(201 days)
Not Found
No
The device description and performance studies focus on the physical and biological characteristics of a hemoconcentrator, a passive filtration device. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
Yes
The device is designed to remove excess fluid from the blood and maintain proper hematocrit and protein concentration during cardiopulmonary bypass, which addresses a physiological condition.
No
Explanation: The device is a hemoconcentrator designed to remove excess fluid from blood, which is a therapeutic function rather than a diagnostic one. It does not measure, analyze, or interpret biological signals or data for the purpose of identifying disease or a health condition.
No
The device description clearly outlines physical components like filters, hollow fibers, cartridges, rings, connectors, potting, and O-rings, indicating it is a hardware device.
Based on the provided information, the Purema® H Hemoconcentrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to remove excess fluid from blood during cardiopulmonary bypass and for reinfusion of blood remaining in the circuit. This is a direct treatment or processing of blood within an extracorporeal circuit connected to the patient.
- Device Description: The device is a filter that physically removes fluid and molecules from blood. It's a mechanical process applied to the blood outside the body but as part of a therapeutic procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood, detect substances, or provide information for diagnosis. Its function is purely therapeutic/supportive during a medical procedure.
- Performance Studies: The performance studies focus on the device's ability to filter blood, its mechanical integrity, and its biocompatibility with blood. These are typical performance characteristics for devices that interact directly with blood for treatment purposes, not for diagnostic analysis.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Purema® H Hemoconcentrator's function is to process blood during a medical procedure, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories.
The Purema® H Hemoconcentrator Models DP07HC, DP09HC, and DP12HC are intended to be used for adult patients.
Product codes
KDI
Device Description
Purema® H hemoconcentrators are single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). Purema® H hemoconcentrators are hemoconcentrators of various dimensions that can be used in treatments which require the removal of liquids that are in excess. Blood is pumped through a membrane that has high permeability, and the pressure gradient, through the membrane (TMP) determines the passage of water and molecules with a mechanism that is similar to glomerular filtration (convective mechanism). The fraction of filtrated liquid depends on the osmotic pressure, hydrostatic transmembrane pressure, the surface, membrane permeability and patient hematocrit. The Purema® H hemoconcentrators are designed to be used in a healthcare facility.
Purema® H hemoconcentrators can be sterilized using Ethlyene Oxide (EtO). The EtO sterilized Purema® H hemoconcentrators consist of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings.
The EtO sterilized Purema® H Hemoconcentrator is available in three models: DP07HC, and DP12HC. The main differences in these models are their total membrane surface areas. Details the technical features of each model.
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
adult patients
Intended User / Care Setting
hospital setting
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)
The following biological safety, mechanical characteristics, performance characteristics, and hemocompatibility studies were performed, the results of which demonstrate that the EtO sterilized Purema® H Hemoconcentrators are substantially equivalent to the predicate device, the Terumo Capiox Hemoconcentrator:
Biological Safety:
- In vitro sterility ●
- Non pyrogenicity
Mechanical Characteristics:
- Blood Compartment Integrity ●
- Structural integrity
- Hemoconcentrator blood and filtrate ports
Performance Characteristics:
- Solute clearance
- Sieving coefficient (SC) for albumin
- Ultrafiltration coefficient
- Pressure drop of the blood compartment
Hemocompatibility:
- Plasma free Hemoglobin
- White Blood Cells and Platelets counts
- o Blood Clotting at minimum flow rate
The biocompatibility evaluation for the EtO sterilized Purema H Hemoconcentrator was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Tests conducted:
- Cytotoxicity (ISO 10993-5 (2009) and ISO 10993-11 (2017))
- Acute systemic toxicity tests (ISO 10993-5 (2009) and ISO 10993-11 (2017)))
- Intracutaneous reactivity irritation (ISO 10993-12)
- Guinea pig maximization sensitization (delayed hypersensitivity test) (ISO 10993-12)
- Material-mediated pyrogen (USP )
- Reverse Mutation Assay using Bacteria (ISO 10993-1; ISO 10993-3; ISO 10993-12; and ISO/TR 10993-33)
- Mammalian Cell Gene Mutation Assay (ISO 10993-1; 10993-3; and 10993-12)
- Sc5b-9 complement activation assay (FDA Biocompatibility Guidance and ISO 10993-4:2017)
- Non-activated Partial Thromboplastin Time (PTT) assay (ASTM F2382-18)
- Platelet and Leukocyte Count assay (ASTM F2888-19)
All testing met predetermined testing criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2024
Tecnoideal America % Ahmad Bayat Sr. Director Amarex Clinical Research, LLC 20201 Century Blvd, Fourth Floor Germantown, Maryland 20874
Re: K232171
Trade/Device Name: Purema® H Hemoconcentrator (EtO Sterilized) Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: January 9, 2024 Received: January 9, 2024
Dear Ahmad Bayat:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Maura Rooney -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232171
Device Name Purema® H Hemoconcentrator
Indications for Use (Describe)
The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories.
