(90 days)
Not Found
No
The device description and performance studies focus on the mechanical function and safety of a surgical cannula and introducer, with no mention of AI or ML.
No.
The device's intended use is to provide access for surgical and diagnostic instruments, not to treat a condition or disease directly.
No
Explanation: The device is a cannula with an introducer, used to provide access for surgical and diagnostic instruments during a procedure. While it facilitates the use of diagnostic instruments, the device itself does not perform diagnostic functions. Its purpose is access, not diagnosis.
No
The device description clearly states it is a "hand held device comprised of a Cannula with an Introducer," detailing physical components like a cannula body, inflatable valve/seal, stopcock, and introducer tips. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access for surgical and diagnostic instruments for the duration of a surgical procedure." This describes a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical device used for creating and maintaining access during surgery, including components like a cannula body, valve/seal, stopcock, and introducer. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or assays
The device's function is purely mechanical and related to providing access for other instruments during a surgical procedure.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
Not Found
§ 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).
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 Device
Stable 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/box
w/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 |
| Compliance
w/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.