(147 days)
Not Found
None
No
The summary does not mention any AI or ML terms, image processing, or performance studies related to algorithmic analysis. The device description is purely mechanical.
Yes
The device is intended for endoscopic removal of stones in the biliary system, which directly treats a medical condition.
No
The device is described as being used for the "endoscopic removal of stones" and "for contrast injection," which are therapeutic and imaging (interventional) functions, not diagnostic. While contrast injection can be used for diagnosis, in the context of stone removal, it's typically for guiding the interventional procedure rather than primarily establishing a diagnosis.
No
The device description explicitly states it consists of a "film membrane attached onto a catheter," indicating it is a physical device with hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "endoscopic removal of stones in the biliary system and for contrast injection." This describes a procedure performed within the body (in vivo) to treat a condition and visualize anatomy.
- Device Description: The device is a physical tool (catheter with a membrane) used for a procedural intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely procedural and interventional.
N/A
Intended Use / Indications for Use
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
Product codes
LQR, GCA, FGE
Device Description
The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
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)
Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc., Fusion Extraction Balloon with Multiple Sizing, Cook Medical
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.
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K090485
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JUL 2 2 2009
510(k) Summary
Percutaneous Systems, Inc.'s Coaxial Accordion ERCP Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Percutaneous Systems, Inc. 3260 Hillview Avenue Suite 100 Palo Alto, CA 94304
| Phone: | (650) 493 - 4200 |
|---|---|
| Facsimile: | (650) 493 - 4201 |
Contact Person: Thomas Lawson
Date Prepared: February 20, 2009
Common or Usual Name
Biliary Catheter
Classification Name
Biliary Catheter and Accessories
Predicate Devices
Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc. Fusion Extraction Balloon with Multiple Sizing, Cook Medical
5.1
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K090485
Page 1 of 2
Intended Use
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
Technological Characteristics
The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.
Performance Data
Not required.
Substantial Equivalence
The Coaxial Accordion ERCP Device has the same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices. Thus, the Coaxial Accordion ERCP Device is substantially equivalent to the cleared predicate devices.
5.2
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2
Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2009
Thomas Lawson, Ph.D. VP, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 3260 Hillview Avenue Suite 100 PALO ALTO CA 94304
K090485 Re:
Trade/Device Name: Coaxial Accordion ERCP Device Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Codes: LQR, GCA and FGE Dated: July 13, 2009 Received: July 15, 2009
Dear Dr. Lawson:
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 of medical
3
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko90485
Device Name: Coaxial Accordion ERCP Device
Indications for Use:
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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