(50 days)
I'm sorry, I cannot fulfill that request. I need an image or text containing the K/DEN numbers to identify them.
You provided the following input: "Wait, this is an an image. I can't read this." This indicates that you are describing an image but not providing the image itself or any text from it.
Please provide the text from the image, or a description that includes the K/DEN numbers, so I can identify them for you.
I'm sorry, I cannot extract the K/DEN number from an image. My current capabilities do not allow me to process and interpret information from image files.
No
The device description focuses on mechanical function and physical manipulation, with no mention of AI/ML terms, image processing for analysis, or data sets for training/testing.
No
The device is used to physically entrap and remove calculi and foreign objects and to guide instrumentation, not to treat a disease or condition itself.
No
Explanation: The device is intended for entrapping and removing calculi and other foreign objects, and for guiding instrumentation in the ureteral tract. It is a stone management device used during surgical procedures, not for diagnosis.
No
The device description clearly details a physical medical device with a film membrane, guidewire, and handle, intended for endoscopic use within the urinary tract. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Accordion Piccolo Function: The Accordion Piccolo Stone Management Device is used within the body (in vivo) to physically manipulate and remove objects (stones, foreign objects) from the urinary tract. It is a surgical tool, not a diagnostic test performed on a sample.
The description clearly outlines its use in endoscopic procedures to entrap and remove objects and guide instrumentation, which are all in-vivo actions.
N/A
Wait, this is an image. I can't read this.
§ 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
Image /page/0/Picture/2 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 a stylized image of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
THS International, Inc. dba Accordion Medical David Ouigley President 9465 Counselors Row, Suite 200 Indianapolis. Indiana 46240
K172299 Re:
Trade/Device Name: Accordion Piccolo Stone Management Device Regulation Number: 21 CFR 876.4680 Regulation Name: Ureteral Stone Dislodger Regulatory Class: Class II Product Code: FFL Dated: September 5, 2017 Received: September 11, 2017
Dear David Quigley:
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
1
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 (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172299
Device Name
Accordion Piccolo Stone Management Device
Indications for Use (Describe)
The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for THS International. The logo consists of a blue square with a white abstract design on the left, followed by the letters "THS" in large, bold, blue font. Below the letters, the word "INTERNATIONAL" is written in a smaller, blue font.
510(K)SUMMARY
THS International, Inc. dba Accordion Medical's Accordion Piccolo Stone Management Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
THS International, Inc. dba Accordion Medical
9465 Counselors Row Suite 200
Indianapolis, IN 46240
| Phone: | (317) 759-2869 |
|---|---|
| Facsimile: | (317) 688-8373 |
| Contact Person: | David Quigley |
| Date Prepared: | June 30, 2017 |
Device Information
| Proprietary Name: | Accordion Piccolo Stone Management Device (PA |
|---|---|
| 1205-27-10) | |
| Classification Name: | Ureteral Stone Dislodger |
| Product Code: | FFL |
| Device Class: | 2 |
Predicate Devices/ Substantial Equivalence
Accordion Stone Management Device (PA 1205-06-10) (K052048) Accordion CoAx Stone Control Device (PA 1305-01-10, PA 1305-01-15) (K082803)
Intended Use/Indications for Use
The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
4
Image /page/4/Picture/0 description: The image shows the logo for THS International. The logo consists of a square with a white abstract design inside, followed by the letters "THS" in large, bold font. Below the letters "THS" is the word "INTERNATIONAL" in a smaller font. The logo is a dark blue color.
Rational for Special 510k
| Accordion Stone
Management Device
vs Accordion Piccolo | Effect on
Intended Use | Alters the fundamental scientific technology of the
device |
|-----------------------------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Length of device:
From 150cm to 94cm | No Change to
Intended Use | No change to fundamental scientific technology of the device: Device still spans the ureteral length and is longer than average flexible and semi-rigid scopes
This length falls within already approved length parameters stated in the Accordion Stone
Management Device 510k submission (K050428) |
| Diameter of shaft:
From 0.035" OD to
0.032"OD | No Change to
Intended Use | No change to fundamental scientific technology of the device: still delivered with a cystoscope and can be used to pass other instrumentation
This diameter falls within already approved diameter parameters stated in the Accordion Stone
Management Device 510k submission (K050428) |
| Material of Shaft:
From Pebax to
Polyimide | No Change to
Intended Use | No change to fundamental scientific technology of the device: Still biocompatible material: same material used in the CoAx Stone Control Device (K082803 on Nov. 13, 2008) with same Intended Use |
| Material of Core
Wire:
From Stainless steel to
Nitinol | No Change to
Intended Use | No change to fundamental scientific technology of the device: Same nitinol used in wires for Accordion occlusion film. |
Device Description
The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.
5
Image /page/5/Picture/0 description: The image shows the logo for THS International. The logo consists of a square with a white design inside, followed by the letters "THS" in large, bold font. Below the letters, the word "INTERNATIONAL" is written in a smaller font size.
Technological Characteristics
The Accordion Piccolo is fundamentally a shorter version of the Accordion Stone Management device (K052048). Its core wire, or inner shaft, uses Nitinol rather than stainless steel. The nitinol allows a more flexible tip which some Doctors prefer. Testing of the core wire was conducted to ensure that while the tip is more flexible, the device still performs the same functions. The Accordion Piccolo core wire is the same nitinol found in the occlusion film.
The braided shaft, or outer shaft. is the only material difference between the Accordion Piccolo and the Accordion Stone Management Device. The braided shaft of the Accordion Piccolo has the same polyimide material used in manufacturing of the braided shaft of the CoAx Stone Control Device (K082803). The change in materials allowed us a smaller diameter, preferred by doctors, without changing the functionality of the device, allowing the same structure but with a smaller diameter.
The occlusion film, handle, introducer, and all packaging components are the same as the Accordion Stone Management Device. Testing was conducted to ensure that the change diameter would not impact the functionality of the current Accordion Stone Control handle. The film, introducer and packaging are unchanged by the length or diameter changes.
Performance Data
50-0111-01 - Accordion Piccolo Benchtop Report (Full Device)
- Torque Handle grip test (Core wire and handle compatibility)
- Benchtop Test Accordion Niti Floppiness test (Core wire testing)
- Benchtop test Accordion Niti poke strength test (Core wire testing)
Conclusion
The Accordion Piccolo device testing demonstrates that the device is as safe, as effective, and performs as well as the Accordion Stone Management Device.
Previous Submissions for this device
N/A