(208 days)
Not Found
Not Found
No
The summary describes a physical medical device (dialyzer) and its intended use and reprocessing. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is a dialyzer intended for hemodialysis treatment for patients with chronic or acute renal failure, which is a therapeutic intervention.
No
The device description indicates that the Asahi AM-BIO Series Dialyzers are "hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis." Hemodialysis is a treatment for kidney failure, not a diagnostic procedure. The text describes its use for treating chronic and acute renal failure, its components, and reprocessing guidelines, all related to treatment delivery rather than diagnosis.
No
The device description clearly describes a physical hemodialysis membrane (hollow fiber dialyzer) made of modified cellulose and housed in a plastic casing. It is a hardware device used in conjunction with reprocessing systems and dialysis systems.
Based on the provided text, the Asahi AM-BIO Series Dialyzers are not an In Vitro Diagnostic (IVD) device.
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.
- Device Description: The device is described as a "family of hemodialysis membranes, or hollow fiber dialyzers." This is a physical device used to filter blood, not a reagent or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes or biomarkers
The device is clearly intended for extracorporeal blood purification, which is a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
- Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
- Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.
- Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-BIO Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-BIO Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
-
- The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
-
- The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin in conjunction with the Renatron Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
-
- The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
-
- The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
-
Product codes (comma separated list FDA assigned to the subject device)
78 MSE
Device Description
The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.
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)
Non-clinical Testing:
The performance of the Asahi AM-BIO Series Dialyzers under reuse conditions were evaluated according to the FDA's May 23, 1996, letter to industry and its accompanying Guidance for Hemodialyzer Reuse Labeling.
The largest wet model (AM-BIO-100) has been subjected to the reprocessing (4) agents and/or processes for 15 cycles and subsequently tested for biocompatibility. The biocompatibility tests comprised: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), genotoxicity, hemocompatibility, and pyrogenicity.
The smallest wet model (AM-BIO-50) and the largest wet model (AM-BIO-100) (ର) have been tested in vitro under initial use and reprocessed/reused conditions for 15 cycles using outdated human blood from a blood bank to produce in vitro measurements of ultration coefficient (Kur) and clearances for urea, creatinine, and vitamin B12. The in virro performance testing was performed using dialysis machines equipped with volumetric ultrafiltration controllers. To evaluate the effects of reprocessing, widely utilized reprocessing agents formaldehyde (also known as formalin) and Renalin and associated reprocessing systems were utilized.
Clinical Testing:
The largest wet model (AM-BIO-100) has been tested in a confirmatory clinical study under initial use and reprocessed reused conditions to produce clinical measurements of ultrafiltration coefficient (Kur) and removal rates for urea, creatinine, and albumin.
Objective 1: Demonstrate safety of the device by characterizing the effect of repeated patient exposures by treating subjects 36 consecutive times with the device.
Objective 2: Quantitate the low molecular weight substance removal performance and the ultrafiltration coefficient (Kur) of the Asahi AM-BIO-100 dialyzer upon initial use.
Objective 3: Demonstrate that these indices of performance remain acceptable after reprocessing and reuse, to a maximum of 15 reprocessing/reuse cycles per patient.
Objective 4: Document complement activation (C3a and C5a) during the course of the study.
Study Design: Prospective design. Initial dialysis procedures served as baselines for comparison.
Sample size: Study continued at each site until 12 patients were enrolled at the site, with the intent for all to be treated 36 consecutive times with the dialyzer, reusing a subject's unit up to 15 times.
Inclusion criteria: Patients who receive chronic dialysis and who are stable on thrice weekly dialysis.
Key results:
The performance characteristics of the AM-BIO Series Dialyzers for single or initial (first) use and after reprocessing for reuse, as reflected in the biocompatibility testing, in vitro performance testing, and confirmatory clinical testing, are comparable to the performance characteristics for single or initial (first) use of the Asahi and competitor predicate devices.
Enhanced hemocompatibility has been demonstrated by showing lower complement activation (C3 and C5) when compared to regular cellulose membranes as well as when compared to a currently marketed hemodialyzer membranes bearing labeling claims for enhanced hemocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Asahi AM Series Dialyzers, Asahi AM-R Series Dialyzers, Baxter HT Dilayzers, Garmbro COBE Centrysystem HG Dialyzers, Gambro Alwall GFS Plus Dialyzers
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Asahi Medical Company, Ltd. 9-1. Kanda Mitoshirocho Chiyoda-ku, Tokyo 101-8482 Japan
Tel: 81-3-3259-5880 Fax: 81-3-3259-5899
Date Summary Was Prepared
October 21, 1998
Name of Device
Asahi AM-BIO Series Dialyzers
Identification of Predicate Devices
Asahi AM Series Dialyzers Asahi AM-R Series Dialyzers Baxter HT Dilayzers Garmbro COBE Centrysystem HG Dialyzers Gambro Alwall GFS Plus Dialyzers
Description of the Device ﺎ
The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient.