The Purema® H Hemoconcentrator Models DP07HC, DP09HC, and DP12HC are intended to be used for adult patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
6 510(K) SUMMARY 6.1 OWNER INFORMATION
This Premarket Notification is submitted by:
Tecnoideal America
7600 Standish Place Derwood, Maryland 20855
Phone: +1 (240) 403 4063 Fax: +1 (240) 801-8875 Email: office@tecnoidealamerica.com Website: https://tecnoidealamerica.com
Tecnoideal Contact: Paul Rodbhajon Email: prodbhajon@tecnoidealamerica.com
MEDICA S.p.A is the parent company of Tecnoideal America.
Correspondent Contact Information:
Ahmad Bayat, M.D.
Tecnoideal America Authorized Representative Sr. Director, Regulatory Affairs Amarex Clinical Research, LLC 20201 Century Blvd, Fourth Floor Germantown, MD 20874
Phone: (301) 956-2523 Fax: (301) 528-2300 Email: ahmadb(@amarexcro.com
Date Prepared:
July 21, 2023
5
6.2 DEVICE NAME
Device Trade/Proprietary Name: Purema® H Hemoconcentrator Common Name: Hemoconcentrator Classification: Dialyzer, High Permeability with or without Sealed Dialysate System Regulatory Class: Class 2 Product Code: KDI Regulation Number: 21 CFR Part 876.5860
DEVICE DESCRIPTION 6.3
Purema® H hemoconcentrators are single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). Purema® H hemoconcentrators are hemoconcentrators of various dimensions that can be used in treatments which require the removal of liquids that are in excess. Blood is pumped through a membrane that has high permeability, and the pressure gradient, through the membrane (TMP) determines the passage of water and molecules with a mechanism that is similar to glomerular filtration (convective mechanism). The fraction of filtrated liquid depends on the osmotic pressure, hydrostatic transmembrane pressure, the surface, membrane permeability and patient hematocrit. The Purema® H hemoconcentrators are designed to be used in a healthcare facility.
Purema® H hemoconcentrators can be sterilized using Ethlyene Oxide (EtO). The EtO sterilized Purema® H hemoconcentrators consist of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings.
The EtO sterilized Purema® H Hemoconcentrator is available in three models: DP07HC, and DP12HC. The main differences in these models are their total membrane surface areas. Details the technical features of each model.
