(79 days)
No
The device description and performance studies focus on the physical properties and functionality of a catheter, with no mention of AI or ML technologies.
Yes
The device is used to drain urine from the bladder, which is a therapeutic intervention for individuals unable to urinate naturally or with significant residual urine.
No
Explanation: The device is a catheter used for draining urine, which is a therapeutic function, not a diagnostic one. It does not provide information to identify a disease or condition.
No
The device description clearly describes a physical, disposable catheter made of polyurethane with a hydrophilic coating, eyelets, and different tip configurations. It also mentions sterilization and packaging, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ready-to-Use Hydrophilic Catheter is a physical device inserted into the body (urethra and bladder) to facilitate the drainage of urine. It does not analyze or test a specimen in vitro.
- Intended Use: The intended use clearly describes a physical intervention to manage urine flow, not a diagnostic test performed on a sample.
The device is a medical device, specifically a catheter, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
Product codes
GBM, EZD
Device Description
The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and The catheter is prelubricated with a coating containing sterilized. polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film.
The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types.
The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.
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
The Ready-to-Use Hydrophilic Catheter is available for men, women and children.
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
Performance testing for Ready-to-Use Hydrophilic Catheter was conducted according to applicable sections of voluntary standards:
a) Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.
b) Bench testing was completed per ISO 20696, ASTM D 1894 and internal test methods. Performance testing was conducted according to applicable sections of standards in order to document the following properties of the Ready-to-Use hydrophilic catheter:
- Strength was checked by the test method in Annex A of ISO 20696.
- Connector security was checked by the test method in Annex B of ISO 20696.
- Flow rate was checked by the test method in Annex E of ISO 20696.
- Kink stability was checked by the test method in Annex G of ISO 20696.
- Peak tensile force was checked by the test method in Annex H of ISO 20696.
- Coefficient of friction was checked by the test method in ASTM D 1894.
- Coating adhesion was checked by the test method in BEVER internal methods.
All tests passed.
c) Sterilization validation was conducted according to AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2 and AAMI/ANSI/ISO 11137-3.
d) Accelerated Aged (in compliance with ASTM F1980) Shelf life testing was completed.
All tests met the pre-determined acceptance criteria.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
November 27, 2019
Hangzhou Bever Medical Devices Co., Ltd. Ms. Allyson Zhou Management Representative Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian St., Yuhang District Hangzhou, Zhejiang Province 311121 CHINA
Re: K192468
Trade/Device Name: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter Female, Nelaton-tip Ready-to-Use Hydrophilic Catheter Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM, EZD Dated: September 4, 2019 Received: September 9, 2019
Dear Ms. Zhou:
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.
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 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. Acting Assistant Director DHT3B: Division of Reproductive, Gynecological, and Urological 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
510(k) Number (if known)
Device Name
Ready-to-Use Hydrophilic Catheter
Indications for Use (Describe)
The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved:: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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3
Image /page/3/Picture/1 description: The image shows the logo for B. Ever. The logo consists of two vertical lines followed by a stylized letter B. The word "EVER" is written in capital letters to the right of the B. The logo is in black and white.
Hangzhou Beve al Devices Co., Ltd.
Add: Building 2, No. 1-1, Houmuqiao, Yongle Village, Canggian Street, Yuhang District 311121, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515
510(k) Summary
Date of summary: November 22, 2019
1. Submitter (Owner) of 510 (k):
Hangzhou Bever Medical Devices Co., Ltd. Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street, Yuhang District 311121, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Registration Number: 3008729910
2. Contact person:
Allyson Zhou Management Representative Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Email: allyson@bevermedical.com
3. De vice Name :
Common Name: Catheter, Urethral Trade Name: Ready-to-use Hydrophilic Catheter Classification Name: Urological catheter and accessories (21 CFR 876.5130) Product Code: GBM Regulation Class: II
4. Legally Marketed predicate(s):
Predicate Device: SpeediCath - K023254
Reference Device(s): LoFric® Primo™ - K122078 Self Cath - K100878
5. Device Description
The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and The catheter is prelubricated with a coating containing sterilized. polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film.
4
K192468, pg. 2 of 4
The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types.
The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.
6. Indications for Use
The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
7. Technological Characteristics
| Characteristic | Subject device | Predicate device | Reference device | |
|---|---|---|---|---|
| Ready-to-Use | ||||
| Hydrophilic Catheter | SpeediCath | |||
| K023254 | LoFric® Primo™ | |||
| K122078 | Self Cath | |||
| K100878 | ||||
| Indication for | ||||
| use | Indicated for | |||
| intermittent | ||||
| catheterization of the | ||||
| urethra for those | ||||
| individuals who are | ||||
| unable to promote a | ||||
| natural urine flow or | ||||
| for those individuals | ||||
| who have a | ||||
| significant volume of | ||||
| residual urine | ||||
| following a natural | ||||
| bladder - voiding | ||||
| episode. The catheter | ||||
| is inserted into the | ||||
| urethra to reach the | ||||
| bladder allowing | ||||
| urine to drain. | Indicated for use by | |||
| patients with | ||||
| chronic urine | ||||
| retention and | ||||
| patients with a post | ||||
| void residual | ||||
| volume (PVR) due | ||||
| to neurogenic and | ||||
| non-neurogenic | ||||
| voiding | ||||
| dysfunction. The | ||||
| catheter is inserted | ||||
| into the urethra to | ||||
| reach the bladder | ||||
| allowing urine to | ||||
| drain. | Intended for | |||
| Intermittent | ||||
| catheterization | ||||
| of the urethra. | Indicated for | |||
| those individuals | ||||
| unable to | ||||
| promote a natural | ||||
| urine flow or for | ||||
| those individuals | ||||
| who have a | ||||
| significant | ||||
| volume of | ||||
| residual urine | ||||
| following a | ||||
| natural bladder- | ||||
| voiding episode. |
The table below summarizes the technological characteristics of Ready-to-Use Hydrophilic Catheter (subject device) as compared to the legally marketed predicates.
