(284 days)
The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.
The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.
This document describes the acceptance criteria and study that proves the PS 15® Hemodialyzer meets these criteria. The device is intended for hemodialysis in patients with acute or chronic renal failure.
1. Acceptance Criteria and Reported Device Performance
The PS 15® Hemodialyzer was evaluated against a predicate device, the Altrex 170 Hemodialyzer, and in some functional tests, also against the Fresenius F60 Polysulfone Dialyzer. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to these legally marketed predicate devices through comparable functional and biocompatibility test results.
Table: Acceptance Criteria (as demonstrated by predicate device performance) and PS 15® Hemodialyzer Performance
| Feature/Test | Acceptance Criteria (based on predicate Altrex 170 / Fresenius F60) | PS 15® Hemodialyzer Reported Performance |
|---|---|---|
| Functional Tests | ||
| Total Blood Volume Measured (ml) | Altrex 170: 91 ml; Fresenius F60: 83 ml | 79 ml |
| Effective Membrane Surface Area (m²) | Altrex 170: 1.61 m²; Fresenius F60: 1.25 m² | 1.5 m² |
| Wall Thickness (μ) | Altrex 170: 30 μ; Fresenius F60: 40 μ | 20 μ |
| Maximum TMP | Altrex 170: 500; Fresenius F60: 650 | 500 |
| Clearance (ml/min) - Urea | Altrex 170: 178; Fresenius F60: 185 | 171 |
| Clearance (ml/min) - Creatinine | Altrex 170: 163; Fresenius F60: 172 | 155 |
| Clearance (ml/min) - Phosphate | Altrex 170: 155; Fresenius F60: 170 | 141 |
| Clearance (ml/min) - B12 | Altrex 170: 106; Fresenius F60: 118 | 73 |
| Hemolysis | < 3% of Control (Altrex 170) | < 3% of Control |
| Pyrogenicity | Non-pyrogenic (Altrex 170) | Non-pyrogenic |
| Acute Toxicity | Meets USP (Altrex 170) | Meets USP |
| Sterility | Sterile (Altrex 170) | Sterile |
| Leakage | No Leaks (Altrex 170) | No Leaks |
| Sterilization Method | Gamma (Altrex 170) | Gamma |
| Biocompatibility Tests | Primarily "Pass" based on predicate device compliance | |
| Cytotoxicity Study (USP Elution Method) | Pass | Pass |
| ISO Sensitization Study (Guinea Pig) | Pass | Pass |
| Subchronic Intravenous Toxicity Study (Rat) | Pass | Pass |
| Acute Intracutaneous Reactivity Study (Rabbit) | Pass | Pass |
| Acute Systemic Toxicity Study (Mouse) | Pass | Pass |
| ISO Muscle Implantation Study (Rabbit) | Pass | Pass |
| Genotoxicity: Salmonella typhimurium | Pass | Pass |
| Genotoxicity: Sister Chromatid Exchange | Pass | Pass |
| Genotoxicity: Chromosomal Aberration | Pass | Pass |
| Rabbit Pyrogen Study | Pass | Pass |
| Hemolysis Study In Vitro Procedure | Pass | Pass |
| Microtoxicity and Hemolysis Test | Pass | Pass |
Note: The acceptance criteria for functional tests are based on the reported values of the predicate devices, with the expectation that the PS 15® Hemodialyzer performs comparably. For biocompatibility, the acceptance criterion is a "Pass" result, indicating the device meets established safety standards.
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size for each functional and biocompatibility test. However, the tests are described as in vitro (e.g., clearance tests) or in vivo (e.g., animal biocompatibility studies in guinea pigs, rats, rabbits, and mice). The data provenance is not specified beyond being "functional testing" and "biocompatibility testing." Given the nature of a 510(k) submission, these tests would typically be laboratory-based and conducted under controlled conditions to demonstrate device performance and safety, rather than drawing from real-world patient data. It is implied these are prospective studies conducted specifically for this submission. The country of origin for the data is not mentioned but assumed to be the manufacturer's location or a recognized testing facility.
