(59 days)
No
The document describes a physical drainage catheter and its accessories. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is described as a drainage catheter for fluid or air in various parts of the body, which addresses symptoms but does not inherently provide a therapeutic effect on a medical condition.
No.
The device descriptions and intended uses indicate that these are drainage catheters designed to remove fluid or air from the body, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a radiopaque polyurethane catheter, cannulas, and a trocar needle, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the percutaneous drainage of fluid or air from various anatomical sites (chest, abdomen, pelvis, urinary system, biliary tree). This is a direct intervention on the patient's body to remove substances.
- Device Description: The description details a physical catheter designed for insertion into the body for drainage.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform such analysis on specimens. It is a therapeutic/interventional device.
The device is a medical device used for drainage procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.
Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE, LJE, GBO
Device Description
The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.
The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest, abdomen, pelvis, urinary system, biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 performance evaluation of the proposed Exodus Drainage Catheter included testing conducted in accordance to the following FDA Guidance Documents, and international standards: Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use.
- Tensile Testing
- . Catheter Surface
- RO Marker Band Scrape Test ●
- Radiopacity Testing ●
- Flow Rate Testing ●
- Fluid Leak Testing
- Aspiration Strength
- . Catheter Column Strength
- Coating Lubricity
- Pigtail Diameter
- Suture Force to Pigtail
- Catheter Compatibility ●
- Biocompatibility Testing per ISO 10993-1 ●
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.
K103353,K141335,K951475,K053245
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized depiction of three human profiles merging into a single form, often interpreted as representing health, humans, and services. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2015
Navilyst Medical, Inc. Michael P. Hanley Specialist 1, Regulatory Affairs 26 Forest Street Marlborough, MA 01752
Re: K152069
Trade/Device Name: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, LJE, GBO Dated: July 23, 2015 Received: July 29, 2015
Dear Michael P. Hanley,
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.
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 (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 contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 vours.
Jeffrey W. Cooper -S
for
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) K152069
Device Name
Exodus Array Multipurpose Drainage Catheters Exodus Nuance Nephrostomy Drainage Catheters Exodus Believe Biliary Drainage Catheters
Indications for Use (Describe)
Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.
Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
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) |
|---|---|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - Exodus Drainage Catheters
OR
A. Sponsor
Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752
B. Contact
Michael P. Hanley Specialist I, Global Regulatory Affairs 508-658-7983
C. Device Name
Trade Name:
Common/Usual Name:
Classification Name:
Classification Panel: Pro Code:
D. Predicate Device(s)
Predicate 510(k) Trade Name:
Common/Usual Name: Classification Name:
Classification Panel: Pro Code: Reference 510 (k)s
Wanda Carpinella Director, Global Regulatory Affairs 508-658-7929
Exodus Array Multipurpose Drainage Catheter Exodus Nuance Nephrostomy Drainage Catheter Exodus Believe Biliary Drainage Catheter
Biliary, Nephrostomy, Multipurpose Percutaneous Drainage Catheters
- . FGE - Catheter, Biliary, Diagnostic 21 CFR §876.5010, Class II
- LJE - Catheter, Nephrostomy Pre-Amendment, unclassified
- GBO - Catheter, Nephrostomy, General & Plastic Surgery 21 CFR§878.4200, Class I
Gastroenterology - Urology FGE, LJE, GBO
K093392
Exodus Multipurpose Drainage Catheter Exodus Nephrostomy Drainage Catheter Exodus Biliary Drainage Catheter
Percutaneous Drainage Catheter
- . FGE - Catheter, Biliary, Diagnostic 21 CFR §876.5010, Class II
- LJE Catheter, Nephrostomy Pre-. Amendment, unclassified
- GBO Catheter, Nephrostomy, General & ● Plastic Surgery 21 CFR§878.4200, Class I
- GBX Catheter, Nephrostomy, General & ● Plastic Surgery 21 CFR§878.4200, Class I
Gastroenterology - Urology FGE, LJE, GBO K103353,K141335,K951475,K053245
4
E. Device Description
The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.
The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).
F. Intended Use/Indications for Use
The proposed Exodus Drainage Catheter has the following Indications for Use:
- . Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications
- Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of ● fluid collections in the urinary system.
- Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary ● tree.
G. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed Exodus Drainage Catheter is substantially equivalent to the Navilyst Medical Percutaneous Drainage Catheter. When compared to the predicate, the proposed Exodus Drainage Catheters have similar materials, design, components, fundamental technology, and operating principles and the same indications for use. The modifications from the predicate device include: new catheter material and polymer marker band; addition 6F sizes; and 15cm as shortest catheter length. These similarities and differences are illustrated in the following table.
| Comparison of Proposed Exodus Drainage Catheters | ||
|---|---|---|
| And Predicate Percutaneous Drainage Catheter | ||
| Characteristic | Proposed Exodus Drainage Catheters | Predicate Drainage Catheter (K093392) |
| Types of Catheters | Multipurpose Drainage Catheter | |
| Nephrostomy Drainage Catheter | ||
| Biliary Drainage Catheter | Multipurpose Drainage Catheter | |
| Nephrostomy Drainage Catheter | ||
| Biliary Drainage Catheter | ||
| Shaft Materials | Blended: | |
| Carbothane 55D (70%) | ||
| Carbothane 95A (30%) | Co-extruded: | |
| Carbothane 55D (inner layer) | ||
| Carbothane 85A (outer layer) | ||
| Shaft Depth Markers | Yes | Yes |
| Proximal Hub Assembly | SureTwist Hub locking | |
| Mechanism | SureTwist Hub locking | |
| Mechanism | ||
| Distal Hydrophilic Coating | Yes | Yes |
| Distal Configuration | Locking Pigtail | Non-Locking |
| Locking Pigtail | ||
| Sizes | 6, 8, 10, 12 &14 French | 8, 10, 12, &14 French |
| Radiopaque Marker | Yes: | Yes |
5
| Comparison of Proposed Exodus Drainage Catheters
| And Predicate Percutaneous Drainage Catheter | ||
|---|---|---|
| Characteristic | Proposed Exodus Drainage Catheters | Predicate Drainage Catheter (K093392) |
| Polymer Marker band on select | ||
| Multipurpose Catheters and all | ||
| Biliary Drainage Catheters | Platinum / Iridium RO marker on | |
| all Biliary Drainage only | ||
| Useable Length | 15 cm | |
| 25 cm | ||
| 35 cm | 20 cm | |
| 25 cm | ||
| 35 cm | ||
| Included Insertion Accessories | Plastic Stiffening Cannula, | |
| Metal Stiffening Cannula | ||
| Trocar | Plastic Stiffening Cannula, | |
| Metal Stiffening Cannula | ||
| Trocar | ||
| Packaging | Tyvek/Mylar (PET/LDPE) Pouch | Tyvek/Mylar (PET/LDPE) Pouch |
| Sterilization Method | Ethylene oxide | Ethylene oxide |
H. Performance Data
The performance evaluation of the proposed Exodus Drainage Catheter included testing conducted in accordance to the following FDA Guidance Documents, and international standards: Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use.
- Tensile Testing
- . Catheter Surface
- RO Marker Band Scrape Test ●
- Radiopacity Testing ●
- Flow Rate Testing ●
- Fluid Leak Testing
- Aspiration Strength
- . Catheter Column Strength
- Coating Lubricity
- Pigtail Diameter
- Suture Force to Pigtail
- Catheter Compatibility ●
- Biocompatibility Testing per ISO 10993-1 ●
I. Conclusion
Based upon successful results of testing and responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent.