(352 days)
Not Found
No
The document describes a standard medical device (Foley catheter) and does not mention any AI or ML components or capabilities.
Yes.
The device is a Foley Catheter used for routine drainage of the bladder, which is a therapeutic function.
No
Explanation: The device description and intended use clearly state that the Foley catheters are for "routine drainage of the bladder" and "bladder irrigation," which are therapeutic or supportive functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly outlines a physical medical device (catheter) made of latex with various physical components (funnel, valve, balloon, channels). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for routine drainage of the bladder and bladder irrigation. This is a direct therapeutic or management function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical catheter designed to be inserted into the body for drainage and irrigation. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to provide diagnostic information. The device's function is purely mechanical and related to fluid management within the body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.
Product codes
EZL
Device Description
The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.
PURE GOLD
The Coude Foley Catheter PURE GOLD is designed with a Coudè tip and one eye. Catheter dimensions range from 12 Fr. to 24 Fr. and have a range of 4.00 mm to 8.67 mm in Outer Diameter. The catheters have an overall length of 402-422 mm. The nominal balloon inflation volume for this model is 5 or 30 cm3.
Gold Pediatric
The Gold Pediatric Foley Catheter is designed with a cylindrical tip and two opposing eyes. The 8 Fr. and 10 Fr. catheter have a range of 2.67 mm to 3.33 mm in Outer (OD). The catheters have an overall length of 287-307 mm. The 8 Fr. and 10 Fr. catheter include a pre-loaded stylet (Nylon- 0.65 mm Clear) to facilitate insertion. The nominal balloon inflation volume for this model is 3 cm3.
Gold
The Gold 2 Way Foley Catheter is designed with a cylindrical tip and two opposing eyes. Catheter size ranges from 12 Fr. to 24 Fr. and have a range of 4.00 mm in Outer Diameter (OD). The catheter has a length of 397-417 mm.
The Gold 3 Way Foley Catheter is designed with a cylindrical tip and two vertically oriented eves. Catheter size ranges from 16 Fr. to 26 Fr. for the 3-way shaft. There is a range of 6.00 mm to 7.33 mm in the catheter Outer Diameter (OD). The catheter has a length of 397-417 mm.
The nominal balloon inflation volume for this model is 5 or 30 cm³.
Gold Haematuria
The Gold 3 Way Haematuria catheter is designed with a cylindrical tip and two vertically oriented eyes. Catheter size ranges from 18 Fr. to 24 Fr. and has a 3-way shaft. There is a range of 6.00 mm to 8.00 mm in the catheter Outer Diameter (OD). The catheter has a length of 397-417 mm. A portion of the shaft includes a nylon winding enabling shaft to be rigid. The nominal balloon inflation volume for this model is 30 cm³.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder, urethra, urinary bladder
Indicated Patient Age Range
Adult and Pediatric
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)
Nonclinical Testing Summary:
- Biocompatibility testing per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017, ISO 10993-6:2016. Results demonstrate biocompatibility.
- Sterilization validation per ISO 11137-1:2006 (R)2015 and ISO 11137-1:2013.
- Accelerated aging per ASTM F1980-16 for shelf life support. Results demonstrate functional performance and packaging sterility over shelf life.
- Performance/Functional testing per ASTM 623-19. The device met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2024
Teleflex Medical, Inc. Angela Bouse Senior Manager, Regulatory Affairs - Product Management 3015 Carrington Mill Blvd, Suite 600 North Morrisville, North Carolina 27560
Re: K232469
Trade/Device Name: Rüsch Latex Gold Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 14, 2003 Received: July 18, 2024
Dear Angela Bouse:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Sharon M. Andrews -S
for Jessica K. Nguyen, 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) K232469
Device Name Rüsch Latex Gold Foley Catheter
Indications for Use (Describe)
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring 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)
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3
TRADITIONAL 510(K) SUMMARY
1. SUBMITTER INFORMATION
| Applicant & Official
Correspondent | Angela Bouse
Sr. Manager Regulatory Affairs – Product Managemen
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville, NC 27560
Phone: 919-332-8189
Fax: 919-361-3939
Email: angela.bouse@teleflex.com |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 31, 2024 |
| 2. DEVICE NAME | |
| Trade Name of the Device | Rüsch Latex Gold Foley Catheter |
| Common Name: | Foley Catheter |
| Classification Name: | Urological catheter and accessories |
| Classification Regulation: | 21 CFR 876.5130 |
| Device Class: | II |
| Product Code: | EZL (Catheter, Retention Type, Balloon) |
| Panel: | Gastroenterology/Urology |
| 3. PREDICATE DEVICE | K173340, YiKang Latex Foley Catheter |
IDENTIFICATION
The predicate device was never subjected to a design related recall.
4. DEVICE DESCRIPTION:
The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.
4
PURE GOLD
The Coude Foley Catheter PURE GOLD is designed with a Coudè tip and one eye. Catheter dimensions range from 12 Fr. to 24 Fr. and have a range of 4.00 mm to 8.67 mm in Outer Diameter. The catheters have an overall length of 402-422 mm. The nominal balloon inflation volume for this model is 5 or 30 cm3.
Gold Pediatric
The Gold Pediatric Foley Catheter is designed with a cylindrical tip and two opposing eyes. The 8 Fr. and 10 Fr. catheter have a range of 2.67 mm to 3.33 mm in Outer (OD). The catheters have an overall length of 287-307 mm. The 8 Fr. and 10 Fr. catheter include a pre-loaded stylet (Nylon- 0.65 mm Clear) to facilitate insertion. The nominal balloon inflation volume for this model is 3 cm3.
