(55 days)
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter for dilation, with no mention of AI or ML technologies.
Yes
The device is used to dilate strictures, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a dilatation catheter used to physically dilate strictures, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a balloon, shaft, guidewire, and inflation device, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is a physical device used to mechanically dilate strictures within the alimentary tract and Sphincter of Oddi. It is inserted into the body and directly interacts with the tissue.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or providing diagnostic information based on analysis of biological material. Its purpose is therapeutic (dilatation), not diagnostic.
The device is a therapeutic medical device used for a procedure, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Product codes (comma separated list FDA assigned to the subject device)
FGE, KNO
Device Description
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consists of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device.
The EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm.
The balloon is inflated with a 60cc inflation device, which will be sold separately.
The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, Sphincter of Oddi
Indicated Patient Age Range
adult and adolescent populations
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)
The predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609) and the proposed EZDilate 3-Stage Balloon Dilatation Catheter are identical in every respect. Minor process changes to the predicate EZDilate - Wire Guided 18-19-20 balloon catheter resulted in rounders to the balloon; enhancing balloon visualization. As a result of the process changes, the following performance tests were repeated.
- Visual Inspection
- Dimensional Measurements
- Tensile Testing
- Fatigue Testing
- Luer Gauging Test
- Balloon Working Length
- Tip Stiffness Testing
- Compliance Testing
- Balloon Burst Testing
- Balloon Insertion Force Testing
- Balloon Retrieval Force Testing
- Balloon Friction Testing
- Balloon Deflation Testing
- Balloon Endoscope Compatibility Testing
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 8, 2018
Gyrus ACMI, Inc. Mary Anne Patella Senior Specialist Regulatory Affairs 136 Turnpike Road Southborough, MA 01772
Re: K180086
Trade/Device Name: Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNO Dated: January 11, 2018 Received: January 12, 2018
Dear Mary Anne Patella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180086
Device Name
Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
Indications for Use (Describe)
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Traditional 510(k) Notification January 11, 2018
510(k) Summary Gyrus ACMI, Inc. Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
General Information
| Contract Manufacturer: | Vention Medical, Inc.
261 Cedar Hill Drive
Marlborough, MA 01752
Phone: 508-481-6233 |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3004734318 |
| 510(k) Submitter: | Olympus Surgical Technologies America
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Mary Anne Patella
Senior Specialist Regulatory Affairs
508-804-2771
Maryanne.patella@olympus-osta.com |
| Date Prepared: | January 11, 2018 |
| Device Description | |
| Classification Name:
CFR citation
Procode
Classification
Classification Panel | Biliary catheter and accessories
Esophageal dilator
21 CFR 876.5010, 876.5365
FGE, KNQ
Class II
Gastroenterology/Urology |
| Trade Name: | Gyrus ACMI – EZDilate 3-Stage Balloon
Dilatation Catheter |
| Generic/Common Name: | Balloon Dilation Catheter |
| Predicate Devices | |
| Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | K143609 |
|---|---|
| Boston Scientific CRE Dilatation Balloon | K112994 |
4
K180086 Page 2 of 4
Product Description
Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device.
Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm.
The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).
Technological Characteristics
The proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter has the same intended use, design, and scientific technology as the predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609). Both devices are the same design and there were no new issues of safety or effectiveness with the proposed device.
The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.
Material
No material changes were made to the predicate EZDilate 3-Stage Balloon Dilatation Catheter cleared under K143609.
Intended Uses
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
5
Summary of Sterilization and Shelf Life Discussion
Like the predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609), the proposed EZDilate 3-Stage Balloon Dilatation Catheter will be distributed in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of three (3) years.
Summary of Performance Testing
The predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609) and the proposed EZDilate 3-Stage Balloon Dilatation Catheter are identical in every respect. Minor process changes to the predicate EZDilate - Wire Guided 18-19-20 balloon catheter resulted in rounders to the balloon; enhancing balloon visualization. As a result of the process changes, the following performance tests were repeated.
