(266 days)
The Toraysulfone™ Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.
The Toraysulfone Dialyzer, BS-L Series consists of highly permeable polysulfone hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. High permeability dialyzers must be used only in conjunction with dialysis machines equipped with an ultrafiltration controller. The Toraysulfone Dialyzer, BS-L Series is provided in a range of three sizes based on the surface area of the hollow fiber membrane. The device is gammaray sterilized and intended for single use only.
The provided text describes the "Toraysulfone Dialyzer, BS-L Series," a medical device used for hemodialysis. The information details the device's technical characteristics, its intended use, and its equivalence to predicate devices, but it does not provide explicit acceptance criteria with specific numerical targets.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study for Toraysulfone™ Dialyzer, BS-L Series
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Implied) |
|---|---|---|
| Bench Testing | All applicable tests conducted in accordance with FDA guidance. | "All samples met the acceptance criteria." "The test results establish that the Toraysulfone Dialyzer, BS-L Series possesses performance characteristics that make it acceptable for its intended use." |
| Performance Characteristics (General) | Characteristics suitable for hemodialysis treatment of patients with acute or chronic renal failure; similar flow and clearance data to predicate devices. | "The features and capabilities of the predicate and proposed devices are identical: they also have similar flow and clearance data." "Some performance characteristics... are described in published materials included in this 510(k) Notification." |
| Material | Membrane material identical to legally marketed Toraysulfone dialyzer. | "The material of the membrane (hollow fiber) of the Toraysulfone Dialyzer, BS-L Series is identical to that of the legally marketed Toraysulfone dialyzer." |
Note: The document explicitly states that "All samples met the acceptance criteria" for bench testing and that the device characteristics are "identical" or "similar" to predicate devices, implying that specific, pre-defined acceptance criteria were met. However, the exact numerical or qualitative targets for these criteria are not detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "All samples met the acceptance criteria" for bench testing, but the number of samples is not given.
- Data Provenance: Not explicitly stated as retrospective or prospective. Bench testing data is typically generated in a lab setting. The document also mentions "published materials included in this 510(k) Notification" for some performance characteristics, but their provenance (e.g., country of origin) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of information is typically relevant for studies involving subjective assessments, such as image interpretation or clinical diagnosis. The Toraysulfone Dialyzer, BS-L Series is a physical medical device, and its performance is evaluated through objective bench testing and comparison to predicate devices, rather than expert-established ground truth on a test set in the same manner as an AI algorithm.
4. Adjudication Method for the Test Set
Not applicable for a physical device undergoing bench testing. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or algorithms assess discrete outcomes and discrepancies need to be resolved. Performance for this device is based on objective measurements from bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening tools where reader performance is a key outcome. The Toraysulfone Dialyzer, BS-L Series is a treatment device, and its evaluation focuses on its physical and functional performance, not on human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical hemodialyzer, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation largely consists of:
- Objective Measurements: Results from bench testing (e.g., flow and clearance data).
- Predicate Device Performance: Performance data from already legally marketed devices (Toraysulfone Dialyzer K002512 and Fresenius Optiflux 200NR Hemodialyzer K002277), which serve as the standard for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are developed and refined, but not through a "training set" of data in the same way an AI model is.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in this context.
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SEP 2 9 2003
K030050
Page 1 of 1
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR & 807.92.
Submitter's Name: Toray Industries (America), Inc. 600 Third Avenue, 5th floor New York, NY 10016-1902 Telephone: (212) 697-8150 Contact person: Mr. Koji Hagimoto, Director, Medical and Pharmaccutical
Date of Summary: January 2, 2003
Device Name: Toraysulfone™ Dialyzer, BS-L Series
Device Classification Name: High permeability hemodialysis system (78 KDI); 21 CFR, Part 876.5860
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Toraysulfone™ Dialyzer (K002512), determined to be substantially equivalent to a legally marketed (preAmendment) device on October 15, 2001: and the Fresenius Optiflux 200NR Hemodialyzer (K002277), determined to be substantially equivalent to a legally marketed (preAmendment) device on August 25, 2000.
Device Description: The Toraysulfone Dialyzer, BS-L Series consists of highly permeable polysulfone hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. High permeability dialyzers must be used only in conjunction with dialysis machines equipped with an ultrafiltration controller. The Toraysulfone Dialyzer, BS-L Series is provided in a range of three sizes based on the surface area of the hollow fiber membrane. The device is gammaray sterilized and intended for single use only.
Intended Use: The Toraysulfone Dialyzer, BS-L Series is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The material of the membrane (hollow fiber) of the Toraysulfone Dialyzer, BS-L Series is identical to that of the legally marketed Toraysulfone dialyzer. The features and capabilities of the predicate and proposed devices are identical: they also have similar flow and clearance data.
Performance Data:
Bench Testing: Applicable testing was conducted on the Toraysulfone Dialyzer, BS-L Series in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the Toraysulfone Dialyzer, BS-L Scries possesses performance characteristics that make it acceptable for its intended use.
Clinical Evaluations: Some performance characteristics of the Toraysulfone Dialyzer, BS-L Series are described in published materials included in this 510(k) Notification.
Conclusion: The information and data provided in this 510(k) Notification establish that the Toraysulfone Dialyzer, BS-L Series is substantially equivalent to the legally marketed predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2003
Toray Industries (America), Inc. c/o Ms. Lisa Jones Regulatory Affairs Consultant Devices for the Future 540 College Street BELLAIRE, TX 77401
Re: K030050
Trade/Device Name: Toraysulfone™ Dialyzer BS-L Series Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: June 30, 2003 Received: July 1, 2003
Dear Ms. Jones:
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 (Act) that do not require approval of a premarket approval application (PMA). 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 (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 (OS) 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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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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
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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KC30050
January 2, 2003
Page 1 of 1
510(k) Number: K030050
Device Name: Toraysulfone™ Dialyzer, BS-L Series
Indications for Use: The Toraysulfone Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Qamil A. digman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.”