized human figure. The text around the logo reads "OF HEALTH & HUMAN SERVICES • USA". To the right of the logo, the letters "DEP" are visible, suggesting the beginning of a longer word, likely "DEPARTMENT".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP - 3 2009
Lexion Medical, LLC c/o Mr. Bernard Horwath Consultant to Lexion Medical, LLC 5000 Township PKWY St. Paul, MN 55110
Re: K091366
Trade/Device Name: Insuflow Dewheart Regulation Number: 21 CFR 884.1730 Regulation Name: Jet. Lavage, Insufflator, laparoscopic Regulatory Class: Class II (two) Dated: August 27, 2009 Received: August 28, 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.
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Page 2 - Mr. Bernard Horwath
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 (reporting of medical 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/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/ResourcesforYou/Industry/default.htm.
Fri Jun 23, 2017/Microbial Ecology/ Resource Ecology Flow method Production.xls
Sincerely vours.
Dana R. Verner
Image /page/3/Picture/8 description: The image shows a black and white drawing of a cursive letter 'S'. The letter is stylized with curved lines and appears to be handwritten. The letter is the only element in the image and is set against a white background.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
A. INDICATIONS FOR USE
510(k) Number_K091366
Device Name: Insuflow® DewHeart™
Indications for Use:
The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) R. Valinks burner (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ko 913 6 G
OR
1981 2221 1
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Prescription Use X (Per 21 CFR 801.109) のと、なっている。 े हैं कि किसी की
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Over the Counter Use
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Confidential
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