(248 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and function of a catheter, with no mention of AI or ML. The sections related to AI/ML training and testing data are marked as "Not Applicable (Device is a catheter, not an AI/ML device)".
Yes
The device is clearly indicated for medical purposes (draining urine from the bladder for individuals unable to do so naturally or with residual urine), which is a therapeutic function.
No
The device description clearly states its purpose as an "intermittent pathway for drainage of the bladder," which is a treatment or management function, not a diagnostic one.
No
The device description clearly states it is a physical catheter made of polyvinyl chloride and includes various physical components like a water sachet, collection bag, gauze tissue, etc. It is a hardware device for draining the bladder.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The FULL CARE Disposable PVC Nelaton Catheter is a physical device inserted into the urethra to drain urine directly from the bladder. It is used in vivo (within the body) to facilitate a physiological process (urine drainage).
- Intended Use: The intended use clearly describes a physical intervention for urine drainage, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components and function of a catheter, not a device designed for analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the physical properties and safety of the catheter, not the accuracy or performance of a diagnostic test.
The device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FULL CARE Disposable PVC Nelaton 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. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
Product codes (comma separated list FDA assigned to the subject device)
GBM, EZD, FCM
Device Description
The FULL CARE Disposable PVC Nelaton Catheter is a sterile, single use device designed as an intermittent pathway for drainage of the bladder. It is available for male, female and pediatric, in uncoated and coated variants and in two different tip configurations (straight and rounded). There are two drainage eyelets on the catheter.
The PVC catheter is designed as an intermittent pathway for drainage of the bladder. The devices consist of the following parts(with different combination):
- -Intermittent Urinary Catheter;
- hydrophilic coated Nelaton Catheter;
- water sachet; -
- collection bag;
- gauze tissue;
- povidone iodine swabs ; -
- two gloves;
- underpad;
- BZK; -
- -Lubricant;
- -Interface tube;
- pouch
The device is made of polyvinyl chloride. The catheter is provided sterile in a variety of lengths and sizes.
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
Available for male and female, and pediatric male and female.
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The biocompatibility evaluation for the Disposable PVC Nelaton Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The catheter testing included the following tests:
- Cytotoxicity
- Sensitization
- . Irritation
The catheter is considered surface contacting for duration of less than 24 hours.
Bench testing:
- . EN 1616:1997+A1:1999
- EN 1618:1997
It's found from the test results that the proposed devices meet the requirements.
Animal and clinical study:
The subject of this premarket submission, Disposable PVC Nelaton Catheter, does not require clinical studies to support 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.
K072539, K110653, K132500, K080881
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.
No reference devices were used in this submission.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Shaoxing Fuqing Health Products Co., Ltd. % Mike Gu RA Manager Osmunda Medical Device Technology Service Co., Ltd Floor 7, Jingui Business Building 982 Congyun Rd., Baiyum District Guangzhou 510420 China
Re: K151745
Trade/Device Name: FULL CARE Disposable PVC Nelaton Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: January 28, 2016 Received: February 2, 2016
Dear Mike Gu,
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. 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. You must comply
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K151745
Device Name
FULL CARE Disposable PVC Nelaton Catheter
Indications for Use (Describe)
The FULL CARE Disposable PVC Nelaton Catheter is indicated for intermittent of the urethra for those individuals who are unable to promote a natural urine 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 watheter comes in a variety of sizes packaged sterile for single-use.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Shaoxing Fuqing Health Products Co., Ltd.