1
Kq83726 lay 2/7
The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers.
The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.
Intended Use
The intended use statement of the Asahi AM-BIO Series Dialyzers reads:
-
- Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
- Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a b. physician familiar with hemodialysis and familiar with the conditions of the patient.
- Asahi AM-B10 Series Dialyzers have been tested in vitro and in confirmatory clinical C. studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations. Asahi AM-BIO Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Asahi and as recommended immediately below. It is noted that the Asahi AM-BIO Series Dialyzers have not been
2
K 983720
tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
-
- The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
-
- The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renaline in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
-
- The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
-
- The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
Additionally, the Asahi AM-BIO Series Dialyzers exhibit enhanced hemocompatibility when compared to dialyzers of regular membrane materials and when compared to other dialyzers of hemocompatible membrane materials.
Comparison of Device Characteristics to Predicates
The indications for use, design, and manufacturing of the Asahi AM-BIO Series Dialyzers are the same as the predicate devices (i.e., Asahi AM Series Dialyzers and AM-R Series Dialyzers as well as hemophan dialyzers: Baxter HT Dialyzers, Gambro COBE Centrysystem HG Dialyzers, and Gambro Alwall GFS Plus Dialyzers).
page 3/7
3
The AM-BIO Series Dialyzers differ from the Asahi AM-Series Dialyzers and AM-R Series Dialyzers (i.e., predicate Asahi devices) in that they have slightly different casing dimensions and they utilize a membrane material (i.e., surface modified cellulose derived from cuprammonium rayon) that is more compatible to the patient's blood, generally manifested through lower complement activation (C3, and C5,) compared with regular cellulose membranes. Therefore, from the perspective of technological characteristics, the AM-BIO Series Dialyzers under this 510(k) are substantially equivalent to predicate devices.
1age 47
The performance characteristics of the AM-BIO Series Dialyzers for single or initial (first) use and after reprocessing for reuse, as reflected in the biocompatibility testing, in vitro performance testing, and confirmatory clinical testing, are comparable to the performance characteristics for single or initial (first) use of the Asahi and competitor predicate devices. The single or initial (first) use as well as reuse performance characteristics will be included in device labeling to provide clinical users with accurate information in the comparable performance of these conventional hemodialysis membranes. Therefore, from the perspective of performance characteristics, the AM-BIO Series Dialyzers under this 510(k) are substantially equivalent to the predicate devices (i.e., Asahi AM Series and AM-R Series Dialyzers and hemophan dialyzers: Baxter HT Dialyzers, Gambro COBE Centrysystem HG Dialyzers, and Gambro Alwall GFS Plus Dialyzers).
Therefore, the family of AM-BIO Series Dialyzers that are the subject of this 510(k), when indicated for single use or initial (first) use as well as for reprocessing and reuse are substantially equivalent to currently marketed conventional hemodialyzers.
Additionally, enhanced hemocompatibility has been demonstrated by showing lower complement activation (C3 and C5 ) when compared to regular cellulose membranes as well as when compared to a currently marketed hemodialyzer membranes bearing labeling claims for enhanced hemocompatibility.
Non-clinical Testing
The performance of the Asahi AM-BIO Series Dialyzers under reuse conditions were evaluated according to the FDA's May 23, 1996, letter to industry and its accompanying Guidance for
Date - October 21. 1998 ASAHI MEDICAL COMPANY. UTD. - AM-BIO SERIES DIALYZER
4
Hemodialyzer Reuse Labeling. Accordingly, the performance testing that has been conducted includes:
- The largest wet model (AM-BIO-100) has been subjected to the reprocessing (4) agents and/or processes for 15 cycles and subsequently tested for biocompatibility. The biocompatibility tests comprised: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), genotoxicity, hemocompatibility, and pyrogenicity.
- The smallest wet model (AM-BIO-50) and the largest wet model (AM-BIO-100) (ર) have been tested in vitro under initial use and reprocessed/reused conditions for 15 cycles using outdated human blood from a blood bank to produce in vitro measurements of ultration coefficient (Kur) and clearances for urea, creatinine, and vitamin B12. Reflecting the dominant use pattern in modern hemodialysis facitlities, the in virro performance testing was performed using dialysis machines equipped with volumetric ultrafiltration controllers. Also to evaluate the effects of reprocessing, widely utilized reprocessing agents formaldehyde (also known as formalin) and Renalin® and associated reprocessing systems were utilized.
Clinical Testing
The largest wet model (AM-BIO-100) has been tested in a confirmatory clinical study under initial use and reprocessed reused conditions to produce clinical measurements of ultrafiltration coefficient (Kur) and removal rates for urea, creatinine, and albumin.
An objective of the study was to demonstrate safety of the device by characterizing the effect of repeated patient exposures by treating subjects 36 consecutive times with the device, as recommended by FDA. Other objectives of the study were (1) quantitate the low molecular weight substance removal performance and the ultrafiltration coefficient (Kur) of the Asahi AM-BIO-100 dialyzer upon initial use, and (2) to demonstrate that these indices of performance remain acceptable after reprocessing and reuse, to a maximum of 15 reprocessing/reuse cycles per patient.
