(61 days)
Not Found
No
The description mentions a "micro-processor controlled insufflation, recirculation and filtration unit," which is standard for medical devices and does not indicate the presence of AI or ML. There are no mentions of AI, ML, deep learning, image processing, or any related concepts.
Yes
The "Intended Use / Indications for Use" section states that the device "is intended for use in diagnostic and/or therapeutic endoscopic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "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 is for "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." This describes a device used during a surgical procedure on a patient's body, not a device used to test samples outside of the body (in vitro).
- Device Description: The components listed (trocar, cannula, tube sets, insufflation unit) are all consistent with surgical instruments and equipment used for laparoscopic procedures.
- Anatomical Site: The device is used in the "peritoneal cavity," which is an internal body cavity. IVD devices typically analyze samples like blood, urine, tissue, etc., which are collected from the body but tested externally.
IVD devices are specifically designed to perform tests on biological samples to diagnose diseases or conditions. This device's function is to facilitate surgical procedures, not to perform diagnostic tests on samples.
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.
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. 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 10-6 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
§ 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.
0
K 121 336
公
SurgiQuest, Inc. , Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification
XI. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
2012
| SUBMITTER | SurgiQuest, Inc.
333 Quarry Road
Milford, CT 06460 | JUL | 3 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---|
| CONTACT PERSON | Daniel Donovan
Sr. Director of Operations - SurgiQuest, Inc. | | |
| DATE PREPARED | February 24, 2012 | | |
| CLASSIFICATION | Endoscope and accessories under 21 C.F.R. 876.1500;
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
PREDICATE
DEVICE(S) | SurgiQuest AirSeal® iFS (Name subject to change)
SurgiQuest AirSeal® Optical Trocar & Cannula System with
integrated Insufflator DPIS2000
SurgiQuest, Inc. (Orange, CT)
K103692 | | |
| 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. | | |
| 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. | | |
| 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. | | |
| | Sterility validation is in accordance with ISO 11137:2006 | | |
| | | 21 | |
6/20/2012
(2)
1/2
1
SurgiQuest, Inc.
Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification
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 10-6 is achieved.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgiquest, Incorporated % Mr.Daniel Donovan Senior Director of Operations 333 Quarry Road Milford, Connecticut 06460
3 2012 JUL
Re: K121336
Trade/Device Name: Modified 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: June 18, 2012
Received: June 22, 2012
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 (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. 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.
3
Page 2- Mr. Daniel Donovan
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 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,
Eunel Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121336
Device Name: Modified 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. O'aide forman
Page 1 of 1
(Division Sign-Of (Division Sign-On)
Division of Surgical, Orthopedic, Avishorative Devices
510(k) Number K121336