(228 days)
Not Found
No
The device description and intended use focus on mechanical function and physical properties, with no mention of AI/ML terms or capabilities.
No
The device is intended for mechanical purposes—bypassing, entrapping, removing, preventing migration of calculi, and guiding instrumentation—rather than providing therapeutic treatment to a disease or condition.
No
The provided text describes a device used for managing stones in the urinary tract by bypassing, entrapping, and removing them, and preventing migration during lithotripsy. These are therapeutic and procedural functions, not diagnostic ones. The device is designed to interact physically with stones and anatomy rather than to identify diseases or conditions. While it's visible under fluoroscopic imaging, this is a guidance mechanism for the procedure rather than a diagnostic application of imaging.
No
The device description clearly outlines a physical medical device consisting of a film membrane, wire guide, and handle, intended for mechanical manipulation within the urinary tract. It is 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 clearly describes a device used within the body for physical manipulation of stones and guidance of instruments. This is an in vivo (within a living organism) procedure, not an in vitro (in glass, or outside the body) diagnostic test.
- Device Description: The description details a physical device with a film membrane, wire guide, and handle, designed to be inserted into the urinary tract. This is consistent with a surgical or interventional device, not a diagnostic test that analyzes samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like urine or tissue), detecting biomarkers, or providing diagnostic information about a patient's condition. The device's function is purely mechanical and procedural.
IVD devices are typically used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.
Product codes (comma separated list FDA assigned to the subject device)
FFL
Device Description
The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
urinary tract, ureter
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)
Bench top and clinical data from the literature were submitted in support of the proposed performance claims for this 510(k) submission. as well as in support of documenting that the changes in device materials and sterilization method has not affected design specifications.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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MAY 16 2011 510(k) Summary
Advertising Language for the Accordion Stone Management 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 x 204 |
|---|---|
| Facsimile: | (650) 493 4201 |
| Contact Person: | Thomas Lawson |
Date Prepared: February 1, 2011
Common or Usual Name
Urology Retrieval Device
Classification Name
Ureteral stone dislodger 21 CFR 876.4680 Class II Product Code FFL
Predicate Devices
Accordion Stone Management Device, Percutaneous Systems, Inc. (K052048) Stone Cone, Boston Scientific Corporation (K864874)
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Intended Use
The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to quide instrumentation within the ureter.
Device Description
The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.
Performance Data
Bench top and clinical data from the literature were submitted in support of the proposed performance claims for this 510(k) submission. as well as in support of documenting that the changes in device materials and sterilization method has not affected design specifications.
Substantial Equivalence
The subject of this 510(k) is the device that was cleared under K052048 (with a few modifications) and is equivalent in technology and intended use to the Stone Cone (K864874). Both the Accordion and Stone Cone devices have a component to reduce migration of stones and stone fragments during lithotripsy. Both are advanced via the working channels of endoscopes and can be used in either ureteroscopic cases (advanced retrograde) or percutaneous nephrolithotomy cases (advanced antegrade). The antiretropulsion component of the Accordion device is a film, while that of the Stone Cone is a wire spiral. The main purpose of this 510(k) submission is to obtain clearance of performance claims to be used in labeling.
Conclusions
The bench top and clinical data show the Accordion device is as safe and as effective as the predicate devices and support the proposed advertising claims.
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 stylized human figure with three arms or lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Thomas Lawson, Ph.D. VP. Clinical & Regulatory Affairs Percutaneous Systems. Inc. 3260 Hillview Avenue PALO ALTO CA 94304
MAY 16 2011
Re: K102887
Trade/Device Name: PercSys Accordion® Stone Management Device Regulation Number: 21 CFR 8876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: FFL Dated: May 9, 2011 Received: May 10, 2011
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. 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
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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,
Huchard Lemmer 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): K102887
Device Name: PercSys Accordion® Stone Management Device
Indications for Use:
The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.
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)
Yoncurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign/Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102887
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