(88 days)
Not Found
No
The device description details a purely mechanical system for inflating and monitoring pressure, with no mention of computational or learning components.
No
This device is an inflation device for balloons used in gastrointestinal dilation, not the therapeutic device itself.
No
The device is described as a hand-held mechanical device used to inflate, deflate, and monitor pressure for gastrointestinal dilation balloons, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "hand-held mechanical device consisting of a 20cc capacity syringe, a 300 psi/20atm pressure gauge, a plunger mechanism, lever, extension line, and stopcock," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inflate, deflate and monitor pressure for gastrointestinal dilation balloons." This is a mechanical function used during a medical procedure on a patient, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a mechanical device (syringe, pressure gauge, plunger, etc.) used for physical manipulation (inflation/deflation) and monitoring pressure. This aligns with a medical device used in a procedure, not an IVD which typically involves reagents, assays, and analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and mechanical.
N/A
Intended Use / Indications for Use
This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.
Product codes
74 MAV
Device Description
The Wilson-Cook Balloon Inflation Device is a hand-held mechanical device consisting of a 20cc capacity syringe, a 300 psi/20atm pressure gauge, a plunger mechanism, lever, extension line, and stopcock. This device is to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
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
The Wilson-Cook Balloon Inflation device has been subjected to in-house functional testing to demonstrate device integrity. All samples tested were deemed acceptable in that testing specifications were met.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Page 7 of 9
APR 2 6 1996
RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK BALLOON INFLATION DEVICE
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted Bv:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Balloon Inflation Device is a hand-held mechanical device consisting of a 20cc capacity syringe, a 300 psi/20atm pressure gauge, a plunger mechanism, lever, extension line, and stopcock. This device is to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.
Classification Name: Syringe, Balloon Inflation, 74 MAV
Classification: FDA has classified similar devices as Class II. This device falls within the purview of the Gastroenterology and Urology Devices Panel.
Trade/Proprietary Name: Wilson-Cook Dilation Balloon Inflation Device.
Common/Usual Name: Balloon Inflation Device
Performance Standards To the best of our knowledge, performance standard for this device do not exist.
Sterility: Validated EO cycle following AAMI Overkill Method to SAL 10°.
Intended Use: This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.
Predicate Devices: This device is similar with respect to technological characteristics and intended use to predicate balloon inflation devices, including the Microvasive Digiflator™ (K860589) and the Wilson-Cook Balloon Inflation Device (K936168).
1
PREMARKET NOTIFICATION FOR THE WILSON-COOK BALLOON RE: INFLATION DEVICE
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| CHARACTERISTIC | Wilson-Cook Balloon
Inflation Device
[Subject of 510(K)] | Microvasive
Digiflator™
(K860589) | Wilson-Cook
Quantum Inflation
Device (K936168) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to inflate, deflate
and monitor pressure
of the Wilson-Cook
line of balloon dilators
for GI use. | Used to inflate, deflate
and monitor pressure
of balloon dilators for
GI use. | Used to inflate, deflate
and monitor pressure
of the Wilson-Cook
line of balloon dilators
for GI use. |
| Construction | Plunger mechanism to
control pressure.
20 cc syringe
Hand held design.
Extension line with
stopcock for
connection to balloon. | Plunger mechanism to
control pressure.
60 cc syringe
Hand held design.
Extension line for
connection to balloon. | Plunger mechanism to
control pressure.
60 cc syringe
Hand held design.
Extension line for
connection to balloon. |
| Sterility | Analog pressure gauge
Sterile and non-sterile. | Digital pressure gauge
Available sterile and
non-sterile. | Analog pressure gauge
Non-sterile. |
| | Disposable | Disposable | Disposable |
Testing: The Wilson-Cook Balloon Inflation device has been subjected to in-house functional testing to demonstrate device integrity. All samples tested were deemed acceptable in that testing specifications were met.