(45 days)
Not Found
No
The description focuses on mechanical and gas-handling functions (trocar, cannula, gas seal, pump, filtration) and does not mention any computational or data-driven capabilities indicative of AI/ML.
No
The device is a surgical instrument (trocar and cannula) used to create and maintain a port of entry and evacuate smoke during minimally invasive surgery. It does not directly treat a disease or condition.
No
The device is a surgical trocar and cannula system used to create and maintain a port of entry during endoscopic surgery and evacuate smoke. Its purpose is to facilitate surgical procedures, not to diagnose conditions.
No
The device description clearly states it is a surgical trocar and cannula composed of medical grade materials, a physical device used to create and maintain a port of entry. It also includes a re-circulation and filtration pump, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a surgical trocar and cannula system used to create and maintain a port of entry during endoscopic surgery, evacuate smoke, and maintain pneumoperitoneum. These are all surgical functions performed on the patient during a procedure, not tests performed on samples from the patient.
- Intended Use: The intended use is for "abdominal and thoracic minimally invasive surgical procedures." This directly relates to surgical intervention, not diagnostic testing of samples.
The device is a surgical instrument, not a diagnostic tool.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL) of 10-
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.
K063859, K903419, K032676, K052797, K911154
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
§ 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.
0
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 2B
Orange, CT 06477 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Kourosh Azarbarzin
Founder & C.E.O. - SurgiQuest, Inc. |
| DATE PREPARED | May 25, 2007 |
| CLASSIFICATION | Laparoscopic trocar, GCJ
Class: II |
| COMMON NAME | Disposable Endoscopic Trocar & Cannula |
| PROPRIETARY NAME | SurgiQuest™ AirSeal™ Optical Trocar & Cannula System
(Trademark name to be determined) |
| PREDICATE
DEVICE(S) | Surgiport™ Blunt Tip Trocar
U.S. Surgical Corp. (Norwalk, CT)
K903419
EndoPath III Trocar System
Ethicon Endo-Surgery, Inc. (Cincinnati, OH)
K032676
Elastomeric Optical Trocar & Cannula
SurgiQuest, Inc. (Orange, CT)
K063859
LapEvac Filtration Device for the Pneumoperitoneum
Buffalo Filter (Buffalo, NY)
K052797
Sun Medical Smoke / Fluid Evacuation System
Sun Medical Inc. (Arlington, TX)
K911154 |
| DEVICE DESCRIPTION | 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 |
10/20/2008
1
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.
2
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.
3
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
4
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