(248 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "FULL CARE Disposable PVC Nelaton Catheter." It aims to demonstrate that this new device is substantially equivalent to existing legally marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, mapped to your requested points:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance in a quantitative table format. Instead, it relies on demonstrating compliance with recognized standards and successful completion of specific tests. The reported performance is summarized qualitatively.
| Criterion Type | Standard/Test Name | Reported Device Performance |
|---|---|---|
| Biocompatibility | 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" | "The biocompatibility evaluation for the Disposable PVC Nelaton Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 ... and International Standard ISO 10993-1 ... as recognized by FDA. The catheter testing included the following tests: Cytotoxicity, Sensitization, Irritation." (Implied: met requirements, as no adverse findings are noted) |
| Biocompatibility - Tests | International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" (Specifically, tests for surface-contacting devices for duration less than 24 hours) | Cytotoxicity, Sensitization, Irritation. (Implied: met requirements) |
| Bench Testing | EN 1616:1997+A1:1999 (No further detail on what this standard covers provided in the document) | "It's found from the test results that the proposed devices meet the requirements." |
| Bench Testing | EN 1618:1997 (No further detail on what this standard covers provided in the document) | "It's found from the test results that the proposed devices meet the requirements." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the biocompatibility or bench testing. It only states that these tests were conducted.
- Data Provenance: The tests would likely have been conducted in a laboratory setting, presumably in China where Shaoxing Fuqing Health Products Co., Ltd. is located, or by a certified testing facility contracted by them. The document does not specify the country of origin of the testing data.
- Retrospective or Prospective: These tests are prospective in nature, as they are performed specifically to evaluate the new device for premarket submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the type of device and studies described. The "ground truth" concept is typically relevant for diagnostic devices that require expert interpretation of results (e.g., imaging, pathology). For a urological catheter, the "ground truth" is established by direct measurement and standardized chemical/biological assays (e.g., for biocompatibility) or physical performance tests (e.g., for bench testing) against defined criteria. There were no human experts involved in establishing a "ground truth" for interpretation, only laboratory personnel conducting standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is also not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a consensus ground truth. Since the studies conducted were lab-based biocompatibility and bench tests, there's no mention or need for such adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or mentioned. This type of study is relevant for AI-powered diagnostic tools, not for a physical medical device like a PVC Nelaton Catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device with no AI component, and therefore no algorithm-only performance study was conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For this device, the "ground truth" or reference for evaluating performance is based on:
- Standardized Test Methods and Criteria: For biocompatibility, this refers to the pass/fail criteria defined by ISO 10993-1 (e.g., absence of cytotoxicity, sensitization, irritation).
- Engineering Standards: For bench testing, this refers to the requirements set forth in EN 1616:1997+A1:1999 and EN 1618:1997. The device is reported to "meet the requirements," implying it satisfied objective, predetermined specifications within these standards.
