(46 days)
- SLIP Urology Introducer Sheath, Percutaneous Systems, Inc.
- SEIF Orology introducer Should, + Stoutentific Corp.
- Movable Core Guidewire, CR Bard, Inc.
Not Found
No
The summary describes a mechanical guidewire for stone removal and guidance, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is intended to entrap and remove objects and guide instrumentation, which are interventional rather than therapeutic actions.
No
Explanation: The device is described as a guidewire used for removing objects and guiding instrumentation, not for diagnosing conditions.
No
The device description clearly states it consists of a physical guidewire with a removable handle, indicating it is a hardware device, 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 states the device is used endoscopically to entrap and remove objects from the urinary tract and guide instrumentation within the ureteral tract. This is a direct intervention and manipulation of the body, not a test performed in vitro (outside the body) on biological samples.
- Device Description: The description of a guidewire with a removable handle aligns with a surgical or interventional device, not a diagnostic test kit or instrument used for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the ACCORDION Urological Occluding Guidewire is a medical device used for interventional procedures within the urinary tract, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACCORDION Urological Occluding Guidewire is intended to be used The ACCORDION Offical Occluding Calability Calability of other from the endoscopically to chirap anstrumentation within the ureteral tract.
The ACCORDION Urolgoical Occluding Guidewire is intended to rely and on the column in whose colouli and other foreign be used endoscopically to entrap and remove care. objects from the urinary tract and to guide instrumentation within the ureteral tract.
Product codes
FFL
Device Description
The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral tract, urinary tract
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)
SLIP Urology Introducer Sheath, Percutaneous Systems, Inc.; SEIF Orology introducer Should, + Stoutentific Corp.; Movable Core Guidewire, CR Bard, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
SEP 1 3 2005
510(k) SUMMARY
Percutaneous Systems, Inc.'s ACCORDION Urological Occluding Guidewire
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 Mountain View, CA 94043-1359
| Phone: | (650) 969-8800 |
|---|---|
| Facsimile: | (650) 969-8801 |
Thomas Lawson Contact Person:
May 10, 2005 Date Prepared:
Common or Usual Name
Urology Retrieval Device
Classification Name
G-U Devices
Predicate Devices
SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. SEIF Orology introducer Should, + Stoutentific Corp. Movable Core Guidewire, CR Bard, Inc.
Intended Use
The ACCORDION Urological Occluding Guidewire is intended to be used The ACCORDION Offical Occluding Calability Calability of other from the endoscopically to chirap anstrumentation within the ureteral tract.
Image /page/0/Picture/17 description: The image contains a handwritten number "49" enclosed within a roughly drawn circle. The number is written in a simple, slightly slanted style, with the circle loosely surrounding it. The overall impression is that of a quick sketch or annotation.
1
Technological Characteristics
The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.
Performance Data
Not required.
Substantial Equivalence
The ACCORDION Urological Occluding Guidewire has the same intended The ACCORDION Orologiour Orologiour Oroclading Coperation and Very similar use, Indications for doe, ans as the predicate devices. Thus, the technological charactenstics as the prodicate about - Includes devices.
Image /page/1/Picture/6 description: The image contains a hand-drawn circle with the number 50 written inside. The number is written in a simple, slightly irregular style, suggesting it was drawn quickly. The circle is also not perfectly round, adding to the hand-drawn aesthetic of the image.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo. The logo features a stylized image of a bird in flight, with three curved lines representing its wings. The bird is positioned to the right of a circular text element. The text is arranged around the circumference of the circle, but it is difficult to read due to the image quality.
SEP 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Lawson, Ph.D. Thomas Lawoon, I'mical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, #101 MOUNTAIN VIEW CA 94043-1359
Re: K052048
K052048
Trade/Device Name: ACCORDION Urological Occluding Guidewire, Models AC281205 ACCORDION Orological Goofs annog Canading Co., AC2814510; AC381205
through AC2812010; AC281455 through AC2814510; through AC2812010; and, AC381455 through AC3814510 Regulation Number: 21 CFR §876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: FFL Dated: May 28, 2005 Received: July 29, 2005
Dear Dr. Lawson:
Dodl Dr. Lawson.
We have reviewed your Section 510(k) prematically and set the indication for use stated in We have reviewed your Section 310(R) premation invinced (for the indications for uses stated in
above and have determined the device is substantially equivalent commerce pri above and have delerinned the device is scessaries. Species marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enaculient use of the Frederal Food, Drug, and Cosmetic Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act reclassified in accordance with the provisions of the country (PMA). You may, therefore, market the do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Act. The device, subject to the gelleral condois provincies of devices, good manufacturing practice, labeling, morado requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into extrely. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 41, Paris 800 to 8 device can be found in the Code of Federal ing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issuance of a substance of the requirements of the Act or ally
FDA has made a determination that your device complex with securies. You must comp FDA has made a determination mar your device connect was agencies. You must comply with all the Federal statues and regulations administered by band issung (2) CFR Part 807); labeling Act's requirements, including, but hot mined to reguirements set for t in the quality systems (QS) (2) CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
The supportunities and consisted and pubscription of your device to a legal This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA Indine if your device and this permits premarket notification. The FDA Inding of substantial equivaliation for your device of the results your dovice to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the summer on any and of the following numbers, based on the regula If you desire specific advice for your device on our labeling regaration (10 - 120)
contact the Office of Compliance at one of the following numbers, based on the regulation the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, " Misoration on your responsibilities under the Act from the Act from the 807.97). You may obtain other general information on your responsibility and its toll-free number (800)
Division of Small Manufacturers, International Incon DIVIsion of Small Manator or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ K OS 2 50 4 B
Device Name: ACCORDION Urological Occluding Guidewire
Indications for Use:
The ACCORDION Urolgoical Occluding Guidewire is intended to
rely and on the column in whose colouli and other foreign be used endoscopically to entrap and remove care.
objects from the urinary tract and to guide instrumentation within the ureteral tract.
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use________________________________________________________________________________________________________________________________________________
(Please do not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
Nancy Snowdon
and Radiological D 510(k) Number
Image /page/4/Picture/12 description: The image shows a circle with the number 54 written inside of it. The number is written in a simple, handwritten style. The circle appears to be hand-drawn as well, with slight imperfections in its shape. The overall impression is that of a quick sketch or marking.