(38 days)
Not Found
No
The description focuses on mechanical and insufflation functions, with no mention of AI/ML terms or capabilities. The "micro-processor controlled" unit refers to standard electronic control, not necessarily AI/ML.
No
The device is described as being for "diagnostic and/or therapeutic endoscopic procedures" but its function is to "distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke," which are all supportive functions for therapeutic procedures rather than being therapeutic in themselves.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use in diagnostic and/or therapeutic endoscopic procedures".
No
The device description explicitly lists hardware components such as a trocar, cannula, tube sets, and a micro-processor controlled insufflation unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in a surgical setting: distending the peritoneal cavity with gas, establishing and maintaining a path for instruments, and evacuating surgical smoke. These are all actions performed on the patient during a procedure, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The components (trocar, cannula, tube sets, insufflation unit) are all designed for surgical access and manipulation within the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on the device's ability to function mechanically during simulated and actual surgical procedures (creating and maintaining a port, maintaining pneumoperitoneum, evacuating smoke). This aligns with a surgical device, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is entirely procedural and therapeutic/diagnostic in the context of providing access for other diagnostic or therapeutic instruments.
N/A
Intended Use / Indications for Use
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HIF
Device Description
The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable. The subject device of this filing is a modification to the original filing. The modification is to allow the operation of two trocars simultaneously, one AirSeal trocar and one conventional trocar. The predicate filing was a modification to allow the simultaneous operation of two AirSeal* trocars.
The device has met the criteria for acceptance, safety and effectiveness and is substantially equivalent to the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal 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)
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.
Engineering test summaries accompany this filing:
-
- Engineering Test 0627131045 01, "iFS with Smoke Evac PLUS filtered tube set study"
- Engineering Test 0627131059 01, "Smoke Evac 2. PLUS filtered tube set Co2 Consumption Study"
Sterility validation of reusable devices 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 106 is achieved.
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
§ 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
K132169
XI. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
.. '
| SUBMITTER | SurgiQuest, Inc.
333 Quarry Road
Milford, CT 06460 | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON | Daniel Donovan
Sr. Director of Operations - SurgiQuest, Inc.
Phone:203.799.2400 ext 202 | AUG 2 2 2013 |
| DATE PREPARED | July 9, 2013 | |
| CLASSIFICATION | Laparoscopic Insufflator under 21 C.F.R. 884.1730
Product Code: GCJ and HIF
Class: II | |
| COMMON NAME | Disposable Endoscopic Trocar and Cannula;
Carbon Dioxide Insufflator for Laparoscopy | |
| PROPRIETARY NAME | SurgiQuest AirSeal® iFS (Name subject to change) | |
| PREDICATE
DEVICE(S) | SurgiQuest AirSeal® Optical Trocar & Cannula System with
integrated Insufflator DPIS2000
SurgiQuest, Inc. (Orange, CT)
K103692
Modified SurgiQuest AirSeal® Optical Trocar & Cannula
System with Integrated Insufflator DPIS 2000
SurgiQuest, Inc. (Milford, CT)
K121336 | |
| DEVICE DESCRIPTION | The SurgiQuest AirSeal® Optical Trocar & Cannula System
with integrated Insufflator DPIS 2000 (the "DPIS 2000
System") consists of the following major components: (1) a
trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor
controlled insufflation, recirculation and filtration unit (the
"DPIS 2000 Unit"). The cannula, trocar and tube sets are
sterile, single-use products. The DPIS 2000 Unit is non-
sterile and reusable. The subject device of this filing is a
modification to the original filing. The modification is to
allow the operation of two trocars simultaneously, one
AirSeal trocar and one conventional trocar. The predicate
filing was a modification to allow the simultaneous operation
of two AirSeal* trocars.
The device has met the criteria for acceptance, safety and
effectiveness and is substantially equivalent to the predicate. | |
1
The SurgiQuest AirSeal Optical Trocar & Cannula System INDICATIONS FOR with integrated Insufflator DPIS 2000 (the "DPIS 2000 USE System'') is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
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
Engineering test summaries accompany this filing:
-
- Engineering Test 0627131045 01, "iFS with Smoke Evac PLUS filtered tube set study"3
- Engineering Test 0627131059 01, "Smoke Evac 2. PLUS filtered tube set Co2 Consumption Study"
Sterility validation of reusable devices 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 106 is achieved.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Daniel Donovan Senior Director of Operations SurgiQuest, Incorporated 333 Quarry Road Milford, Connecticut 06460
Re: K132169
Trade/Device Name: SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: August 1, 2013 Received: August 6, 2013
Dear Mr. Donovan:
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 ffor 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. Iisting 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 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
3
Page 2 - Daniel Donovan
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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
IX. STATEMENT FOR INDICATIONS FOR USE
| 510(k) Number: | K132169 |
|---|---|
| ---------------- | --------- |
Device Name: SurgiQuest AirSeal* Optical Trocar & Cannula System with integrated Insufflator DPIS 2000
Indications for Use: The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Image /page/4/Picture/7 description: The image shows the name "Joshua C. Nipper -S" in a simple, sans-serif font. The letters are black against a white background, creating a clear contrast. There is a logo in the background that is difficult to make out.
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K132169