(184 days)
Not Found
No
The description mentions "software controlled" and "numerous features intended to optimize the process," but there is no explicit mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The features described are standard for a computerized insufflator.
Yes
The device is described as providing "intra-abdominal distention during laparoscopic surgery," which is a medical procedure. While it doesn't directly treat a disease, it performs a physiological function necessary for a surgical intervention to occur and is used in a therapeutic context.
No
The device is described as an insufflator, used to provide intra-abdominal distention during laparoscopic surgery. Its functions are related to maintaining pneumoperitoneum (flow control, pressure monitoring, venting excess pressure), not to diagnose a medical condition.
No
The device description explicitly states it is an "Insufflator," which is a hardware device used to provide intra-abdominal distention. While it is "software controlled," it is not solely software. The performance studies also mention hardware-related testing like UL 544 and EMI/EMC testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide intra-abdominal distention during laparoscopic surgery." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that controls gas flow and pressure within the abdomen during surgery. It monitors and manages the physical state of the patient's abdomen during the procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions based on in vitro testing.
This device is a surgical instrument used to facilitate a surgical procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery.
Product codes
P292
Device Description
The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a CO2 tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient's abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-abdominal
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
Performance testing conducted on the Snowden-Pencer Computerized High Flow Insufflator includes software verification and validation, UL 544 testing and certification, VDE 0871/0876/0877 and CISPR 11:1990/EN55011 testing/certification for radiated emissions (EMI/EMC). The device was also tested by the Emergency Care Research Institute (ECRI) and conforms to the ECRI Test Criteria for High-flow Laparoscopic Insufflators.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
8172
510(k) SUMMARY
JAN 10 1997
for
DSP Worldwide's Snowden-Pencer Computerized High Flow Insufflator
1. DATE PREPARED
July 9, 1996
2. SPONSOR INFORMATION
| Address: | DSP Worldwide |
|---|---|
| 600 Airport Road | |
| Fall River, MA 02720-4740 |
Timothy N. Thomas Contact: Phone: 508-677-6545 FAX: 508-677-6666
3. DEVICE NAME
Snowden-Pencer Computerized High Flow Insufflator Proprietary Name: Common/Usual Name: Insufflator Classification Name: Laparoscopic Insufflator
4. DEVICE DESCRIPTION AND INTENDED USE
The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a CO2 tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient's abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.
1
K 96 2683
P292
5. COMPARISON TO PREDICATE DEVICES
The Snowden-Pencer Computerized High Flow Insufflator is similar in design, function, and intended use to other high flow insufflators currently in commercial distribution in the United States. The predecessor Snowden-Pencer Computerized High Flow Insufflator (K920986) had many of the identical features to the current model device with the exception of the continuous monitoring of patient pressure, the CO2 warmer, and the video interface. These three new features have been added to the device in order to improve device performance and user convenience. Other electronic high flow insufflators, such as the WISAP Flow Therme Insufflator (K952508) also include a CO, heater.
6. DEVICE TESTING
Performance testing conducted on the Snowden-Pencer Computerized High Flow Insufflator includes software verification and validation, UL 544 testing and certification, VDE 0871/0876/0877 and CISPR 11:1990/EN55011 testing/certification for radiated emissions (EMI/EMC). The device was also tested by the Emergency Care Research Institute (ECRI) and conforms to the ECRI Test Criteria for High-flow Laparoscopic Insufflators.