(129 days)
Not Found
No
The summary describes a microprocessor-controlled peristaltic pump for fluid management during arthroscopy. It mentions software verification and validation according to standard medical device software guidelines (IEC 62304) but does not mention any AI or ML specific terms, algorithms, or training/test data sets.
Yes
The device is used for fluid distension and irrigation during arthroscopic procedures, which are medical interventions. While it primarily handles fluids, its essential role in facilitating a medical procedure makes it a therapeutic device.
No
The device is an arthroscopy system designed to provide fluid distension and irrigation, as well as fluid suction during arthroscopic procedures. It functions as a pump for fluid management, not for diagnosing conditions.
No
The device description explicitly states that the DOUBLEFLO system contains a "microprocessor-controlled pump" as a main component and mentions electrical safety, EMC, biocompatibility, and sterilization testing, all of which relate to hardware components and their interaction with the body and environment. While software verification and validation are mentioned, they are part of the overall system validation, not the sole component.
Based on the provided information, the DOUBLEFLO system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures." This involves direct interaction with the body during a surgical procedure, not the examination of specimens derived from the human body.
- Device Description: The description details a pump that transports and aspirates fluid within joint cavities. This is a mechanical function performed on the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, reagents, or diagnostic purposes. IVD devices are used to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
Therefore, the DOUBLEFLO system is a surgical device used for fluid management during arthroscopic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
Product codes
HRX
Device Description
The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces.
The pump can be connected to various shaver systems.
The pump has to be used with the following tube sets:
Product Category: Tubing Set, Model Designation: DAY TUBE Set, Part Number: 72205353
Product Category: Tubing Set, Model Designation: Patient Tube Set, Part Number: 72205354
Product Category: Tubing Set, Model Designation: Inflow Tube Set, Part Number: 72205355
Product Category: Tubing Set, Model Designation: Outflow Tube Set, Part Number: 72205356
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, elbow, ankle and wrist joint cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following performance data were provided in support of the substantial equivalence determination:
Software: The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304- Medical Device Software - Software Life Cycle Processes. Software tests were conducted to satisfy the requirements of the guidance and standard. The software was considered a "moderate" level of concern. Software verification activities were performed during the "Design, coding & testing" and "Verification" phases. Outputs included unit test reports, integration test reports, system test reports, overall software test report, verification test reports, and overall software validation report. Tests were performed according to the Software Test Plan, and verification tests for each requirement according to the Software Verification Plan. Conformity of software with user needs and intended use was performed through the "Validation" phase. Design verification testing demonstrated the device performs as intended and does not raise new questions of safety and effectiveness.
Electrical safety and electromagnetic compatibility: Electrical safety and EMC testing were conducted on the DOUBLEFLO system. The device complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device.
Biocompatibility testing: The biocompatibility evaluation for DOUBLEFLO system tubing sets was conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1. These tubing sets are categorized as externally communicating devices in indirect contact with tissue/bone for a limited time (
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
April 5, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hemodia SAS % Arne Briest Managing Director VISAMED GmbH Kastellstr. 8 Karlsruhe76227 Germany
Re: K203480/S001
Trade/Device Name: DOUBLEFLO system Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: March 5, 2021 Received: March 8, 2021
Dear Mr. Briest:
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
Laura C. Rose -S
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203480
Device Name DOUBLEFLO system
Indications for Use (Describe)
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92 upon which substantial equivalence is based.
SUBMISSION SPONSOR and APPLICATION CORRESPONDANT -
A. SUBMISSION SPONSOR
HEMODIA SAS
85 rue du Chêne vert 31670 Labège - France www.hemodia.com Tel +33 (0) 5 61 00 03 50
Contact Person :
Adeline Théron Regulatory Affairs Engineer adeline.theron@hemodia.com
B. APPLICATION CORRESPONDANT
VISAMED GmbH
Kastellstr. 8 D-76227 Karlsruhe-Germany www.visamed.com Tel +49 (0) 721 476 4847
Contact Person :
Arne Briest CEO arne.briest@visamed.com
II. Dated prepared: April 5, 2021
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III DEVICE IDENTIFICATION
| Name of Device: | DOUBLEFLO system |
|---|---|
| Common Name: | Pump (Arthroscopy pump) |
| Classification Name: | Arthroscope (21 CFR § 888.1100) |
| Classification Panel: | Orthopedic |
| Regulatory Class: | II |
| Product Code: | HRX |
| 510k #: | K203480 |
- IV PREDICATE DEVICE
K192921 - ZEOS Aqua Vision Pump and tubing sets
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V. DEVICE DESCRIPTION
The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces.
The pump can be connected to various shaver systems.
The pump has to be used with the following tube sets:
| Tubing Sets | ||
|---|---|---|
| Product Category | Model Designation | Part Number |
| Tubing Set | DAY TUBE Set | 72205353 |
| Tubing Set | Patient Tube Set | 72205354 |
| Tubing Set | Inflow Tube Set | 72205355 |
| Tubing Set | Outflow Tube Set | 72205356 |
VI INDICATIONS FOR USE
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9%NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
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VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The ZEOS Aqua Vision Pump is the predicate device for the DOUBLEFLO system (pump, tubing sets and accessories).
