(38 days)
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.
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.
Here's a summary of the acceptance criteria and study information for K132169, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes general functionalities that the device's testing aimed to demonstrate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to create and maintain a port of entry. | The device was tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Ability to maintain adequate pneumoperitoneum. | The device was tested to show its ability to maintain adequate pneumoperitoneum during the course of laparoscopic surgery. |
| Ability to aid in the evacuation of smoke. | The device was tested to show its ability to aid in the evacuation of smoke. |
| Sterility of reusable devices. | Sterility validation was done in accordance with ISO 11137:2006 and AAMI TIR 27:2001, achieving a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Operation of two trocars simultaneously (one AirSeal, one conventional). | The subject device is a modification to allow simultaneous operation of one AirSeal trocar and one conventional trocar (the predicate filing allowed two AirSeal trocars). Testing would have validated this. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text refers to "Engineering Test summaries" but does not provide details on the number of units or test runs.
- Data Provenance: The tests are described as "Engineering Tests." It's highly probable these were conducted internally by SurgiQuest, Inc. in the US (Milford, CT is their location). The data is prospective in nature, as it involves active testing of the device's performance.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable. The tests described are engineering performance tests, not clinical studies requiring expert interpretation of medical data.
4. Adjudication Method for Test Set
Not applicable, as this was an engineering performance study, not a clinical study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission concerns an insufflator and trocar system, and the studies mentioned are engineering performance tests, not studies analyzing human reader performance with medical images.
6. Standalone Performance Study
Yes, the studies described ("Engineering Test 0627131045 01" and "Engineering Test 0627131059 01") are standalone performance studies. They assess the device's technical capabilities (e.g., smoke evacuation, CO2 consumption) directly.
7. Type of Ground Truth Used
The ground truth for these engineering tests would be derived from:
- Measured physical parameters: Data obtained from sensors and instruments measuring aspects like gas flow, pressure, CO2 consumption, and smoke evacuation rates during simulated procedures.
- Engineering specifications and standards: Adherence to established performance parameters as defined by internal design specifications and relevant industry standards (e.g., ISO for sterility).
8. Sample Size for Training Set
Not applicable. This is an engineering device, not an AI/machine learning algorithm that requires a training set of data.
9. How Ground Truth for Training Set Was Established
Not applicable.
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K132169
XI. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
.. '
| SUBMITTER | SurgiQuest, Inc.333 Quarry RoadMilford, CT 06460 | |
|---|---|---|
| CONTACT PERSON | Daniel DonovanSr. 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. 884.1730Product Code: GCJ and HIFClass: II | |
| COMMON NAME | Disposable Endoscopic Trocar and Cannula;Carbon Dioxide Insufflator for Laparoscopy | |
| PROPRIETARY NAME | SurgiQuest AirSeal® iFS (Name subject to change) | |
| PREDICATEDEVICE(S) | SurgiQuest AirSeal® Optical Trocar & Cannula System withintegrated Insufflator DPIS2000SurgiQuest, Inc. (Orange, CT)K103692Modified SurgiQuest AirSeal® Optical Trocar & CannulaSystem with Integrated Insufflator DPIS 2000SurgiQuest, Inc. (Milford, CT)K121336 | |
| DEVICE DESCRIPTION | The SurgiQuest AirSeal® Optical Trocar & Cannula Systemwith integrated Insufflator DPIS 2000 (the "DPIS 2000System") consists of the following major components: (1) atrocar, (2) a cannula, (3) tube sets, and (4) a micro-processorcontrolled insufflation, recirculation and filtration unit (the"DPIS 2000 Unit"). The cannula, trocar and tube sets aresterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable. The subject device of this filing is amodification to the original filing. The modification is toallow the operation of two trocars simultaneously, oneAirSeal trocar and one conventional trocar. The predicatefiling was a modification to allow the simultaneous operationof two AirSeal* trocars.The device has met the criteria for acceptance, safety andeffectiveness and is substantially equivalent to the predicate. |
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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.
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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
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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
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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
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(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K132169
§ 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.