(224 days)
Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.
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.
This document is a 510(k) Premarket Notification from the FDA regarding the Actreen® Mini Intermittent Urinary Catheters. It does not describe a study that uses AI or machine learning algorithms, nor does it provide detailed acceptance criteria and performance data in the context of such studies.
Therefore, I cannot provide a description of acceptance criteria and a study proving device performance as requested, because the provided text does not contain information about an AI/ML powered device, acceptance criteria or performance studies of the type requested in the prompt.
The document states that biocompatibility and performance testing were performed in accordance with ISO 10993-1 and EN 1616 to support substantial equivalence to predicate devices, but it does not specify the details of these tests, acceptance criteria, or the results.
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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 (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)
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 BoulevardAllentown, PA 18109-9341610-266-0500 |
| Contact:Sierra MertzPhone: (610) 266-0500Fax: (610) 266-4962E-mail: sierra.mertz@bbraun.com | |
| DEVICE NAME: | Actreen® Mini Intermittent Urinary Catheters |
| COMMON NAME: | Intermittent Urinary Catheter |
| DEVICECLASSIFICATION: | 21 CFR §876.5130, Class IIUrological Catheter and AccessoriesClassification Product Code: GBM |
| PREDICATE DEVICE: | 510(k) Number: K121457Device Name: SpeediCath Compact SetClassification Product Code: GBMRegulation Number: §876.5130, Class IIApplicant: Coloplast Corp510(k) Number: K072808Device Name: SpeediCath CompactClassification Product Code: GBMRegulation Number: §876.5130. Class IIApplicant: 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.
§ 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.