(31 days)
Not Found
No
The summary describes a simple, uncoated PVC catheter for routine urine drainage and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described for routine drainage of urine, which is a supportive rather than therapeutic function. It is not indicated for treating or curing a disease or condition.
No
Explanation: The device is indicated for "routine drainage of urine from the bladder," which is a therapeutic function, not a diagnostic one. There is no mention of it being used to detect or identify a condition.
No
The device description clearly states it is a physical catheter made of PVC material, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's intended use is for the "routine drainage of urine from the bladder." This is a physical intervention to remove a bodily fluid, not an analysis of a specimen to gain diagnostic information.
- Lack of Diagnostic Elements: The description doesn't mention any components or processes related to analyzing urine or providing diagnostic results. It's a simple catheter for drainage.
Therefore, based on the provided information, this intermittent urethral catheter is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Product codes
EZC
Device Description
The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as the connecting device. PVC material used in the catheter. The product sizes range from 10 Ch. to 24 Ch. The device shaft is uncoated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
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 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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
August 29, 2022
Teleflex Medical Kelly Breheim Sr. MDR Regulatory Project Manager 3015 Carrington Mill Blvd Morrisville, NC 27560
Re: K22279
Trade/Device Name: Rusch Intermittent Urethral Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZC Dated: July 29, 2022 Received: July 29, 2022
Dear Kelly 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. 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
1
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-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 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,
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)
Device Name Rusch Intermittent Urethral Catheters
Indications for Use (Describe)
These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Rusch Intermittent Urethral Catheters
510(k) SUMMARY
I. SUBMITTER
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA
Phone: 612-500-1344 Fax: 919-433-4996
Contact Person: Kelley Breheim, Sr. MDR Regulatory Project Manager Date Prepared: July 29, 2022
II. DEVICE
| Trade Name: | Rusch Intermittent Urethral Catheter |
|---|---|
| Classification Name: | Catheter, Coude |
| Product Code: | EZC |
| Regulation Number: | 876.5130 |
| Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |
III. PREDICATE DEVICES
Rusch Intermittent Urethral Catheters cleared in submission K173596
IV. DEVICE DESCRIPTION
The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as the connecting device. PVC material used in the catheter. The product sizes range from 10 Ch. to 24 Ch. The device shaft is uncoated.
V. INDICATIONS FOR USE
These catheters are indicated for use for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON TO THE PREDICATE DEVICE
This submission only affects the labeling of these products by adding contraindications to the IFUs. There were no modifications made to the Rusch Intermittent Urethral Catheters.