Actreen Mini Intermittent Urinary Catheters

K151772 · B.Braun Medical, Inc. · GBM · Feb 9, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151772
• Device Name: Actreen Mini Intermittent Urinary Catheters
• Applicant: B.Braun Medical, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.

Device Story

Actreen Mini Intermittent Urinary Catheters are sterile, single-use devices designed for female patients to manage chronic urine retention or voiding dysfunction. The device consists of a pre-lubricated catheter tube and connector; the 'Mini Set' variant includes an integrated, pre-attached urine collection bag. Available in 3.5-inch lengths with straight tips in 10 FR, 12 FR, and 14 FR gauges. The device is intended for intermittent use, facilitating bladder drainage. It is operated by the patient or a caregiver. The device functions as a mechanical conduit for urine; it does not involve electronic processing, software, or automated analysis.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993-1. Performance testing conducted per EN 1616.

Technological Characteristics

Pre-lubricated catheter tube and connector; optional pre-attached urine collection bag. Available in 3.5-inch length, straight tip, 10-14 FR gauges. Materials are similar to predicate devices. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for intermittent urinary catheterization in female patients with chronic urine retention or voiding dysfunction.

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

• SpeediCath Compact Set (K121457)
• SpeediCath Compact (K072808)

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

February 9, 2016

B. Braun Medical Inc. Sierra Mertz Regulatory Affairs Analyst 901 Marcon Blvd. Allentown. PA 18109

Re: K151772

Trade/Device Name: Actreen® Mini Intermittent Urinary Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: Class II Product Code: GBM Dated: January 20, 2016 Received: January 27, 2016

Dear Sierra Mertz,

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)

K151772

Device Name Actreen Mini Intermittent Urinary Catheters

Indications for Use (Describe)

Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.

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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### 5. 510(k) SUMMARY

| DATE: | June 29, 2015 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
| | Contact:<br>Sierra Mertz<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| DEVICE NAME: | Actreen® Mini Intermittent Urinary Catheters |
| COMMON NAME: | Intermittent Urinary Catheter |
| DEVICE<br>CLASSIFICATION: | 21 CFR §876.5130, Class II<br>Urological Catheter and Accessories<br>Classification Product Code: GBM |
| PREDICATE DEVICE: | 510(k) Number: K121457<br>Device Name: SpeediCath Compact Set<br>Classification Product Code: GBM<br>Regulation Number: §876.5130, Class II<br>Applicant: Coloplast Corp<br><br>510(k) Number: K072808<br>Device Name: SpeediCath Compact<br>Classification Product Code: GBM<br>Regulation Number: §876.5130. Class II<br>Applicant: Coloplast Corp |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

The Actreen Mini Intermittent Urinary Catheters include the Actreen Mini Cath and the Actreen Mini Set. The Actreen Mini Set is identical to the Actreen Mini Cath, except that the Actreen Mini Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are available in one length of 3.5 in with a straight tip, and offered in gauges 10 FR, 12 FR, 14 FR.

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# INDICATIONS FOR USE

Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.

# SUBSTANTIAL EQUIVALENCE

B. Braun Medical Inc's. Actreen Mini Intermittent Urinary Catheters are substantially equivalent to the predicate devices having similar intended use, technological properties, and performance.

### Technical Characteristics

The Actreen Mini Intermittent Urinary Catheters have similar physical and technical characteristics to the predicate devices. The Actreen Mini Intermittent Urinary Catheters are offered in similar sizes and are comprised of similar components to the predicate devices. The proposed devices and predicate devices include a pre-lubricated catheter tube and connector. The Actreen Mini Set and Coloplast SpeediCath Compact Set each include a pre-attached urine collection bag.

### Performance Data

Biocompatibility and performance testing were performed to support substantial equivalence of the subject devices to the predicate devices. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing was performed according to relevant sections of EN 1616.

## CONCLUSION

Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Actreen Mini Intermittent Urinary Catheters are considered substantially equivalent to the predicate devices.