(414 days)
Not Found
Not Found
No
The 510(k) summary describes mechanical dilators and sheaths used in urological procedures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The devices listed are primarily for dilatation and manipulation during medical procedures, such as stone removal or maintaining a tract, rather than providing direct therapy or treatment for a disease. They are surgical tools.
No
The devices are used for dilatation, stone manipulation, or maintaining a tract, which are interventional or procedural uses, not diagnostic.
No
The intended use and device descriptions clearly indicate physical medical devices (dilators, sheaths, catheters) used for surgical procedures, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended uses described for these devices involve direct interaction with the patient's body (dilating the ureter, renal tract, maintaining a nephrostomy tract, etc.).
- The descriptions focus on mechanical actions within the body. They are tools used for procedures, not for analyzing biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance.
These devices are surgical or procedural instruments used within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.
Product codes (comma separated list FDA assigned to the subject device)
EZN, LJE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intramural and Ureter, Renal Tract, Nephrostomy 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 Found
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.
Not Found
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
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
May 5, 2023
Allwin Medical Devices, Inc. Digish Mehta Business Development Executive 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806
Re: K220781
Trade/Device Name: Allwin Dilator & Sets Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN, LJE Dated: April 5, 2023 Received: April 5, 2023
Dear Digish Mehta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen -S
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220781
Device Name Allwin Dilator & Sets
| Indications for Use (Describe) |
|---|
| -------------------------------- |
| ARMADA Ureteral Dilator Set: |
|---|
| Used for step by step dilatation of the intramural and ureter and / or for stone manipulation. |
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy 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."