(26 days)
The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.
The Wiygul Catheter intended for use in neonatal and pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter. The Wiygul Catheter is comprised of a two-layer design, including an inner sampling catheter and protective outer sheath to minimize contamination of the eyelets. The tip will be atraumatic. The handle of the device will utilize a slider to facilitate the retraction of the outer sheath once inserted into the bladder to expose eyelets for sampling. This catheter is a6Fr catheter with a working length of 300mm +/- 5mm. Material composition of the catheter is provided in in Table 5-1 below.
The Wiygul Catheter is provided in a box containing the main device (sampling catheter), a cleared syringe and Instructions for Use.
The mechanism of action will be mechanical for pulling back the outer sheathe and negative pressure from the attached syringe to withdraw a urine sample.
This FDA 510(k) summary describes the Wiygul Catheter but does not provide the detailed acceptance criteria or results of a study in the format requested. The document states "All tests met the pre-determined acceptance criteria" for various performance tests, but it does not specify what those criteria were or provide quantitative results beyond this general statement.
Therefore, many of the requested fields cannot be extracted directly from this document.
Here's an attempt to answer based on the provided text, highlighting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document mentions several performance tests were conducted and states: "All tests met the pre-determined acceptance criteria." However, the specific acceptance criteria and the detailed reported device performance for each test are not provided in this summary.
| Test Name | Acceptance Criteria (Not Specified) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Pouch Sealing | Not specified | Met pre-determined criteria |
| Visual Inspection | Not specified | Met pre-determined criteria |
| Dimensional Inspection | Not specified | Met pre-determined criteria |
| Simulated Use Testing | Not specified | Met pre-determined criteria |
| Flow Rate Testing | Not specified | Met pre-determined criteria |
| Kink Testing | Not specified | Met pre-determined criteria |
| Tensile Testing | Not specified | Met pre-determined criteria |
| Luer Testing per BBB ISO 80369-7 | Not specified | Met pre-determined criteria |
| Package Distribution Simulation Testing per ASTM 4169-16 | Not specified | Met pre-determined criteria |
| Package Integrity Visual Inspection | Not specified | Met pre-determined criteria |
| Package Integrity Bubble Leak Testing per ASTM F2096-11 | Not specified | Met pre-determined criteria |
| Package Strength Testing per ASTM F88/F88M-15 | Not specified | Met pre-determined criteria |
| Bend Radius Test | Not specified | Met pre-determined criteria |
| KY Jelly Compatibility Test | Not specified | Met pre-determined criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on non-clinical performance testing of the device itself (e.g., mechanical properties, packaging) rather than clinical study data from a patient test set.
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)
This information is not applicable as the provided document details non-clinical laboratory testing, not a study involving expert assessment of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the provided document details non-clinical laboratory testing.
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
This information is not applicable. The document describes a medical device (catheter), not an AI-powered diagnostic tool, and it does not include any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" would be established by the specific engineering and material science standards and methodologies used for each test (e.g., ISO, ASTM standards, internal specifications). For example, for "Dimensional Inspection," the ground truth would be the design specifications for the catheter's dimensions. However, the document does not elaborate on these specific ground truth definitions for each test.
8. The sample size for the training set
This information is not applicable as the document describes a medical device (catheter) and its non-clinical performance testing. It does not refer to a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" mentioned in the context of this device's documentation.
{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.
September 30, 2020
Big Blue Biotech, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, MN 55114
Re: K202566
Trade/Device Name: Wiygul Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: September 3, 2020 Received: September 4, 2020
Dear Prithul Bom:
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,
Sharon M. Andrews 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)
Device Name Wiygul Catheter
Indications for Use (Describe)
The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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."
{3}------------------------------------------------
510(k) Summary
The following information is provided in accordance with 21 CFR 807.92, for the Premarket 510(k) Summary:
SUBMITTER INFORMATION
| Company Name: | Big Blue Biotech, Inc. |
|---|---|
| Company Address: | 690 Canton Street, Suite 302 |
| Westwood, MA 02090 | |
| Company Telephone: | 781-329-2993 |
| Contact Name: | Russ Olsen |
| Contact Address: | 690 Canton Street, Suite 302 |
| Westwood, MA 02090 | |
| Contact Telephone: | 862.432.1194 |
| Contact Fax: | 781 329.2968 |
| Contact E-mail: | rolsen@healthpolicyassociates.com |
| Date Prepared: | September 18, 2020 |
DEVICE INFORMATION:
| Trade Name: | Wiygul Catheter |
|---|---|
| Common Name: | Pediatric Urinary Sampling Catheter |
| Regulatory Class: | Class II |
| Product Code: | EZD |
| Product Code Name: | Catheter, Straight |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5130 |
PREDICATE DEVICE INFORMATON:
Trade Name: Common Name: Subject to design-related recall: 510(k) Number: Decision Date:
NeoMed Urinary Catheter Urological Catheter and Accessories No K072997 December 19, 2007
DEVICE DESCRIPTION:
The Wiygul Catheter intended for use in neonatal and pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter. The Wiygul Catheter is comprised of a two-layer design, including an inner sampling catheter and protective outer sheath to minimize contamination of the eyelets. The tip will be atraumatic. The handle of the device will utilize a slider to facilitate the retraction of the outer sheath once inserted into the bladder to expose eyelets for sampling. This catheter is a6Fr catheter with a working length of 300mm +/- 5mm. Material composition of the catheter is provided in in Table 5-1 below.
