(755 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard performance of a Foley catheter, with no mention of AI or ML capabilities.
Yes
This device is used for the "drainage of the bladder," which is a medical intervention aimed at managing a patient's health condition.
No
The device is a catheter used for drainage and irrigation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a physical catheter made of PVC with lumens, a balloon, and an inflation valve, indicating it is a hardware medical device.
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 transurethral drainage of the bladder" and "bladder irrigation." This is a direct medical intervention on the patient's body for therapeutic or drainage purposes.
- Device Description: The description details a physical catheter designed to be inserted into the bladder. It's a medical device used for drainage and irrigation, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like urine, blood, etc.) in vitro (outside the body) to provide information about a physiological state, health condition, or disease.
IVD devices are used to perform tests on samples to diagnose, monitor, or screen for conditions. This device is a therapeutic/drainage device used directly on the patient.
N/A
Intended Use / Indications for Use
2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Adult
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)
Biocompatibility
The biocompatibility evaluation for the Rusch SoftSimplastic Foley Catheters was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Tests performed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Bacterial Reverse Mutation Assay (ISO), Acute Systemic Toxicity Test (ISO), Material Mediated Pyrogenicity Test (ISO/USP), Mouse Lymphoma Assay (ISO), Implantation Test (ISO), 28-Day Systemic Toxicity (Dual Route Repeated Exposure Method) Test (ISO).
Performance - Bench
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device.
Tests performed: Visual inspection - Shaft, Visual inspection - Balloon, Visual inspection - Funnel, Visual inspection - Tip, Effective Shaft Length, Strength of Catheter, Connector Security, Balloon Safety, Inflation and Deflation Test, Flow Rate Through Catheter, Kink Stability, Peak Tensile Force - Shaft, Peak Tensile Force - Funnel, Peak Tensile Force - Balloon, Peak Tensile Force - Tip, Inflated Balloon Response to Traction, Flow Rate Through Drainage Lumen, Balloon Integrity (Resistance to Rupture), Balloon Volume Maintenance, Balloon and Shaft Size, Deflation Reliability, Radiopacity, Ethylene Oxide Sterilization, EO Residuals, Packaging.
Key result: Performance test results demonstrate that the subject device is as safe and effective as the predicate device. The Rusch SoftSimplastic Foley Catheter is substantially equivalent to the predicate device.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 27, 2023
Teleflex Medical, Inc. Kelley Breheim Sr. MDR Regulatory Project Manager 3015 Carrington Mill Blvd. Morrisville, NC 27560
Re: K212077
Trade/Device Name: Rusch SoftSimplastic Foley Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: June 23, 2023 Received: June 23, 2023
Dear Kelley Breheim:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
Jessica K. Nguyen -S
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) K212077
Device Name Rusch SoftSimplastic Foley Catheters
Indications for Use (Describe)
2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral 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
510(k) Summary [As required by 21 CFR 807.92] Date Prepared: July 26, 2023 510(k) Number: K212077
Submitter's Name / Contact Person
Manufacturer Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 612-500-1344
Contact Person Kelley Breheim Sr. MDR Regulatory Project Manager
General Information
| Trade Name: | Rusch SoftSimplastic Foley Catheters |
|---|---|
| Common / Usual Name: | Disposable Balloon-Retention Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZL |
| Device Class: | Class II |
| Predicate Device | K162989, Rusch Simplastic Foley Catheters. This predicate device has not been subject to a design-related recall. |
Device Description
The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
4
| Product Codes | Size (Fr) | Product Description |
|---|---|---|
| 4426/662430 | 14 – 24 | SoftSimplastic 2 Way 30ml Catheter Coude/Mercier Tip |
| 5706/664130 | 16 – 24 | SoftSimplastic 3 Way 30ml Catheter Couvelaire Tip |
| 5707/662530 | 16 – 24 | SoftSimplastic 2 Way 30ml Catheter Couvelaire Tip |
| 5708/664176 | 18 – 24 | SoftSimplastic 3 Way 75ml Catheter Couvelaire Tip |
Indications for Use
2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.
Comparison of Technological Characteristics with the Predicate Device
A comparison of the technological characteristics between the Rusch SoftSimplastic Foley Catheters and the predicate device are provided in the following table.
| Comparison of Technological Characteristics | ||
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Characteristic | Rusch SoftSimplastic | |
| Foley Catheters | Rusch Simplastic Foley | |
| Catheters | ||
| Classification Name | Catheter, Retention Type, | |
| Balloon | Catheter, Retention Type, | |
| Balloon | ||
| Product Code | EZL | EZL |
| Regulation Number | 876.5130 | 876.5130 |
| Class | II | II |
5
| Indications for Use | 2 Way SoftSimplastic
Catheters:
Indicated where routine
transurethral drainage of the
bladder is required either
postoperatively or for
patients with conditions
requiring transurethral urine
drainage.
