HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Device Facts
| Record ID | K261438 |
|---|---|
| Device Name | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) |
| Applicant | Eurosets S.R.L |
| Product Code | DTZ · Cardiovascular |
| Decision Date | Sep 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
HORIZON 8AF is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. HORIZON 8AF integrated arterial filter provides additional protection against air and solid emboli. HORIZON 8AF includes Horizon CVR which collects, defoams and filters venous blood and suction blood. Horizon CVR can be used post-operatively for chest drainage. HORIZON 8AF is intended to be used for 6 hours or less.
Device Story
Extracorporeal circulation system for adult cardiopulmonary bypass; consists of oxygenator with integrated heat exchanger, 38 µm arterial filter, and hard-shell cardiotomy/venous reservoir. Operates via microporous polypropylene hollow fiber membrane for gas exchange (passive diffusion); stainless-steel heat exchanger for temperature control (water-circulated); integrated filter for emboli removal. Reservoir supports gravity and vacuum-assisted venous drainage (VAVD). Used in surgical settings by perfusionists/clinicians. Provides gas exchange, temperature regulation, and blood filtration; supports post-operative chest drainage. Benefits include emboli protection and hemodynamic support during bypass.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench performance testing, including blood cell damage, gas transfer rates, pressure drop, heat exchanger performance, filtration efficiency (oxygenator and reservoir), air handling, and shipping validation (ASTM D4169).
Technological Characteristics
Sterile, single-use extracorporeal device. Microporous polypropylene hollow fiber membrane; stainless-steel heat exchanger; 38 µm polyester arterial filter. Supports gravity and vacuum-assisted venous drainage (VAVD). Ethylene oxide sterilization. Rated max blood flow 8 L/min. Membrane surface area 1.98 m2; filter surface area 330 cm2.
Indications for Use
Indicated for adult patients (22+ years) undergoing surgical procedures requiring cardiopulmonary bypass for up to 6 hours; provides gas exchange, blood temperature control, filtration of air/solid emboli, and collection/defoaming of venous/suction blood; includes post-operative chest drainage capability.
Regulatory Classification
Identification
A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
Predicate Devices
- Inspire 8F M Hollow Fiber Oxygenator with integrated AF (K180448)
- LivaNova Inspire 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
September 14, 2026
Eurosets S.R.L
% Sebastian Feye
Regulatory Consultant
Accurate Consultants, Inc.
4367 Narragansett Ave.
San Diego, California 92107
Re: K261438
Trade/Device Name: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Regulation Number: 21 CFR 870.4350
Regulation Name: Cardiopulmonary Bypass Oxygenator
Regulatory Class: Class II
Product Code: DTZ, DTR, DTM, DTN
Dated: August 3, 2026
Received: August 4, 2026
Dear Sebastian Feye:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-assistance/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).
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Sincerely,
# Meaghan Erlewein -S
For Nicole Gillette
Assistant Director
DHT2B: Division of Circulatory Support, Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261438 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | | | |
| Please provide your Indications for Use below. | | | ? |
| HORIZON 8AF is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. HORIZON 8AF integrated arterial filter provides additional protection against air and solid emboli. HORIZON 8AF includes Horizon CVR which collects, defoams and filters venous blood and suction blood. Horizon CVR can be used post-operatively for chest drainage. HORIZON 8AF is intended to be used for 6 hours or less. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |
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K261438
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Traditional 510(k) Submission
### 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807 (particularly §807.92).
# I. CONTACT DETAILS
Date Prepared: April 30, 2026
Submitter Name & Address: Eurosets S.R.L
Strada Statale 12, n°143
Medolla, 41036, Italy
Contact Person: Mrs. Katia Vescovini
Email: kvescovini@eurosets.com
Phone: 39 3402287199
# II. DEVICE
Trade or Proprietary Name: Horizon 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Common Name: Cardiopulmonary bypass oxygenator
Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: 21 CFR 870.4350 Cardiopulmonary Bypass Oxygenator
Product Code(s): DTZ (primary), DTR, DTM, DTN
Regulation Class: Class II
# III. LEGALLY MARKETED PREDICATE DEVICES
Primary Predicate Device: K180448 Inspire 8F M Hollow Fiber Oxygenator with integrated AF (Product Code: DTZ)
Additional Predicate Device: K120185 LivaNova Inspire 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (Product Code: DTZ)
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# IV. DEVICE DESCRIPTION
The Horizon 8AF System consists of the Horizon 8AF oxygenator with an integrated heat exchanger and arterial filter, together with the Horizon hard-shell cardiotomy/venous reservoir. The reservoir is intended to collect, store, and filter venous and cardiotomy suction blood during cardiopulmonary bypass procedures and is designed to support both gravity drainage and vacuum-assisted venous drainage (VAVD).
# V. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Horizon 8AF System is a sterile, single-use extracorporeal circulation device intended for adult cardiopulmonary bypass procedures. The system consists of the Horizon 8AF oxygenator with an integrated heat exchanger and 38 µm arterial filter, together with the Horizon hard-shell cardiotomy/venous reservoir.
The oxygenator utilizes microporous polypropylene hollow fiber membrane technology to provide respiratory gas exchange. Oxygen is transferred to the blood and carbon dioxide is removed by passive diffusion across the microporous membrane while blood flows externally to the hollow fibers and sweep gas flows through the fiber lumens.
Blood temperature is controlled by an integrated stainless-steel heat exchanger through circulating temperature-controlled water.
The integrated arterial filter utilizes polyester filter media with a nominal pore size of 38 µm to remove gaseous microemboli and particulate microaggregates before blood is returned to the patient.
