CLASSIC INTERMITTENT CATHETER

{0}------------------------------------------------ K132619 Page I of 4 Image /page/0/Picture/1 description: The image shows the logo for Flexicare. Below the name is the phrase "TOTAL QUALITY - TOTAL CARE". The address "Cynon Valley Business Park, Mountain Ash" is printed below the phrase. Mid Glamorgan, CF45 4ER UK. Tel: +44 (0) 1443 474647 Fax: +44 (0)1443 474222 Customer Services: +44 (0;1443 471580 Purchasing Fax: +44 (0)1443 476332 Email. enquiries@flexicare.com www.llexicare.com OCT 1 1 2013 ## 510(k) Summary Trade name C.F.R Section Product Code: Manufacturer: Regulatory Affairs Contact: Telephone: Date Summary Prepared: Common Name: Classification: Predicative Devices Description: Classic ™ Intermittent Catheter. 21 CFR 876.5130. Urological catheter and accessories EZD Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. Mid. Glam. CF45 4ER. United Kingdom Christopher Watkins Quality Regulatory & Technical Director Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom 00 44 1443 471 593 September 2013 Intermittent catheter Class 2 - BARD "Interglide" which was cleared for marketing by 510(k) � No K951260. - Coloplast "Self Cath" which was cleared for marketing by . 510k No K100878 Classic ™ Intermittent Catheter is a PVC plastic device that is intended to be inserted through urethra and into bladder of patient to allow drainage of urine. The Classic Intermittent catheter in pouch consists of a tube which is bonded onto a drainage funnel. Classic™ Intermittent Catheter has a round polished finish tip to provide maximum comfort for user. Each catheter features two large evelets in order to drain urine efficiently. Drainage eyelets cut-outs are smooth and rounded to minimize the risk of injury/discomfort when in use. Classic ™ Intermittent Catheters are available in: Adult Male. Available in coude tip or straight tip {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for Flexicare. The logo is black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" are the words "TOTAL QUALITY . TOTAL CARE" in a smaller font. Adult Female. Available in straight tip Paediatric. Available in straight tip | Coudé tip | Straight tip | |-----------|--------------| |-----------|--------------| Sizes are as follows: | French size | ID (mm) | OD (mm) | Total length | |-------------|---------|---------|-------------------| | 6 | 1.1 | 2.0 | | | 8 | 1.7 | 2.7 | Male: 400mm | | 10 | 2.3 | 3.3 | | | 12 | 2.8 | 4.0 | Female: 160mm | | 14 | 3.0 | 4.7 | | | 16 | 3.6 | 5.3 | Paediatric: 240mm | | 18 | 4.2 | 6.0 | | | 20 | 4.7 | 6.7 | | Intended Use: Classic ™ intermittent catheters are intended for use in male, female and paediatric patients when regular assisted bladder drainage has been instructed by a physician. Classic ™ intermittent catheters are indicated for use by individuals whose ability to void the bladder fully by natural bodily functions is impaired. Substantial Equivalence The Classic Intermittent Catheter has the same intended use as predicate devices: - BARD "Interglide", which was cleared for marketing by . 510k No K951260. - Coloplast "Self Cath" which was cleared for marketing by . 510k No K100878. All three intermittent cathelers are single patient use devices. All three devices are not life supporting or life sustaining. Only the Catheter Tube has invasive patient contact. Patient Contact - Invasive - Limited Exposure (A) Classification: Mucosal Membranes (B) | Limited (A). All three intermittent catheters do not use software/ not electronically driven. All three intermittent catheters are supplied sterile in individual peel pouches. All three intermittent catheters are able to be used with accessories such as drainage bags, which are industry standard devices used with catheters. All three intermittent catheters are designed for the same intended use in the same intended conditions. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Flexicare. The logo has a stylized letter F on the left side, followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font. All three intermittent catheters consist of 2-3 components made from injection molded, sheet & extruded plastics. From companson testing it was determined that all invasive components of the three devices are manufactured from PVC. The connector of the Classic 74 Intermittent Catheler and the Colopiast Self Cath are also manufactured from PVC, and have the same colour connector for each size. The BARD Interglide catheter's connector is manufactured from TPE, however, TPE has similar characteristics to PVC (easily moulded, coloured, flexible, provides secure push fit connections, bonds easily with adhesives) The Bard Interglide size 14 connector was green like the FML and Colopfast samples, however, other sizes were not available to compare colours. All samples ODAD's were very similar, within a range of ±0.2mm for each size. Full ID/OD details are recorded in TR079/12 Test report. (Section 12). | Sample | Total length | |----------------------|--------------| | FML male | 400mm | | FML female | 160mm | | FML paediatric | 240mm | | Coloplast male | 420mm | | Coloplast female | Un-available | | Coloplast paediatric | 240mm | | BARD male | 355mm | | BARD female | Un-available | | BARD paediatric | Un-available | Summary of Testing: "Classic" intermittent catheter has been evaluated in accordance with: BS EN 1616 - 1997 - Sterile Urethral Catheters for single use BS EN 1618 - 1997 - Catheters other than intravascular catheters Tests Performed: | Test | Standard? / In-House? | Outcome? | |---------------------------------------------------------------------------------|---------------------------------------------|------------------| | Visual inspection | In-House/ EN 1616:1997 - 4.2.