(231 days)
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.
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.
The provided text is a 510(k) Pre-market Notification for a medical device, the Actreen® Hi-Lite Intermittent Urinary Catheters. This document details the process for obtaining FDA clearance for a device by demonstrating its "substantial equivalence" to a predicate device already on the market.
It's important to understand that a 510(k) summary does not contain the detailed clinical study results or statistical analyses that would typically be required to answer your specific questions about acceptance criteria for an AI/ML medical device, especially regarding aspects like MRMC studies, human-in-the-loop performance, or the nuances of ground truth establishment for complex image analysis.
The "studies" described in this document are primarily non-clinical performance tests demonstrating the physical, chemical, and biological safety and functionality of a physical medical device (a catheter) compared to an existing, similar catheter.
Therefore, many of your questions are not applicable to the information provided in this 510(k) summary. I can, however, extract the relevant "acceptance criteria" and "performance data" as presented for this specific type of device.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/ML context:
Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K180801) through various non-clinical tests. The "performance" is the successful outcome of these tests, confirming that the new device performs similarly and safely to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are for a physical urinary catheter, not an AI/ML device. They relate to material compatibility, physical properties, and sterility, as outlined in the referenced standards. The "performance" is the successful meeting of these standards, which is stated as a conclusion rather than detailed results.
| Category | Acceptance Criteria Type (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: 2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) - specifically for surface-contacting devices, mucosal membrane, prolonged exposure (24 hours to < 30 days) | "Biocompatibility testing was performed in accordance with ISO 10993-1: 2009." Outcome: Results "demonstrate that they are substantially equivalent to the predicate device." |
| Design Verification | EN 1616: 1997 (Sterile Urethral Catheters for Single Use) | "Design verification performance testing was performed according to EN 1616: 1997 Sterile Urethral Catheters for Single Use." Outcome: Results "demonstrate that they are substantially equivalent to the predicate device." |
| Sterilization | Not explicitly stated as a separate "acceptance criteria" but implied standard for Beta Irradiation (E-beam) | "Beta Irradiation (E-beam)" (Same as predicate) |
| Materials | Material compatibility (implicit acceptance that materials are the same as predicate and suitable for use) | Catheter tube: Thermoplastic Polyolefin (TPO); Lubricant: hydrophilic lubricant; Connector: EVA; Connector glue: Acrylate UV or Cyanoacrylate. (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the 510(k) summary for the biocompatibility or design verification tests. These tests are typically conducted on a representative number of samples to ensure statistical validity, but the exact count isn't disclosed in this public summary.
- Data Provenance: Not specified. Testing would typically be conducted at the manufacturer's facilities or a certified testing lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these are lab-based performance tests, not clinical studies in the typical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This document describes the performance testing of a physical medical device (catheter) against engineering and biocompatibility standards, not the evaluation of an AI algorithm requiring expert ground truth for image interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. No expert adjudication method is described as this is not an AI/ML or clinical diagnostic study. The "adjudication" is essentially the successful completion and interpretation of the standard-based tests by qualified lab personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is specifically designed for evaluating the impact of an AI diagnostic aid on human reader performance, typically in diagnostic imaging. This document pertains to the
510(k) clearance of a physical medical device (a urinary catheter) and does not involve diagnostic imaging or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by the established and validated methodologies within the referenced international standards (ISO 10993-1 for biocompatibility, EN 1616 for physical performance). For example, a successful biocompatibility test result is "ground truth" that the materials are non-toxic and compatible with the human body under specified conditions.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set or AI algorithm is involved.
{0}------------------------------------------------
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
5. 510(k) SUMMARY
| DATE: | September 18, 2019 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500 |
| Contact: Anita J. NemethPhone: (610) 596-2581Fax: (610) 266-4962E-mail: anita.nemeth@bbraunusa.com | |
| DEVICE NAME: | Actreen® Hi-Lite 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: K180801Device Name: Actreen® Hi-Lite Intermittent UrinaryCatheters Classification Product Code: GBMRegulation Number: §876.5130, Class IIApplicant: 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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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: KXXXXXXProduct code: GBM | Predicate Device: K180801Product code: GBM |
| Actreen® Hi-Lite Cath | Actreen® Hi-Lite CathActreen® Hi-Lite Set | |
| Intended Use | Intermittent urinary catheterization | Intermittent urinary catheterization |
| Indications forUse | Actreen® Hi-Lite Intermittent Urinary Catheters areindicated for intermittent urinary catheterizationby adult and pediatric patients with chronic urineretention or voiding dysfunction. | Actreen® Hi-Lite Intermittent Urinary Catheters areindicated for intermittent urinary catheterization byadult and pediatric patients with chronic urineretention or voiding dysfunction. |
| Description | The Actreen® Hi-Lite Catheters are sterile, singleuse, disposable catheters designed for use by maleor female patients.Once removed from the package, the catheters areready to use and are pre-lubricated with ahydrophilic lubrication. They are available in onelength, 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 Setare sterile, single use, disposable catheters designedfor use by male or female patients.Once removed from the package, the catheters areready to use and are pre-lubricated with a hydrophiliclubrication. They are available in one length, with astraight or curved tip configuration to accommodatethe individual anatomy of both male and female users.The catheter is available in six gauges sizes, while theset 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 tubelength,French gauge sizes 06, 08, 10, 12, 14, 16 | Catheter: 14.5 inch straight or curved tipcatheter tube length,French gauge sizes 08, 10, 12, 14, 16, 18Set: 14.5 inch straight or curved tip cathetertube length,French gauge sizes 10, 12, 14, 16, 18Actreen® Hi-Lite Set urine collection bagvolume: 1000mL |
| Materials | Catheter tube : Thermoplastic Polyolefin (TPO)Lubricant : hydrophilic lubricantConnector : EVAConnector glue : Acrylate UV orCyanoacrylateActreen® Hi-Lite Cath primary packaging :Polyethylene, Polypropylene | Catheter tube : Thermoplastic Polyolefin (TPO)Lubricant : hydrophilic lubricantConnector : EVAConnector glue : Acrylate UV orCyanoacrylateActreen® Hi-Lite Cath primary packaging :Polyethylene, PolypropyleneActreen® Hi-Lite Set primary packaging andcollection bag : Polyethylene, Polypropylene |
| GeneralPerformanceRequirements | EN 1616: 1997 - Sterile Urethral Catheters forSingle Use. | EN 1616: 1997 - Sterile Urethral Catheters forSingle Use. |
| Biocompatibility | In accordance with ISO 10993-1: 2009Classification: surface-contacting devices -mucosal membraneContact Duration: prolonged exposure and aduration of use greater than 24 hours but lessthan 30 days. | In accordance with ISO 10993-1: 2009Classification: surface-contacting devices -mucosal membraneContact Duration: prolonged exposure and aduration of use greater than 24 hours but lessthan 30 days. |
| SterilizationProcess | Beta Irradiation (E-beam) | Beta Irradiation (E-beam) |
{6}------------------------------------------------
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.
§ 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.