ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

K220781 · Allwin Medical Devices, Inc. · EZN · May 5, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K220781
• Device Name: ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
• Applicant: Allwin Medical Devices, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: May 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Allwin Dilator & Sets comprise various manual surgical instruments for urological procedures. Devices include ureteral dilators (step-by-step or one-step), renal dilators, Amplatz renal dilator sets, Amplatz sheaths, fascial dilators, introducer sheaths, and catheters. Used by urologists in clinical or surgical settings to dilate the ureter or renal tract, facilitate stone manipulation, or maintain nephrostomy access. Operation involves manual advancement of dilators over guidewires to progressively enlarge anatomical tracts. Devices provide mechanical dilation to prepare surgical sites for subsequent instrumentation or stone removal. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instruments including dilators, sheaths, and catheters. Materials and design are consistent with standard urological dilator sets. No energy source, software, or electronic connectivity.

Indications for Use

Indicated for patients requiring ureteral or renal tract dilatation, stone manipulation, or maintenance of nephrostomy tracts during urological procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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