(255 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a balloon dilation catheter and do not mention any AI or ML components or capabilities.
Yes
The device is used to dilate urethral strictures, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as a "Balloon Dilation Catheter" used for "dilation of urethral strictures" by exerting "radial force to dilate narrow urethral segments." Its function is therapeutic (dilation), not diagnostic (identifying or characterizing disease).
No
The device description clearly describes a physical catheter with a balloon, guidewire compatibility, and radiopaque markers, indicating it is a hardware medical device.
Based on the provided information, the Optilume Basic Urological Balloon Dilation Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Optilume Basic Function: The Optilume Basic is a device used directly within the body (in vivo) to physically dilate a urethral stricture. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states "dilation of urethral strictures," which is a therapeutic procedure.
- Device Description: The description details a catheter with a balloon for physical dilation, not a system for analyzing biological samples.
Therefore, the Optilume Basic Urological Balloon Dilation Catheter falls under the category of a therapeutic medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.
Product codes (comma separated list FDA assigned to the subject device)
KOE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cystoscope and/or fluoroscopy
Anatomical Site
urethral (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)
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.
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.
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
§ 876.5520 Urethral dilator.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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 | |
| 2495 Xenium Lane N. | |
| Minneapolis MN 55441 | |
| Tel:763-670-5247 | |
| Fax: 763-477-6357 |
Primary Submission Contact Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Tel: 763-232-3701 Email: mcchew@libramed.com
| Secondary Submission Contact | Sew-Wah Tay |
|---|---|
| Regulatory Consultant, Libra Medical, Inc. | |
| 8401 73rd Ave North, Suite 63 | |
| Brooklyn Park, MN 55428 | |
| Tel: 612-801-6782 | |
| Email: swtay@libramed.com |
1.1.2 DEVICE INFORMATION
| Trade Name | Optilume Basic Urological Balloon Dilation
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.
5
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
Catheter |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the
dilatation of the
urinary tract. | Same |
| Indication for Use | The Optilume Basic
Urological Balloon
Dilation Catheter is
indicated for the
dilation of urethral
strictures. | Uromax Ultra TM
Balloon Dilatation
Catheters are
recommended for
dilatation of the urinary
tract. |
| Catheter usable
length | 75 cm | Same |
| Balloon diameters | 6 mm, 8 mm, 10 mm, | 4mm, 5mm, 6mm, 7 mm,
8mm, 10 mm |
| Balloon lengths | 30 mm, 50 mm | 40 mm, 60 mm, 80 mm,
100 mm |
| Rated burst pressure | 10 atm, 12 atm | 20 atm |
| Guidewire
compatible | 0.038" (0.9652 mm) | Same |
| Biocompatibility
compliance | ISO 10993-1 for
mucosal tissue | Same |
| Delivery of catheter
to treatment site | Insert into the working
channel of a
cystoscope. | Same |
| Visualization during
placement | Cystoscope and/or
fluoroscopy –
radiopaque marker
bands | Same |
| Sterilization | EO, one-time use,
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.