| DP07HC | DP09HC | DP12HC | |
|---|---|---|---|
| Fiber material | Polyethersulfone (Purema® H) | ||
| Surface area (m²) | 0.7 | 0.9 | 1.2 |
| Blood Ports | Twist Lock | ||
| Filtrate Ports | Female Luer Lock | ||
| Max TMP (mmHg) | 500 | ||
| Max Blood Flow (ml/min) | 300 | 300 | 400 |
| Min. Blood Flow Rate (ml/min) | 100 | 100 | 100 |
| Priming Volume (ml) | 49 | 57 | 75 |
| Sterilization | EtO | ||
| Fiber internal diameter (µm) | 200 | ||
| Fiber external diameter (µm) | 260 | ||
| Fiber Wall thickness (µm) | 30 | ||
| Fiber length (mm) | 140 | 225 | |
| Number of fibers | 9.300 | 11.000 | 9.300 |
Table 1. Technical Features of Purema® H Hemoconcentrator Models DP07HC, and DP12HC
6
| DP07HC | DP09HC | DP12HC | |
|---|---|---|---|
| Filter housing internal diameter (mm) | 38 | ||
| Potting compound | Polyurethane | ||
| Housing material | Polycarbonate (PC) | ||
| Cap material | Polycarbonate (PC) | ||
| Total length (mm) | 180 | 265 | |
| Ulltrafiltration rate (ml/h/mmHg) | 32 | 41 | 55 |
6.4 INTENDED USE
The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories.
The Purema® H Hemoconcentrator Models DP07HC, and DP12HC are intended to be used for adult patients.
6.5 INDICATIONS OF USE
Same as intended use.
7
6.6 PREDICATE DEVICE
| Name of Device: | CAPIOX® Hemoconcentrator |
|---|---|
| Common Name: | Hemoconcentrator |
| Classification: | Dialyzer, High Permeability with or without Sealed Dialysate System |
| Regulatory Class: | Class 2 |
| Product Code: | KDI |
The proposed predicate device for the Purema® H Hemoconcentrator is the CAPIOX® Hemoconcentrator [510(k) number K973516] from Terumo Medical Corp., a Class II medical device cleared by the FDA and marketed in the US under regulation 21CFR Part 876.5860 (Product Code: KDI). The CAPIOX® Hemoconcentrator was used to established substantial equivalence.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6.7 PREDICATE DEVICE
The EtO sterilized Purema® H hemoconcentrators and the predicate device, the Terumo Capiox Hemoconcentrator have the same intended use and indication for use, as shown in Table 2. Both the Purema® H hemoconcentrators Terumo Capiox Hemoconcentrator have similar specifications as seen in Table 2 below. Both devices are based on the same technological elements: they provide ultra filtration rates which permit the sufficient removal of excess fluid by a slight hydrostatic pressure differential across the membrane without loss of essential plasma proteins.
| | Purema® H Hemoconcentrator
(EtO Sterilized) | | | Terumo Capiox Hemoconcentrator
[K973516] | |
|-------------------------------|------------------------------------------------|--------|--------|---------------------------------------------------------------------|-------|
| | DP07HC | DP09HC | DP12HC | HC05 | HC11 |
| Fiber material | Polyethersulfone | | | Polysulfone | |
| Surface area (m²) | 0.7 | 0.9 | 1.1 | 0.5 | 1.1 |
| Intended Use | Adult | | | Pediatric | Adult |
| Blood Ports | Twist Lock | | | 1/4" (6,4 mm) slip | |
| Filtrate Ports | Female Luer Lock | | | 1/2" (12,7 mm) (1/4" 6,4 mm adapter) | |
| Max TMP (mmHg) | 500 | | | 500 | |
| Max Blood Flow (ml/min) | 300 | 300 | 400 | 500 | |
| Min. Blood Flow Rate (ml/min) | 100 | 100 | 100 | 100 | 100 |
| Priming Volume (ml) | 49 | 57 | 75 | 34 | 67 |
| Sterilization | EtO | | | EtO | |
| Intended Use | The Purema® H Hemoconcentrator is designed to | | | The CAPIOX Hemoconcentrator is designed to remove excess fluid from | |
Table 2. Technological Characteristics, Intended Use, and Indications for Use Compared to Predicate Device
8
| | Purema® H Hemoconcentrator
(EtO Sterilized) | | | Terumo Capiox Hemoconcentrator
[K973516] | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | DP07HC | DP09HC | DP12HC | HC05 | HC11 |
| | remove excess fluid from the
blood to maintain proper
hematocrit and protein
concentration during
cardiopulmonary bypass and to
enable reinfusion of blood
remaining in the circuit after
bypass. | remove excess fluid from the
blood to maintain proper
hematocrit and protein
concentration during
cardiopulmonary bypass and to
enable reinfusion of blood
remaining in the circuit after
bypass. | remove excess fluid from the
blood to maintain proper
hematocrit and protein
concentration during
cardiopulmonary bypass and to
enable reinfusion of blood
remaining in the circuit after
bypass. | the blood in order to maintain proper
hematocrit and protein concentration
during cardiopulmonary bypass and to
enable reinfusion of blood remaining
in the circuit after bypass. | |
| | It is intended to be used in a
hospital setting, in connection
with a suitable circuit for
extracorporeal blood circulation
and a pump that regulates its flow.
