Optilume Basic Urological Balloon Dilation Catheter

K191061 · Urotronic, Inc. · KOE · Jan 2, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191061
• Device Name: Optilume Basic Urological Balloon Dilation Catheter
• Applicant: Urotronic, Inc.
• Product Code: KOE · Gastroenterology, Urology
• Decision Date: Jan 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optilume Basic Urological Balloon Dilation Catheter is intended for the dilation of the urinary tract.

Device Story

Optilume Basic is an over-the-wire (OTW) balloon dilation catheter; dual-lumen design with tapered atraumatic tip; 75 cm usable length. Used in clinical settings by physicians; compatible with standard flexible cystoscopes and 0.038" guidewires. Device inserted into urethral stricture site under cystoscopic or fluoroscopic visualization; balloon inflated with saline/contrast medium to exert radial force; dilates narrow urethral segments. Radiopaque marker bands facilitate accurate positioning. Benefits include mechanical restoration of urethral patency. Single-use, sterile device.

Clinical Evidence

Bench testing included dimensional, balloon burst, leakage, kink resistance, compatibility, tensile, fatigue, and balloon compliance testing. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity) and packaging/aging studies were performed. A GLP animal study in canines evaluated safety and performance; results showed the device performed as intended with no device-related adverse events.

Technological Characteristics

Dual-lumen OTW catheter; semi-compliant inflatable balloon; 75 cm length; 0.038" guidewire compatible. Radiopaque marker bands for visualization. Sterilized via ethylene oxide (SAL 10^-6). Biocompatibility per ISO 10993-1. Mechanical dilation principle using saline/contrast inflation.

Indications for Use

Indicated for the dilation of urethral strictures in patients requiring urinary tract dilation.

Regulatory Classification

Identification

A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

Special Controls

*Classification.* (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Boston Scientific UroMAX Ultra Balloon Dilatation Catheter (K130804)

Submission Summary (Full Text)

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January 2, 2020

Urotronic Inc % Ms. Ming Cheng Chew Regulatory Consultant Libra Medical Inc. 8401 73rd Ave N. Suite 63 Minneapolis, MN 55428

Re: K191061

Trade/Device Name: Optilume Basic Urological Balloon Dilation Catheter Regulation Number: 21 CFR 876.5520 Regulation Name: Urethral Dilator Regulatory Class: Class II Product Code: KOE Dated: November 22, 2019 Received: November 25, 2019

Dear Ms. Chew:

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

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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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecological and Urological 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)

K191061

Device Name

Optilume Basic Urological Balloon Dilation Catheter

Indications for Use (Describe)

The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.

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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# 510(K) SUMMARY 1.0

#### ADMINISTRATIVE INFORMATION 1.1

#### Date of Summary Preparation: 12/31/19

#### CONTACT INFORMATION 1.1.1

| Submitter/Manufacturer | |
|------------------------|-------------------------------------------------------------------------------------------------------|
| | Urotronic Inc<br>2495 Xenium Lane N.<br>Minneapolis MN 55441<br>Tel:[phone]<br>Fax: [phone] |

Primary Submission Contact Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Tel: [phone] Email: [e-mail]

| Secondary Submission Contact | Sew-Wah Tay |
|------------------------------|--------------------------------------------|
| | Regulatory Consultant, Libra Medical, Inc. |
| | 8401 73rd Ave North, Suite 63 |
| | Brooklyn Park, MN 55428 |
| | Tel: [phone] |
| | Email: [e-mail] |

#### 1.1.2 DEVICE INFORMATION

| Trade Name | Optilume Basic Urological Balloon Dilation<br>Catheter |
|-----------------------|--------------------------------------------------------|
| Common Name | Dilator, Urethral |
| Classification Name | Urethral Dilator |
| Regulation Number(s): | 876.5520 |
| Class | II |
| Classification Panel | Gastroenterology/Urology |
| Product Code | KOE |
| Previous Submission | none |

There are no previous submission for the subject device.

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#### 1.2 PREDICATE DEVICE

Boston Scientific UroMAX Ultra Balloon Dilatation Catheter (K130804)

### DEVICE DESCRIPTION OVERVIEW 1.3

The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.

### 1.4 INTENDED USE

The Optilume Basic Urological Balloon Dilation Catheter is intended for the dilation of the urinary tract.

# 1.5 INDICATION FOR USE

The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.

### 1.6 PERFORMANCE DATA OVERVIEW

The Optilume Basic Urological Balloon Dilation Catheter underwent extensive testing including:

- Dimensional ●
- Balloon Burst ●
- Leakage Testing ●
- Kink Resistance ●
- Guidewire, Luer, and Cystoscope Compatibility ●
- Trackability
- Tensile Testing
- Fatigue Testing ●
- Balloon Compliance Testing
- Biocompatibility Testing Cytotoxicity, Sensitization, Irritation, Systemic Toxicity ●
- Packaging Testing seal strength, bubble leak, distribution ●
- Accelerated aging ●

A GLP animal study was performed in canines to evaluate the safety and use of the device. The device performed as intended and no device-related adverse events occurred.

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#### 1.7 SUBSTANTIAL EQUIVALENCE

The Optilume Basic Urological Balloon Dilation Catheter is substantially equivalent to the UroMax device (K130804). It has the same intended use for the dilation of the urinary tract. The test data showed that the technological difference between the Optilume Basic Urological Balloon Dilation Catheter and its predicate do not raise safety and efficacy issues.

| Characteristic | Optilume Basic | Uromax Ultra Balloon<br>Catheter |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the<br>dilatation of the<br>urinary tract. | Same |
| Indication for Use | The Optilume Basic<br>Urological Balloon<br>Dilation Catheter is<br>indicated for the<br>dilation of urethral<br>strictures. | Uromax Ultra TM<br>Balloon Dilatation<br>Catheters are<br>recommended for<br>dilatation of the urinary<br>tract. |
| Catheter usable<br>length | 75 cm | Same |
| Balloon diameters | 6 mm, 8 mm, 10 mm, | 4mm, 5mm, 6mm, 7 mm,<br>8mm, 10 mm |
| Balloon lengths | 30 mm, 50 mm | 40 mm, 60 mm, 80 mm,<br>100 mm |
| Rated burst pressure | 10 atm, 12 atm | 20 atm |
| Guidewire<br>compatible | 0.038" (0.9652 mm) | Same |
| Biocompatibility<br>compliance | ISO 10993-1 for<br>mucosal tissue | Same |
| Delivery of catheter<br>to treatment site | Insert into the working<br>channel of a<br>cystoscope. | Same |
| Visualization during<br>placement | Cystoscope and/or<br>fluoroscopy –<br>radiopaque marker<br>bands | Same |
| Sterilization | EO, one-time use,<br>SAL 10-6 | Same |
| Inflation fluid | Saline/contrast | Same |

Table 1-1: Device Comparison to the Predicate Device

#### CONCLUSION 1.8

Based on the test data and the same intended use, the Optilume Basic Urological Balloon Dilation Catheter is found to be substantially equivalent to its predicate.