(60 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Vessel Guardian®" device, a laparoscopic insufflator gas conditioner. Instead of presenting a detailed study, the submission relies on the concept of "substantial equivalence" to predicate devices already on the market. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present in this document.
Here's an analysis based on the provided text, outlining why certain sections of your request cannot be fulfilled and what information is available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission states: "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the specific acceptance criteria (e.g., target temperature ranges, humidification levels, filtration efficiency) and the quantitative results of this testing are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As the submission relies on demonstrating substantial equivalence rather than presenting an original clinical study with a test set, there are no details about sample sizes, data provenance, or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Establishing ground truth is typically relevant in studies where diagnostic accuracy or similar performance is being evaluated against expert opinion. This document does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are specific to clinical trials and diagnostic performance studies, which are not outlined here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. An MRMC study is not relevant for this type of device, which is a physical accessory (gas conditioner) rather than an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This question is not applicable to a physical medical device like the Vessel Guardian®.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Ground truth is not relevant in the context of this 510(k) submission, as it focuses on technological characteristics and equivalence rather than clinical outcomes or diagnostic accuracy requiring ground truth.
8. The sample size for the training set
This information is not provided. Training sets are relevant for machine learning algorithms, which are not described as part of this device.
9. How the ground truth for the training set was established
This information is not provided. This question is not applicable for the reasons mentioned in point 8.
Summary of Available Information from the Document:
The core argument for the Vessel Guardian®'s safety and effectiveness is its substantial equivalence to predicate devices.
-
Predicate Devices:
-
Claim of Equivalence: "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."
-
Performance Testing (General Statement): "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the details of this testing, including specific acceptance criteria and results, are not included in the provided summary. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This means the FDA found sufficient evidence in the full submission to support the claim of equivalence, which would include the performance testing mentioned, even if not detailed in this summary.
In conclusion, this document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical study report. Therefore, most of the specific data points requested regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this public summary.
{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
{4}------------------------------------------------
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
5
§ 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.