(188 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a 'catheter' used for 'dilation of the nephrostomy tract', which is a direct medical intervention for treatment.
No
The device is a dilation catheter used for therapeutic purposes (dilation of the nephrostomy tract), not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter with a balloon, radiopaque markers, and mentions performance studies related to physical properties like burst testing, kink testing, and bond strength, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a surgical device used to physically dilate a passage (the nephrostomy tract) within the body. It does not analyze biological samples.
- Intended Use: The intended use clearly states "dilation of the nephrostomy tract," which is a procedural action, not a diagnostic test on a sample.
- Device Description: The description details the physical components of a catheter and balloon, not equipment for analyzing biological specimens.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
Therefore, based on the provided information, this device is a surgical or interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.
Product codes (comma separated list FDA assigned to the subject device)
LJE
Device Description
The Gvrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate the nephrostomy tract.
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. Upon inflation, a radial force is delivered over the length of the balloon.
The dilation catheter(s) is sold separately, or as part of a kit containing an inflation device. The inflation device is also available for individual sale.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nephrostomy tract
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)
The following performance tests were conducted:
- . First Article Inspection
- Balloon Burst Testing
- Balloon Kink Testing
- Durability Testing (cycle testing) .
- . Compliance Testing
- Balloon Shape Characteristics Testing
- Balloon Insertion Force Testing .
- Bond Strength .
- Fluoroscopy Testing .
- Amplatz Sheath Visibility and Compression 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.
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
N/A
0
11
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.
Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter
General Information
Contract Manufacturer:
Future Matrix Interventional, Inc. 1605 Enterprise Street Athens, TX 75751 Phone: 903-677-9166
Establishment Registration Number:
510(k) Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
3003790304
Gyrus ACMI, Inc.
136 Turnpike Rd.
1646831
Neil Kelly Regulatory Affairs Specialist 508-804-2690 Neil.kelly@olympus-osta.com
Southborough, MA 01772-2104
July 31, 2013
Catheter, Nephrostomy Unclassified LJE Gastroenterology/Urology
Balloon Dilation Catheter
Gyrus ACMI Nephro – EZDilate
Nephrostomy Balloon Dilation Catheter
Trade Name:
Generic/Common Name:
Predicate Devices
Boston Scientific NephroMax High Pressure Balloon Dilation Catheter
July 31, 2013
FEB - 4 2014
1
Product Description
The Gvrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate the nephrostomy tract.
Technological Characteristics
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. Upon inflation, a radial force is delivered over the length of the balloon.
The dilation catheter(s) is sold separately, or as part of a kit containing an inflation device. The inflation device is also available for individual sale.
Material
A polycarbonate two-way hub at the proximal end leads into a polyurethane strain relief and into polyamide outer tube. The Polyethylene Terephthalate balloon joins the outer catheter body and sits over a non-patient contacting loaded polyamide inner catheter body. A guidewire is positioned within the patient and the proposed device is then fed over the guidewire and into position.
Intended Uses
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.
Compliance to Voluntary Standards
The design of the proposed device complies with the following standards:
ISO 10993-5, 2009 ISO 10993-10, 2010 ISO 10993-11, 2006 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007
2
Gyrus ACMI Nephro -EZDilate Nephrostomy Balloon Dilation Catheter Traditional 510(k) Notification Gyrus ACMI, Inc. July 31, 2013
Summary of Sterilization and Shelf Life Discussion
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is delivered 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 one(1) year.
Summary of Performance Testing
The following performance tests were conducted:
- . First Article Inspection
- Balloon Burst Testing
- Balloon Kink Testing ●
- Durability Testing (cycle testing) .
- . Compliance Testing
- Balloon Shape Characteristics Testing ●
- Balloon Insertion Force Testing .
- Bond Strength .
- Fluoroscopy Testing .
- Amplatz Sheath Visibility and Compression Testing .
Substantial Equivalence
The proposed Gyrus ACMI Nephro – EZDilate Nephrostomy Balloon Dilation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific NephroMax Balloon Dilation Catheter (K121614). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device.
Conclusion:
In summary, the Gyrus ACMI Nephro – EZDilate Nephrostomy Balloon Dilation Catheter is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
13
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Olympus Surgical Technologies America Gyrus ACMI, Inc. Neil Kelly Regulatory Affairs Specialist 136 Turnpike Road Southborough, MA 01772
K132383 Re:
Trade/Device Name: Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter Regulation Number: None
Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: January 2, 2014 Received: January 6, 2014
Dear Neil Kelly,
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, listing 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.
4
Page 2 - Neil Kelly
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for Beniamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Gyrus ACMI Nephro -EZDilate Nephrostomy Balloon Dilation Catheter Gyrus ACMI, Inc.
Traditional 510(k) Notification July 31, 2013
Indications for Use
.
• • • • • • •
Device Name: Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter
510(k) Number: K132383
Indications for use:
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is . recommended for dilation of the nephrostomy tract.
Prescription Use: __ X __
OR Over-the-Counter Use: _
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert F 7-05'00' 2014.02.04 0