(90 days)
No
The summary describes a physical medical device (dialyzer) and its intended use and materials. There is no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is a dialyzer used for treating chronic or acute renal failure, which is a therapeutic intervention.
No
Explanation: The device, the AM-R Series Dialyzer, is indicated for use in hemodialysis treatment for patients with renal failure. This is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical device with hollow fiber membranes and a plastic casing, indicating it is hardware, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemodialysis treatment of patients who have chronic renal failure or acute renal failure." This is a therapeutic treatment performed directly on the patient, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The device is a "hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing." This describes a physical device used in a treatment process, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic or monitoring information based on test results
Therefore, the Asahi AM-R Series Dialyzers are a therapeutic medical device used for hemodialysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.
Product codes
78 FJI
Device Description
Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Asahi AM-R Series Dialyzers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. 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
JUL 29 1999
K991512
Page 1 of 1
Asahi AM-R Series Dialyzers
| Submitter: | Asahi Medical Company, Ltd.
9-1, Kanda Mitoshirocho
Chiyoda-ku, Tokyo 101-8482
Japan |
|----------------------------------------|-----------------------------------------------------------------------------------------------|
| Date summary was prepared: | April 2, 1999 |
| Name(s) of the device: | Asahi AM-R Series Dialyzers |
| Identification of predicate device(s): | Asahi AM-R Series Dialyzers |
Description of the device:
Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.
Intended Use:
The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.
Comparison To Predicate:
The previously cleared Asahi AM-R Series Dialzyers are being modified to update the dialyzer casings. No other changes to the dialyzers are being made.
Conclusion:
Revisions to the casing dimensions for the AM-R Series dialyzers are demonstrated to have an insignificant impact on the performance of the dialyzers. The indications for use remains unchanged and no new issues of safety or effectiveness are expected to be raised as a consequence of this modification. Therefore the modified AM-R series dialyzers are considered substantially equivalent to the original AM-R series dialyzers.
1
Image /page/1/Picture/0 description: The image is a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a sphere. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Asahi Medical Company, Ltd. c/o David L. West, Ph.D. Vice President Quintiles Consulting 15825 Shady Grove Road, Suite 130 Rockville, MD 20850-4008
Re: K991512 Asahi AM-R Series of Dialyzers Dated: April 29, 1999 Received: April 30, 1999 Requlatory Class: II 21 CFR §876.5820/Procode: 78 FJI
Dear Dr. West:
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 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), 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 requlations 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 regult 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), piease 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use Statement
None assigned as of this time
Device Name:
510(k) Number:
Asahi AM-R Series Dialyzers
Indications for Use:
The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.
==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Image /page/2/Picture/8 description: The image shows a simple square shape. The square is formed by four straight lines, creating a closed geometric figure. The lines appear to be of uniform thickness, and the square is oriented with its sides parallel to the horizontal and vertical axes.
Over-the Counter Use
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991512