- Visual Inspection ●
- Dimensional Measurements ●
- Tensile Testing
- Fatigue Testing
- Luer Gauging Test ●
- Balloon Working Length
- Tip Stiffness Testing
- Compliance Testing
- Balloon Burst Testing ●
- Balloon Insertion Force Testing
- Balloon Retrieval Force Testing
- Balloon Friction Testing ●
- Balloon Deflation Testing ●
- Balloon Endoscope Compatibility Testing
Substantial Equivalence
The proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter has the same design, and scientific technology as the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter; and the same intended use population as the Predicate Boston Scientific CRE Dilatation Balloon (K112994). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device. Please see the following Substantial Equivalence Comparison Table:
6
| Traditional 510(k) Notification |
|---|
| January 11, 2018 |
| Design Feature | Proposed Gyrus ACMI
EZDilate 3-Stage
Balloon Dilatation
Catheter - Wire Guided | Predicate Gyrus ACMI
EZDilate 3-Stage
Balloon Dilatation
Catheter - Wire Guided
(K143609) | Predicate Boston
Scientific CRE™
Dilatation Balloon
(K112994) | Comments | | | |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Indication for
Use | The EZDilate 3-Stage
Balloon Dilatation
Catheters are indicated
for use in adult and
adolescent populations to
endoscopically dilate
strictures of the
alimentary tract. It is also
indicated in adults for
endoscopic dilatation of
the Sphincter of Oddi
with or without prior
sphincterotomy. | The EZDilate 3-Stage
Balloon Dilatation
Catheters are indicated
for use in adult
populations to
endoscopically dilate
strictures of the
alimentary tract. It is also
indicated in adults for
endoscopic dilatation of
the Sphincter of Oddi
with or without prior
sphincterotomy. | The CRE™ Wireguided
Balloon Dilatation
Catheter is indicated for
use in adult and
adolescent populations to
endoscopically dilate
strictures of the
alimentary tract. It is also
indicated in adults for
endoscopic dilatation of
the Sphincter of Oddi
with or without prior
sphincterotomy. | Identical to the
predicate Boston
Scientific CRETM
Dilatation Balloon
(K112994) | | | |
| Balloon Length | 5.5cm, 6.5cm | 5.5cm, 6.5cm | 5.5cm | Similar (The 6-7-8 and
8.5-9.5-10.5 balloons
are 6.5cm) | | | |
| Inflated Outer
Diameter
(OD)/Inflation
Pressure (ATM) | Inflated
OD
6-7-8
8.5-9.5-
10.5
11-12-13
13.5-
14.5-15.5
16-17-18
18-19-20 | Pressure
ATM
2.0-5.5-9.5
2.0-5.5-9.5
2.0-3.5-5.5
2.5-4.0-6.0
2.5-4.0-5.5
2.5-3.5-5.0 | Inflated
OD
6-7-8
8.5-9.5-
10.5
11-12-13
13.5-
14.5-
15.5
16-17-18
18-19-20 | Pressure
ATM
2.0-5.5-9.5
2.0-5.5-9.5
2.0-3.5-5.5
2.5-4.0-6.0
2.5-4.0-5.5
2.5-3.5-5.0 | Inflated
OD
6-7-8
8-9-10
10-11-12
12-13.5-
15
15-16.5-
18
18-19-20 | Pressure
ATM
3-6-10
3.5-5-9
3-5-8
3-4.5-8
3-4.5-7
3-4.5-6 | Similar (Identical
maximum/minimum
inflated outer
diameters.
Intermediate sizes may
vary.) |
| Device
Working
Length | 240 cm | 240 cm | 240 cm (Esophageal,
Pyloric, Colonic &
Biliary)
180 cm (Esophageal,
Pyloric & Biliary) | Similar (Boston
Scientific offers an
additional length.) | | | |
| Compatible
Guidewire | 0.035" | 0.035" | 0.035" | Identical | | | |
| Semi-
Compliant
Balloon | Yes | Yes | Yes | Identical | | | |
| Radiopaque
Marker | Yes | Yes | Yes | Similar (Marker
location may vary.) | | | |
| Rounded
balloon taper | Yes | Yes | Yes | Similar (Facilitates
endoscopic
visualization of the
stricture through the
balloon.) | | | |
| Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------------------ | -- | -- |
Conclusion:
In summary, the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.