(147 days)
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.
The Coaxial Accordion ERCP Device is a medical device intended for the endoscopic removal of stones in the biliary system and for contrast injection.
Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Data (e.g., efficacy in stone removal, safety, durability) | Not Required |
Explanation: The documentation explicitly states "Performance Data: Not required" for this 510(k) submission. This indicates that Percutaneous Systems, Inc. did not conduct a specific performance study with defined acceptance criteria for this device. Instead, the device's clearance was based on demonstrating substantial equivalence to predicate devices already on the market.
2. Sample Size Used for the Test Set and Data Provenance
Since a dedicated performance study was "Not required," there is no test set sample size or data provenance information provided in this submission for the Coaxial Accordion ERCP Device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as no dedicated performance study using a test set was conducted.
4. Adjudication Method for the Test Set
This information is not applicable as no dedicated performance study using a test set was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not conducted as no dedicated performance study was required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical device (biliary catheter), not an algorithm or AI product. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
This information is not applicable as no dedicated performance study was conducted.
8. The Sample Size for the Training Set
This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device.
Summary of Device Acceptance and Study:
The Coaxial Accordion ERCP Device gained market clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices:
- Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc.
- Fusion Extraction Balloon with Multiple Sizing, Cook Medical
The study that proved the device met the acceptance criteria was the substantial equivalence comparison. This comparison focused on demonstrating that the Coaxial Accordion ERCP Device has the same intended use, indications for use, principles of operation, and very similar technological characteristics as the already legally marketed predicate devices. Because of this similarity, the FDA determined that a separate, dedicated performance study with specific acceptance criteria was "Not required" for this submission. The assumption of substantial equivalence implies that the new device carries the same safety and effectiveness profile as the predicate devices that have established performance.
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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
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K090485
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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.
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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
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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
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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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§ 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.