(90 days)
The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.
GSI's Cannula with Introducer is a hand held device comprised of a Cannula with an Introducer. The Cannula is comprised of a cannula body, an inflatable valve/seal and a stopcock. The inflatable valve/seal is inflated and deflated through the stopcock. The inflatable valve/seal provides a seal for surgical tools and diagnostic instruments during minimally invasive procedures using gas insufflation. The Cannula may be supplied with either a Sharp Tip or Blunt Tip Introducer. The Introducer is used for placement of the Cannula into an endoscopic or laparoscopic surgical space.
The provided text describes a 510(k) summary for a medical device (GSI Cannula with Introducer) and does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.
The document discusses:
- Device Description: A hand-held device comprising a cannula with an introducer, designed for minimally invasive procedures.
- Intended Use: To provide access for surgical and diagnostic instruments during a surgical procedure, identical to the predicate device.
- Comparison to Predicate Device: A table comparing the GSI Cannula with an Introducer to the Hasson Stable Access Cannula (K903078) across various design and material aspects.
- Testing: Mentions "performance bench tests" were conducted to verify that differences from the predicate device do not affect safety or efficacy.
There is no mention of:
- Acceptance criteria related to performance metrics for AI/ML. The document is for a physical medical device, not an AI/ML powered one.
- Any study involving AI/ML performance.
- Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to AI/ML, nor the other requested details regarding an AI/ML study, as this information is not present in the provided text.
{0}------------------------------------------------
费 广
Section 10.0: 510(K) Summary
APR 2 1 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92( c ).
10.1 Contact Person
Cathleen Mantor
General Surgical Innovations, Inc.
3172A Porter Drive
Palo Alto, CA 94304
(415) 812-9740 extension 292
(415) 812-9731 fax
Date Summary Prepared 10.2
January 14, 1997
10.3 Trade Name
To Be Determined
Common Name 10.4
Cannula with Introducer
10.5 Predicate Device
Hasson Stable Access Cannula. Manufacturer: Marlow Surgical K903078 Technology.
10.6 Device Description
GSI's Cannula with Introducer is a hand held device comprised of a Cannula with an Introducer. The Cannula is comprised of a cannula body, an inflatable valve/seal and a stopcock. The inflatable valve/seal is inflated and deflated through the stopcock. The inflatable valve/seal provides a seal for surgical tools and diagnostic instruments during minimally invasive procedures using gas insufflation. The Cannula may be supplied with either a Sharp Tip or Blunt Tip Introducer. The Introducer is used for placement of the Cannula into an endoscopic or laparoscopic surgical space.
1 d
{1}------------------------------------------------
10.7 Intended Use
The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.
Tanza d
| Predicate DeviceStable Access Cannula(K903078) | GSI's Cannula with Introducer | |
|---|---|---|
| Intended Use | Access for minimally invasive procedures | Access for minimally invasive procedures |
| Principles of Operation | Insertion through incision, under direct visualization (when possible) when using sharp tip | Insertion through incision, under direct visualization (when possible) when using sharp tip |
| Design:-cannula | rigid | flexible |
| -valve/seal | flexible valve and seal | inflatable, flexible valve/seal |
| -anchoring-method | inflatable balloon type | screw type |
| -insufflation port | included | not included |
| Materials | molded rigid plastic, elastomeric polymer and stainless steel | molded rigid plastic, elastomeric polymer and stainless steel |
| Supplied | Sterile, 5 devices/boxw/5mm reducer,disposable | Sterile, 5 devices/box,inflatable valve/seal provides reducer function,disposable |
| Introducer Type | blunt & sharp | blunt & sharp |
| Cannula Lumen | 10/12 mm | 10 mm |
| Compliancew/Standards | No known standards | No known standards |
10.8 Comparison to Predicate Devices
Testing in Support of Substantial Equivalence Determination 10.9
Results of performance bench tests verify that the differences between the Cannula with Introducer and the predicate device do not affect the safety or efficacy of the GSI Cannula with Introducer.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).