| No. 599 Wuxie Road, Shaoxing High-Tech Industrial Development Zone, | |
|---|---|
| Shaoxing Zhejiang, CHINA 312000 | |
| Phone: | +86-575-88675000-830 |
| Fax: | +86-575-88676000 |
| Primary Contact Person: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Mr. Dean Wu |
| Shaoxing Fuqing Health Products Co., Ltd. | |
| Date Prepared: | April 14, 2015 |
II. DEVICE
| Name of Device: | FULL CARE Disposable PVC Nelaton Catheter |
|---|---|
| Common/Usual Name: | Urethral Catheter |
| Classification Names: | Catheter, Urethral (21 CFR876.5130) |
| Regulation Class: | II |
| Product Code: | GBM, EZD, FCM |
5
lll. PREDICATE DEVICE
Cure Catheter™, K072539
Cure Pediatric Catheter, K110653
Cure Catheter™ Hydrophilic Coated, K132500
Cure Catheter™ Closed System, K080881
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The FULL CARE Disposable PVC Nelaton Catheter is a sterile, single use device designed as an intermittent pathway for drainage of the bladder. It is available for male, female and pediatric, in uncoated and coated variants and in two different tip configurations (straight and rounded). There are two drainage eyelets on the catheter.
The PVC catheter is designed as an intermittent pathway for drainage of the bladder. The devices consist of the following parts(with different combination):
- -Intermittent Urinary Catheter;
- hydrophilic coated Nelaton Catheter;
- water sachet; -
- collection bag;
- gauze tissue;
- povidone iodine swabs ; -
- two gloves;
- underpad;
- BZK; -
- -Lubricant;
- -Interface tube;
- pouch
The device is made of polyvinyl chloride. The catheter is provided sterile in a variety of lengths and sizes.
6
> INDICATIONS FOR USE
The FULL CARE Disposable PVC Nelaton 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. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The sponsor identified the similarities and differences of the proposed FULL CARE Disposable PVC Nelaton Catheter device to the legally marketed predicates K072539, K132500 and K080881 to which substantial equivalency is claimed.
| Specification | Predicate Device | Predicate Device | Proposed |
|---|---|---|---|
| Device name | Cure Catheter™ | Cure Pediatric Catheter | Nelaton Catheter |
| (NC) | |||
| 510k number | K072539 | K110653 | NA |
| Manufacturer | Cure Medical, LLC | Cure Medical, LLC | Shaoxing Fuqing |
| Health Products | |||
| Co., Ltd |
7
| | | An intermittent urinary
catheter that is inserted
through the urethra and
indicated for the purpose
of bladder drainage for
pediatric males and
females. The urinary
catheter comes in a variety
of sizes packaged sterile
for single-use. | The FULL CARE
Disposable PVC
Nelaton 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. The urinary
catheter comes in
a variety of sizes
packaged sterile
for single-use. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The FULL CARE Disposable PVC Nelaton
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. The urinary catheter comes in a
variety of sizes packaged sterile for
single-use. | | |
| Patient
Population | Available for male and female | Available for pediatric male
and female | Available for male
and female, and
pediatric male and
female. |
8
| Dimension | Female straight tip 6 inch from 8Fr to
18Fr with 2Fr increments;
Male straight tip 16 inch from 8Fr to
18Fr with 2Fr increments. | Pediatric straight tip 10
inch from 8Fr to 14Fr with
2Fr increments; | Male NC without
lubricant is
available from 8Fr
to 20Fr, female NC
without lubricant
is available from
8Fr to 16Fr with
2Fr increments;
Both male and
female NC with
lubricant is
available from 8Fr
to 18Fr with 2Fr
increments;
Pediatric is
available from 6Fr
to 10Fr with 2Fr
increments. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
method | EO | EO | EO |
| Material | PVC | PVC | PVC |
| Specification | Predicate Device | Proposed |
|---|---|---|
| Device name | Cure CatheterTM Hydrophilic Coated | Hydrophilic Coated Nelaton Catheter (HNC) |
| 510k number | K132500 | NA |
| Manufacturer | Cure Medical, LLC | Shaoxing Fuqing Health Products Co., Ltd |
9
| Indications
for Use | The Cure Catheter™ Hydrophilic
Coated is an intermittent urinary