8. The sample size for the training set
This question is not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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 FuqingHealth ProductsCo., Ltd |
{7}------------------------------------------------
| An intermittent urinarycatheter that is insertedthrough the urethra andindicated for the purposeof bladder drainage forpediatric males andfemales. The urinarycatheter comes in a varietyof sizes packaged sterilefor single-use. | The FULL CAREDisposable PVCNelaton Catheteris indicated forintermittentcatheterization ofthe urethra forthose individualswho are unable topromote a naturalurine flow or forthose individualswho have asignificant volumeof residual urinefollowing a naturalbladder-voidingepisode. Thecatheter isinserted intourethra to reachthe bladderallowing urine todrain. The urinarycatheter comes ina variety of sizespackaged sterilefor single-use. | ||
|---|---|---|---|
| Indicationsfor Use | The FULL CARE Disposable PVC NelatonCatheter is indicated for intermittentcatheterization of the urethra for thoseindividuals who are unable to promotea natural urine flow or for thoseindividuals who have a significantvolume of residual urine following anatural bladder-voiding episode. Thecatheter is inserted into urethra toreach the bladder allowing urine todrain. The urinary catheter comes in avariety of sizes packaged sterile forsingle-use. | ||
| PatientPopulation | Available for male and female | Available for pediatric maleand female | Available for maleand female, andpediatric male andfemale. |
{8}------------------------------------------------
| Dimension | Female straight tip 6 inch from 8Fr to18Fr with 2Fr increments;Male straight tip 16 inch from 8Fr to18Fr with 2Fr increments. | Pediatric straight tip 10inch from 8Fr to 14Fr with2Fr increments; | Male NC withoutlubricant isavailable from 8Frto 20Fr, female NCwithout lubricantis available from8Fr to 16Fr with2Fr increments;Both male andfemale NC withlubricant isavailable from 8Frto 18Fr with 2Frincrements;Pediatric isavailable from 6Frto 10Fr with 2Frincrements. |
|---|---|---|---|
| Sterilizationmethod | 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}------------------------------------------------
| Indicationsfor Use | The Cure Catheter™ HydrophilicCoated is an intermittent urinarycatheter that is inserted through theurethra and indicated for the purposeof bladder drainage for males andfemales. The urinary catheter comes ina variety of sizes packaged sterile forsingle-use. | The FULL CARE Disposable PVC Nelaton Catheteris indicated for intermittent catheterization ofthe urethra for those individuals who are unableto promote a natural urine flow or for thoseindividuals who have a significant volume ofresidual urine following a natural bladder-voiding episode. The catheter is inserted intourethra to reach the bladder allowing urine todrain. The urinary catheter comes in a variety ofsizes packaged sterile for single-use. |
|---|---|---|
| PatientPopulation | Available for male and female | Available for male and female |
| Dimension | Female 6 inch straight tip in size from6Fr to 18Fr with 2Fr increments;Male 16 inch straight and coude tip insize from 8Fr to 18Fr with 2Frincrements;Pediatric 10 inch straight tip in sizefrom 6Fr to 14Fr with 2Fr increments; | The CB is available in size from 8Fr to 16Fr with2Fr increments;The Smile Cath is available in size from 8Fr to18Fr with 2Fr increments;The CS1 and CS2 are available in size from 8Fr to16Fr with 2Fr increments; |
| Sterilizationmethod | EO for catheter and Radiation for watersachet | EO for catheter and Radiation for water sachet |
| Material | PVC catheter with DSM Comfort Coat-polyvinylpyrrolidone-HydrophilicMaterial Coating-and sterile watersachet | PVC catheter with P41001 coat, and purifiedwater. |
| 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 |
|---|---|---|
| Indicationsfor Use | The Cure Catheter Closed System is anintermittent urinary catheter attachedto a collection bag that is insertedthrough the urethra and indicated forthe purpose of bladder drainage formales andfemales. The urinarycatheter comes in a variety of sizespackaged sterile for single-use. | The FULL CARE Disposable PVC Nelaton Catheteris indicated for intermittent catheterization ofthe urethra for those individuals who are unableto promote a natural urine flow or for thoseindividuals who have a significant volume ofresidual urine following a natural bladder-voiding episode. The catheter is inserted intourethra to reach the bladder allowing urine todrain. The urinary catheter comes in a variety ofsizes packaged sterile for single-use. |
| PatientPopulation | Available for male and female | Available for male and female |
| Dimension | The CB is available in size from 8Fr to16Fr with 2Fr increments;The CS is available in size from 8Fr to16Fr with 2Fr increments; | The CB is available in size from 8Fr to 16Fr with2Fr increments;The Smile Cath is available in size from 8Fr to18Fr with 2Fr increments;The CS1 and CS2 are available in size from 8Fr to16Fr with 2Fr increments; |
| AnatomicalSites | Urethra, bladder | Urethra, bladder |
| Sterilizationmethod | EO | EO |
| Material | PVC | PVC |
| Kit | Cure Catheter, collection bag, a BZKwipe, three Povidone-iodineswabsticks, one pair of gloves, a sterilewipe, and an underpad | CS1:CB, underpad, gauze tissue, povidone iodineswab, 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.
§ 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.