(605 days)
The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.
Cruz™ Catheter
The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the Cruz® Peritoneal Dialysis Catheter (K964514). These documents do not contain any information regarding acceptance criteria or a study proving device performance against such criteria. They primarily state that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them based on these documents.
Here's why and what kind of information would be needed:
- Acceptance Criteria: Acceptance criteria for medical devices typically involve performance metrics such as safety, effectiveness, biocompatibility, durability, and specific technical specifications (e.g., tensile strength, flow rate). These would be defined by the manufacturer and assessed by testing.
- Study Data: A study proving device performance would involve details about:
- Clinical trials or bench testing: Protocols, results, statistical analysis.
- Sample sizes: How many devices were tested or how many patients were enrolled.
- Ground truth: How outcomes were determined (e.g., clinical diagnosis, pathology).
- Expert involvement: If human readers/experts were involved in assessing performance.
- Comparative studies: If the device was compared to a predicate or alternative treatment.
The documents refer to "general controls provisions of the Act" and "Current Good Manufacturing Practice requirements," which are regulatory frameworks for manufacturing quality and safety, but do not detail specific performance criteria or studies.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized representation of a bird in flight, with three curved lines forming the body and wings. The word "DEPARTMENT" is written vertically along the left side of the logo, with the letters stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1998
Ms. Stephanie J. Wasielewski Director, Regulatory Affairs/Quality CORPAK MedSystems 100 Chaddick Drive Wheeling, Illinois 60090
Dear Ms. Wasielewski:
Re: K964514
Cruz® Peritoneal Dialysis Catheter Dated: April 9, 1998 Received: April 14, 1998 Regulatory Class: II 21 CFR §876.5630/Procode: 78 FKO
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 probibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
K964514/A1
Page / of /
510(k) Number (if known): K964514
Cruz™ Catheter Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.
Tom Kuhn
President and COO
President and COO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satherg
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K964514 510(k) Number
Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)
OR
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.