(62 days)
K/DEN: Not Found
No
The device description and performance studies focus on the physical characteristics and drainage function of a catheter, with no mention of AI or ML.
No.
The device is a drainage catheter that removes fluid from the body, which is a supportive rather than a therapeutic function according to the provided text.
No
Explanation: The device described is a drainage catheter, intended for therapeutic fluid removal, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a flexible tube, drainage holes, a hub assembly, and accessories like stiffening cannulas and a trocar, 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 clearly describes the device as being used for percutaneous drainage of fluid from various anatomical sites within the body (chest, abdomen, pelvis, urinary system, biliary tree). This is a therapeutic or interventional procedure performed directly on the patient.
- Device Description: The device description details a physical catheter designed to be inserted into the body to drain fluid. It mentions features like a flexible tube, drainage holes, a lubricious surface, and a Luer lock hub for connecting to a collection device. These are characteristics of a medical device used for drainage, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue) outside of the body. IVDs are designed for diagnostic purposes, providing information about a patient's health status through the examination of these samples.
In summary, this device is a medical device used for a therapeutic procedure (drainage) performed in vivo, not an IVD used for diagnostic testing in vitro.
N/A
Intended Use / Indications for Use
- Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, . abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
- Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections . in the urinary system.
- Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. .
Product codes
FGE
Device Description
The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.
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
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 proposed drainage catheters were tested and compared to predicate devices. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
DEC 31 2009
510(k) SUMMARY
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Wanda Carpinella Acting Project Manager, Global Regulatory Affairs
C. Device Name
Trade Name: Common/Usual name: Classification Name:
D. Predicate Device(s)
Common/Usual name: Classification Name: Regulation Number: Premarket Notification:
Lorraine M. Hanley Director, Global Regulatory Affairs
To be determined Percutaneous Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II LJE-Catheter, Nephrostomy Pre-Amendment, Unclassified, GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I
Boston Scientific Corporation Flexima Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR&876.5010, Class II K023870 Boston Scientific Corporation Flexima Drainage Catheter FFA-Tube, Drainage, Subrapubic 21CFR 8876.5090, Class II K944290 Angiodynamics Total Abscession Biliary Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II K060023
1
Image /page/1/Picture/0 description: The image shows the text "K093392" in a stylized font. Below this, the text "Abbreviated 510(K" is visible. To the right of this text, there is another stylized text string that is difficult to decipher.
Image /page/1/Picture/1 description: The image shows a logo for Navilyst Medical. The logo consists of a circular graphic on the left and the text "Navilyst" above the text "Medical" on the right. The graphic appears to be an abstract representation of a medical device or technology.
E. Device Description
The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.
F. Intended Use
.
- Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, . abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
- Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections . in the urinary system.
- Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. .
G. Technology Characteristics
The proposed device has similar materials, design and components and technological characteristics as currently marketed drainage catheters.
H. Performance Data
The proposed drainage catheters were tested and compared to predicate devices. 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.
Conclusion l.
Based on responses to questions posed in the FDA's Decision Making Tree, the proposed devices are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the eagle. The text is in a circular format, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES USA" on the right side.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC 3 1 2009
Ms. Wanda Carpinella Acting Project Manager, Global Regulatory Affairs Navilyst Medical, Inc. 26 Forest Street MARLBOROUGH MA 01752
Re: K093392
Trade/Device Name: Percutaneous Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 29, 2009 Received: October 30, 2009
Dear Ms. Carpinella:
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.
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. 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
3
Page 2 -
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for Navilyst Medical. The logo features a stylized image to the left of the company name. The company name is written in a bold, sans-serif font, with the word "Medical" appearing below and slightly offset to the left of "Navilyst".
Abbreviated 510(K) NMI PDC 29-October-2009 Abbreviated 510(K) NMI PDC 29-October-2009
Indications for Use
510(k) Number (if Known):
Device Name:
Percutaneous Drainage Catheter
Indications for Use:
Multipurpose Drainage: Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Nephrostomy Drainage: Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Biliary Drainage: Catheters are intended for percutaneous drainage of the biliary tree.
Prescription Use (21 CFR 801 Subpart D)
区 And/Or
AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
4-2