(261 days)
The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.
PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.
The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.
The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
This document describes a 510(k) premarket notification for Disposable Urinary Catheters (PVC, Silicone, and Latex). It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo evaluation of clinical effectiveness with an AI component. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this document.
Here's an analysis of the provided information, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting specified performance standards. The reported device performance is that the device "Passed" all tests against these requirements.
| Test Category | Specific Test / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| PVC Urinary Catheter (based on EN 1616:1997(R2007)) | ||
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007). | Passed |
| Biocompatibility (based on ISO 10993 series) | ||
| Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Passed |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed |
| Irritation | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed |
| Systemic toxicity | ISO 10993-11 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity | Passed |
| Sterility | SAL ≤ 10^-6^ | Passed |
| Silicone Urinary Catheter (based on ASTM F623-99(2013)) | ||
| Flow rate through drainage lumen | Meet the requirement of 4.1 of ASTM F623-99(2013). | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTM F623-99(2013). | Passed |
| Inflated Balloon Response to Traction | Meet the requirement of 4.3 of ASTM F623-99(2013). | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTM F623-99(2013). | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTM F623-99(2013). | Passed |
| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTM F623-99(2013). | Passed |
| Biocompatibility (same ISO standards as PVC) | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation | Passed | |
| Systemic toxicity | Passed | |
| Implantation (Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation) | Passed | |
| Sterility | SAL shall be less than 10^-6^ . | Passed |
| Latex Urinary Catheter (based on EN 1616:1997(R2007) and ASTM F623-99(2013)) | ||
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007) and 4.1 of ASTM F623-99(2013). | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTM F623-99(2013). | Passed |
| Inflated Balloon Response to Traction | Meet the requirement of 4.3 of ASTM F623-99(2013). | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTM F623-99(2013). | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTM F623-99(2013). | Passed |
| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTM F623-99(2013). | Passed |
| Biocompatibility (same ISO standards as above) | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation | Passed | |
| Systemic toxicity | Passed | |
| Implantation | Passed | |
| Sterility | SAL ≤ 10^-6^. | Passed |
2. Sample size used for the test set and the data provenance
This document describes non-clinical "bench testing" and "biocompatibility tests" performed in accordance with standards like EN 1616, ASTM F623, and ISO 10993. These types of tests do not typically involve patient-specific data or test sets in the context of AI. The sample sizes for these bench tests are not specified in this document, nor is the data provenance in terms of country of origin or retrospective/prospective status as it would be for a clinical study. The device manufacturer is Zhanjiang Star Enterprise Co., Ltd based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical, bench testing submission. No "ground truth" established by experts in a clinical context (e.g., radiologists) is mentioned or required for this type of submission.
4. Adjudication method for the test set
Not applicable. There are no clinical test sets or expert evaluations requiring adjudication in this submission.
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
Not applicable. This device is a urinary catheter, not an AI-powered diagnostic or assistive technology. No MRMC studies were conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (urinary catheter) and does not involve an algorithm or AI.
7. The type of ground truth used
For the performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., EN 1616, ASTM F623). For biocompatibility, the "ground truth" is adherence to the criteria set forth in the ISO 10993 series of standards. This is not clinical "ground truth" such as pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore, no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this device.
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Image /page/0/Picture/0 description: The image contains 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.
October 13, 2017
Zhanjiang Star Enterprise Co., Ltd % Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong GD755 CHINA
Re: K170233
Trade/Device Name: Disposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD. EZL Dated: August 5, 2017 Received: September 1, 2017
Dear Elly Xu:
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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 (DICE) 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.
