(57 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a Foley catheter used for draining urine, which is a supportive function rather than a therapeutic treatment for a disease or condition.
No
The provided text states that the Medline Latex Foley Catheter is intended for "draining urine and other fluids from the urinary tract," which is a therapeutic function, not a diagnostic one. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description clearly indicates it is a physical, flexible tubular device made from latex, designed for draining urine. It is a hardware medical device.
Based on the provided information, the Medline Latex Foley Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to drain urine and other fluids from the urinary tract by inserting the catheter through the urethra. This is a direct intervention on the body for therapeutic and diagnostic purposes (draining urine for analysis, but the device itself isn't performing the analysis).
- Device Description: The description details a physical device for insertion and drainage. It doesn't mention any components or processes related to analyzing samples outside of the body.
- Lack of IVD Indicators: The document does not contain any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Reagents, calibrators, or controls.
- Measurement of specific analytes or markers.
- Use in a laboratory setting for diagnostic testing.
The Medline Latex Foley Catheter is a medical device used for drainage, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.
Product codes
EZL
Device Description
A Foley catheter is needed when normal urination is disrupted or it is necessary to keep track of urine production. The catheter is threaded through the urinary duct (urethra) and into the bladder. It is secured by means of a balloon at the tip which is inflated with sterile water after insertion. The Medline Latex Foley Catheter offers 3 different balloon sizes (3cc, 5cc, 30cc) and a wide range of catheter sizes to accommodate pediatric and adult applications (refer to table below). The relative size of the Foley catheter is described using French units (Fr). 1 Fr is equivalent to 0.33 mm or .013".
The Medline Latex Foley Catheter is a flexible tubular device manufactured from natural high grade latex. For a listing of all the raw materials used, refer to attachment 2. It is sterile as packaged and intended for single patient use. The Medline Latex Foley Catheter consists of two types (2-way & 3-way) of devices. These catheters constitute a double or triple lumen drainage tube with two opposing eyelets on the proximal tip. On the other end of the catheter shaft, the urine drains out into an appropriate collection device. The 3-way catheter has an additional set of eyelets for irrigation purposes.
A silicon elastomer coating is applied to the catheter through a dipping process.
The catheters are supplied in individually packaged, sealed single use poaches. Packaging Materials: Paper/Poly/Mylar film Sealing Method: Heat sealed
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Pediatric, Female / Male
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)
The Medline Latex Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the currently marketed predicate device (K903777). The predicate device was tested in accordance with relevant standards for performance and function.
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
EXECUTIVE SUMMARY - Medline Latex Foley Catheter
Device Description
JUL 1 8 2007
A Foley catheter is needed when normal urination is disrupted or it is necessary to keep track of urine production. The catheter is threaded through the urinary duct (urethra) and into the bladder. It is secured by means of a balloon at the tip which is inflated with sterile water after insertion. The Medline Latex Foley Catheter offers 3 different balloon sizes (3cc, 5cc, 30cc) and a wide range of catheter sizes to accommodate pediatric and adult applications (refer to table below). The relative size of the Foley catheter is described using French units (Fr). 1 Fr is equivalent to 0.33 mm or .013".
| Catheter type | Balloon capacity | Size (Fr) | Item Number |
|---|---|---|---|
| 2-way standard | 3cc | 6 | DYND11706 |
| 2-way standard | 3cc | 8 | DYND11708 |
| 2-way standard | 3cc | 10 | DYND11710 |
| 2-way standard | 5cc | 12 | DYND11752 |
| 2-way standard | 5cc | 14 | DYND11754 |
| 2-way standard | 5cc | 16 | DYND11756 |
| 2-way standard | 5cc | 18 | DYND11758 |
| 2-way standard | 5cc | 20 | DYND11760 |
| 2-way standard | 5cc | 22 | DYND11762 |
| 2-way standard | 5cc | 24 | DYND11764 |
| 2-way standard | 5cc | 26 | DYND11766 |
| 2-way standard | 5cc | 28 | DYND11768 |
| 2-way standard | 5cc | 30 | DYND11770 |
| 2-way coude tip | 5cc | 14 | DYND11214 |
| 2-way coude tip | 5cc | 16 | DYND11216 |
| 2-way coude tip | 5cc | 18 | DYND11218 |
| 2-way coude tip | 5cc | 20 | DYND11220 |
| 2-way coude tip | 5cc | 22 | DYND11222 |
| 2-way coude tip | 5cc | 24 | DYND11224 |
| 2-way standard | 30cc | 12 | DYND11772 |
| 2-way standard | 30cc | 14 | DYND11774 |
| 2-way standard | 30cc | 16 | DYND11776 |
| 2-way standard | 30cc | 18 | DYND11778 |
| 2-way standard | 30cc | 20 | DYND11780 |
| 2-way standard | 30cc | 22 | DYND11782 |
| 2-way standard | 30cc | 24 | DYND11784 |
| 2-way standard | 30cc | 26 | DYND11786 |
| 2-way standard | 30cc | 28 | DYND11788 |
| 2-way standard | 30cc | 30 | DYND11790 |
| 3-way standard | 30cc | 16 | DYND11800 |
| 3-way standard | 30cc | 18 | DYND11801 |
| 3-way standard | 30cc | 20 | DYND11802 |
| 3-way standard | 30cc | 22 | DYND11803 |
| 3-way standard | 30cc | 24 | DYND11804 |
| 3-way standard | 30cc | 26 | DYND11805 |
1
The Medline Latex Foley Catheter is a flexible tubular device manufactured from natural high grade latex. For a listing of all the raw materials used, refer to attachment 2. It is sterile as packaged and intended for single patient use. The Medline Latex Foley Catheter consists of two types (2-way & 3-way) of devices. These catheters constitute a double or triple lumen drainage tube with two opposing eyelets on the proximal tip. On the other end of the catheter shaft, the urine drains out into an appropriate collection device. The 3-way catheter has an additional set of eyelets for irrigation purposes.
