(30 days)
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
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The provided document is a 510(k) Premarket Notification for a medical device, the Fresenius Ultraflo HPX Single Use Hemodialyzer. This type of regulatory submission is specifically for demonstrating substantial equivalence to a previously cleared device, not for proving that a device meets particular acceptance criteria through clinical studies in the way a new drug or novel medical device would.
Therefore, the information you've requested regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not applicable or available within this document for the following reasons:
- No Clinical Testing: The document explicitly states: "No clinical testing was performed." The evaluation was based solely on in vitro testing to demonstrate substantial equivalence to predicate devices.
- Substantial Equivalence: The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, materials, and in vitro performance, not by establishing specific clinical acceptance criteria met by a new study.
- Safety and Effectiveness Summary vs. Efficacy Study: The information provided is a "Summary of Safety and Effectiveness" which focuses on comparing the device to existing predicate devices and summarizing in vitro test results, not detailing a large-scale clinical efficacy study with acceptance criteria.
However, I can extract the in vitro performance reported and the general assessment of equivalence:
Acceptance Criteria and Reported Device Performance
Given that no clinical acceptance criteria were established or assessed in a human study, the "acceptance criteria" here refer to the in vitro performance benchmarks derived from the predicate devices. The reported device performance indicates that the Ultraflo HPX met these benchmarks, demonstrating substantial equivalence.
| Acceptance Criteria (Inferred from Predicate Devices / In Vitro Benchmarks) | Reported Device Performance (Fresenius Ultraflo HPX) |
|---|---|
| Equivalent Priming Volume | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Bloodside Pressure Drops | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Dialysate-side Pressure Drops | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Ultrafiltration Coefficient | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Urea Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Creatinine Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Vitamin B12 Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Phosphate Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Lysozyme Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Substantially Equivalent in Construction, Design, Materials, and Intended Use | Confirmed through comparison with predicate devices. |
Study Details (Not Applicable/Available for Clinical Efficacy)
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set. In vitro testing was performed, but the sample sizes for these bench tests are not specified in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hemodialyzer, not a diagnostic imaging device typically evaluated with MRMC studies. No AI component is mentioned.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm or AI component is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for showing substantial equivalence was the in vitro performance of the predicate devices. The new device's in vitro performance was compared against these established benchmarks.
- The sample size for the training set: Not applicable. No AI model or training set is mentioned for this device.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this document describes a 510(k) submission based on in vitro testing and comparison to predicate devices to establish substantial equivalence, rather than a clinical study with detailed acceptance criteria and performance metrics as typically seen for novel devices requiring clinical efficacy data.
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KO34064
Fresenius Medical Care
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
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: | 95 Hayden AveLexington, MA 02420 |
| Phone: | 1-781-402-9068 |
| Fax: | (781) 402-9635 |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 29 December 2003 |
B. Device Name:
| Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate System |
|---|---|
| Product Code/Classification Panel: | 78KDI/Gastroenterology-Urology |
C. Predicate Device
The predicate devices for the Fresenius Ultraflo HPX Hemodialyzer are:
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Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in length from top to bottom, creating a perspective effect.
Fresenius Ultraflo HPX Sinqle Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
D. Indications for Use:
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Ultraflo HPX dialyzers are devices pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the Ultraflo HPX is identical to that for the Optiflux 200NR and Ultraflux and is as follows:
Intended Use for Ultraflux
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
Intended Use for Optiflux 200NR
Optiflux 200NR dialyzers are designed for single use acute and chronic hemodialysis.
Intended Use for Ultraflux
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Ultraflo HPX dialyzers are equivalent in materials, sterilization and indications for use to the currently manufactured Optiflux 200NR and Ultraflux dialyzers. The technological characteristics of the Ultraflo HPX dialyzers are equivalent to those of the Optiflux 200NR and Ultraflux and raise no new types of safety or effectiveness questions.
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KO3406A
Fresenius Medical Care
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Ultraflo HPX dialyzers and demonstrates that it is substantially equivalent to the Optiflux 200NR and Ultraflux.
F. Safety Summary
The Ultraflo HPX dialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux and Ultraflux hemodialyzers. In addition, testing of Ultraflo HPX dialyzers indicates that they are safe and effective for their intended use.
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
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 dialyzer.
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JAN 3 0 2004
Ms. Nichole Riek Regulatory Affairs Supervisor Frescnius Medical Care North American Two Ledgemont Center 95 Hayden Avenue LEXINGTON MA 02173
Re: K034064
Trade/Device Name: Fresenius Ultraflo HPX Single Use Hemodialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 29, 2003 Received: December 31, 2003
Dear Ms. Riek:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encream. 776, 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, de noos that have been require approval of a premarket approval application (PMA). and Cosmote Fee (110) the device, subject to the general controls provisions of the Act. The I ou may, distore, mains of the Act include requirements for annual registration, listing of general controls provision gractice, 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 i lease of advisou that i Dr instian that your device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must of any I edetar statures and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordline and quality by overse (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) I his letter will anow you to begin mative. 3 > prematication. The PDF intellight 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 If you destle specific advice tor your do to 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 Additionally, for questions on the prosse note the regulation entitled, "Misbranding Onlice of Compliance at (501) 57 - 155 (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Obliess http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. I rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid or funnel, with horizontal lines inside. Below the shape, the text "Fresenius Medical Care" is written in a clear, sans-serif font.
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Indications for Use Statement
Device Name:
Fresenius Ultraflo HPX Hemodialyzers
Indications for Use:
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K034064
000035
§ 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.”