(268 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and standard performance testing of a urinary catheter, with no mention of AI or ML capabilities.
No
The device is described as a "urinary drainage catheter" used for "draining urine from the bladder," which is a supportive or maintenance function, not a therapeutic treatment.
No
Explanation: The BONREE Nelaton Catheter is described as a device for draining urine from the bladder, which is a therapeutic function, not a diagnostic one. It does not analyze or interpret physiological data to identify a condition or disease.
No
The device description clearly outlines a physical, sterile, single-patient use urinary drainage catheter made from PVC with specific dimensions and configurations. The performance studies also focus on physical and biological properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- BONREE Nelaton Catheter Function: The BONREE Nelaton Catheter is a device that is inserted into the body (specifically, the urethra and bladder) to drain urine. It is a therapeutic and diagnostic tool used for a procedure (catheterization), not for analyzing a sample of urine outside the body.
The description clearly states its purpose is for "draining urine from the bladder" and describes its physical components and how it is used for this purpose. There is no mention of analyzing urine or any other bodily fluid in a laboratory setting.
N/A
Intended Use / Indications for Use
The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
EZD, EZC
Device Description
The BONREE Nelaton Catheter is sterile, single patient use, urinary drainage catheter that is made from PVC. The catheter is comprised of shaft, tip and funnel. It has two drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel.
The BONREE Nelaton Catheters are produced with two different models—Straight Tip and Coude Tip. Both models will be available for male, female and pediatric. The difference between two models is the tip design.
For Straight Tip catheters, the dimensions range from 6Fr to 22Fr which is a range of 2.0 mm to 7.33 mm in Outer Diameter with a straight tip shape.
For Coude Tip catheters, the dimensions range from 10Fr to 18Fr which is a range of 3.33 mm to 6.0 mm in Outer Diameter with a bent catheter tip shape.
The difference between the Female and Male type is the tube lengths. The Male type is offered in a 400mm tube overall length and 370mm tube effective length, whereas the Female type is offered in a 200mm tube overall length and 170mm tube effective length.
The BONREE Nelaton Catheter is composed of biologically safe materials and supplied sterile (sterilized by EO) and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, bladder
Indicated Patient Age Range
male, female and pediatric patients (2 years old to less than 12 years old)
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)
Performance testing was carried out to verify the safety and the effectiveness of the subject device.
Nonclinical functional performance testing was performed in accordance with:
- a) ASTM F623-19 Standard Performance Specification for Foley Catheter
- b) ISO 20696:2018 Sterile urethral catheters for single use
Testing datas and results are included in this submission, and demonstrated that the BONREE Nelaton Catheter meets all the pre-determined testing and acceptance criteria.
Biocompatibility evaluation for the BONREE Nelaton Catheter was conducted in accordance with:
- a) ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- b) FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" published on June 16, 2016
The subject device was considered mucosal membrane contacting with prolonged exposure (> 24 hours and up to 30 days). The following tests were performed: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Systemic Toxicity and Pyrogenicity.
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible. All evaluation acceptance criteria were met.
Sterilization Process has been validated accordance with ISO 11135:2014. The sterility assurance level is SAL 10-6.
Accelerated aging was completed to validate a shelf life of 5 years.
The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicates and support a determination of substantial equivalence.
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.
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.
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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2022
Bonree Medical Co., Ltd He Hongbo General Manager No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan, Guangdong 528451 China
Re: K212430
Trade/Device Name: BONREE Nelaton Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD, EZC Dated: March 18, 2022 Received: March 30, 2022
Dear He Hongbo:
We have reviewed vour 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 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 (OS) 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 medical devices and radiation-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,
Jessica K. Nguyen, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name BONREE Nelaton Catheter
Indications for Use (Describe)
The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old) for draining urine from the from the bladder.
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)
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.
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 18, 2022 |
|---|---|
| Submitter: | BONREE MEDICAL CO., LTD |
| Address: No.4 Longzhu Garden, Wanmu Industrial | |
| Estate, Nanlang, Zhongshan, Guangdong, CN 528451 | |
| Contact Person: | He Hongbo |
| General Manager | |
| BONREE MEDICAL CO., LTD | |
| Email: he@bonreemed.com | |
| Tel: +86-760-8520 7588 | |
| Fax: +86-760-8520 7568 | |
| Device Name: | |
| Common Name: | |
| Requlation Number: | |
| Regulation Name: | |
| Review Panel: | |
| Product Code: | |
| Regulatory Class: | BONREE Nelaton Catheter |
| Urological Catheter | |
| 21 CFR § 876.5130 | |
| Urological catheter and accessories | |
| Gastroenterology/Urology | |
| EZD, EZC | |
| Class II | |
| Predicate Device(s): | K142575 - Bard RiteCath Intermittent Urinary Catheter |
1. Indications for Use
The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.
2. Device Description
The BONREE Nelaton Catheter is sterile, single patient use, urinary drainage catheter that is made from PVC. The catheter is comprised of shaft, tip and funnel. It has two drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel.
The BONREE Nelaton Catheters are produced with two different models—Straight Tip and Coude Tip. Both models will be available for male, female and pediatric. The difference between two models is the tip design.
For Straight Tip catheters, the dimensions range from 6Fr to 22Fr which is a range of 2.0 mm to 7.33 mm in Outer Diameter with a straight tip shape.
For Coude Tip catheters, the dimensions range from 10Fr to 18Fr which is a range of 3.33 mm to 6.0 mm in Outer Diameter with a bent catheter tip shape.