Joyce M. Whang -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
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Indications for Use
510(k) Number (if known) K170233
Device Name Disposable Urinary Catheter
Indications for Use (Describe)
The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Version: A/0
VOL 005_510(k) Summary
1. Submission Sponsor
| Applicant Name | Zhanjiang Star Enterprise Co., Ltd |
|---|---|
| Address | NO.1, West Jinhua Rd. Zhanjiang, Guangdong, P. R.CHINA |
| Post Code | 524094 |
| Phone No. | 86-759-2701619 |
| Fax No. | 86-759-2706838 |
| Contact Person | Rongsheng Tang |
| Tangrs@starcompany.com.cn | |
| Date Prepared | 2017-08-19 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 1122, No.55 Shizhou Middle Road, NanshanDistrict,Shenzhen,Guangdong,P.R.China |
| Image: logo | |
| 卓远天成 | |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Elly Xu; Field Fu |
| elly@cefda.com; cefda13485@163.com |
3. Devices Identification
| Trade name | Disposable Urinary Catheter |
|---|---|
| Common name | Disposable Urinary Catheter |
| Model | PVC Urinary Catheter, Silicone Urinary Catheter,Latex Catheter |
| Classification | II |
| Classification name | Urological catheter and accessories |
| Regulation number | 876.5130 |
| Product code | EZD, EZL |
| 510(k) review panel | Gastroenterology/Urology |
| Performance standards | The performance and safety was evaluated inaccordance with EN 1616:1997(R2007) and ASTMF623-99(2013).Biocompatibility tests were done in conformance withrelevant requirements of ISO10993. |
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Version: A/0
| Trade Name | Bard RiteCath Intermittent Urinary Catheter |
|---|---|
| Regulation number | 876.5130 |
| Regulation class | II |
| Regulation name | Urological catheter and accessories |
| 510(k) Number | K142575 |
| Product Code | EZD |
| Manufacturer | BARD Medical Division C. R. BARD, Inc. |
| Trade Name | Disposable Silicone Foley Catheter |
| Regulation number | 876.5130 |
| Regulation class | II |
| Regulation name | Urological catheter and accessories |
| 510(k) Number | K130908 |
| Product Code | EZL |
| Manufacturer | Guangdong Baihe Medical Technology Co., Ltd. |
I egally Marketed Predicate Devices এ -
| Trade Name | Medline Latex Foley Catheter |
|---|---|
| Regulation number | 876.5130 |
| Regulation class | II |
| Regulation name | Urological catheter and accessories |
| 510(k) Number | K071423 |
| Product Code | EZL |
| Manufacturer | Medline Industries, Inc. |
5. Device Description
Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.
PVC Urinary Catheter
PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Silicone Urinary Catheter
Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage
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eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Latex Urinary Catheter
Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.
The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.
The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
6. Indications for Use Statement
-
The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
- A The Silicone Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
- A The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean intermittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
7. Substantial Equivalence Discussion
7.1 Comparison between PVC Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter
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Version: A/0
| Item | Proposed Device:PVC Urinary Catheter | Predicate Device:Bard RiteCathIntermittent UrinaryCatheter (K142575) | Comments | |
|---|---|---|---|---|
| Product Code | EZD | EZD | Same | |
| Intended Use | The PVC UrinaryCatheter is launched forclean intermittentcatheterization (CIC)treatment. It is intendedfor use in the drainage offluid from the urinarytract. It is indicated foruse in male, female, andpediatric patients 2-12years old. | The Bard RiteCathIntermittent UrinaryCatheter is intended for useby adult and pediatric, maleand female patients fordraining urine from thebladder. Pediatric patientsinclude neonates, infants,children and adolescents. | Same | |
| Device Structure | Color-coded funnel,shaft, eyelets and tip | Color-coded funnel, shaft,staggered eyelets and tip | Same | |
| Cathetermaterial | PVC | PVC | Same | |
| Size | Male: 12Fr-20FrFemale: 12Fr-20Fr | Male: 12Fr-18FrFemale: 12Fr-18Fr | Similar. Compared with thepredicate device, theproposed device has 20Fr.The 20Fr size for UrinaryCatheter is widely used inthe market and had beenapproved in FDA (Such asK142563, K130908 ). Andthe sizes for pediatric iscovered in the scope ofpredicate device. | |
| Pediatric: 8Fr-10Fr | Pediatric: 6Fr-10Fr | |||
| Condition of use | It is used for cleanintermittentcatheterization (CIC)treatment. | It is used for cleanintermittent catheterization(CIC) treatment. | Same | |
| Sterilization | SAL: 10-6Method: EO Sterilized | SAL: 10-6Method: EO Sterilized | Same | |
| Performance | Complied with BS EN1616: 1997(R2007) | Complied with BS EN1616: 1997(R2007) | Same | |
| Shelf Life | 4 years | Unknown | The shelf life of 4 yearshas been verified and thetest report is shown inVOL 14 | |
| Item | Proposed Device:PVC Urinary Catheter | Predicate Device:Bard RiteCathIntermittent UrinaryCatheter (K142575) | Comments | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| Sensitization,irritation | ISO 10993-10:2010 | ISO 10993-10:2010 | Same | |
| Systemictoxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same | |
| Implantation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |
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7.2 Comparison between Silicone Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter
| Item | Proposed Device:Silicone Urinary Catheter | Predicate Device:Disposable Silicone FoleyCatheter (K130908) | Comments | |
|---|---|---|---|---|