3. Number of Experts and Qualifications for Ground Truth
This submission does not involve clinical data or medical image analysis requiring expert ground truth establishment. The "ground truth" for the functional tests comprises measured physical and chemical properties and clearance rates obtained through standardized in vitro methods. For biocompatibility tests, the ground truth is established by standardized testing protocols (e.g., USP, ISO) and the associated pass/fail criteria, which are expert-defined industry standards for medical devices, not specific human experts adjudicating individual cases.
4. Adjudication Method for Test Set
Not applicable. The reported tests are objective measurements and standardized biological/chemical assays, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device clearance for a hemodialyzer, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical hemodialyzer, not an algorithm. The reported performance metrics are for the device itself.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is derived from:
- Performance Benchmarks: Comparison to established specifications and the reported performance of legally marketed predicate devices (Altrex 170 Hemodialyzer and Fresenius F60 Polysulfone Dialyzer) for functional characteristics.
- Standardized Test Results: Pass/fail criteria from recognized in vitro and in vivo biocompatibility testing protocols (e.g., USP, ISO standards) for safety.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of this submission. The manufacturing process of the device would be subject to quality control, but this is distinct from a training set for an algorithm.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set.
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12/7/99
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required by 21 CFR 807.92(c)]
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92(a).
SUBMITTER INFORMATION L.
- Althin Medical, Inc. Company Name: a. 14620 NW 60th Avenue Company Address: b. Miami Lakes, Florida 33014-9308 (305) 823-5240 Company Phone: C. Amaury Sanchez Contact Person: ರ. Compliance Regulatory Senior Coordinator February 24, 1999 Date Summary Prepared: e.
DEVICE IDENTIFICATION ll.
- PS 15® Hemodialyzer Trade/Proprietary Name: a.
- Hemodialyzer Common Name: b.
- High Permeability Hemodialyzer 21 CFR Classification Name: C. 876.5860
Substantially Equivalent Legally Marketed Device: III.
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Althin Medical, Inc. | Altrex 170Hemodialyzer | K945597 | 3/8/95 |
| Fresenius MedicalCare | Fresenius F60Polysulfone Dialyzer | K852251 | 7/25/85 |
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The PS 15® Hemodialyzer is substantially equivalent to other predicate devices currently in commercial distribution in terms of their intended use. The fundamental technical characteristics are similar to those of the predicate devices.
IV. DEVICE DESCRIPTION
The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web.
The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.
V. INTENDED USE OF THE DEVICE
The disposable PS 150 Hemodialyzer is Intended for use in conjunction with commercially available blood tubing, blood access devices and relation we hemodialysis equipment. The intended use of the PS 150 Hemodialyzer and predicate Altrex 170 Hemodialyzer is identical in that the devices are intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. Both devices are labeled as sterite, nonpyrogenic, and for single use only. The devices are restricted to sale by or on the order of a physician.
VI. COMPARISON OF TECHNICAL CHARACTERISTICS
The design configuration of the PS 15® Hemodialyzer is similar to legally marketed devices from Althin Medical, Inc. and polysulfone membrane from Fresenius Medical Care.
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With the exception of polysulfone, the PS 15® Hemodialyzer and predicate Altrex 170 use identical materials, similar manufacturing processes, the same package and are gamma sterilized.
The polysulfone membrane used in the PS 15® Hemodialyzer is substantially equivalent to other polysulfone membranes marketed by Fresenius Medical Care. Results from the functional, chemical and biological tests demonstrate that the PS 15® Hernodialyzer is equivalent to a legally marketed device.
A comparison of the features of the PS 15® Hemodialyzer and those of the previously cleared predicate device are presented in the following table.