4
The difference between the Female and Male type is the tube lengths. The Male type is offered in a 400mm tube overall length and 370mm tube effective length, whereas the Female type is offered in a 200mm tube overall length and 170mm tube effective length.
Model Number:
| Model | Type | Model No. |
|---|---|---|
| Straight Tip | Pediatric | 30506002 30508002 30510002 30606002 30608002 30610002 |
| Female | 30612002 30614002 30616002 30618002 30620002 30622002 | |
| Male | 30512002 30514002 30516002 30518002 30520002 30522002 | |
| Coude Tip | Pediatric | 30710002 30810002 |
| Female | 30812002 30814002 30816002 30818002 | |
| Male | 30712002 30714002 30716002 30718002 |
The BONREE Nelaton Catheter is composed of biologically safe materials and supplied sterile (sterilized by EO) and intended for single use only.
3. Substantial Equivalence-Comparison to Predicate Device
A side by side comparison of the proposed device and the predicate device are provided below.
| Comparison
Items | Proposed Device | Predicate Device | Discussion of
Differences |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Devece Name | BONREE Nelaton Catheter | Bard RiteCath Intermittent Urinary
Catheter | --- |
| 510k Number | --- | K142575 | --- |
| Product Code | EZD, EZC | EZD, EZC | Same |
| Regulation
Number | 21 CFR § 876.5130 | 21 CFR § 876.5130 | Same |
| Regulatory
Class | Class II | Class II | Same |
| Indications for
Use/
Intended Use | The
BONREE Nelaton
Catheter is used for clean
intermittent catheterization
(CIC) treatment. It is intended
for use by male, female and
pediatric patients (2 years old
to less than 12 years old) for
draining urine from the
bladder. | The Bard RiteCath Intermittent
Urinary Catheter is intended for
use by adult and pediatric, male
and female patients for draining
urine from the bladder. Pediatric
patients include neonates, infants,
children and adolescents. | Same |
| Size Range | 6Fr-22Fr | 6Fr-18Fr | Similar |
| Materials | Shaft: PVC
Funnel: PVC | Shaft: PVC
Funnel: PVC | Similar |
| Design Feature | Consist of shaft, tip and funnel;
Have two polished drainage
eyes located in the proximal
tip for efficient drainage. | Consist of shaft, tip and funnel;
Have two polished eyelets located
in the proximal tip for efficient
drainage. | Same |
| Tip
Configuration | Straight tip
Coude tip | Straight tip
Coude tip | Similar |
| Lumen | 1-way | 1-way | Same |
| Duration of Use | For intermittent use | For intermittent use | Same |
| Packing | Peel pack comprises paper
and film;
Corrugated board inner;
Corrugated board outer case | Peel pack comprises paper and
film;
Corrugated board inner;
Corrugated board outer case | Same |
5
| Supplied Sterile | Yes | Yes | Same |
|---|---|---|---|
| Single Use | Yes | Yes | Same |
| Sterilization | |||
| Method | EO sterilized | EO sterilized | Same |
| Materials | |||
| Biocompatibility | ISO 10993-1 | ||
| Cytotoxicity | |||
| Penile Irritation | |||
| Sensitization | |||
| Acute Systemic Toxicity | |||
| Subchronic Toxicity | |||
| Pyrogenicity | ISO 10993-1 | ||
| Cytotoxicity | |||
| Vaginal Mucosal Irritation | |||
| Sensitization | Similar |
The BONREE Nelaton Catheter described in this 510(k) have similar technological and performance characteristics to the predicate device.
The proposed device has the same classification information, same intended use and technological characteristics as compared to the predicate device. Any difference that exists between the BONREE Nelaton Catheter and the predicate device have no negative effect on safety or effectiveness, or raise different questions of safety and effectiveness. The similarities and differences between the proposed and predicate device have been identified and explained in the comparison matrix which has been included in Section 12 of this submission.
Therefore, the proposed BONREE Nelaton Catheter is substantially equivalent to the legally marketed predicate Bard RiteCath Intermittent Urinary Catheter(K142575). The proposed device has the same classification information, same intended use and technological characteristics as compared to the predicate device.
4. Summary of Non-Clinical Performance Testing
The BONREE Nelaton Catheter has been verified for its safety and effectivity based on the following performance data.
1) Performance Testing
Performance testing was carried out to verify the safety and the effectiveness of the subject device.
Nonclinical functional performance testing was performed in accordance with:
- a) ASTM F623-19 Standard Performance Specification for Foley Catheter
- b) ISO 20696:2018 Sterile urethral catheters for single use
Testing datas and results are included in this submission, and demonstrated that the BONREE Nelaton Catheter meets all the pre-determined testing and acceptance criteria.
2) Biocompatibility
Biocompatibility evaluation for the BONREE Nelaton Catheter was conducted in accordance with:
- a) ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- b) FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" published on
6
June 16, 2016
The subject device was considered mucosal membrane contacting with prolonged exposure (> 24 hours and up to 30 days). The following tests were performed: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Systemic Toxicity and Pyrogenicity.
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible. All evaluation acceptance criteria were met.
3) Sterilization and Shelf-Life
Sterilization Process has been validated accordance with ISO 11135:2014. The sterility assurance level is SAL 10-6.
Accelerated aging was completed to validate a shelf life of 5 years.
Conclusions Drawn from the Non-Clinical Testing
The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicates and support a determination of substantial equivalence.
5. Conclusion
The BONREE Nelaton Catheter is substantially equivalent to predicate device Bard RiteCath Intermittent Urinary Catheter(K142575). Based on the intended use, principle of operation, performance characteristics, and technological characteristics, the proposed BONREE Nelaton Catheter is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device.