(222 days)
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a standard intermittent urinary catheter, with no mention of AI or ML.
Yes
The device is used to manage chronic urine retention or voiding dysfunction, which are medical conditions, and it is a catheter inserted into the body to pass fluids.
No.
The device is a urinary catheter, indicated for passing fluids from the urinary tract, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, tubular device (catheter) and a collection bag, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction." This describes a procedure performed on the patient's body to manage a physical condition, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a "flexible tubular device that is inserted through the urethra and used to pass fluids from the urinary tract." This is a description of a medical device used for drainage, not for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze a biological sample (like urine itself for diagnostic purposes). The focus is on the physical act of catheterization and fluid removal.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.
Product codes
GBM
Device Description
The B. Braun Actreen® Hi-Lite Intermittent Urinary Catheters include the Actreen® Hi-Lite Cath and Actreen® Hi-Lite Set. The Actreen® Hi-Lite Set is identical to the Actreen® Hi-Lite Cath, except that the Actreen® Hi-Lite Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. The Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 14.5 inch length, a variety of gauge sizes and straight or curved tip configurations to accommodate the individual anatomy of both male and female users. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, urinary tract
Indicated Patient Age Range
adult and pediatric patients
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 EN 1616: 1997 Sterile Urethral Catheters for Single Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 5, 2018
B. Braun Medical, Inc. Anita J. Nemeth Senior Regulatory Affairs Analyst 901 Marcon Boulevard Allentown, PA 18109
Re: K180801
Trade/Device Name: Actreen® Hi-Lite Intermittent Urinary Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: October 15, 2018 Received: October 16, 2018
Dear Anita J. Nemeth:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -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® Hi-Lite Intermittent Urinary Catheters
Indications for Use (Describe)
Actreen® Hi-Lite Intermittent Urinary Catheted for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.
Type of Use (Select one or both, as applicable)
|--|--|
X 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: | March 23, 2018 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Anita J. Nemeth | |
| Phone: (610) 596-2581 | |
| Fax: (610) 266-4962 | |
| E-mail: anita.nemeth@bbraunusa.com | |
| DEVICE NAME: | Actreen® Hi-Lite 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: K151772 |
| Device Name: Actreen® Mini Intermittent Urinary Catheters | |
| Classification Product Code: GBM | |
| Regulation Number: §876.5130, Class II | |
| Applicant: B. Braun Medical Inc. | |
| REFERENCE DEVICE: | 510(k) Number: K141642 |
| Device Name: VaPro TM Intermittent Catheter | |
| Classification Product Code: GBM | |
| Regulation Number: §876.5130, Class II | |
| Applicant: Hollister, Incorporated |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The B. Braun Actreen® Hi-Lite Intermittent Urinary Catheters include the Actreen® Hi-Lite Cath and Actreen® Hi-Lite Set. The Actreen® Hi-Lite Set is identical to the Actreen® Hi-Lite Cath, except that the Actreen® Hi-Lite Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. The Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 14.5 inch length, a variety of gauge sizes and straight or curved tip configurations to accommodate the individual anatomy of both male and female users. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.
CONFIDENTIAL
4
INDICATIONS FOR USE
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatic patients with chronic urine retention or voiding dysfunction.
SUBSTANTIAL EQUIVALENCE
B. Braun Medical Inc. Actreen® Hi-Lite Intermittent Urinary Catheters are substantially equivalent to the Actreen® Mini Intermittent Urinary Catheters (K151772) predicate devices having similar intended use, technological properties, and performance.
The Actreen® Hi-Lite Intermittent Urinary Catheter differs from the predicate device in that the Actreen® Hi-Lite Intermittent Urinary Catheter is available in a longer length, additional gauge sizes and straight or curved tip configurations to accommodate the individual anatomy of both male and female users. The predicate device is offered in a 3.5 inch straight catheter tube length in French gauge sizes ranging from 10-14, whereas the proposed device is offered in a 14.5 inch catheter tube length with straight or curved tip options and French gauge sizes ranging from 8-18 for the catheter and French gauge sizes from 10-18 for the set. Additionally, the pre-attached urine collection bag on the predicate device is designed to hold a volume up to 700mL, while the proposed device collection bag holds a volume up to 1000mL.
Intended Use
The Actreen® Hi-Lite Intermittent Urinary Catheters have similar intended use to the predicate devices. Both the proposed device and the predicate device are intended for intermittent urinary catheterization.