| Feature | PS 15®Hemodialyzer | Altrex 170Hemodialyzer |
|---|---|---|
| Classification Name | High PermeabilityHemodialyzer orartificial kidney | High PermeabilityHemodialyzer orartificial kidney |
| Classification | Class III device per21 CFR 876.5860(b) | Class III device per 21CFR 876.5860(b) |
| Panel | Gastroenterology andUrology | Gastroenterology andUrology |
| Product Code | 78KDI | 78KDI |
| Indications for Use | Same | Same |
| Product Specifications | Similar | Similar |
| Component configuration | Same | Same |
| Component functions | Same | Same |
| Compatible Hemodialysis Equipment | Same | Same |
| Labeling | Similar content | Similar content |
| Intended use | Same | Same |
| Labeled sterile, non-pyrogenic for single use only | Yes | Yes |
| Restricted to sale by or on Order of a Physician | Yes | Yes |
| Materials | PolysulfonePolycarbonatePolyurethaneABSPolyethylene | Cellulose AcetatePolycarbonatePolyurethaneABSPolyethylene |
| Design | Similar | Similar |
| Hemolysis | < 3% of Control | < 3% of Control |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Acute Toxicity | Meets USP | Meets USP |
| Sterility | Sterile | Sterile |
| Leakage | No Leaks | No Leaks |
| Sterilization Method | Gamma | Gamma |
| Packaging | Foil/PETG tray | Foil/PETG tray |
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VII. FUNCTIONAL TESTING
Functional testing has been conducted to evaluate the performance of the PS 15® Hemodialyzer. The results of the functional testing attest that the PS 150 Hemodialyzer conforms to its specifications and has demonstrated the suitability of the PS 15® Hemodialyzer for its intended use.
| PS 150® Hemodialyzer | **Altrex 170 | **Fresenius F60 | |
|---|---|---|---|
| Total Blood VolumeMeasured (ml) | 79 | 91 | 83 |
| Effective Membrane SurfaceArea (m²) | 1.5 | 1.61 | 1.25 |
| Wall Thickness (μ) | 20 | 30 | 40 |
| Maximum TMP | 500 | 500 | 650 |
| Clearance (ml/min)* | |||
| Urea | 171 | 178 | 185 |
| Creatinine | 155 | 163 | 172 |
| Phosphate | 141 | 155 | 170 |
| B12 | 73 | 106 | 118 |
*Q, 200, Q 500 in vitro Qr 10 ml/min UFR
**In Vitro Q; 0.0 ml/min
The Althin Medical, Inc., PS 15® Hemodialyzer is similar in design, construction, indication for use, and performance characteristics to other commercially available hemodialyzers. The results from nonclinical tests demonstrate that the PS 15® Hemodialyzer is substantially equivalent to predicate devices.
BIOCOMPATIBILITY TESTING VIII.
All appropriate biocompatibility tests have been performed. The following tests were performed:
| Test Name | Results |
|---|---|
| Cytotoxicity Study (USP Elution Method) | Pass |
| ISO Sensitization Study in the Guinea Pig (Maximization Method) | Pass |
| Subchronic Intravenous Toxicity Study in the Rat | Pass |
| Acute Intracutaneous Reactivity Study in the Rabbit | Pass |
| Acute Systemic Toxicity Study in the Mouse | Pass |
| ISO Muscle Implantation Study in the Rabbit | Pass |
| Genotoxicity: Salmonella typhimurium Reverse Mutation Study | Pass |
| Genotoxicity: Sister Chromatid Exchange Study | Pass |
| Genotoxicity: Chromosomal Aberration Study in Mammalian Cells | Pass |
| Rabbit Pyrogen Study | Pass |
| Hemolysis Study In Vitro Procedure | Pass |
| Microtoxicity and Hemolysis Test | Pass |
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The results of the biocompatibility testing demonstrate that the PS 150 Hemodialyzer conforms to the specifications set forth. The subject and legally marketed devices conform to similar specifications see
IX. Conclusions
The information included in this notification demonstrate that the PS 15® Hemodialyzer and predicate device are similar in design, materials, manufacturing processes, performance, safety, effectiveness, intended uses, indications, labeling and institions for use. Therefore, based on the information provided in this premarket notification, the PS 15® Hemodialyzer is considered substantially
equivalent to the predicate devices equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Public Health Service
DEC - 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Amaury Sanchez, RAC Senior Regulatory Compliance Coordinator Althin Medical, Inc. 14620 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K990643 PS 15° Polysulfone Hemodialyzer Dated: June 24, 1999 Received: June 28, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI
Dear Mr. Sanchez:
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, subject to the general controls provisions of the Act. The general controls provisions of the Act includerequirements for annual registration. Ilsting 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 dass 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 assumplions. 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 ville diagnostic cievices), please contact the Office of Compirance 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
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INDICATIONS FOR USE
510(k) Number:
Device Name:
PS 15® Polysulfone Hollow Fiber Membrane Hemodialyzer
Indications for Use:
The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.
L
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, ENT,
and Radiological Devices
510(k) Number. K990643
§ 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.”