(65 days)
No
The summary describes a physical medical device (ureteral catheter) and its material and structural characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is described as a "ureteral catheter" designed for purposes such as "ureteral dilation" and "stone displacement," which are therapeutic interventions.
No
The device description indicates it is a catheter used as a conduit for various procedures like dilation, stone displacement, and guidewire/fluid placement, but it does not mention any function related to diagnosing medical conditions.
No
The device description clearly describes a physical, hollow plastic tube (a catheter) with lumens, adaptors, and a flexible tip, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a conduit for procedures within the ureter (ureteral dilation, stone displacement, delivery of agents, guidewire placement). These are all in vivo procedures, meaning they are performed within a living organism.
- Device Description: The description details a physical catheter designed to be placed inside the ureter. This is consistent with a device used for internal medical procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, tissue, etc., outside of the body to provide diagnostic information. This device is clearly designed for direct intervention within the body.
N/A
Intended Use / Indications for Use
The dual lumen ureteral catheter is designed for percutaneous and transurethral ureteral access. This ureteral catheter is indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, delivery of contrast media/anesthetic agents and guidewire placement.
Product codes
78 EYB
Device Description
Like the predicate Flexible Tip (open or closed) Ureteral Catheter, the Dual Lumen Catheter is a ureteral catheter with a flexible tip used for guidewire placement and for contrast injection.
The Dual Lumen Catheter incorporates the same technological characteristics as the predicate device. The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness. Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns. The method of manufacture (extrusion) is the same for both the predicate and the proposed device. The new material used in the Dual Lumen Catheter has been used in other legally marketed devices within the same classification regulation for the same intended use and has had an established history of successful clinical application in Urology.
Like the predicate device, the Dual Lumen Catheter features a hollow plastic tube placed inside the ureter, which, as in the predicate device, allows for the passage of guidewires and for the injection of fluid. Both catheters are fitted with female luer lock Tuohy-Borst adaptors, and feature soft tips to ensure protection of tissue during passage.
This Special 510(k) proposes an addition of the second lumen to the catheter, a modification of the material characteristics, shortening of the working length and a change of color of the device. The indications for use, principles of operation, and diameter of the Dual Lumen Catheter remain the same as in the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral
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
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
Dual Lumen Catheter ACMI Corporation 136 Turnpike Road Southborough, MA 01772
MAR 3 - 2005
Special 510(k) Notification Summary of Safety and Effectiveness Dec 27, 2004
510(k) Summary of Safety and Effectiveness ACMI Corporation Dual Lumen Catheter
Pg 1 of 3
General Information
Manufacturer:
ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
2020483
Contact Person:
Graham A.L. Baillie Senior Regulatory Affairs Specialist
Date Prepared:
December 27, 2004
Device Description
Classification Name:
Urological catheter and accessories (21 CFR 876.5130), Class II
Trade Name:
Dual Lumen Catheter
Generic/Common Name:
Ureteral Catheter
Predicate Device
K930483 Ureteral Catheter
(The Flexible Tip (open or closed) Ureteral Catheter)
Intended Uses
Dual Lumen Catheter has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safe wire/guidewire placement.
1
Southborough, MA 01772
Special 510(k) Notification Summary of Safety and Effectiveness Dec 27, 2004
Kou358i
pg 243
Product Description
Like the predicate Flexible Tip (open or closed) Ureteral Catheter, the Dual Lumen Catheter is a ureteral catheter with a flexible tip used for guidewire placement and for contrast injection.
The Dual Lumen Catheter incorporates the same technological characteristics as the predicate device. The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness. Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns. The method of manufacture (extrusion) is the same for both the predicate and the proposed device. The new material used in the Dual Lumen Catheter has been used in other legally marketed devices within the same classification regulation for the same intended use and has had an established history of successful clinical application in Urology.
Like the predicate device, the Dual Lumen Catheter features a hollow plastic tube placed inside the ureter, which, as in the predicate device, allows for the passage of guidewires and for the injection of fluid. Both catheters are fitted with female luer lock Tuohy-Borst adaptors, and feature soft tips to ensure protection of tissue during passage.
This Special 510(k) proposes an addition of the second lumen to the catheter, a modification of the material characteristics, shortening of the working length and a change of color of the device. The indications for use, principles of operation, and diameter of the Dual Lumen Catheter remain the same as in the predicate device.
2
Dual Lumen Catheter ACMI Corporation 136 Turnpike Road Southborough, MA 01772 Special 510(k) Notification Summary of Safety and Effectiveness Dec 27, 2004
Summary of Safety and Effectiveness
K 043581
pg 3183
The proposed modifications for the Dual Lumen Catheter, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right. To the left of the eagle, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Graham Baillie Quality Assurance Manager ACMI Corporation 3037 Mt. Pleasant Street RACINE WI 53404
K043581 Re:
Trade/Device Name: Dual Lumen Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated. December 27, 2004 Received: December 28, 2004
Dear Mr. Baillie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, devices mat nave occh receasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterere, mains of the Act include requirements for annual registration, listing of general volided by provisions 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 your device is easonial 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 that a Dederal statutes and regulations administered by other Federal agencies. You must of any I ederal battatos and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), laborning (21 Segulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of over (sions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 leval This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaleered this pe premarket notification. The FDA inding of substantial or 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 If you desire specific advice for your device of our laceming regulation (
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 | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entitled, "Misonalians on your responsibilities under the Act from the (80 807.97). You may obtain other gelleral manon on your copied.
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
Dual Lumen Catheter ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Statement of Intended Use Dec 27, 2004
Device Name: Dual Lumen Catheter
510(k) Number:
Indications for use:
The dual lumen ureteral catheter is designed for percutaneous and THC uddi lamon aretoral os indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, including, but not limited tial/anesthetic agents and guidewire placement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X __
Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
David W. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number