3 Way SoftSimplastic
Catheters:
Indicated where routine
transurethral drainage of the
bladder is required either
postoperatively, for patients
with conditions requiring
transurethral urine drainage
and for patients requiring
bladder irrigation. | These catheters are indicated
for routine transurethral
drainage of the bladder or for
routine post-operative
transurethral drainage and
irrigation of the bladder. |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristic | Subject Device | |
| Rusch SoftSimplastic | ||
| Foley Catheters | Primary Predicate Device | |
| Rusch Simplastic Foley | ||
| Catheters | ||
| Shelf Life | 5 Year | 1 Year |
| Size Range | 14-24Fr | 12-28Fr |
| Balloon Sizes | 30 and 75 ml | 30 and 75 ml |
| Balloon Material | Latex | Latex |
| Shaft Material | PVC with dioctyl | |
| terephthalate (DOTP) | ||
| plasticizer | PVC with bis(2-ethylhexyl) | |
| phthalate (DEHP) plasticizer | ||
| Connections | Luer Taper/Funnel | Luer Taper/Funnel |
| Lumen | Two way and three way | Two way and three way |
| Population | Adult | Adult and Pediatric |
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| Biocompatibility | Materials have been tested
per ISO 10993 | Materials have been tested
per ISO 10993 |
|-------------------------|---------------------------------------------|---------------------------------------------|
| Sterile | Yes | Yes |
| Method of Sterilization | Ethylene Oxide | Ethylene Oxide |
| Single Use or Reusable | Single Use | Single Use |
| Coated or Uncoated | Uncoated | Uncoated |
| Radiopacity | Yes | Yes |
In this 510(k), the sponsor proposed modifications to their previously cleared device, including a material change, an extension of shelf-life and minor labeling changes. Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing
Biocompatibility
The biocompatibility evaluation for the Rusch SoftSimplastic Foley Catheters was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
| Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Sensitization | ISO 10993-10 |
| Intracutaneous Reactivity | ISO 10993-23 |
| Bacterial Reverse Mutation Assay (ISO) | ISO 10993-3 |
| Acute Systemic Toxicity Test (ISO) | ISO 10993-11 |
| Material Mediated Pyrogenicity Test (ISO/USP) | ISO 10993-11 |
| Mouse Lymphoma Assay (ISO) | ISO 10993-3 |
| Implantation Test (ISO) | ISO 10993-6 |
| 28-Day Systemic Toxicity (Dual Route Repeated | |
| Exposure Method) Test (ISO) | ISO 10993-11 |
Performance - Bench
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The following table of test methods and standards (including packaging and sterility) were relied upon for a determination of substantial equivalence.
7
| Test | Reference to Standard
(if applicable) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Visual inspection - Shaft | ISO 20696:2018 |
| Visual inspection - Balloon | ISO 20696:2018 |
| Visual inspection - Funnel | ISO 20696:2018 |
| Visual inspection - Tip | ISO 20696:2018 |
| Effective Shaft Length | ISO 20696:2018 |
| Strength of Catheter | ISO 20696:2018 |
| Connector Security | ISO 20696:2018 |
| Balloon Safety | ISO 20696:2018 |
| Inflation and Deflation Test | ISO 20696:2018 |
| Flow Rate Through Catheter | ISO 20696:2018 |
| Kink Stability | ISO 20696:2018 |
| Peak Tensile Force - Shaft | ISO 20696:2018 |
| Peak Tensile Force - Funnel | ISO 20696:2018 |
| Peak Tensile Force - Balloon | ISO 20696:2018 |
| Peak Tensile Force - Tip | ISO 20696:2018 |
| Inflated Balloon Response to Traction | ISO 20696:2018 |
| Flow Rate Through Drainage Lumen | ASTM F623-99 |
| Balloon Integrity (Resistance to Rupture) | ASTM F623-99 |
| Inflated Balloon Response to Traction | ASTM F623-99 |
| Balloon Volume Maintenance | ASTM F623-99 |
| Balloon and Shaft Size | ASTM F623-99 |
| Deflation Reliability | ASTM F623-99 |
| Radiopacity | ASTM F640-12 |
| Ethylene Oxide Sterilization | ISO 11135-1 |
| EO Residuals | ISO 10993-7 |
| Packaging | ISO 11607-1
ISO 11607-2
ASTM D4169
ASTM F1886/F1886M
ASTM F88/F88M
EN 868-5
ASTM F2096 |
8
Conclusion
The Rusch SoftSimplastic Foley Catheter has the same intended use, technological characteristics, and construction as its predicate, with the exception of different PVC plasticizer material. Performance test results demonstrate that the subject device is as safe and effective as the predicate device. The Rusch SoftSimplastic Foley Catheter is substantially equivalent to the predicate device.