A silicon elastomer coating is applied to the catheter through a dipping process.
The catheters are supplied in individually packaged, sealed single use poaches. Packaging Materials: Paper/Poly/Mylar film Sealing Method: Heat sealed
Substantial Equivalence
| Feature | Proposed Device | Predicate Device |
|---|---|---|
| Name | Medline Latex Foley Catheter | Foleycath NR Latex Balloon |
| Catheter (K903777) | ||
| Intended Use | The Medline Latex Foley | |
| Catheter is intended to be used as | ||
| a urological catheter inserted | ||
| through the urethra for the | ||
| purpose of draining urine and | ||
| other fluids from the urinary tract. | The Foleycath is intended to be | |
| used for the drainage of urine and | ||
| other fluids from the urinary | ||
| bladder. | ||
| Patient Populations | Male, Female & Pediatric | Male, Female & Pediatric |
| Types | • 2-way | |
| • 3-way | • 2-way | |
| • 3-way | ||
| Size Range (Fr) | • Pediatric (6-10) | |
| • Female / Male (12-30) | • Pediatric (6-10) | |
| • Female / Male (12-30) | ||
| Balloon Capacity | 3cc, 5cc, 30cc | 3cc, 5cc, 30cc |
| Material | Natural rubber latex | Natural rubber latex |
| Coating | Silicone | Silicone |
| Labeling | See attachment I | See attachment I |
Discussion of similarities and differences:
The proposed Medline Latex Foley Catheter is identical in intended uses, function and mode of operation to the predicate device which received marketing approval under K903777.
There are no significant differences between the two products. As reflected in the table above, they include identical product lines which support the same patient populations. They are fabricated from the same materials and designed in a same fashion.
2
Biocompatibility / Sterilization
Per the Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s, August 12,2005, section 15 – "If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods."
As noted, this device is identical to that of WRP Foleycath (K903777). The manufacturing and sterilization methods remain unchanged. The history of the biocompatibility of these products is therefore well established.
The product is sterilized by a Gamma Irradiation method. Refer to attachment 2 for details of this process.
Summary of Performance Testing
The Medline Latex Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the currently marketed predicate device (K903777). The predicate device was tested in accordance with relevant standards for performance and function.
Product Labeling
The labeling, dimensional drawings & promotional materials for this device can be found in Attachment 1.
Conclusions
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Latex Foley Catheter is safe, effective and substantially equivalent as described herein.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 8 2007
Mr. Matt Clausen Regulatory Affairs Medline Industries. Inc. One Medline Place MUNDELEIN IL 60060-4486
Re: K071423
Trade/Device Name: Medline Latex Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 18, 2007 Received: May 25, 2007
Dear Mr. Clausen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a circular seal with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the seal. Below the letters, the word "Centennial" is written in a curved font. Three stars are arranged below the word "Centennial", and the entire seal is surrounded by a ring of small stars.
Protecting and Promoting Public Health
4
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 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours, .
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K07/422
Device Name: Medline Latex Foley Catheter
Indications for Use:
The Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.
Precautions:
Do not use petroleum based ointments or lubricants.
Contraindications:
Those individuals with a known sensitivity or allergy to latex are excluded from the use of this device. Product use should be discontinued should signs of sensitization occur.
Prescription Use XX (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)
currence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K071423
(3)