The hard-shell cardiotomy/venous reservoir collects, filters, stores, and returns venous and cardiotomy suction blood during cardiopulmonary bypass. The reservoir incorporates venous and cardiotomy filtration and supports both gravity drainage and vacuum-assisted venous drainage (VAVD).
The device is supplied sterile, non-pyrogenic, individually packaged, and sterilized using ethylene oxide.
# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Extracorporeal circulation to support gas exchange, blood temperature control, and blood filtration/collection during cardiopulmonary bypass (CPB) is the
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shared technological principle underlying the subject device and both predicate devices. All three devices use microporous hollow fiber membrane technology to accomplish gas exchange, an integrated heat exchanger to control blood temperature, an integrated arterial filter to remove gaseous and particulate emboli from the arterial line, and a hardshell reservoir to collect, defoam, and filter venous and cardiotomy suction blood prior to return to the patient.
The Horizon 8AF is compared against a primary predicate, the LivaNova INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (K180448, cleared as a Special 510(k)), and a secondary predicate, the LivaNova INSPIRE 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir (K120185, cleared as a Traditional 510(k)). K120185 is cited as the secondary predicate because it underwent the full traditional battery of testing including the reservoir-specific testing (air handling, defoaming efficiency, dynamic priming volume, filtration efficiency) whereas K180448, as a Special 510(k) modifying an earlier cleared device, required only limited functional testing on the modified gas outlet port.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- Hollow fiber membrane oxygenation technology using microporous polypropylene fibers, with oxygen transferred to blood and carbon dioxide removed by passive diffusion across the fiber wall (blood external to the fibers, sweep gas through the fiber lumens)
- An integrated stainless-steel heat exchanger using circulating temperature-controlled water to warm or cool blood
- An integrated arterial filter positioned downstream of the oxygenator to remove gaseous microemboli and particulate microaggregates before blood is returned to the patient
- A hardshell cardiotomy/venous reservoir that collects, defoams, and filters both venous return and cardiotomy suction blood
- Reservoir support for both gravity drainage and vacuum-assisted venous drainage (VAVD)
- Single-use, sterile, non-pyrogenic device construction, terminally sterilized with ethylene oxide
- Same intended use environment and duration: adult surgical procedures requiring cardiopulmonary bypass, for periods of six hours or less
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The identified differences of the subject and predicate devices are limited to material selection and dimensional/volumetric specifications rather than a change in operating principle:
- Heat exchanger material. The Horizon 8AF uses a stainless-steel heat exchanger, compared with polyurethane in both predicates. Stainless steel is a well-characterized, widely used heat-exchange material in cardiopulmonary bypass devices with an established safety and performance history.
- Arterial filter surface area and static priming volume. The Horizon 8AF's larger filter surface area (330 cm2 vs. 97 cm2 / 68 cm2) and lower static priming volume (268 mL vs. 351 mL / 284 mL) represent design optimizations consistent with, rather than a departure from, the established technological principle larger filtration area supports the device's higher rated flow capacity.
- Membrane surface area. The larger membrane surface area (1.98 m2 vs. 1.75 m2 / 1.40 m2) is consistent with, and sized to support, the subject device's rated maximum blood flow of 8 L/min.
# VII. INDICATIONS FOR USE
HORIZON 8AF is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control.
HORIZON 8AF integrated arterial filter provides additional protection against air and solid emboli.
HORIZON 8AF includes Horizon CVR which collects, defoams and filters venous blood and suction blood. Horizon CVR can be used post-operatively for chest drainage.
HORIZON 8AF is intended to be used for 6 hours or less.
# VIII. INDICATIONS FOR USE COMPARISON
The subject device and the predicate devices have the same intended use. They are intended for use in adult surgical procedures requiring cardiopulmonary bypass. The Oxygenators provides gas exchange support and blood temperature
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control and provides additional protection against air and solid emboli. The Oxygenators are intended to be used for 6 hours or less.
The CVR indications for use are the same as the LivaNova 6F CVR which is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. The CVR can be used post-operatively for chest drainage and is intended to be used for 6 hours or less.
# IX. PERFORMANCE DATA
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) has undergone the appropriate nonclinical bench performance testing to determine its substantial equivalence to the predicate device Inspire 8F M Hollow Fiber Oxygenator with integrated AF (K180448) and Inspire 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185).
The following non-clinical bench performance tests were completed and met all acceptance criteria or the appropriate standard requirements:
1. Blood cell damage
2. Gas transfer rate and blood pressure drop
3. Heat Exchanger Performance
4. Blood pathway and connection integrity
5. Breakthrough volume
6. Dynamic hold up volume
7. Blood volume capacity
8. Oxygenator Filtration efficiency
9. Reservoir Filtration efficiency
10. Defoaming and max blood flow rate
11. Blood, water and gas pathway integrity
12. Air handling capability
13. Coating integrity, coverage and stability testing
14. Shipping validation per ASTM D4169
The Horizon 8AF system has not undergone any Clinical Testing.
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## X. CONCLUSION
The comprehensive nonclinical testing program provides substantial evidence that the Horizon 8AF system is substantially equivalent to the predicate devices. The cumulative test results provide substantial evidence that the device meets the safety parameters of the predicate device, maintains functional integrity under worst-case conditions, and fully complies with all applicable regulatory standards and guidelines. These results support the conclusion that the Horizon 8AF system performs as well as the legally marketed predicate devices while maintaining the same intended use and fundamental technological characteristics.
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