(138 days)
Not Found
No
The device description focuses on the physical components and function of heating, humidifying, and filtering CO2 gas for insufflation. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device facilitates surgical procedures by providing a path for instruments and conditioning CO2 gas for insufflation, but it does not directly treat or diagnose a disease or condition.
No
The device is described as a gas conditioning device and a path of entry for surgical instruments during minimally invasive surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a disposable single-use device with a filter, heater/humidifier, tubing set, and a path of entry access port device, as well as a reusable control module housing control and safety circuits. This is not a software-only device.
Based on the provided information, the Insuflow® Synergy™ Port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to establish a path of entry for surgical instruments and to condition and introduce CO2 gas into a surgical cavity during minimally invasive procedures. This is a surgical device used in vivo (within the body).
- Device Description: The description details a device for delivering conditioned gas and providing access for surgical instruments into the patient's body. It does not describe a device used to examine specimens in vitro (outside the body) to obtain information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, or controls, which are typical components and uses of IVD devices.
The device is clearly intended for use directly on or within a patient during surgery, which falls under the category of surgical or therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
Product codes (comma separated list FDA assigned to the subject device)
HIF, GCJ
Device Description
The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning 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 via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem. Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity. The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, abdominal and 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 Insuflow Synergy™ Port (Dual and Single Lumen) performs in accordance with its specifications and applicable standards. Flow/pressure performance, gas temperature and humidity characterization, insertion/removal testing, and seal leak integrity testing were successfully completed.
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.
0
K|20640
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
· JUL 18 2012
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for Insuflow Synergy™ Port.
| SUBMITTER'S NAME: | LEXION Medical LLC |
|---|---|
| ADDRESS: | 545 Atwater Cr. |
| St. Paul, MN 55103 | |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 27 Feb 2012 |
1. Identification of device
Proprietary Name: Insuflow® Synergy™ Port Common Name: Gas Conditioner Insufflator Device with integral path of entry device Classification Status: Class II per regulations 884.1730, Product Code: HIF Class II per regulations 876.1500, Product Code: GCJ
2. Equivalent devices
LEXION Medical believes that Insuflow Synergy™ Port is substantially equivalent to the following devices:
SurgiQuest Trocar with integrated Insufflator, K103692 Insuflow®, K090456 EndoPath Xcel Trocar, K032676
Insuflow® Synergy™ Port is a similar gas conditioner insufflator accessory device as Insuflow cleared under 510(k) K090456 with an integral path of entry access port device similar to the predicate trocar device. The Insuflow Synergy™ Port has the same integrated intended use as the predicate devices.
3. Description of the Device
The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning 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 via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem.
1
Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.
The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.
4. Intended use
Insuflow Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat. humidify, filter and introduce a CO> gas stream for insufflation of the surgical cavity.
Technological characteristics, comparison to predicate device. 5.
Technically, the Insuflow Synergy™ Port gas conditioning technology is similar to the Insuflow® cleared for market in 510(k) K090456; the devices perform a similar gas conditioning function with minor design configuration and material changes. The Insuflow Synergy™ Port path of entry access device is essentially equivalent to the trocar predicate; the Insuflow Synergy™ Port however is configured in single and dual lumen configurations, while the predicate has only a single lumen configuration. The indications for use for the Insuflow Synergy™ Port 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 Insuflow Synergy™ Port (Dual and Single Lumen) performs in accordance with its specifications and applicable standards. Flow/pressure performance, gas temperature and humidity characterization, insertion/removal testing, and seal leak integrity testing were successfully completed. In addition, biocompatibility testing per ISO 10993-1 was successfully conducted.
7. Conclusion
Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXIQN Medical that Insuflow Synergy™ Port (Dual and Single Lumen) 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Bernard Horwath Regulatory Consultant LEXION Medical, LLC. 5000 Township Parkway ST. PAUL MN 55110
JUL 18 2012
Re: K120640
Trade/Device Name: Insuflow® Synergy Port Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, GCJ Dated: July 11, 2012 Received: July 12, 2012
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 for abo stated in the 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 or any I 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
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Evans
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ______K120640/S2
Insuflow® Synergy Port Device Name:
Indications For Use:
Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hhluu
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number_ K 120640
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