<br>ASTM F1886 | All samples pass | | Dimensional inspection | In-House/ EN 1616:1997 - 4.3 | All samples pass | | Flow rate | ASTM F623-99 | All samples pass | | Tensile testing - catheter to connector | In-House | All samples pass | | Tube hardness | In-House | All samples pass | | Force to connect/ disconnect catheter<br>connector to leg bag stepped connector | In-House | All samples pass | | Strength of catheter | EN 1616:1997 - Annex A | All samples pass | | Leak testing - catheter tube to connector | EN 1618:1997 - Annex C | All samples pass | | Accelerated age testing - then all above | ASTM F1980, ASTM F88, ASTM<br>F1929 | All samples pass | | EO & ECH residuals | ISO 10993-7:2008 | All samples pass | | Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010 | All samples pass | | | BS EN ISO 10993-5:2009 | All samples pass | | Colour comparison | BS EN ISO 8836:2009 | All samples pass | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Flexicare. The logo is black and white and features a stylized letter "f" with two horizontal lines above it. To the right of the "f" is the word "lexicare" in a sans-serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font. All Samples passed the performance testing when tested against methods and criteria from both In-House test methods and relevant BS EN standards. The results of this testing which are included in TR079/12 show that the Classic™ Intermittent Catheters pass all performance tests and perform at least as well as both marketed predicate devices. TR079/12 can be found in section 12 of this document. Although very similar in design and function, there are some differences between the Flexicare Intermittent catheter and its predicate devices listed within this submission. The Flexicare Classic™ Intermittent Catheter is un-coated whilst the predicate BARD "Interglide" Intermittent Catheter has a Hydrophilic coating which aids insertion when submerged in water. However, users of un-coated intermittent catheters can use a lubricant (not supplied) if required which will aid insertion without needing a sterile water source. The Flexicare Classic™ Intermittent Catheter also differs from the BARD "Interglide" and the Coloplast "Sell-Cath" predicates as is includes a sliding tube grip, which is not present on the predicate devices. This prevents the user having to touch the invasive tube of the catheter during insertion, reducing the risk of urinary tract infection. The Flexicare Classic™ Intermittent Cathers from the predicate devices in available lengths, being available in a French size 20. The Flexicare Classic™ Intermittent Catheter & Coloplast "Self-Cath" drainage funnels are Manufactured from PVC. This differs from the drainage funnel of the BARD "Interglide" sample which ls manufactured from TPE. This difference is not critical as both materials are flexible, able to be Colored and have an elastic nature, allowing a push fit connection to a drainage bag connector. Signature of contact Person: Chris Watkins ewaxreno 20-09-2013 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002 October 11, 2013 FLEXICARE MEDICAL LTD. % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313 Re: K132619 > Trade/Device Name: Classic™ Intermittent Catheter Regulation Number: 21 CFR\$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: September 27, 2013 Received: September 30. 2013 Dear Mark Job. 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 enacunent 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 is 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 {5}------------------------------------------------ Page 2 - Mark Job 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 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, Benjamin R. Fisher -S Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "Flexicare". The logo is black and white and features a stylized "F" with two curved lines above it. The word "Flexicare" is written in a bold, sans-serif font to the right of the "F". Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font. ## Indications for Use 510(k) Number (if known): K 132619 Page 1 of 1 Device Name: Classic ™ Intermittent Catheter. Indications for Use: Classic™ intermittent catheters are intended for use in Mate, Female and Paediatic patients when regular assisted bladder drainage has been instructed by a physician. Classic™ intermittent catheters are indicated for use by individuals whose ablity to void the bladder fully by natural bodily functions is impaired. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ## Benjamin R. Fisher -S 2013.10.11 13:12:10 -04'00'