{4}------------------------------------------------
The Wiygul Catheter is provided in a box containing the main device (sampling catheter), a cleared syringe and Instructions for Use.
The mechanism of action will be mechanical for pulling back the outer sheathe and negative pressure from the attached syringe to withdraw a urine sample.
| Component | Surface Area (in^2) | Percent Surface Are | Volume (in^3) | Percent Volume | Material | Color |
|---|---|---|---|---|---|---|
| Outer Sheath | 5.429 | 36% | 0.0216 | 12% | Dow 690 Health+ LDPE, 9% Elvax 660, 0.2% Crodamide | 2925c |
| Sampling Catheter | 3.815 | 25% | 0.0192 | 10% | Dow 690 Health+ LDPE, 9% Elvax 660, 0.2% Crodamide | 286c |
| Distal Handle | 2.600 | 17% | 0.0729 | 39% | Bayblend T85 XF-000000 | UN0005 39 |
| roximal Luer Handl | 1.683 | 11% | 0.0411 | 22% | Bayblend T85 XF-000000 | UN0005 39 |
| Slider Handle | 1.498 | 10% | 0.0317 | 17% | Cycoloy C1200HF-1000 | 286c |
Table 5-1: Material Composition
INTENDED USE OF Wiygul Catheter
The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Attributes | Subject deviceWiygul Catheter | Predicate deviceNeoMed Urinary Catheter | Remarks |
|---|---|---|---|
| 510k Number | K2020566 | K072997 | N/A |
| Trade Name | Wiygul Catheter | NeoMed Urinary Catheter | N/A |
| Classification Name | Urological Catheter and Accessories | Urological Catheter and Accessories, Urethral Catheter | The predicate has one additional procode. |
| Device Classification | Class II | Class II | Same |
| Product Code | EZD | EZD and GBM | The predicate has one additional procode. |
| Indications for Use | Urine Sampling | Urine Sampling and/or bladder drainage | Similar.The subject device is intended to collect the urine sample only, and it is not intended for bladder drainage. |
| Intended Use | This Wiygul Catheter is intended for use in neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter. | This product is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days. | Similar.The subject device is intended to collect the urine sample only, and it is not intended for bladder drainage. |
| Device Description | The Wiygul Catheter is comprised of a two-layer design, including an inner sampling catheter and protective outer sheath. The tip is atraumatic. The handle of the device will utilize a slider to facilitate the retraction of the outer sheath once inserted to expose eyelets for sampling. | The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine.The device consists of the following components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter) | SimilarBoth devices have sampling catheter, and luer lock connector to connect the syringe and draw the urine sample. The subject device has an additional outer sheath. The outer sheathe of the subject device has laser engraved |
{5}------------------------------------------------
| Attributes | Subject deviceWiygul Catheter | Predicate deviceNeoMed Urinary Catheter | Remarks |
|---|---|---|---|
| Target Population | Neonatal and Pediatric patients | Neonatal and Pediatric patients | Same |
| Materials | PC/ABS and LDPE/Elvax/Crodamideblend | Silicone | Different.The biocompatibility, performance test and simulated use data demonstrates that the difference in material of the subject device compared to its predicate does not raise any safety and effectiveness concerns. |
| Biocompatibility | Passed ISO 10993 Cytotoxicity,Irritation, and Sensitization testing | "The NeoMed Urinary Catheter materials that come in direct contact with the patient have a long history of use in catheter and urethral catheter manufacture and are biocompatible." | Similar.The biocompatibility test results of the subject device demonstrate that the subject device is biocompatible. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Performance Data | Functional test results demonstrate that the Wiygul Catheter performs its intended use of urine sampling and is equivalent to the predicate device. | Functional test results demonstrate that the NeoMed Urinary catheter performs its intended use of urine drainage and is equivalent to the predicate device. | Similar. |
| Anatomical Sites | Urethral | Urethral | Same |
PERFORMANCE DATA
Summary of Performance Testing
The following non-clinical performance data are provided in support of the substantial equivalence determination:
- O Pouch Sealing
- Visual Inspection O
- O Dimensional Inspection
- Simulated Use Testing O
- Flow Rate Testing O
- Kink Testing O
- O Tensile Testing
- Luer Testing per BBB ISO 80369-7 O
- Package Distribution Simulation Testing per ASTM 4169-16 0
- 0 Package Integrity Visual Inspection
- Package Integrity Bubble Leak Testing per ASTM F2096-11 O
- O Package Strength Testing per ASTM F88/F88M-15
- Bend Radius Test O
- KY Jelly Compatibility Test 0
All tests met the pre-determined acceptance criteria.
{6}------------------------------------------------
Conclusion:
The subject device has the same indented use and similar technological characteristics to the currently-marketed predicate device. The subject device is substantially equivalent to the currentlymarketed predicate devices. The non-clinical performance testing conducted on the product demonstrates the Wiygul Catheter is as safe and effective as the predicate device for it's intended use.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.