(60 days)
Not Found
No
The description focuses on the mechanical and electrical components for heating, humidifying, and filtering CO2 gas, with no mention of AI or ML technologies.
No
The device is described as an accessory device intended to heat, humidify, and filter a CO2 gas stream for insufflation during surgical procedures, not to directly treat a medical condition or disease.
No
The device is described as 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. Its function is to prepare the gas for insufflation, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a disposable filter heater/humidifier tubing set and a control module housing control and safety circuits, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Vessel Guardian® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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." This describes a device used during a surgical procedure to prepare a gas for insufflation into a patient's body.
- Device Description: The description details how the device warms, humidifies, and filters CO2 gas before it enters the surgical cavity. This is a direct interaction with the patient's internal environment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vessel Guardian® does not perform any such analysis of biological samples.
The device is clearly intended for use in vivo (within the living body) during a surgical procedure, not in vitro (in glass, or outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Vessel Guardian®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 (comma separated list FDA assigned to the subject device)
HIF
Device Description
The Vessel Guardian® 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 Guardian® 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 Vessel Guardian® device, through the in-line filter, continues along the tube to enter the Vessel Guardian® 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 Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards.
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.
VasoVapor™, K101320, Insuflow®, K090456
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.
0
Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top appears to be a code or identifier, "K102136". Below this, the text reads "Pg. 1 of 2", indicating that it is page 1 of a 2-page document. The handwriting is clear and legible.
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
�)
SEP 2 7 2010
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for Vessel Guardian®.
| 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: | 23 July 2010 |
1. Identification of device
Proprietary Name: Vessel Guardian® 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 Guardian® is substantially equivalent to the following devices:
VasoVapor™, K101320 Insuflow®, K090456
Vessel Guardian® is the same gas conditioner insufflator accessory device as cleared under 510(k) K101320 and K090456 and has the same intended use as the predicate device cleared under 510(k) K101320.
Description of the Device 3.
The Vessel Guardian® 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 Guardian® 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 Vessel Guardian® device, through the in-line filter, continues along the tube to enter the Vessel Guardian® 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 Vessel Guardian® 510k
Confidential
1
4. Intended use
Vessel Guardian® 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.
5. Technological characteristics, comparison to predicate device.
Technically, the Vessel Guardian® is identical to the VasoVapor™ and Insuflow devices cleared for market in 510(k) K101320 and K090456, respectively. The indications for use for the Vessel Guardian® are patterned after 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 Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards.
7. Conclusion
Based on a comparison to the predicate devices, it is the conclusion of LEXION Medical that Vessel Guardian® 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the seal, with the department's emblem prominently displayed in the center.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Bernard Horwath Regulatory Consultant LEXION Medical LLC 5000 Township Parkway ST PAUL MN 55110
Re: K102136 Trade Name: Vessel Guardian® Regulation Number: 21 CFR $884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: July 23, 2010 Received: July 29, 2010
SEP 2 7 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
3
Page 2
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/CDRH0ffices/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 Lemur MD
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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Page 1 of 1
B. INDICATIONS FOR USE
510(k) Number K102136
Device Name: Vessel Guardian®
SEP 27 2010
Indications for Use:
Vessel Guardian®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 U (Per 21 CFR 801.109)
OR
Over the Counter Use
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K102136 |
LEXION Medical Vessel Guardian® 510k
Confidential
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