Gold
The Gold 2 Way Foley Catheter is designed with a cylindrical tip and two opposing eyes. Catheter size ranges from 12 Fr. to 24 Fr. and have a range of 4.00 mm in Outer Diameter (OD). The catheter has a length of 397-417 mm.
The Gold 3 Way Foley Catheter is designed with a cylindrical tip and two vertically oriented eves. Catheter size ranges from 16 Fr. to 26 Fr. for the 3-way shaft. There is a range of 6.00 mm to 7.33 mm in the catheter Outer Diameter (OD). The catheter has a length of 397-417 mm.
The nominal balloon inflation volume for this model is 5 or 30 cm³.
Gold Haematuria
The Gold 3 Way Haematuria catheter is designed with a cylindrical tip and two vertically oriented eyes. Catheter size ranges from 18 Fr. to 24 Fr. and has a 3-way shaft. There is a range of 6.00 mm to 8.00 mm in the catheter Outer Diameter (OD). The catheter has a length of 397-417 mm. A portion of the shaft includes a nylon winding enabling shaft to be rigid. The nominal balloon inflation volume for this model is 30 cm³.
5
5. INDICATIONS FOR USE:
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Comparison Element | Subject Device:
Rüsch Latex Gold Foley Catheter | Predicate Device:
YiKang Latex Foley Catheter |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K232469 | K173340 |
| Indications for Use | 2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder
is required either postoperatively or for patients
with conditions requiring urine drainage
3 Way Latex Foley Catheters
Indicated where routine drainage of the bladder
is required either postoperatively or for patients
with conditions requiring urine drainage and for
patients requiring bladder irrigation. | The YiKang Foley Catheter is intended
to be placed in the bladder, through the
urethra, to drain urine and other fluids
from the urinary bladder |
| Prescription use | Yes | Yes |
| Intended Population | Adult and Pediatric, Male and Female | Adult and Pediatric, Male and Female |
| Device usage | Single use sterile | Single use sterile |
| Size Range | Pediatric: 8-10 Fr.
Male/Female:12-26 Fr. | Pediatric: 6-10 Fr.
Male/Female: 12-30 Fr. |
| Overall catheter length | PURE GOLD:
402-422 mm
Gold Pediatric:
287-307 mm
Gold & Gold Haematuria:
397-417 mm | Pediatrics:
260-280 mm
2-Way Male:
390-410 mm
2-Way Female:
255-270 mm
3-Way Standard:
390-410 mm |
| Effective length | PURE GOLD:
355 (+20, -15) mm
Gold Pediatric
245 (+15, -20) mm
Gold
360 (+10, -25) mm
Gold Haematuria
345 (+25, -10) mm | Pediatrics
190-200 mm
2-Way Male:
280-300 mm
2-Way Female:
150-165 mm
3-Way Standard:
280-300 mm |
| | | |
| Indwelling time | Maximum indwell time less than 30 days | Maximum indwell time of less than 30
days |
| Lumens | 2-way and 3-way | 2-way and 3-way |
| Nominal Balloon
Inflation Volume | 3 cm3, 5 cm3, 30 cm3 | 3 cm3, 5 cm3, 30 cm3 |
| Shaft | Tubular | Tubular |
| Material | Natural latex | Natural latex |
| Surface Finish
(Coating) | Silicone | Silicone or PTFE |
| Eyelets | Yes | Yes |
| Primary Packaging | Paper and film peel back | Paper and film peel back |
| Sterile | Yes | Yes |
| Sterilization Method | Ethylene Oxide,
ISO 11135 | Gamma Irradiation, ISO 11137-2 |
| Stylet | Yes, in Gold pediatric | Not included |
| Tip shape | Coude and cylindrical | Cylindrical |
6
As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. The differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
7. SUMMARY OF NONCLINICAL TESTING:
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
- . Biocompatibility was conducted per ISO 10993-1:2018- Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process and Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", issued September 2023. The following tests were conducted in the biocompatibility assessment of the device:
- o Cytotoxicity per ISO 10993-5:2009.
- Sensitization per ISO 10993-10:2021. O
- Irritation per ISO 10993-23:2021. O
- Acute Systemic Toxicity per ISO 10993-11:2017. O
- Subacute Systemic Toxicity per ISO 10993-11:2017. O
- Material Mediated Pyrogenicity per ISO 10993-11:2017. O
- Implantation per ISO 10993-6:2016. O
The results of biocompatibility testing demonstrate that the subject device is biocompatible.
- . Sterilization validation was conducted per the following FDA-recognized standards:
- ISO 11137-1:2006 (R)2015 Sterilization of healthcare products Radiation Part 1: O Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 11137-1:2013 Sterilization of healthcare products Radiation Part 2: Establishing the o sterilization dose.
7
- Accelerated aging was performed in conformance with ASTM F1980-16, Standard Guide for ● Accelerated Aging of Sterile Barrier Systems for Medical Devices to support the shelf life of the device. The results of accelerated aging testing demonstrate that the subject device maintains its function performance and that its packaging maintains the sterility of the device over the duration of its shelf life via bench testing and transportation simulation and package integrity testing, respectively.
- . Performance/Functional testing was conducted per ASTM 623-19 Standard Performance Specification for Foley Catheter. The subject device met the acceptance criteria outlined in the standard.
8. CONCLUSIONS
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate device.