(89 days)
The Magic3 Go™ Intermittent Urinary Catheter is intended for urological use only. If is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
Magic3 Go™ Intermittent Urinary Catheter is a ready-to-use silicone intermittent urinary catheter with a self-hydrating coating over a hydrophilic coating.
The device consists of an all silicone single lumen catheter with a thermoplastic elastomer (TPE) handle which does not contain DEHP and/or phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating is applied. The additional coating does not require activation with water prior to use. The handle provides the user with an area for a secure grip and no-touch area with which to insert the catheter.
The provided document describes a 510(k) premarket notification for a medical device, the Magic3 Go™ Intermittent Urinary Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's effectiveness through clinical trials with specific acceptance criteria like those often seen for AI/ML devices or novel therapies.
Therefore, many of the requested elements (like a multi-reader multi-case study, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets) are not applicable to this type of regulatory submission for this particular device.
However, I can extract information related to the performance data provided to support substantial equivalence.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a urinary catheter, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device and meeting relevant industry standards. There are no numerical performance metrics (like sensitivity, specificity, accuracy) provided in the document for the device itself against a specific clinical outcome.
| Acceptance Criteria (Implied by Equivalence and Standards) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Cytotoxicity (ISO 10993-5) | Met standard (successfully passed) |
| - Sensitization (ISO 10993-10) | Met standard (successfully passed) |
| - Vaginal Mucosal Irritation (ISO 10993-10) | Met standard (successfully passed) |
| Nonclinical Functional Performance | |
| - Sterile urethral catheters for single use (BS EN 1616:1997 + A1:1999) | Met standard |
| - Coefficient of friction (low lubricity) | Low coefficient of friction, demonstrating low friction between catheter and urethral mucosa, demonstrating substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/not specified for performance metrics in the context of clinical outcomes. The performance data refers to laboratory testing on device materials and function.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for clinical data, as this is laboratory and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in this context, would be the results of the laboratory tests based on established ISO and BS EN standards, not expert clinical interpretation.
4. Adjudication method for the test set
- Not applicable. The "test set" here refers to physical/material performance tests, which are objective and do not require expert adjudication in the way clinical diagnostic interpretations would.
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
- No. This is not an AI/ML device and therefore an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the performance data (biocompatibility and nonclinical functional performance) is based on established international and national standards (ISO 10993-5, ISO 10993-10, BS EN 1616:1997 + A1:1999) and quantitative measurements (e.g., coefficient of friction). For the substantial equivalence argument, the predicate device's established safety and effectiveness also serves as a "ground truth" reference.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2015
C.R. Bard, Inc. William Heard Regulatory Affairs Specialist I 8195 Industrial Blvd Covington, GA 30014
K150345 Trade/Device Name: Magic3 GoTM Intermittent Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: February 10, 2015 Received: February 11, 2015
Dear William Heard,
Re:
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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150345
Device Name
Magic3 GoTM Intermittent Urinary Catheter
Indications for Use (Describe)
The Magic3 Go™ Intermittent Urinary Catheter is intended for urological use only. If is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
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)
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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Magic2 Go™ Intermittent Urinary Catheter 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
- Sponsor: Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
- Contact: William Heard Regulatory Affairs Specialist I Bard Medical Division Ph: 770-784-6267 Fax: 770-385-4706
- February 6, 2015 Submission Date:
Trade Name: Magic3 Go™ Intermittent Urinary Catheter Subject Device: Common Name: Urological Catheter Classification Name: Urological catheter and accessories Regulation: 21 CFR §876.5130 Regulatory Classification: II Product Code: EZD
- Predicate Device: Legally marketed device to which substantial equivalence is claimed HydroSil, Magic, Personal Catheter - K122785 .
Device Description
Magic3 Go™ Intermittent Urinary Catheter is a ready-to-use silicone intermittent urinary catheter with a self-hydrating coating over a hydrophilic coating.
The device consists of an all silicone single lumen catheter with a thermoplastic elastomer (TPE) handle which does not contain DEHP and/or phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating is applied. The additional coating does not require activation with water prior to use. The handle provides the user with an area for a secure grip and no-touch area with which to insert the catheter.
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Indications for Use
The Magic® Go™ Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
Comparison of Technological Characteristics with the Predicate Device
The Magic3 Go™ Intermittent Urinary Catheter has similar technological characteristics as the predicate device, HydroSil, Maqic, Personal Catheter cleared via K122785. The subject and predicate device are based on the following technological elements:
- Same intended use
- Same indications for use -
- Same design features (tip, eyes, size) ।
- Provided sterile for single-use -
- Composed of biocompatible materials -
- Ergonomic handle design ।
- -Same catheter materials
- Same hydrophilic coating -
The subject device has a new self-hydrating coating.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibilitv
The biocompatibility evaluation of the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" May 1, 1995 and ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The subject device is considered as a mucosal contacting surface device with limited exposure. The battery of testing included the following:
- Cytotoxicity (ISO 10993-5) ।
- Sensitization (ISO 10993-10) -
- -Vaginal Mucosal Irritation (ISO 10993-10)
Nonclinical functional performance testing
Nonclinical functional performance testing of the subject device was performed in accordance with BS EN 1616: 1997 + A1:1999. Sterile urethral catheters for single use.
Coefficient of friction testing was also conducted on the subject device to determine the lubricity of the catheter surface and demonstrate substantial equivalence to the predicate device. The Magic3 Go™ Intermittent Urinary Catheter has a low coefficient of friction resulting in low friction between the catheter and urethral mucosa.
Conclusions
The Magic Go™ Intermittent Urinary Catheter is substantially equivalent to the legally marketed predicate device as demonstrated by the same intended use, same indications for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.
§ 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.