catheter that is inserted through the
urethra and indicated for the purpose
of bladder drainage for males and
females. The urinary catheter comes in
a variety of sizes packaged sterile for
single-use. | The FULL CARE Disposable PVC Nelaton 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. The urinary catheter comes in a variety of
sizes packaged sterile for single-use. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Population | Available for male and female | Available for male and female |
| Dimension | Female 6 inch straight tip in size from
6Fr to 18Fr with 2Fr increments;
Male 16 inch straight and coude tip in
size from 8Fr to 18Fr with 2Fr
increments;
Pediatric 10 inch straight tip in size
from 6Fr to 14Fr with 2Fr increments; | The CB is available in size from 8Fr to 16Fr with
2Fr increments;
The Smile Cath is available in size from 8Fr to
18Fr with 2Fr increments;
The CS1 and CS2 are available in size from 8Fr to
16Fr with 2Fr increments; |
| Sterilization
method | EO for catheter and Radiation for water
sachet | EO for catheter and Radiation for water sachet |
| Material | PVC catheter with DSM Comfort Coat-
polyvinylpyrrolidone-Hydrophilic
Material Coating-and sterile water
sachet | PVC catheter with P41001 coat, and purified
water. |
| Specification | Predicate Device | Proposed |
|---|---|---|
| Device name | Cure Catheter® Closed Systems | Intermittent Catheterization Bag (CB)+ |
| Intermittent Catheterization Kit (Smile- Cath)+ | ||
| Intermittent Catheterization Kit (CS1)+ | ||
| Intermittent Catheterization Kit (CS2) | ||
| 510k number | K080881 | NA |
10
| Manufacturer | Cure Medical, LLC | Shaoxing Fuqing Health Products Co., Ltd |
|---|---|---|
| Indications | ||
| for Use | The Cure Catheter Closed System is an | |
| intermittent urinary catheter attached | ||
| to a collection bag that is inserted | ||
| through the urethra and indicated for | ||
| the purpose of bladder drainage for | ||
| males and | ||
| females. The urinary | ||
| catheter comes in a variety of sizes | ||
| packaged sterile for single-use. | The FULL CARE Disposable PVC Nelaton 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. The urinary catheter comes in a variety of | ||
| sizes packaged sterile for single-use. | ||
| Patient | ||
| Population | Available for male and female | Available for male and female |
| Dimension | The CB is available in size from 8Fr to | |
| 16Fr with 2Fr increments; | ||
| The CS is available in size from 8Fr to | ||
| 16Fr with 2Fr increments; | The CB is available in size from 8Fr to 16Fr with | |
| 2Fr increments; | ||
| The Smile Cath is available in size from 8Fr to | ||
| 18Fr with 2Fr increments; | ||
| The CS1 and CS2 are available in size from 8Fr to | ||
| 16Fr with 2Fr increments; | ||
| Anatomical | ||
| Sites | Urethra, bladder | Urethra, bladder |
| Sterilization | ||
| method | EO | EO |
| Material | PVC | PVC |
| Kit | Cure Catheter, collection bag, a BZK | |
| wipe, three Povidone-iodine | ||
| swabsticks, one pair of gloves, a sterile | ||
| wipe, and an underpad | CS1:CB, underpad, gauze tissue, povidone iodine | |
| swab, a BZK wipe, one pair of gloves. | ||
| CS2: NC, collection bag, a BZK wipe, underpad, | ||
| one pair of gloves, lubricant, |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
11
The biocompatibility evaluation for the Disposable PVC Nelaton Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The catheter testing included the following tests:
- Cytotoxicity
- Sensitization
- . Irritation
The catheter is considered surface contacting for duration of less than 24 hours.
Bench testing:
- . EN 1616:1997+A1:1999
- EN 1618:1997
It's found from the test results that the proposed devices meet the requirements.
Animal and clinical study:
The subject of this premarket submission, Disposable PVC Nelaton Catheter, does not require clinical studies to support substantial equivalence.
VIII. CONCLUSIONS
Shaoxing Fuqing Health Products Co., Ltd. considers the Disposable PVC Nelaton Catheter does not raise any new issues of safety or effectiveness. And is substantially equivalent to the predicate devices.