Purema H Hemoconcentrator - Pediatric

K243920 · Medica USA, Inc. · KDI · Sep 19, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K243920
• Device Name: Purema H Hemoconcentrator - Pediatric
• Applicant: Medica USA, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Sep 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Purema® H Hemoconcentrator - Pediatric 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 - Pediatric model DP03HC is intended to be used for pediatric patients.

Device Story

Purema® H Hemoconcentrator - Pediatric is a single-use device for fluid removal during cardiopulmonary bypass. It utilizes a polyethersulfone hollow fiber membrane to perform convective filtration, mimicking glomerular filtration. Blood is pumped through the membrane; hydrostatic transmembrane pressure (TMP) drives water and molecule passage while retaining essential plasma proteins. Used in hospital settings by clinical staff, the device integrates into an extracorporeal blood circulation circuit with an external pump. Output is the concentrated blood returned to the patient. Benefits include maintenance of proper hematocrit and protein levels and efficient blood salvage post-bypass.

Clinical Evidence

Bench testing only. Performance evaluated via biological safety (sterility, non-pyrogenicity), mechanical characteristics (blood compartment integrity, structural integrity), performance characteristics (solute clearance, albumin sieving coefficient, ultrafiltration coefficient, pressure drop), and hemocompatibility (plasma free hemoglobin, cell counts, clotting). Biocompatibility testing followed ISO 10993-1, including cytotoxicity, systemic toxicity, sensitization, and complement activation. All testing met predetermined acceptance criteria.

Technological Characteristics

Single-use hemoconcentrator; polyethersulfone hollow fiber membrane; cartridge, rings, connectors, potting, O-rings. Sterilized via Ethylene Oxide (EtO). Max TMP 500 mmHg; max blood flow 300 ml/min; priming volume 21 ml. Mechanical filtration principle. No software or electronic components.

Indications for Use

Indicated for pediatric patients requiring removal of excess fluid from blood to maintain hematocrit and protein concentration during cardiopulmonary bypass and for reinfusion of blood remaining in the circuit after bypass.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• CAPIOX® Hemoconcentrator (K973516)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

September 19, 2025

MEDICA USA Inc.
% Ahmad Bayat
Sr. Director II, Regulatory Affairs
Amarex Clinical Research, LLC.
20201 Century Blvd, Fourth Floor
Germantown, Maryland 20874

Re: K243920
Trade/Device Name: Purema® H Hemoconcentrator - Pediatric
Regulation Number: 21 CFR 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: Class II
Product Code: KDI
Dated: August 15, 2025
Received: August 15, 2025

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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" (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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Gema Gonzalez -S

Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K243920 | |
| Device Name Purema® H Hemoconcentrator - Pediatric | |
| Indications for Use (Describe) The Purema® H Hemoconcentrator - Pediatric 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 - Pediatric model DP03HC is intended to be used for pediatric patients. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K243920
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MEDICA USA
Purema® H Hemoconcentrator - Pediatric
Premarket Notification 510(k)

# 510(K) SUMMARY

## OWNER INFORMATION

This Premarket Notification is submitted by:

## MEDICA USA

5610 Rowland Road, STE 145

Minnetonka, MN 55343

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Website: https://us.medica-spa.com/

Company Contact: Greg Collins

Email: [e-mail]

## MEDICA USA is fully controlled by MEDICA S.p.A.

Correspondent Contact Information:

## Ahmad Bayat, M.D.

MEDICA USA Authorized Representative

Sr. Director II, Regulatory Affairs

Amarex Clinical Research, LLC

20201 Century Blvd, Fourth Floor

Germantown, MD 20874

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Date Prepared:

December 18, 2024

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MEDICA USA
Purema® H Hemoconcentrator - Pediatric
K243920
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Premarket Notification 510(k)

# DEVICE NAME

Device Trade/Proprietary Name: Purema® H Hemoconcentrator - Pediatric
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

The Purema® H Hemoconcentrator - Pediatric is a single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). The Purema® H Hemoconcentrator - Pediatric is a hemoconcentrators 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 transmembrane pressure (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 Hemoconcentrator - Pediatric is designed to be used in a healthcare facility.

Purema® H Hemoconcentrator - Pediatric is sterilized using Ethylene Oxide (EtO). The EtO sterilized device consists of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings. The EtO sterilized Purema® H Hemoconcentrator - Pediatric is available in model DP03HC.

# INTENDED USE

The Purema® H Hemoconcentrator - Pediatric 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 - Pediatric model DP03HC is intended to be used for pediatric patients.

# INDICATIONS OF USE

The Purema® H Hemoconcentrator - Pediatric 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 - Pediatric model DP03HC is intended to be used for pediatric patients.

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K243920
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MEDICA USA
Purema® H Hemoconcentrator - Pediatric
Premarket Notification 510(k)

# 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

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The EtO sterilized Purema® H Hemoconcentrator - Pediatric and the predicate device, the Terumo Capiox Hemoconcentrator have the same intended use and indication for use, as shown in Table 1. Both the Purema® H Hemoconcentrator – Pediatric and the Terumo Capiox Hemoconcentrator (specifically pediatric model HC05) have similar specifications as seen in Table 1. 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.

Table 1. Technological Characteristics, Intended Use, and Indications for Use Compared to Predicate Device

| | Purema® H Hemoconcentrator - Pediatric | Terumo Capiox Hemoconcentrator [K973516] | |
| --- | --- | --- | --- |
| | DP03HC | HC05 | HC11 |
| Fiber material | Polyethersulfone | Polysulfone | |
| Surface area (m²) | 0.3 | 0.5 | 1.1 |
| Intended Use | Pediatric | 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 | 500 | |
| Min. Blood Flow Rate (ml/min) | 50 | 100 | 100 |
| Priming Volume (ml) | 21 | 34 | 67 |
| Sterilization | EtO | EtO | |
| Intended Use | The Purema® H Hemoconcentrator - Pediatric 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. | The CAPIOX 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. | |

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K243920
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MEDICA USA
Purema® H Hemoconcentrator - Pediatric
Premarket Notification 510(k)

| | Purema® H Hemoconcentrator - Pediatric | Terumo Capiox Hemoconcentrator [K973516] | |
| --- | --- | --- | --- |
| | DP03HC | HC05 | HC11 |
| | 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 cardio-pulmonary 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. | |

# PERFORMANCE TESTS

The following biological safety, mechanical characteristics, performance characteristics, and hemocompatibility studies were performed, the results of which demonstrate substantial equivalence to the predicate device:

## 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
- Blood Clotting at minimum flow rate

The biocompatibility evaluation for the EtO sterilized Purema H Hemoconcentrator - Pediatric 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 is shown below:

| 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)) |

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K243920
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MEDICA USA
Purema® H Hemoconcentrator - Pediatric
Premarket Notification 510(k)

| Test | Standard |
| --- | --- |
| Intracutaneous reactivity irritation | ISO 10993-12 |
| Guinea pig maximization sensitization (delayed hypersensitivity test) | ISO 10993-12 |
| Material-mediated pyrogen | USP <151> |
| 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.

## CONCLUSIONS

The comparison of performances, technological characteristics, and intended use/indications for use between the EtO Sterilized Purema® H Hemoconcentrator - Pediatric (model DP03HC) and the comparator, the CAPIOX® Hemoconcentrator, indicate that the Purema® H Hemoconcentrator - Pediatric is substantially equivalent to the predicate device.

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