Silicone Foley Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 6, 2019 Biosensors International Pte. Ltd. Jane Chen Jiayan Junior Associate, Regulatory Affairs 36 Jalan Tukang 619266 Singapore Singapore Re: K182463 > Trade/Device Name: Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 18, 2019 Received: September 25, 2019 Dear Jane Chen Jiayan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Glenn B. Bell, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182463 Device Name Silicone Foley Catheter Indications for Use (Describe) This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Biosensors International. The logo consists of a blue symbol that resembles a stylized letter "B" made up of three curved lines stacked on top of each other. Below the symbol, the words "BIOSENSORS" are written in a bold, sans-serif font, and underneath that, the word "INTERNATIONAL" is written in a smaller, sans-serif font with a trademark symbol next to it. # Section 5: 510(k) Summary [As required by section 807.92(c)] # Silicone Foley Catheter (K182463) ### 1. Applicant Information | Company Name: | Biosensors International Pte Ltd | |-----------------------|------------------------------------------------------------------------------------------------------------------------------| | Company Address: | 36 Jalan Tukang, Singapore 619266 | | Establishment Number: | 2084493 | | Contact Person: | Jane Chen Jiayan<br>Manager, QA/RA<br>Phone: +65 6213 5777 (Ext: 735)<br>Fax: +65 6213 5737<br>Email: ja.chen@biosensors.com | | Date Prepared: | 06 Nov 2019 | #### 2. Device Name and Classification | Trade Name: | Silicone Foley Catheter | |--------------------|-------------------------------------| | Regulation Number: | 21 CFR 876.5130 | | Regulation Name: | Urological Catheter and Accessories | | Regulatory Class: | II | | Common Name: | Catheter, Retention Type, Balloon | | Product Code: | EZL | ### 3. Predicate Device Disposable Silicone Foley Catheter (K130908) ### 4. Device Description The Silicone Foley Catheter uses the pressure of the bladder to excrete urine. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid. Foley catheter (2-way) can be used for bladder drainage, and Foley catheter (3-way) also can be used for bladder irrigation. Female type Foley Catheter is equipped with the advancer which can be used instead of tweezers during the catheterization. The Silicone Foley Catheter is for single use, is intended for short-term (less than 14 days) use, and is provided with sterile. Intended population: Pediatric, Male and Female Biosensors International Pte Ltd 36 Jalan Tukang, Singapore 619 Phone: +65 6213 577 Fax: +65 6213 5737 o. Req No. 198904428 www.biosensors-ccp.c {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for Biosensors International. The logo features a stylized blue symbol resembling three interconnected "B" shapes stacked vertically. Below the symbol, the word "BIOSENSORS" is written in a bold, sans-serif font. Underneath "BIOSENSORS", the word "INTERNATIONAL" is written in a smaller, sans-serif font, accompanied by the trademark symbol. #### 5. Indications for Use This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation. ## 6. Summary of Technological Characteristics of Device in relation to Predicate Device The technology of Biosensors Silicone Foley Catheter (K182463) is substantially equivalent to the Disposable Silicone Foley Catheter manufactured by Guangdong Baihe Medical Technology Co.,Ltd (K130908), with similar indications for use and design construction. The safety and effectiveness of Biosensors Silicone Foley Catheter have been assessed and discussed further in section 7 below. | | Subject Device – K182463 | Predicate Device - K130908 | |---------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Common Name | Catheter, Retention Type, Balloon | Same | | Product Code | EZL | Same | | Regulation Number | 876.5130 | Same | | Class | II | Same | | Population | Pediatric, male and female | Same | | Indications for Use | This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation. | Similar | | French Size | 6 - 30 Fr | Similar | | Length | $410 \pm 10mm$ | 310mm and 400mm | | Lumen | Two-way and Three-way | Same | | Balloon | Yes | Same | | Balloon Size | 5ml, 5-15ml, 20-30ml, 30ml | 1.5ml, 3ml, 5ml, 10ml, 15ml, 20ml, 30ml | | Single Use | Yes | Same | | Sterile | Yes | Same | | Main Shaft Material | Silicone | Same | | Validity Period | 2 Years | Same | | Indwelling Time | No more than 14 days | No more than 30 days | | Use with Accessory | Yes | No | #### Comparison between Subject Device and Predicate Device: Biosensors International Pte Ltd 36 Jalan Tukang, Singapore 619266 Phone: +65 6213 5777 Fax: +65 6213 5737 Co. Reg No. 198904428G www.biosensors-ccp.con {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for Biosensors International. The logo features a stylized blue symbol resembling three interconnected arches stacked vertically. Below the symbol, the word "BIOSENSORS" is written in bold, uppercase letters. Underneath "BIOSENSORS", the word "INTERNATIONAL" is written in a smaller font size, followed by the trademark symbol. ## 7. Description of Non-Clinical Testing Testina includes: - . Bench testing of the functional performance - l Biocompatibility testing - I Sterilization validation - Shelf life validation - . Simulation Shipment validation. Standards applied to Non-clinical Testing includes: - l Functional performance testing: ASTM F623-99(2013), ISO 2859-1:1999, ISO 8536-4:2010, USP - . Biocompatibility testing: ISO 10993-3: 2014 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-5:2009 Part 5: Tests for in vitro cytotoxicity ISO 10993-5:2009 Part 5: Tests for in vitro cytotoxicity ISO 10993-9:2019 Part 9: Tests for potential degradation - ISO 10993-6: 2016 Part 6: Tests for local effects after implantation - ISO 10993-10: 2010 Part 10: Tests for irritation and skin sensitization - ISO 10993-11: 2017 Part 11: Tests for systemic toxicity - . Sterilization validation: ISO 11135: 2014, ISO11138-1:2017, ISO 11138-2:2017, ISO 10993-7: 2008/AC:2009, ISO 11737-1:2018, ISO 11737-2: 2009 - Shelf life and simulation shipment validation: ASTM F623-99(2013), ASTMF88/F88M-15, ASTMF1929-15, ASTM F1886/F1886M-16, ISO 11135-2014, EN ISO11607-1:2017, EN ISO11607-2:2017 Results demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use. ### 8. Description of Clinical data Clinical Data includes: - Clinical Evaluation Report, CER-FC-001(A2) ■ - . Silicone Foley Catheter Post Market Clinical Follow-Up Study, PMCF-2018-01(A1) - . Validation protocol and report for simulation model test of Silicone Foley Catheter -Advancer, VPFC-2018-009(01) and TRFC-2018-009 (01) - Clinical Data - Evaluation Form of Silicone Foley Catheter Results of Clinical evaluation, simulation model test with advancer and Clinical Data demonstrate the safety and the effectiveness of Silicone Foley Catheter and using with the accessory - Advancer. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Biosensors International. The logo consists of a stylized blue symbol resembling three stacked, rounded rectangles, positioned above the company name. The text "BIOSENSORS" is written in a bold, sans-serif font, and below it, "INTERNATIONAL" is written in a smaller, sans-serif font with a trademark symbol. #### 9. Conclusion The Silicone Foley Catheter has the similar intended use, technological characteristics and performance characteristics as its predicate device. Performance test results demonstrate that the subject device meets its intended use. It is for these reasons that the subject device can be found substantially equivalent with its predicate device. Biosensors International Pte Ltd 36 Jalan Tukang, Singapore 619266 Phone: +65 6213 5777 Fax: +65 6213 5777 Co. Reg No. 1989044280G www.biosensors-cop.com