There are no other accessories. | | | It is intended to be used during and
after surgical procedures requiring
cardiopulmonary bypass (up to 6
hours) when the removal of excess
fluid from blood is required. It should
not be used as a dialyzer, hemofilter or
other device. | |
| Indications for Use | Same as intended use. | | | Same as intended use. | |
The following biological safety, mechanical characteristics, performance characteristics, and hemocompatibility studies were performed, the results of which demonstrate that the EtO sterilized Purema® H Hemoconcentrators are substantially equivalent to the predicate device, the Terumo Capiox Hemoconcentrator:
Biological Safety:
- In vitro sterility ●
- Non pyrogenicity
Mechanical Characteristics:
- Blood Compartment Integrity ●
- Structural integrity
- Hemoconcentrator blood and filtrate ports
Performance Characteristics:
- Solute clearance
- Sieving coefficient (SC) for albumin
- Ultrafiltration coefficient
- Pressure drop of the blood compartment
Hemocompatibility:
- Plasma free Hemoglobin
- White Blood Cells and Platelets counts
- o Blood Clotting at minimum flow rate
Confidential
9
6.8 MARKETING HISTORY
Purema® H Hemoconcentrators are CE marked in Europe.
6.9 PERFORMANCE DATA
The biocompatibility evaluation for the EtO sterilized Purema H Hemoconcentrator was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
A summary of the biocompatibility tests condcuated is shown in
| Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5 (2009) and ISO 10993-11 |
| (2017) | |
| Acute systemic toxicity tests | ISO 10993-5 (2009) and ISO 10993-11 |
| (2017)) | |
| Intracutaneous reactivity irritation | ISO 10993-12 |
| Guinea pig maximization sensitization | |
| (delayed hypersensitivity test) | ISO 10993-12 |
| Material-mediated pyrogen | USP |
| Reverse Mutation Assay using Bacteria | ISO 10993-1; ISO 10993-3; ISO 10993-12; |
| and ISO/TR 10993-33 | |
| Mammalian Cell Gene Mutation Assay | ISO 10993-1; 10993-3; and 10993-12 |
| Sc5b-9 complement activation assay | FDA Biocompatibility Guidance and ISO |
| 10993-4:2017 | |
| Non-activated Partial Thromboplastin Time (PTT) | |
| assay | ASTM F2382-18 |
| Platelet and Leukocyte Count assay | ASTM F2888-19 |
All testing met predetermined testing criteria.
6.10 CONCLUSIONS
The comparison of performances, technological characteristics, and intended use/indications for use between the EtO Sterilized Purema® H Hemoconcentrator (models DP07HC, and DP12HC) and the comparator, the CAPIOX® Hemoconcentrator (models HC05 and HC11), indicate that the Purema® H Hemoconcentrator is substantially equivalent to the predicate device.
10
7 FINANCIAL CERTIFICATION OR DISCLOSURE STATEMENT
This section is not applicable.