Technical Characteristics
The predicate devices and proposed are comprised of the same materials, with the exception of one material of the primary packaging of the catheter. They include the same components, the same general design and have similar technological characteristics. Both are made of thermoplastic polyolefin (TPO) catheter tubing which is pre-lubricated with a hydrophilic lubricant, and include smooth, oval eyelets designed to minimize friction. The proposed Actreen® Hi-Lite Intermittent Urinary Catheters are available in similar gauge sizes as the Actreen® Mini Intermittent Urinary Catheters. The Actreen® Hi-Lite Set and Actreen® Mini Set both come with a pre-attached polyethylene/polypropylene urine collection bag and both contain an "anti-reflux valve" that allows urine to flow into the bag, but not back out of the bag into the catheter.
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 EN 1616: 1997 Sterile Urethral Catheters for Single Use.
Table 5.1 summarizes the comparison between the Actreen® Hi-Lite Intermittent Urinary Catheters and the Actreen® Mini Intermittent Urinary Catheters.
CONFIDENTIAL
5
| Table 5.1 Device Comparison Table | ||
|---|---|---|
| Item | Proposed Device: KXXXXXX | |
| Product code: GBM | ||
| Actreen® Hi-Lite Cath | ||
| Actreen® Hi-Lite Set | Predicate Device: K151772 | |
| Product code: GBM | ||
| Actreen® Mini Cath | ||
| Actreen® Mini Set | ||
| Intended Use | Intermittent urinary catheterization | Intermittent urinary catheterization |
| Indications for | ||
| Use | Actreen® Hi-Lite Intermittent Urinary Catheters | |
| are indicated for intermittent urinary | ||
| catheterization by adult and pediatric patients with | ||
| chronic urine retention or voiding dysfunction. | Actreen® Mini Intermittent Urinary Catheters are | |
| indicated for intermittent urinary catheterization by | ||
| female patients with chronic urine retention or | ||
| voiding dysfunction. | ||
| Description | The Actreen® Hi-Lite Cath and Actreen® Hi-Lite | |
| Set are sterile, single use, disposable catheters | ||
| designed for use by male or female patients. | ||
| Once removed from the package, the catheters | ||
| are ready to use and are pre- lubricated with a | ||
| hydrophilic lubrication. They are available in | ||
| one length, with a straight or curved tip | ||
| configuration to accommodate the individual | ||
| anatomy of both male and female users. The | ||
| catheter is available in six gauges sizes, while | ||
| the set is available in five gauge sizes. The | ||
| Actreen® Hi-Lite Set includes a pre-attached | ||
| urine collection bag. | The Actreen® Mini Cath and Actreen® Mini Set are | |
| sterile, single use, disposable catheters designed for | ||
| use by females. | ||
| Once removed from the package the catheters are | ||
| ready to use and are pre- lubricated with a | ||
| hydrophilic lubrication. They are available in one | ||
| length with a straight tip. The Actreen® Mini Set | ||
| includes a pre-attached urine collection bag. | ||
| Dimensions | Catheter: 14.5 inch straight or curved tip | |
| catheter tube length, | ||
| French sizes 08, 10, 12, 14, 16, 18 |
Set: 14.5 inch straight or curved tip catheter
tube length,
French sizes 10, 12, 14, 16, 18
Actreen® Hi-Lite Set urine collection bag
volume: 1000mL | Catheter/Set: 3.5 inch straight catheter tube length,
French sizes 10, 12, 14
Actreen® Mini Set urine collection bag volume:
700mL |
| Materials | Catheter tube : Thermoplastic Polyolefin (TPO)
Lubricant : hydrophilic lubricant
Connector : EVA
Connector glue : Acrylate UV or
Cyanoacrylate
Actreen® Hi-Lite Cath primary packaging :
Polyethylene, Polypropylene
Actreen® Hi-Lite Set primary packaging and
collection bag : Polyethylene, Polypropylene | Catheter tube : Thermoplastic Polyolefin (TPO)
Lubricant : hydrophilic lubricant
Connector : EVA
Connector glue : Acrylate UV or
Cyanoacrylate
Actreen® Mini Cath primary packaging :
Polyethylene
Actreen® Mini Set primary packaging and
collection bag : Polyethylene, Polypropylene |
| General
Performance
Requirements | EN 1616 : 1997 - Sterile Urethral Catheters for
Single Use. | EN 1616 : 1997 - Sterile Urethral Catheters for
Single Use. |
| Biocompatibility | In accordance with ISO 10993-1
Classification: surface-contacting devices -
mucosal membrane
Contact Duration: prolonged exposure and a
duration of use greater than 24 hours but less
than 30 days. | In accordance with ISO 10993-1
Classification: surface-contacting devices -
mucosal membrane
Contact Duration: prolonged exposure and a
duration of use greater than 24 hours but less
than 30 days. |
| Sterilization | Beta Irradiation (E-beam) | Beta Irradiation (E-beam) |
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CONCLUSION
Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Actreen® Hi-Lite Intermittent Urinary Catheters are considered substantially equivalent to the predicate devices.