(138 days)
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.
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.
The provided text is a 510(k) summary for the Insuflow® Synergy™ Port, a medical device. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
This document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating the device's meeting specific, quantitative acceptance criteria via a performance study with a test set, ground truth and human readers.
Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available.
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The Insuflow® Synergy™ Port is a gas conditioning insufflator accessory device designed to warm, humidify, and filter CO2 gas for insufflation during minimally invasive surgeries, and to establish a path of entry for endoscopic instruments. The regulatory pathway for this device was a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than a direct clinical performance study with specific acceptance criteria in the format you've requested.
The "acceptance criteria" in this context are implicitly related to demonstrating that the Insuflow® Synergy™ Port performs safely and effectively in a manner substantially equivalent to its predicate devices. The study proving this involved extensive performance testing and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" for a clinical performance study (e.g., sensitivity, specificity thresholds) are not explicitly stated in this 510(k) summary, I can only infer what was tested and that the device "successfully completed" these tests, implying they met internal or standard-based criteria.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Flow/Pressure Performance | Successfully completed |
| Gas Temperature Characterization | Successfully completed |
| Humidity Characterization | Successfully completed |
| Insertion/Removal Testing | Successfully completed |
| Seal Leak Integrity Testing | Successfully completed |
| Biocompatibility (ISO 10993-1) | Successfully conducted |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. The document mentions "extensive performance testing" but does not detail the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It is likely these were bench/laboratory tests rather than tests on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of the device (a gas conditioning insufflator and access port) and the type of testing described (flow/pressure, temperature, humidity, insertion/removal, seal leak, biocompatibility), it's highly improbable that "experts to establish ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images) would be relevant or used. The "ground truth" for the performance tests would be instrument measurements and standardized test procedures.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for the type of testing described in this 510(k) summary. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed for ground truth (e.g., image interpretation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a MRMC comparative effectiveness study was not performed. This device is a surgical instrument accessory, not an AI-powered diagnostic tool, so such a study would not be applicable or relevant to its regulatory approval.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Insuflow® Synergy™ Port is a physical medical device, not an algorithm, so a "standalone" algorithmic performance study without human-in-the-loop would not be relevant.
7. The Type of Ground Truth Used
For the performance tests mentioned (Flow/Pressure, Gas Temperature, Humidity, Insertion/Removal, Seal Leak Integrity), the "ground truth" would be established by objective physical measurements using calibrated instruments and adherence to established engineering and medical device standards. For biocompatibility, it would be established by laboratory testing results against ISO 10993-1. Pathology or outcomes data would not directly serve as ground truth for these types of tests.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
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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.
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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.
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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
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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
Page 1 of 1
§ 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.