(185 days)
Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days.
Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
The Disposable Silicone Foley Catheter is available in two types, two-way disposable silicone Foley catheter and three-way disposable silicone Foley catheter.
The two-way disposable silicone Foley catheter is composed of a double lumen tube, a double lumen hub, one balloon and a tip.
The three-way disposable silicone Foley catheter is composed of a triple lumen tube, a triple lumen hub, one balloon and a tip.
The proposed device is supplied in French size ranging from 6 to 26. It is available in 310mm and 400mm length with various balloon sizes. The devices are applied for male and female; the 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
The Disposable Silicone Foley Catheter is provided EO sterilized as a single used device.
The provided text describes a 510(k) summary for a Disposable Silicone Foley Catheter, which primarily relies on substantial equivalence to a predicate device and bench testing against recognized standards. It is not a study focused on AI or human-in-the-loop performance, so many of the requested categories are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ASTM F88-09 (Seal Strength) | Device met design specifications and standard requirements |
| ASTM F1140-07 (Internal Pressurization Failure) | Device met design specifications and standard requirements |
| ASTM F1929-98(2004) (Detecting Seal Leaks) | Device met design specifications and standard requirements |
| ISO 11135-1:2007 (Ethylene Oxide Sterilization) | Device complies with standards (EO sterilized) |
| USP <85> (Bacterial Endotoxin Limit) | Device complies with standards |
| ASTM F623-99 (2006) Performance Requirements | Device meets performance requirements |
| * Flow Rate | Met |
| * Balloon Integrity | Met |
| * Balloon Response to Pullout | Met |
| * Balloon Volume Maintenance | Met |
| * Manufacturing Tolerances | Met |
| * Balloon Deflation Reliability | Met |
| ISO 10993-5:2009 (Cytotoxicity) | Device complies with standards |
| ISO 10993-10:2010 (Irritation/Sensitization) | Device complies with standards |
| ISO 10993-11:2006 (Systemic Toxicity) | Device complies with standards |
| ISO 10993-6:2007 (Local Effects After Implantation) | Device complies with standards |
Study Details:
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Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of clinical data for performance evaluation. The "tests" mentioned are non-clinical bench tests (e.g., mechanical, biocompatibility, sterilization) that compare the device's physical properties and performance against established international and ASTM standards. No patient data is involved. The data provenance is laboratory testing conducted by the manufacturer, Guangdong Baihe Medical Technology Co., Ltd., in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the non-clinical tests is defined by the requirements of the recognized standards themselves (e.g., a specific flow rate value, a certain seal strength). No human experts were used to establish a "ground truth" for these engineering and biological performance metrics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessments. These were objective bench tests.
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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 submission is for a medical device (Foley Catheter), not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests is represented by the specific performance thresholds and methodologies detailed within the referenced international and ASTM standards (e.g., ISO 11135-1, ASTM F623-99).
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The sample size for the training set: Not applicable. This is not an AI/machine learning study.
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How the ground truth for the training set was established: Not applicable.
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E4 510(k) Summary
Exhibit #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
-
- Date of Submission: March 14, 2013
OCT 03 2013
- Date of Submission: March 14, 2013
ni Sponsor
Guangdong Baihe Medical Technology Co., Ltd. No. 89, Taoyuan East Road, Nanhai, Foshan, Guangdong, 528225, China
Establishment Registration Number: 3006621386
Contact Person: Baoyou Ge Position: Management Representative Tel: +86-757-81207300 Fax: +86-757-81207311 Email: gby8492@163.com
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
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Proposed Device Identification 4.
Common Name: Disposable Balloon-retention Catheter Proposed Device Name: Disposable Silicone Foley Catheter Proposed Device Type: Two-way and Three way
Regulatory Information: Classification Name: Catheter, Retention type, Balloon Classification: II Product Code: EZL Regulation Number: 21 CFR 876.5130 Review Panel: Gastroenterology/Urology Intended Use Statement:
Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indivell time of the proposed device is no more than 30 days. Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
ડ. Predicate Device Identification
510(k) Number: K981612 Product Name: Rochester Medical Corporation All Silicone Foley Catheter Manufacturer: Rochester Medical Corporation
Device Description 6.
·
The Disposable Silicone Foley Catheter is available in two types, two-way disposable silicone Foley catheter and three-way disposable silicone Foley catheter.
The two-way disposable silicone Foley catheter is composed of a double lumen tube, a double lumen hub, one balloon and a tip.
The three-way disposable silicone Foley catheter is composed of a triple lumen tube, a triple lumen hub, one balloon and a tip.
The proposed device is supplied in French size ranging from 6 to 26. It is available in 310mm and 400mm length with various balloon sizes. The devices are applied for male and female; the 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
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The Disposable Silicone Foley Catheter is provided EO sterilized as a single used device.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices:
USP <85> Bacterial Endotoxin Limit
ASTM F 623-99 (2006) Standard Performance Specification for Foley Catheter
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-6:2007, Biological evaluation of medical devices- Part 6: Tests for local effects after implantation
The Disposable Silicone Foley Catheter meets the following performance requirements per testing conducted according to ASTM F623-99 (2006):
Flow Rate
Balloon Integrity
Balloon Response to Pullout
Balloon Volume Maintenance
Manufacturing Tolerances for Catheter Tip, Balloon and Shaft Diameters
Balloon Deflation Reliability
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Substantially Equivalent Conclusion 8 .
| ITEM | Proposed Device | Predicate DeviceK981612 |
|---|---|---|
| Product Code | EZL | EZL |
| Regulation No. | 21 CRF 876.5130 | 21 CRF 876.5130 |
| Class | II | II |
| Intended Use | Same | Same |
| Targetpopulation | Pediatric, male and female | Same |
| Lumen | Two-way and three-way | Same |
| French size | Two-way: 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr and 26FrThree-way: 16Fr, 18Fr, 20Fr, 22Fr, 24Fr and 26Fr | Same |
| Balloon size | 1.5cc, 3cc, 5cc, 10cc, 15cc, 20cc, 30cc | Similar |
| Length | 310mm and 400mm | Similar |
| Sterile | Yes | Yes |
| Single use | Yes | Yes |
| Tab. 3-1 Comparison between proposed device and predicated device | ||||
|---|---|---|---|---|
The proposed device, Disposable Silicone Foley Catheter, is determined to be Substantially Equivalent (SE) to the predicate device, Rochester Medical Corporation All Silicone Foley Catheter (K981612), in respect of safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized emblem, possibly representing a symbol of health or human services. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
Guangdong Baihe Medical Technology Co., Ltd. % Diana Hong General Manager MID-LINK Consulting Co., Ltd. P.O. Box 120-119 Shanghai China 200120
Re: K130908
Trade/Device Name: Disposable Silicone Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 29, 2013 Received: September 4, 2013
Dear Diana Hong.
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. Iisting 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 fourd 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.
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Page 2 - Diana Hong
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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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
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Exhibit #3 Indications for Use
510(k) Number: K130908 Device Name: Disposable Silicone Foley Catheter
Indications for Use:
Two-way Disposable Silicone Foley Catheter. Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no nore than 30 days.
Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Herbert P. Lerner -S 2013.10.03 16:31:36 -04'00'
§ 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.