(90 days)
The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.
COBE® Model Cx™ Hemodialysis Delivery System and COBE® Cartridge Blood Tubing Set
The provided document is a 510(k) clearance letter from the FDA for the COBE® Cx™ Hemodialysis Delivery System and COBE Cartridge® Blood Tubing Set. This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document lacks all of the following information:
- A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to a predicate device. It does not provide any specific performance metrics or acceptance criteria that were met by the device itself.
- Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment.
- Adjudication method for the test set: Not applicable as no test set details are provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: This type of study is not mentioned in the clearance letter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a hemodialysis delivery system and blood tubing set, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
- The type of ground truth used: Not applicable as ground truth is not mentioned.
- The sample size for the training set: There is no mention of a training set.
- How the ground truth for the training set was established: Not applicable as no training set details are provided.
In summary, this document is a regulatory clearance letter, not a study report. To find the requested information, one would typically need to refer to the 510(k) submission itself (K982760), which would contain the technical data and studies demonstrating substantial equivalence to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1998
Mr. William M. Townsend Senior Regulatory Affairs Specialist GAMBRO® Healthcare, Inc. 1185 Oak Street Lakewood, CO 80215-4498
Re: K982760
COBE® Cx™ Hemodialysis Delivery System and COBE Cartridge® Blood Tubing Set Dated: August 5, 1998 Received: August 6, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI
Dear Mr. Townsend:
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 prohibitions 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 i submission does not affect any obligation you might have under sections 531 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/cdrb/dsmadsmam.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
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510(k) number (if known); K982760
Device Name: COBE® Model Cx™ Hemodialysis Delivery System
COBE® Cartridge Blood Tubing Set
Indications For Use:
The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration.
The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers.
The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hind A. Seghman
(Division Sign-Off) Division of Reproductive. Abdominal. ENT. and Radiological Devices
510(k) Number
با
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”