(231 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard intermittent urinary catheter, with no mention of AI or ML capabilities.
No
The device is used to pass fluids from the urinary tract for patients with chronic urine retention or voiding dysfunction, which is a supportive rather than a therapeutic function.
No
Explanation: This device is used for intermittent urinary catheterization to pass fluids from the urinary tract in patients with chronic urine retention or voiding dysfunction. It does not collect or analyze data to diagnose a condition.
No
The device description clearly describes a physical, tubular device (catheter) and mentions hardware-related testing (biocompatibility, design verification). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used in vitro (in glass, or outside the body) to provide information about a physiological state, health, or disease.
- This device is a catheter used to drain urine from the body. It is inserted in vivo (in the body) and is a therapeutic device used to manage urine retention or voiding dysfunction.
The description clearly states its function is to "pass fluids from the urinary tract" and is used for "intermittent urinary catheterization." This is a direct interaction with the body for a therapeutic purpose, not an examination of a specimen outside the body for diagnostic information.
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 proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. 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
Urinary tract (via urethra)
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: Biocompatibility and design verification performance testing.
Sample size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: Results of biocompatibility and performance testing conducted on the proposed Actreen® Hi-Lite Intermittent Urinary Catheters demonstrate that they are substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 7, 2020
B. Braun Medical, Inc. Ms. Anita J. Nemeth Senior Regulatory Affairs Analyst 901 Marcon Boulevard Allentown, PA 18109
Re: K192577
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: April 6, 2020 Received: April 6, 2020
Dear Ms. 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 may, 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 aware 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality 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 Catheters are indicated 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)
| Prescription Use (Part 21 CFR 201 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
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: | September 18, 2019 |
|---|---|
| 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: K180801 |
| Device Name: Actreen® Hi-Lite Intermittent Urinary | |
| Catheters Classification Product Code: GBM | |
| Regulation Number: §876.5130, Class II | |
| Applicant: B. Braun Medical Inc. |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. 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.
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.
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SUBSTANTIAL EQUIVALENCE
The proposed 7.5 inch Actreen® Hi-Lite Intermittent Urinary Catheters are substantially equivalent to the Actreen® Hi-Lite Intermittent Urinary Catheters (K180801) predicate device having the same intended use, technological properties, and performance.
The 7.5 inch Actreen® Hi-Lite Intermittent Urinary Catheters differ from the predicate device in that the proposed Actreen® Hi-Lite Intermittent Urinary Catheters are available in a shorter length, an additional gauge size and only the straight tip configuration. The predicate device is offered in a 14.5 inch catheter tube length with French gauge sizes ranging from 8-18 and straight or curved tip configurations, whereas the proposed device is offered in a 7.5 inch catheter tube length with a straight tip and French gauge sizes ranging from 6-16. Additionally, the predicate device offered a set option designed with a pre-attached urine collection bag, while the proposed device is available with the catheter only at this time.
Intended Use
The 7.5 inch Actreen® Hi-Lite Intermittent Urinary Catheters have the same intended use as the predicate devices. Both the proposed devices and the predicate devices are intended for intermittent urinary catheterization by adult and pediatric patients.
Technical Characteristics
The predicate and proposed devices are comprised of the same materials. They include the same components, the same design and have the same 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 with a shorter length than the predicate Actreen® Hi-Lite Intermittent Urinary Catheters.
Performance Data
Biocompatibility and design verification performance testing were performed which support substantial equivalence of the subject devices to the predicate devices. Biocompatibility testing was performed in accordance with ISO 10993-1: 2009. Design verification performance testing was performed according to EN 1616: 1997 Sterile Urethral Catheters for Single Use.
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Table 5.1 summarizes the comparison of the proposed Actreen® Hi-Lite Intermittent Urinary Catheters and the predicate Actreen® Hi-Lite Intermittent Urinary Catheters.
| Table 5.1 Device Comparison Table | ||
|---|---|---|
| Item | Proposed Device: KXXXXXX | |
| Product code: GBM | Predicate Device: K180801 | |
| Product code: GBM | ||
| Actreen® Hi-Lite Cath | Actreen® Hi-Lite Cath | |
| Actreen® Hi-Lite 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® Hi-Lite Intermittent Urinary Catheters are | |
| indicated for intermittent urinary catheterization by | ||
| adult and pediatric patients with chronic urine | ||
| retention or voiding dysfunction. | ||
| Description | The Actreen® Hi-Lite Catheters 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 tip configuration only, | ||
| which accommodates both male and female users. | ||
| The catheter is available in six gauges sizes. | ||
| There is no set available at this time. | 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. | ||
| Dimensions | Catheter: 7.5 inch straight tip catheter tube | |
| length, | ||
| French gauge sizes 06, 08, 10, 12, 14, 16 | Catheter: 14.5 inch straight or curved tip | |
| catheter tube length, | ||
| French gauge sizes 08, 10, 12, 14, 16, 18 | ||
| Set: 14.5 inch straight or curved tip catheter | ||
| tube length, | ||
| French gauge sizes 10, 12, 14, 16, 18 | ||
| Actreen® Hi-Lite Set urine collection bag | ||
| volume: 1000mL | ||
| 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 | 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 | ||
| 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: 2009 | |
| 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: 2009 | |
| 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 | ||
| Process | Beta Irradiation (E-beam) | Beta Irradiation (E-beam) |
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CONCLUSION
Results of biocompatibility and performance testing conducted on the proposed Actreen® Hi-Lite Intermittent Urinary Catheters demonstrate that they are substantially equivalent to the predicate device.