(107 days)
Not Found
Not Found
No
The 510(k) summary describes a simple irrigation tubing set and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML devices.
No
The device is described as an "Irrigation Tubing Set" intended for the delivery of irrigating solutions. This suggests it is a delivery system, not a device that directly treats or prevents disease itself.
No
The device is described as tubing for delivering irrigating solutions, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly identifies it as a "Tubing Set," which is a physical hardware component used for fluid delivery. There is no mention of software as the primary or sole component.
Based on the provided information, the Nexus Irrigation Tubing Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the delivery of irrigating solutions to a site within the body (bladder, irrigation site during endoscopic/arthroscopic procedures). This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The description doesn't mention analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing.
Therefore, the Nexus Irrigation Tubing Set is a medical device used for delivering fluids during medical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Product codes
LJH, HRX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, Not Specified (for endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 1 5 2006
Ms. Anita Smith Quality Manager Nexus Medical LLC 11315 Strang Line Road LENEXA KS 66215
Re: K062551
Trade/Device Name: Nexus Irrigation Tubing Set Regulation Number: 21 CFR §888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: LJH and HRX Dated: November 7, 2006 Received: November 9, 2006
Dear Ms. Smith:
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 (Premarket Approval), it may be subject to such 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.
Image /page/0/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. The logo is surrounded by a dotted border with stars.
ting and Promoting Du
1
Page 2 -
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K062551
Device Name: Nexus Irrigation Tubing Set
Indications for Use:
The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hanson
August 2006 Nexus Medical, LLC: NITS
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
6-1