(71 days)
The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the GuardianCatheter™-Infant Urinary Collection Kit. This type of document confirms that a device is substantially equivalent to a predicate device already on the market.
It is important to note that 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, and often do not involve extensive new clinical studies with detailed acceptance criteria and performance metrics as might be seen for novel, high-risk devices or those requiring a PMA (Premarket Approval).
Based on the provided text, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. The letter primarily confirms regulatory clearance and substantial equivalence.
Therefore, I cannot populate the table or answer the specific questions about performance metrics and study details from the text provided. The document outlines the device's indications for use and confirms its regulatory classification, but does not present the type of clinical study data you are asking for.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sandra L. Winkler President Marian Medical, Inc. 319 Westport Drive LOUISVILLE KY 40207
MAR 1 5 2007
Re: K070048
Trade/Device Name: GuardianCatheter™-Infant Urinary Collection Kit Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: FCM Dated: December 28, 2006 Received: January 3, 2007
Dear Ms. Winkler:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.
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Page 2 - Ms. Sandra Winkler
In addition, we have determined that your device kit contains Povidone Iodine antiseptic swabs, Surgilube® and KY-Jelly®, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR 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/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
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Indication for Use
510(K) Number (if Known): N/A
Device Name: GuardianCatheter-Infant Urinary Collection Kit
Indications for Use:
The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.
Prescription Use: (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.