| Product Code | EZL | EZL | Same | |
| IntendedUse/Indicationsfor Use | The Silicone Urinary Catheteris intended to be placed in thebladder, through the urethra, todrain urine into a collectiondevice. Two-way catheters areintended for urological bladderdrainage only. Three-waycatheters are intended forurological bladder drainageand bladder irrigation. It isindicated for use in male,female, and pediatric patients2-12 years old. | Two-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage for urological useonly; the indwell time of theproposed device is no morethan 30 days.Three-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage and bladder irrigationfor urological use only; theindwell time of the proposeddevice is no more than 30days. | Same | |
| Item | Proposed Device:Silicone Urinary Catheter | Predicate Device:Disposable Silicone FoleyCatheter (K130908) | Comments | |
| Device Structure | Two-way: double lumen tube, adouble lumen hub, a balloonand a tipThree- way: a triple lumentube, a triple lumen hub, aballoon and a tip | Two-way: double lumen tube, adouble lumen hub, a balloonand a tipThree- way: a triple lumentube, a triple lumen hub, aballoon and a tip | Same | |
| Cathetermaterial | silicone | silicone | Same | |
| Size | Male: 12Fr-24FrFemale: 12Fr-24Fr | Male: 12-26FrFemale:12-26Fr | Similar. Similar.The size ofproposed deviceis included in thescope of thepredicate device. | |
| Pediatric: 8Fr,10Fr | Pediatric: 6Fr,8Fr, 10Fr | |||
| Balloon size | 3 mL, 5 mL, 15 mL, 30 mL | 1.5 mL, 3 mL, 5 mL, 10 mL, 15mL, 20 mL, 30 mL | Similar. Theballoon size ofproposed deviceis included in thescope of thepredicate device. | |
| Condition of use | Indwelling catheterizationtreatment. | Indwelling catheterizationtreatment. | Same | |
| Sterilization | SAL: 10-6Method: EO Sterilized | SAL: 10-6Method: EO Sterilized | Same | |
| Performance | Complied with ASTMF623-99(2013) | Complied with ASTMF623-99(2013) | Same | |
| Shelf Life | 4 years | Unknown | The shelf life of 4years has beenverified and thetest report isshown inVOL_14. | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| Sensitization, | ISO 10993-10:2010 | ISO 10993-10:2010 | Same | |
| Item | Proposed Device:Silicone Urinary Catheter | Predicate Device:Disposable Silicone FoleyCatheter (K130908) | Comments | |
| irritation | ||||
| Systemictoxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same | |
| Implantation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |
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7.3 Comparison between Latex Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter
| Item | Proposed Device:Latex Urinary Catheter | Predicate Device:Medline Latex FoleyCatheter (K071423) | Comments | |
|---|---|---|---|---|
| Product Code | EZL | EZL | Same | |
| Intended Use/Indications forUse | The Latex UrinaryCatheter is intended to beplaced in the bladder,through the urethra, todrain urine into acollection device. Neletoncatheters are launchedfor clean intermittentcatheterization (CIC).Two-way catheters areintended for urologicalbladder drainage only.Three-way catheters areintended for urologicalbladder drainage andbladder irrigation. It isindicated for use in male,female, and pediatricpatients 2-12 years old. | The Medline Latex FoleyCatheter is intended to beused as a urologicalcatheter inserted throughthe Urethral for thepurpose of draining urineand other fluids from theurinary tract. | Similar. SeeIssue 1. | |
| Device Structure | Neleton: funnel, shaft,eyelets and tip | / | Different.See Issue1. | |
| Item | Proposed Device:Latex Urinary Catheter | Predicate Device:Medline Latex FoleyCatheter (K071423) | Comments | |
| Two-way: double lumentube, a double lumen hub,a balloon and a tipThree- way: a triple lumentube, a triple lumen hub, aballoon and a tip | Two-way: double lumentube, a double lumen hub,a balloon and a tipThree-way: a triple lumentube, a triple lumen hub, aballoon and a tip | Same | ||
| Catheter material | Natural rubber latex,Silicone coating | Natural rubber latex,Silicone coating | Same | |
| Size | Male: 12Fr-24FrFemale: 12Fr-24Fr | Male: 12-30FrFemale:12-30Fr | Similar. Thesize ofproposeddevice isincluded inthe scope ofthepredicatedevice. | |
| Pediatric: 8Fr,10Fr | Pediatric: 6Fr,8Fr, 10Fr | |||
| Balloon size | 3 mL, 5 mL, 15 mL, 30mL | 3 mL, 5 mL, 30 mL | Similar.Both of theproposeddevice andpredicatedevice havethe samescope ofballoonsize. Andtheproposeddevice hasmoreoptionalsizes. | |
| Condition of use | Neleton: CIC treatmentTwo-way and three-way:Indwelling catheterizationtreatment. | /Indwelling catheterizationtreatment | Different.See Issue 1Same | |
| Sterilization | SAL: 10-6 | SAL: 10-6 | Same | |
| Item | Proposed Device:Latex Urinary Catheter | Predicate Device:Medline Latex FoleyCatheter (K071423) | Comments | |
| Method: EO Sterilized | Method: GammaIrradiation | Different.See Issue2. | ||
| Performance | Complied with BS EN1616: 1997(R2007) andASTM F623-99(2013) | Complied with ASTMF623-99(2013) | Same | |
| Shelf Life | 4 years | Unknown | The shelflife of 4years hasbeenverified andthe testreport isshown inVOL_14. | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| Sensitization,irritation | ISO 10993-10:2010 | ISO 10993-10:2010 | Same | |
| Systemictoxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same | |
| Implantation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |
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Issue 1: The proposed device has the Neleton type structure compared with the predicate device. As the neleton type has less dwell time compared with the Foley Catheter (two-way and three-way Urinary Catheter), it has less likely to cause a urinary-tract infection in these situations. Moreover, the biocompatibility test reports and the bench test reports for neleton type of the proposed device demonstrate that proposed device is biocompatible and the performance as intended.
