(66 days)
Not Found
No
The description focuses on the mechanical function of the device for surgical access and smoke evacuation, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is used to assist in surgical procedures by providing an access path for instruments and evacuating smoke, which are supportive functions for the surgery, not direct therapeutic actions on the patient's condition.
No
The device is described as an "access port device with smoke evacuation mechanism" intended for use during minimally invasive surgery to establish a path of entry for instruments and evacuate smoke. Its purpose is to aid visualization during surgery by removing obstructions (smoke/plume), not to diagnose a condition or disease.
No
The device description clearly describes a physical, disposable medical device (cannula, port, filter, tubing, valve) intended for surgical procedures, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to establish a path of entry for surgical instruments and evacuate smoke/plume during minimally invasive surgery. This is a surgical tool used during a procedure, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical device for surgical access and smoke evacuation. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to reagents, assays, or diagnostic measurements.
The device is clearly intended for use in vivo (within the living body) during surgery, which is the opposite of in vitro (in glass/outside the living body) diagnostics.
N/A
Intended Use / Indications for Use
PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, FCZ, HIF
Device Description
The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation.
The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, abdominal, gynecologic (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 PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated.
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.
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.
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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 PneuVIEW® XE VeryClear™ Gas Evacuation Cannula.
| SUBMITTER'S NAME: | LEXION Medical LLC |
|---|---|
| ADDRESS: | 545 Atwater Cr. |
| St. Paul, MN 55103 | |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| Consultant to LEXION Medical | |
| ADDRESS: | 4486 Timberline CT |
| Vadnais Heights, MN 55127 | |
| TELEPHONE NUMBER: | 651-231-1761 |
| FAX NUMBER: | 651-636-1671 |
| DATE OF SUBMISSION: | 12 July 2013 |
SEP 2 0 2013
1. Identification of device
Proprietary Name: PneuVIEW® XE VeryClear™ Gas Evacuation Cannula Common Name: Path of entry access port device and smoke evacuation system Classification Status: Class II per regulations 876.1500, Product Code: GCJ Class I per regulation 876.1500, Product Code: FCZ
2. Equivalent devices
LEXION Medical believes that PneuVIEW® XE VeryClear™ Gas Evacuation Cannula is substantially equivalent to the following devices:
SurgiQuest Trocar with Integrated Insufflator, 510(k) K103692 PneuVIEW®XE Smoke Evacuation System, 510(k) exempt Insuflow SynergyTM Port, 510(k) K120640
PneuVIEW® XE VeryClear™ Gas Evacuation Cannula is an accessory device with an integral path of entry access port device with smoke evacuation mechanism similar to the predicate devices. The PneuVIEW® XE VeryClear™ has the same intended use as the predicate devices.
3. Description of the Device
The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port
1
device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation.
The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.
4. Intended use
PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.
Technological characteristics, comparison to predicate device. న్.
Technically, the PneuVIEW® XE VeryClear™ path of entry access port device is essentially equivalent to the Insuflow Synergy™ Port access device predicate with minor design configuration and material colorant differences. The smoke evacuation system is also essentially the same as the PneuVIEW® XE Smoke Evacuation System, with tubing and valves that are connected to a vacuum source for smoke removal. In addition, the SurgiQuest Trocar with Integrated Insufflator is also a combination of devices featuring an access port and smoke evacuation capabilities, just as the PneuVIEW® XE VeryClear™. The indications for use for the PneuVIEW® XE VeryClear™ are patterned after and essentially the same as the predicate devices.
. 6. Discussion of performance testing.
Extensive performance testing has been conducted to assure that the PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated.
7. Conclusion
Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) 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.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2013
Lexion Medical, LLC % Mr. Bernanrd Horwath Regulatory Consultant 4486 Timberline Court Vadnais Heights, Minnesota 55127
Re: K132203
Trade/Device Name: PneuVEIW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Ports) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HIF Dated: July 12, 2013 Received: July 23, 2013
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
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Page 2 - Mr. Bernanrd Horwath
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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Mark N. Melkerson Acting Director Division of Surgical 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
Device Name: PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Ports)
Indications for Use:
PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.
X Prescription Use (Per 21 CFR 801.109)
Over the Counter Use
(Please do not write below this line - continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Holtally signed by Long H. Chen -A
ONL caUS, D=U.S. Government, ou=a Long H. Chen -A 1300369056 07747 19
(Division Sign-off) for MXM Division of Surgical Devices 510(k) Number: K132203