5
Lastly, the study was to document complement activation (C3a and C5a) during the course of the study.
Two clinical sites were chosen to study the effects of reprocessing the dialyzer with the two chosen reprocessing agents and/or processes. The clinical study protocol was identical for both sites, although dialysis sessions were conducted and patients were managed in accordance with. established dialysis practices for the respective institutions.
The study was prospective in design. The initial dialysis procedures served as the baselines for comparison for the subsequent dialysis procedures performed with the reprocessed devices. The study continued at each site until 12 patients were enrolled at the site, of which all were intended to be treated 36 consecutive times with the dialyzer while reusing a subject's unit up to 1,5 times. The main inclusion criteria were patients who receive chronic dialysis and who are stable on thrice weekly dialysis.
Conclusions
ﺎ
The indications for use, design, and manufacturing of the Asahi AM-BIO Series Dialyzers are the same as the predicate devices (i.e., Asahi AM Series Dialyzers and AM-R Series Dialyzers as well as hemophan dialyzers: Baxter HT Dialyzers, Gambro COBE Centrysystem HG Dialyzers, and Gambro Alwall GFS Plus Dialyzers). The AM-BIO Series Dialyzers differ from the Asahi AM-Series Dialyzers and AM-R Series Dialyzers (i.e., predicate devices) in that they have slightly different casing dimensions and they utilize a membrane material (i.e., surface modified cellulose derived from cuprammonium rayon) that is more compatible to the patient's blood, generally manifested through lower complement activation (C3, and C52) compared with regular cellulose membranes. Therefore, from the perspective of technological characteristics, the AM-BIO Series Dialyzers under this 510(k) are substantially equivalent to the predicate devices.
The performance characteristics of the AM-BIO Series Dialyzers for single or initial (first) use and after reprocessing for reuse, as reflected in the biocompatibility testing, in vitro performance testing, and confirmatory clinical testing, are comparable to single or initial (first) use performance characteristics of predicate devices. The single or initial (first) use as well as reuse performance characteristics will be included in device labeling providing clinical users with accurate
Date - October 21. 1998 ASAHI MEDICAL COMPANY, LTD. - AM-BIO SERIES DIALYZER
6
K983720
Page 7/7
information in the comparable performance of these conventional hemodialyzers. Therefore, from the perspective of performance characteristics, the AM-BIO Series Dialyzers under this 510(k) are substantially equivalent to the predicate devices (i.e., Asahi AM-R Series Dialyzers and hemophan dialyzers: Baxter HT Dialyzers, Gambro COBE Centrysystem HG Dialyzers, and Gambro Alwall GFS Plus Dialyzers).
Therefore, the family of AM-BIO Series Dialyzers that are the subject of this 510(k), when indicated for single use or initial (first) use as well as for reprocessing and reuse are substantially equivalent to currently marketed conventional hemodialyzers.
Additionally, enhanced hemocompatibility has been demonstrated by showing lower complement activation (C3, and C5,) when compared to regular cellulose membranes as well as when compared to a currently marketed hemodialyzer membrane bearing claims for enhanced hemocompatibility.
7
Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract eagle or bird in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAY 1 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Medical Company, LTD. c/o David L. West, Ph.D. Quintiles Medical Technology Consultants 15825 Shady Grove Road, Suite 90 Rockville, MD 20850
Re: K983720 Asahi AM-BIOSeries Dialyzers Models 50, 50D, 65, 65D, 75, 75D, 100 and 100D Multiple Use Labeling Dated: February 18, 1999 Received: February 18, 1999 Regulatory Class: II 21 CFR 876.5820/Procode: 78 MSE
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 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/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
8
510(k) Number
None assigned as of this time
K98372-
Device Name
Asahi AM-BIO Series Dialyzers
Indications for Use
- Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of ಇ. patients who have chronic renal failure or acute renal failure.
- Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a b. physician familiar with hemodialysis and familiar with the conditions of the patient.
- Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical c. studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-BIO Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-BIO Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
- 】. The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
- The reprocessing agent may be either (1) 4% formaldehyde (also known as 2. formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.3.
Date - October 21, 1998 ASAHI MEDICAL COMPANY, LTD. - AM-BIO SERIES DIAL YZER Page 11/2
9
Page 2/2
- The instructions provided by the manufacturer of the chosen reprocessing agent 3must be followed in reprocessing the dialyzer.
- The reprocessed dialyzer may be used only on dialysis systems equipped with 4. volumetric ultrafiltration controllers.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- ប្រ
Prescription Use (per 21 CFR 801.109)
Image /page/9/Picture/6 description: The image shows a simple, empty square. The square is outlined with a black border. The interior of the square is white, indicating that it is empty and contains no content or markings.
Over-the Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1983720 510(k) Number