Issue 2: Although the sterilization methods between the proposed device and the predicate device are different, but the EO sterilization effect of the proposed device is proved by the Sterilization report in VOL_014. The validation report showed that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10-6.
8. Non-clinical Testing
All nonclinical testing performed on new devices is to demonstrate the substantial
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equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices.
The following performance data were provided in support of the substantial equivalence determination.
| Test | Requirements | Results |
|---|---|---|
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007). | Passed |
| Biocompatibility | CytotoxicityISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity | Passed |
| SensitizationISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization | Passed | |
| IrritationISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization | Passed | |
| Systemic toxicityBiological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity | Passed | |
| Sterility | SAL≤ 10-6 | Passed |
8.1 PVC Urinary Catheter
8.2 Silicone Urinary Catheter
| Test | Requirements | Results |
|---|---|---|
| Flow rate through drainagelumen | Meet the requirement of 4.1 of ASTMF623-99(2013) | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTMF623-99(2013) | Passed |
| Inflated Balloon Response toTraction | Meet the requirement of 4.3 of ASTMF623-99(2013) | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTMF623-99(2013) | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTMF623-99(2013) | Passed |
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| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTMF623-99(2013) | Passed | |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | ISO 10093-5 Biological evaluation of medicaldevices -Part 5: Tests for in vitro cytotoxicity | Passed |
| Sensitization | ISO 10993-10 Biological evaluation of medicaldevices -Part 10:Tests for irritation and skinsensitization | Passed | |
| Irritation | ISO 10993-10 Biological evaluation of medicaldevices -Part 10:Tests for irritation and skinsensitization | Passed | |
| Systemictoxicity | Biological Evaluation Of Medical Devices - Part 11:Tests For Systemic Toxicity | Passed | |
| Implantation | Biological Evaluation Of Medical Devices - Part 6:Tests For Local Effects After Implantation | Passed | |
| Sterility | SAL shall be less than $10^{-6}$ . | Passed |
8.3 Latex Urinary Catheter
| Test | Requirements | Results |
|---|---|---|
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007) and 4.1 of ASTM F623-99(2013). | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTMF623-99(2013) | Passed |
| Inflated Balloon Response toTraction | Meet the requirement of 4.3 of ASTMF623-99(2013) | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTMF623-99(2013) | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTMF623-99(2013) | Passed |
| Deflation Reliability (Failure toDeflate) | Meet the requirement of 4.6 of ASTMF623-99(2013) | Passed |
| Biocompatibility CytotoxicitySensitization | ISO 10093-5 Biological evaluation of medicaldevices -Part 5: Tests for in vitro cytotoxicityISO 10993-10 Biological evaluation of medicaldevices -Part 10:Tests for irritation and skin | Passed |
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| sensitization | |||
|---|---|---|---|
| Irritation | ISO 10993-10 Biological evaluation of medicaldevices –Part 10:Tests for irritation and skinsensitization | Passed | |
| Systemictoxicity | Biological Evaluation Of Medical Devices - Part 11:Tests For Systemic Toxicity | Passed | |
| Implantation | Biological Evaluation Of Medical Devices - Part 6:Tests For Local Effects After Implantation | Passed | |
| Sterility | SAL $ \leq $ 10-6. | Passed |
9. Clinical Testing
Substantial equivalence does not depend on clinical test data.
10. Conclusions
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed 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.