Magic3 Go Intermittent Urinary Catheter

K150345 · C.R. Bard, Inc. · EZD · May 11, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150345
• Device Name: Magic3 Go Intermittent Urinary Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: May 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magic3 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.

Device Story

Ready-to-use intermittent urinary catheter; all-silicone single-lumen tube with TPE handle; features four drainage eyes at proximal tip and tapered funnel at distal end. Device utilizes dual-layer coating: base hydrophilic layer with outer self-hydrating layer; eliminates need for water activation prior to use. Used by adult female patients for bladder management; inserted via urethra. Handle provides secure grip and no-touch insertion area. Device facilitates urine drainage, collection, and measurement; benefits patient through simplified, ready-to-use design reducing preparation time and potential contamination.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1:2009 included cytotoxicity, sensitization, and vaginal mucosal irritation. Functional performance testing conducted per BS EN 1616:1997 + A1:1999. Coefficient of friction testing demonstrated low surface friction comparable to predicate.

Technological Characteristics

All-silicone single-lumen catheter; TPE handle (phthalate/DEHP-free). Dual-layer coating: hydrophilic base with self-hydrating outer layer. Sterile, single-use. Dimensions: standard catheter form factor with four drainage eyes and tapered funnel. Biocompatibility per ISO 10993; functional performance per BS EN 1616.

Indications for Use

Indicated for adult female patients requiring bladder management, including urine drainage, collection, and measurement via urethral catheterization.

Regulatory Classification

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).

Predicate Devices

• HydroSil, Magic, Personal Catheter (K122785)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone]
- 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.