5
| Size | Female Fr 6, 8, 10,
12, 14, 16, 18
Male Fr 6, 8, 10, 12,
14, 16, 18
Tiemann Fr 8, 10,
12, 14, 16, 18
Pediatric Fr 6, 8, 10 | Female Fr 6, 8, 10,
12, 14, 16
Male Fr 8, 10, 12,
14, 16, 18
Tiemann Fr 10, 12,
14
Pediatric Fr 6, 8, 10
Boy Fr 6, 8, 10, 12 | Nelaton 8in
Fr 8, 10, 12, 14,
16, 18
Nelaton 16in
Fr 8, 10, 12, 14,
16, 18
Tiemann 16in
Fr 10, 12, 14,
16, 18
Pediatric 8in
Fr 6, 8, 10 | Female Fr 8, 10,
12, 14,
Male Fr 8, 10, 12,
14, 16, 18
Tiemann Fr 6, 8,
10, 12, 14, 16, 18
Pediatric Fr 5, 6,
8, 10 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Device
composition | Polyurethane
catheter coated with
polyvinylpyrroli-
done, placed in
water, in single or
combination with an
insertion aid. | Polyurethane
catheter coated
with polyvinylpyr-
rolidone, placed in a
saline solution
containing poly-
vinylpyrrolidone. | Plastic catheter
coated with
polyvinylpyrro-
lidone, packed
with the sterile
water. | Polyvinyl
chloride catheter
(without coating) |
| Condition of
use | Singe Use | Singe Use | Singe Use | Singe Use |
| Coating | PVP(polyvinylpyr-
rolidone) Based
Coating | PVP(polyvinylpyr-
rolidone) Based
Coating | PVP(polyvi-
nylpyrrolidone)
Based Coating | No coating |
| Prelubricated | Yes-by water
hydration | Yes-by saline
solution hydration | Yes-by water
hydration | No |
| Lubricating
solution | Sterile water | Sterile saline
solution | Sterile water | No |
| Ready to use | Yes | Yes | Requires
bursting of
water packet
prior to use | No |
| No touch
design | Yes- contains an
insertion aid (sleeve) | No | Yes- by using
exterior
packaging | No |
| Tip
configuration | Nelaton tip, Tapered
tip and Olive tip | Nelaton tip and
Tapered tip | Nelaton tip and
Tapered tip | Nelaton tip,
Tapered tip and
Olive tip |
| Guide stripe
in the shaft | Yes-
Tiemann Catheter | No | No | Yes-
Tiemann Catheter |
| Drainage
Eyelets | Polished and
staggered | Polished and
staggered | Polished and
staggered | Polished and
staggered |
| End Design | Funnel | Funnel | Funnel | Funnel |
| Duration of
use | For intermittent use | For intermittent use | For intermittent use | For intermittent use |
| Sterile | Yes | Yes | Yes | Yes |
| Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack |
6
8. Summary of Non-Clinical Testing
Performance testing for Ready-to-Use Hydrophilic Catheter was conducted according to applicable sections of voluntary standards:
a) Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.
b) Bench testing was completed per ISO 20696, ASTM D 1894 and internal test methods.
Performance testing was conducted according to applicable sections of standards in order to document the following properties of the Ready-to-Use hydrophilic catheter:
- Strength was checked by the test method in Annex A of ISO 20696.
- Connector security was checked by the test method in Annex B of ISO 20696.
- Flow rate was checked by the test method in Annex E of ISO 20696.
- Kink stability was checked by the test method in Annex G of ISO 20696.
- Peak tensile force was checked by the test method in Annex H of ISO 20696.
- Coefficient of friction was checked by the test method in ASTM D 1894.
- Coating adhesion was checked by the test method in BEVER internal methods.
All tests passed.
c) Sterilization validation was conducted according to AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2 and AAMI/ANSI/ISO 11137-3.
d) Accelerated Aged (in compliance with ASTM F1980) Shelf life testing was completed.
All tests met the pre-determined acceptance criteria.
9. Conclusions
The subject device has the same intended use and similar technological characteristics to the currently-marketed predicate devices. The subject device is substantially equivalent to the currently-marketed predicate devices. Laboratory and safety testing conducted on the product has provided scientific evidence that this subject device is as safe and effective as the predicate device for its intended use.