(255 days)
The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.
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.
The provided text describes the regulatory clearance of the Optilume Basic Urological Balloon Dilation Catheter (K191061) as substantially equivalent to a predicate device. It includes performance data for various engineering and biocompatibility tests, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which would typically involve human readers and assessment of performance metrics like sensitivity, specificity, or AUC.
The document focuses on the physical and biological performance of the device itself, rather than evaluating an AI algorithm's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.
Here's a breakdown of what can and cannot be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests but does not provide explicit acceptance criteria values (e.g., "burst pressure > X atm") alongside the reported results. It only states that the device "underwent extensive testing" and "performed as intended."
| Acceptance Criteria (Not explicitly stated in terms of values) | Reported Device Performance |
|---|---|
| Dimensional: (Implied to meet design specifications) | Tested |
| Balloon Burst: (Implied to meet pressure requirements) | Tested |
| Leakage Testing: (Implied to not leak) | Tested |
| Kink Resistance: (Implied to resist kinking) | Tested |
| Guidewire, Luer, and Cystoscope Compatibility: (Implied to be compatible) | Compatible |
| Trackability: (Implied to track correctly) | Tested |
| Tensile Testing: (Implied to endure tensile forces) | Tested |
| Fatigue Testing: (Implied to withstand fatigue) | Tested |
| Balloon Compliance Testing: (Implied to meet compliance specifications) | Tested |
| Biocompatibility Testing: (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity - Implied to be biocompatible with ISO 10993-1 for mucosal tissue) | Compliant |
| Packaging Testing: (Seal strength, bubble leak, distribution - Implied to meet packaging integrity) | Tested |
| Accelerated aging: (Implied to meet shelf life requirements) | Tested |
| GLP Animal Study (Safety and Use): (Implied to be safe and function as intended) | Performed as intended; no device-related adverse events occurred. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of diagnostic "test set" as this is a medical device for dilation, not a diagnostic algorithm. For the GLP animal study, the sample size is not specified beyond "canines."
- Data Provenance: The GLP animal study was performed in "canines." No country of origin is mentioned for the animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The performance data relates to the physical and biological characteristics of the device, not the interpretation of diagnostic images requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the engineering tests (e.g., balloon burst, tensile testing), the "ground truth" would be the established engineering specifications and physical properties of the materials. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards. For the animal study, the "ground truth" refers to observation of device performance and absence of adverse events in living subjects.
8. The sample size for the training set:
Not applicable. This is not a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning algorithm.
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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
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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 (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
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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 Inc2495 Xenium Lane N.Minneapolis MN 55441Tel:763-670-5247Fax: 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 DilationCatheter |
|---|---|
| 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 BalloonCatheter |
|---|---|---|
| Intended Use | Intended for thedilatation of theurinary tract. | Same |
| Indication for Use | The Optilume BasicUrological BalloonDilation Catheter isindicated for thedilation of urethralstrictures. | Uromax Ultra TMBalloon DilatationCatheters arerecommended fordilatation of the urinarytract. |
| Catheter usablelength | 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 |
| Guidewirecompatible | 0.038" (0.9652 mm) | Same |
| Biocompatibilitycompliance | ISO 10993-1 formucosal tissue | Same |
| Delivery of catheterto treatment site | Insert into the workingchannel of acystoscope. | Same |
| Visualization duringplacement | Cystoscope and/orfluoroscopy –radiopaque markerbands | 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.
§ 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.