(29 days)
Not Found
No
The device description and intended use describe a physical drainage catheter and accessories, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is intended for percutaneous drainage of fluid from various body cavities, such as abscesses, cysts, and pneumothoraces, which are medical conditions; therefore, the device is used to treat or alleviate these conditions.
No
Explanation: The device is a Multipurpose Drainage Catheter used for percutaneous drainage of fluid. Its function is to remove fluid, not to diagnose a condition.
No
The device description clearly outlines physical components such as a flexible tube, distal tip, drainage holes, proximal hub assembly, stiffening cannulas, and a trocar, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of this device clearly states its intended use is for "percutaneous drainage of fluid in the chest, abdomen and pelvis". This is a procedure performed directly on the patient's body to remove fluid, not to analyze a sample in a lab.
- The device description details a physical catheter and accessories for insertion and fluid collection. This aligns with a surgical or interventional device, not a diagnostic test performed on a sample.
Therefore, this Multipurpose Drainage Catheter is a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic test.
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, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Product codes
FGE, LJE, GBO, GBX
Device Description
The proposed Multipurpose 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 as a pigtail configuration. 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 a Trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest, abdomen and pelvis
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
Results of the performance 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
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
K111315.
pg 1 of 2
JUN - 8 2011
510(K) SUMMARY
Date prepared: 06-May-2011
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Wanda Carpinella Sr. Manager, Global Regulatory Affairs 508-658-7929
C. Device Name
Trade Name: Common/Usual name: Classification Name:
· Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945
Multipurpose Drainage Catheter Percutaneous Drainage Catheter GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II LJE-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Unclassified
D. Predicate Device(s)
Common/Usual name: Classification Name:
Premarket Notification(s):
Multipurpose Drainage Catheter
GBO-Catheter, Nephrostomy GBX-Catheter, Nephrostomy FGE-Catheter, Biliary, Diagnostic LJE-Catheter, Nephrostomy
1
E. Device Description
The proposed Multipurpose 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 as a pigtail configuration. 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 a Trocar.
F. Intended Use
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
G. Technological Characteristics
The proposed device has similar materials, design and components and technological characteristics as predicate drainage catheters.
H. Performance Data
Results of the performance 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.
I. Conclusion
Based on responses to questions posed in the FDA's Decision Making Tree, the proposed devices are substantially equivalent.
2
Image /page/2/Picture/1 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 an abstract image of an eagle or bird-like figure with stylized lines representing its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Ms. Wanda Carpinella Sr. Manager Global Regulatory Affairs Navilyst Medical, Inc. 26 Forest Street MARLBOROUGH MA 01752
JUN - 8 2011
Re: KI11315
Trade/Device Name: Multipurpose drainage catheter Regulation Number: 21 CFR 8876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Codes: FGE, LJE, GBO, and GBX Dated: May 6, 2011 Received: May 10, 2011
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. 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. 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
3
Page 2
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,
Herbert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if Known): ·
Device Name:
Multipurpose Drainage Catheter
KIII315
Indications for Use:
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Prescription Use (21 CFR 801 Subpart D) 风 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)
Huld Leena
vision Sign-Off) ion of Reproductive, Gastro-Renal, and gical Devices k) Number