(68 days)
The Fresenius Optiflux® F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Fresenius Optiflux® F250NR dialyzer is substantially equivalent in construction, design, materials, and intended use to the commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzer.
The provided document is a 510(k) summary for a medical device called the Fresenius Optiflux® F250NR Dialyzer. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, many of the requested elements pertaining to AI studies, reader performance, ground truth, and training sets are not applicable to this document. The information focuses on device characteristics, intended use, and comparison to predicate devices, not on the performance of a diagnostic algorithm.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the "acceptance criteria" for the 510(k) submission are based on demonstrating substantial equivalence to existing predicate devices in terms of construction, design, materials, and intended use. Performance is implicitly assessed through bench testing to ensure safety and effectiveness for its intended use, rather than clinical efficacy studies often found with novel diagnostic tools.
| Criterion Type (Implicit for 510(k)) | Description/Performance |
|---|---|
| Intended Use | The device is intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Reported Performance: The intended use is stated to be equivalent to the predicate devices (Baxter Xenium dialyzer model 210 and Asahi Rexeed model 25S). |
| Technological Characteristics | The device's technological characteristics are equivalent to predicate devices and raise no new types of safety or effectiveness questions. Reported Performance: Directly stated that the technological characteristics are equivalent. |
| Construction, Design, Materials | Substantially equivalent to commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzers. Reported Performance: Stated as substantially equivalent. |
| Safety and Effectiveness | Testing of the Fresenius Optiflux F250NR dialyzer indicates it is safe and effective for its intended use. This is a general claim based on bench testing (not detailed in this summary), rather than specific human efficacy metrics. |
2. Sample Size Used for the Test Set and Data Provenance:
- This document describes a medical device (dialyzer), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study.
- The safety and effectiveness assessment is based on device testing (bench testing usually for dialyzers) and comparison to predicate devices. Details of specific testing parameters and sample sizes for this testing are not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI algorithm validation. The "data" involves engineering and performance characteristics of the physical dialyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This is not an AI-assisted diagnostic device, so there is no ground truth established by experts for a test set in that sense. The "ground truth" for a dialyzer's performance would be established through engineering specifications, validated test methods (e.g., in vitro clearance and ultrafiltration tests), and regulatory standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No expert adjudication process for image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, for diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is not an AI algorithm.
7. The Type of Ground Truth Used:
- For a dialyzer, the "ground truth" for its performance characteristics (e.g., solute clearance, ultrafiltration rate, blood compatibility) is established through in vitro performance testing against validated standards and specifications, typically under laboratory conditions. There is no pathology, outcomes data, or expert consensus used as ground truth in the context of diagnostic accuracy for this type of device.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no training set.
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K082414 page 1 of 4
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OCT 2 8 2008
Confidentialresenius Medical C Fresenius Optiflux® F250NR Dialyzer 510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America | |
|---|---|---|
| Address: | 920 Winter StreetWaltham, MA 02451-1457 | |
| Phone: | 1-781-699-4475 | |
| Fax: | (781) 699-9635 | |
| Contact Person: | Janet C. Kay RAC Regulatory Affairs Manager | |
| Date of Preparation: | January 23, 2007 |
B. Device Name:
Proprietary Name:
Common Name:
Optiflux® F250NR dialyzer
Dialyzer, High Permeability with or without Sealed Dialysate System
Product Code/Classification Panel:
78KDI/Gastroenterology-Urology
Classification:
Class II per §876.5860
53
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X0824/4 pgx 2014
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C. Predicate Devices
The Optiflux F250NR dialyzer is substantially equivalent to the Baxter Xenium 210 dialyzer and the Rexeed 25S dialyzer.
Baxter Xenium Dialyzer Model 210
- K062079 (10/19/2006) �
Asahi Kasei Rexeed Dialyzer Model 25S
- . K051187 (6/8/05)
D. Indications for Use/Intended Use:
The Optiflux F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
E. Substantial Equivalence:
5. Is the product a device?
YES - The Fresenius Optiflux F250NR dialyzer is a device pursuant to 21 CFR §201 [321] (h).
6. Does the new device have the same intended use?
YES - The intended use for the Fresenius Optiflux F250NR dialyzer is equivalent to the Baxter Xenium dialyzer model 210 and Asahi Rexeed model 25S
Fresenius Optiflux F250NR dialyzer - Intended Use
Optiflux F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
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Ko 824/4 page 304
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Baxter Xenium dialyzer model 210 - Intended Use
Hemodialysis with Xenium dialyzers is indicated for patients with renal failure with conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Asahi Rexeed dialyzer model 25S - Intended Use
Asahi Rexeed dialyzers are intended for use in hemodialysis treatments in patients who have chronic or acute renal failure.
7. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The technological characteristics of the Fresenius Optiflux F250NR dialyzer is equivalent to that of the Baxter Xenium model 210 dialyzer and Asahi Rexeed 25S and raises no new types of safety or effectiveness questions.
8. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius Optiflux F250NR and that the performance characteristics and other information supplied demonstrate that it is substantially equivalent to the Baxter Xenium dialyzer and Ashai Rexeed 25S.
F. Safety Summary
The Fresenius Optiflux® F250NR dialyzer is substantially equivalent in construction, design, materials, and intended use to the commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzer. In addition, testing of the Fresenius Optiflux F250NR dialyzer indicates that it is safe and effective for its intended use.
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K08244 page 4 of 4
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G. General Safety and Effectiveness Concerns
The device labeling contains a package insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the Fresenius F250NR dialyzer.
Jarch ckay
Janet C. Kay RAC, Regulatory Affairs Manager
19-Aug-2008
Date
RQ
8-20-08
55 6 126
56
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2008
Janet C. Kay, RAC Regulatory Affairs Manager Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K082414
Trade/Device Name: Fresenius Optiflux® F250NR Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 20, 2008 Received: August 21, 2008
Dear Ms. Kay:
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 such 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.
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Page 2
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K00-0414 page 1 of 1
Confidential
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Fresenius Optiflux® F250NR Dialyzer
Device Name:
Fresenius Optiflux® F250NR Dialyzer
Indications for Use:
The Fresenius Optiflux® F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K082414
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Fresenius Medical Care North America
Corporate Headquarters: 920 Winter Street Waltham, MA 02451-1457 781-699-9000
58
§ 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.”