(18 days)
Not Found
No
The summary describes a physical medical device (catheter) with a design feature (curved) for ease of use. There is no mention of software, data processing, or any terms related to AI/ML.
Yes
The device is used for female intermittent self-catheterization of the bladder, which is a therapeutic intervention.
No
Explanation: The device is used for intermittent self-catheterization of the bladder, which is a therapeutic or management function, not a diagnostic one. It facilitates a medical procedure rather than identifying a disease or condition.
No
The description clearly indicates the device is a physical catheter used for intermittent self-catheterization, which 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 "female intermittent self-catheterization of the bladder." This is a procedure performed directly on the patient's body to drain urine, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use clearly indicates a physical device for insertion into the body.
- Lack of IVD Indicators: There is no mention of analyzing samples (like blood, urine, tissue), performing tests, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and therapeutic (draining the bladder).
N/A
Intended Use / Indications for Use
Used for female intermittent self-catheterization of the bladder. Curved design permits makes the catheter easier for patients to manipulate.
Product codes (comma separated list FDA assigned to the subject device)
KOD, EZD
Device Description
American Catheter, W3, with stop shield. Non-sterile, Reusable. Intended for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
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): 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
510(K) SUMMARY
Device Classification Name: Catheter, Urological Requlation Number: 876.5130 Not yet assigned 510 (K) Number: Device Name: W3 American Catheter Applicant: Catheter LLC. P.O. Box 917 106 Groppo Drive Winsted, CT 06098-0917 Email: john@railroadgage.com Telephone: (860) 738-7188 Fax: (860) 379-6678 John C. Devanney Contact: KOD Product Code: Predicate device: Catheter, Urological Device Classification Name: Requlation Number: 876.5130 510(K) Number: K863082 COOK-VPI INTERMITTENT Device Name: CATHETER Cook Urological, Inc. Applicant: 1100 West Morgan Street P.O. Box 227 Spencer, IN 47460 Gerald J. French Contact: KOD Product Code: 08/12/1986 Date Received: Decision Date: 11/07/1986 Substantially Equivalent Decision: (SE) Classification Advisory Gastroenterology Committee: Review Advisory Gastroenterology Committee: Traditional Type : Reviewed by Third Party: No
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures or faces, stacked vertically.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Catheter LLC c/o Mr. John C. Devanney
Re: K030538
MAR 1 0 2003
Trade/Device Name: American Catheter, W3 Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II
Product Code: 78 EZD Dated: February 17, 2003 Received: February 20, 2003
Dear Mr. Devanney:
106 Groppo Drive
WINSTED, CT 06098 0917
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 (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 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.
2
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Yancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kv 30538
510(k) Number Not-assigned
Device Name: W3 American Catheter with stop shield
Indications for Use:
Used for female intermittent self-catheterization of the bladder. Curved design permits Osed for remare interminent betw makes the catheter easier for patients to manipulate.
Non-sterile
Reusable.
Intended for single patient use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030538
Prescription Use (Per 21 CFR 801.109)
(Optional Format 3-10-98)
L