(159 days)
Not Found
No
The description focuses on a micro-processor controlled insufflation unit with different operational modes, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for use in "diagnostic and/or therapeutic endoscopic procedures" and is used 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 actions that facilitate therapeutic interventions.
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: a trocar, a cannula, tube sets, and a micro-processor controlled insufflation, recirculation and filtration 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 medical procedure on a patient's body, not a device used to examine specimens outside of the body to diagnose a condition.
- Device Description: The components (trocar, cannula, tube sets, insufflation unit) are all designed for surgical access and maintaining a surgical space within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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 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 DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.
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)
Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes.
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.
K071571, K083211, K092504, K063367
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/03692
MAY 25 2011
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| Submitter: | SurgiQuest, Inc.
12 Cascade Blvd. - Suite 2B
Orange, CT 06477 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel Donovan
Sr. Dir., Operations |
| | Phone: (203) 799-2400 Ext. 202
Fax: (203) 799-2401
e-mail: ddonovan@surgiquest.com |
| Date Prepared: | December 10, 2010 |
| Trade Name: | SurgiQuest AirSeal® Optical Trocar & Cannula System
with integrated Insufflator DPIS 2000
(Trade name subject to change) |
| Common Name: | Disposable Endoscopic Trocar and Cannula;
Carbon Dioxide Insufflator for Laparascopy |
| Classification Name: | Endoscope and accessories under 21 C.F.R. 876.1500;
Laparoscopic Insufflator under 21 C.F.R. 884.1730 |
| Regulatory Class: | II |
| Product Code: | GCJ and HIF |
| Predicate Devices: | SurgiQuest AirSeal Optical Trocar & Cannula System,
SurgiQuest, Inc., K071571 |
| | AirSeal Optical Trocar & Cannula System, SurgiQuest,
Inc., K083211 |
| | SurgiQuest AirSeal Optical Trocar & Cannula System
SurgiQuest, Inc., K092504 |
| | 45L High Core Insufflator F114
W.O.M. World of Medicine AG, K063367 |
l
1
The SurgiQuest AirSeal® Optical Trocar & Cannula Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 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 DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.
The SurgiQuest AirSeal® Optical Trocar & Cannula Intended Use: 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 DPIS 2000 System is substantially equivalent to the Substantial AirSeal Predicate Device (K071571, K083211, K092504) Equivalence: and to the Insufflation Predicate Device (K063367). Specifically, the proposed device has the same intended use and the same indication for use as the Predicate Devices. In addition, the DPIS 2000 System and the Predicate Devices use the same or similar basic operating principles and incorporate the same or similar basic design features. Finally, biocompatibility, sterility, packaging and bench testing demonstrate the safety and effectiveness of the proposed device.
Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes.
The DPIS 2000 Unit has been developed in accordance with 21 CFR 820, ISO 13485:2003 & ISO 14971:2007
2
and will be tested in accordance with IEC 60601-1. General Requirements for Medical Electrical Equipment -Part 1: General Requirements for Safety and IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
Gamma sterility validation has been performed (and will be in the case of the Smoke Evacuation Tube Set) in accordance with ISO 11137 Sterilization of health care products - Radiation, Part 1 - Part 3 and AAMI TIR 27, Healthcare Products: Sterilization of Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VD Max. ETO sterility validation has been performed ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; and ISO 10993-7, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO