(51 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard intermittent catheter, with no mention of AI or ML capabilities.
Yes
The device is intended to assist bladder drainage for patients whose ability to void naturally is impaired, treating a physiological dysfunction.
No
This device is described as a catheter used for draining urine, indicating a therapeutic or assistive function, not a diagnostic one.
No
The device description clearly states it is a physical PVC plastic device intended for insertion into the body, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Classic™ intermittent catheter is a device inserted into the body (urethra and bladder) to drain urine. It is a therapeutic device used for bladder management, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "regular assisted bladder drainage," which is a direct intervention on the patient's body.
Therefore, the Classic™ intermittent catheter falls under the category of a medical device used for treatment or management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
EZD
Device Description
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
Adult Female. Available in straight tip Paediatric. Available in straight tip
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra and into bladder
Indicated Patient Age Range
Adult Male, Adult Female, Paediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"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:
- Visual inspection: In-House/ EN 1616:1997 - 4.2.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 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 F1929; All samples pass
- EO & ECH residuals: ISO 10993-7:2008; All samples pass
- Cytotoxicity, Irritation, sensitization: BS EN ISO 10993-10:2010, BS EN ISO 10993-5:2009; All samples pass
- Colour comparison: BS EN ISO 8836:2009; All samples pass
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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. | |
| 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 | ||
| 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 | |
| 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
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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
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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)