(45 days)
The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)
The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery and evacuate surgical smoke. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.
This 510(k) submission does not describe a study involving an AI/ML device, but rather a medical device (trocar and cannula system). Therefore, some of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not applicable in this context.
Here's an analysis of the provided text in relation to your request, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions various tests but largely defines them by their purpose rather than explicit quantitative acceptance criteria with corresponding performance metrics. It indicates adherence to standards as the form of "acceptance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pneumoperitoneum Maintenance | Tested to show ability to maintain adequate pneumoperitoneum during laparoscopic surgery. |
| Port of Entry Creation/Maintenance | Tested to show ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Smoke Evacuation | Tested to show ability to aid in the evacuation of smoke. (Referenced Addendum 3 for test data, but not provided here.) |
| Safety & Emissions | Tested in accordance with IEC60601-1 (General Requirements for Safety) and IEC60601-1-2 (EMC Requirements and Tests). |
| Sterility Validation | Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11137:2006 and AAMI TIR 27:2001. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable as this is a physical medical device, not an AI/ML system tested on a dataset. The "tests" described are functional and safety verification tests. The document does not specify the number of units tested for functional performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/ML does not apply here. Performance for a physical device is assessed through engineering tests and adherence to standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable.
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
Not applicable. This is not an AI/ML device or an imaging device requiring human interpretation, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the functional aspects, "ground truth" would be established by direct measurement of physical parameters (e.g., CO2 pressure for pneumoperitoneum, smoke particle reduction for evacuation) against predefined engineering specifications. For safety and sterility, it's compliance with established international standards (IEC, ISO, AAMI).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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K0832.11
SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification
DEC 1 5 2008
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | SurgiQuest, Inc.12 Cascade Blvd. - Suite 2BOrange, CT 06477 |
|---|---|
| CONTACT PERSON | Kourosh AzarbarzinFounder & C.E.O. - SurgiQuest, Inc. |
| DATE PREPARED | May 25, 2007 |
| CLASSIFICATION | Laparoscopic trocar, GCJClass: II |
| COMMON NAME | Disposable Endoscopic Trocar & Cannula |
| PROPRIETARY NAME | SurgiQuest™ AirSeal™ Optical Trocar & Cannula System(Trademark name to be determined) |
| PREDICATEDEVICE(S) | Surgiport™ Blunt Tip TrocarU.S. Surgical Corp. (Norwalk, CT)K903419EndoPath III Trocar SystemEthicon Endo-Surgery, Inc. (Cincinnati, OH)K032676Elastomeric Optical Trocar & CannulaSurgiQuest, Inc. (Orange, CT)K063859LapEvac Filtration Device for the PneumoperitoneumBuffalo Filter (Buffalo, NY)K052797Sun Medical Smoke / Fluid Evacuation SystemSun Medical Inc. (Arlington, TX)K911154 |
| DEVICE DESCRIPTION | The subject is a surgical trocar and cannula composed ofmedical grade materials. The device is used to create andmaintain a port of entry during endoscopic surgery andevacuate surgical smoke. It incorporates a gas seal utilizingCO2, to maintain pneumoperitoneum during the course ofsurgery. It is supplied with a re-circulation and filtration pump |
10/20/2008
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SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification
designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.
TESTING
The device has been tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. It has also been tested to show its ability to maintain adequate pneumoperitoneum during the course of laparoscopic surgery and to aid in the evacuation of smoke.
(See Addendum 3 for test data regarding smoke evacuation)
The unit has been tested for safety and emissions in accordance with IEC60601-1, General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems and IEC60601-1-2, General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility Requirements and Tests.
Sterility validation is in accordance with ISO 11137:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and AAMI TIR 27:2001. Sterilization of Healthcare Products - Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VD Max
A Sterility Assurance Level (SAL) of 10- is achieved.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2008
Mr. Kourosh Azarbarzin Founder & CEO SurgiQuest, Incorporated 12 Cascade Boulevard, Suite 2B ORANGE CT 06477
Re: K083211
Trade/Device Name: SurgiQuest™ AirSeal™ Optical Trocar and Cannula System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 1, 2008 Received: October 31, 2008
Dear Mr. Azarbarzin:
We have reviewed vour 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Voque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification
STATEMENT FOR INDICATIONS FOR USE
083211
510(k) Number:
Device Name: SurgiQuest™ AirSeal™ Optical Trocar & Cannula System (Trademark name to be determined)
Indications for Use: The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
eld lema
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
29
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.