K Number
K151772
Device Name
Actreen Mini Intermittent Urinary Catheters
Date Cleared
2016-02-09

(224 days)

Product Code
Regulation Number
876.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.
Device Description
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.
More Information

Not Found

No
The summary describes a physical medical device (urinary catheter) and its accessories. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.

No.
The device is a urinary catheter, which is used for drainage, not for treating a disease or condition. While it helps manage symptoms of chronic urine retention or voiding dysfunction, it does not provide therapy to cure or improve these conditions themselves.

No

This device is an intermittent urinary catheter, used for management of urine retention or voiding dysfunction, not for diagnosing a condition.

No

The device description clearly states it is a physical catheter and collection bag, which are hardware components, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The Actreen Mini Intermittent Urinary Catheters are used to drain urine directly from the bladder. They are inserted into the body and perform a physical function (catheterization). They do not analyze or test a specimen taken from the body.
  • Intended Use: The intended use is for "intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction." This describes a procedure performed on the patient, not a test performed on a sample.

Therefore, based on the provided information, the Actreen Mini Intermittent Urinary Catheters are a medical device used for a therapeutic or management purpose, not an in vitro diagnostic purpose.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GBM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121457, K072808

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection.

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

1

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)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) SUMMARY

DATE:June 29, 2015
SUBMITTER:B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
610-266-0500
Contact:
Sierra Mertz
Phone: (610) 266-0500
Fax: (610) 266-4962
E-mail: sierra.mertz@bbraun.com
DEVICE NAME:Actreen® Mini Intermittent Urinary Catheters
COMMON NAME:Intermittent Urinary Catheter
DEVICE
CLASSIFICATION:21 CFR §876.5130, Class II
Urological Catheter and Accessories
Classification Product Code: GBM
PREDICATE DEVICE:510(k) Number: K121457
Device Name: SpeediCath Compact Set
Classification Product Code: GBM
Regulation Number: §876.5130, Class II
Applicant: Coloplast Corp

510(k) Number: K072808
Device Name: SpeediCath Compact
Classification Product Code: GBM
Regulation Number: §876.5130. Class II
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.