Both pump systems are designed, developed and manufactured using the same general design principles and similar mechanical and electrical components. They have the same intended use and incorporate the same basic design. Specifically, both the ZEOS Aqua Vision Pump and tubing sets and the DOUBLEFLO system are for use during arthroscopic procedures to provide fluid irrigation and aspiration. They are both roller pumps that function according to the peristaltic principle and are to be used with specially designed tube sets.
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| Device | Predicate Devices | Subject Device | Description and Indication for Use | Technical Characteristics | Comparison Analysis |
|---|---|---|---|---|---|
| ZEOS Aqua Vision Pump | |||||
| (K192921) | DOUBLEFLO system | ||||
| (K203480) | |||||
| Illustration | Image: ZEOS Aqua Vision Pump | Image: DOUBLEFLO system | |||
| General Device | |||||
| Description | Dual Pump Arthroscopic System, the | ||||
| irrigation/aspiration system has a common | |||||
| control system with two separate pumps, one | |||||
| pump dedicated to irrigation and one pump | |||||
| dedicated to aspiration. | Dual Pump Arthroscopic System, the | ||||
| irrigation/aspiration system has a common | |||||
| control system with two separate pumps, one | |||||
| pump dedicated to irrigation and one pump | |||||
| dedicated to aspiration. | Similar overall set up and | ||||
| user interface, identical | |||||
| principle of operations | |||||
| Principle of | |||||
| operation | Microprocessor controlled | Identical | |||
| Roller Pump and automatic fluid management | |||||
| Irrigation and | |||||
| suction in one | |||||
| unit: | |||||
| Independent | |||||
| inflow/outflow | |||||
| control | Yes, two separate irrigation / aspiration | ||||
| pumps | Identical |
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Image /page/8/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features the letter 'H' in a stylized, green gradient design, with the word "hemodia" written vertically above it in a sans-serif font. Below "hemodia", the words "Medical Partner" are written in a smaller, lighter font.
| Predicate Devices | Subject Device | Comparison Analysis | |
|---|---|---|---|
| Regulates | |||
| pressure and | |||
| flow | yes | yes | Substantially |
| equivalent, the only | |||
| difference is that the | |||
| subject device maintains | |||
| the pressure constant | |||
| when the flow rate is | |||
| changed. | |||
| Maximum | |||
| allowable | |||
| pressure | 280 mmHg | 150 mmHg | The maximum preset |
| pressure allowable by the | |||
| DOUBLEFLO system | |||
| software is lower than that | |||
| of the ZEOS AQUA | |||
| VISION pump. | |||
| Substantially | |||
| equivalent. | |||
| Minimum | |||
| allowable | |||
| pressure | 20 mmHg | 5 mmHg | |
| Default pressure | |||
| at | |||
| start of the | |||
| pump | 60 mmHg | 50 mmHg | Substantially |
| equivalent. | |||
| The default pressures | |||
| defined by the | |||
| DOUBLEFLO system | |||
| software is lower than | |||
| that of the ZEOS | |||
| AQUA VISION | |||
| pump |
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| Predicate Devices | Subject Device | Comparison Analysis | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recommended | |||||||||||||
| Initial | |||||||||||||
| pressure setting | Joint | Pressure level | |||||||||||
| with tourniquet | Pressure level | ||||||||||||
| without | |||||||||||||
| tourniquet | FLUSH RATE | Shaver | |||||||||||
| suction | Joint | Pressure level with | |||||||||||
| tourniquet | Pressure level | ||||||||||||
| without | |||||||||||||
| tourniquet | RINSE SUCTION | SHAVER | |||||||||||
| SUCTION | |||||||||||||
| mmHg | LH2O | mmHg | LH2O | mmHg | mmHg | ||||||||
| Shoulder joint | / | / | 60 | 30 | Low or Med | Low or Med | Shoulder joint | / | 60 | Low or Med | Low or Med | Identical | |
| Acromioplasty | / | / | 60 | 30 | Low or Med | Med or High | Acromioplasty | / | 60 | Low or Med | Med or High | ||
| Knee scope | 30 | 10 | 65 | 30 | Low or Med | Low or Med | Knee scope | 30 | 65 | Low or Med | Low or Med | Substantially equivalent | |
| Wrist | 50-60 | 20-30 | 50-60 | 20-30 | Low or Med | Med or High | Wrist | 30 | 65 | Low or Med | Low or Med | ||
| Elbow, ankle | 30 | 10 | 65 | 30 | Low or Med | Low or Med | Elbow, ankle | 40 | 65 | Low or Med | Low or Med | Substantially equivalent | |
| Hip | 40 | 20 | 65 | 30 | Low or Med | Low or Med | Hip | / | 65 | Low or Med | Low or Med | ||
| / | / | / | 65 | 30 | Low or Med | Low or Med | / | / | 65 | Low or Med | Low or Med | ||
| Pressure Rate | |||||||||||||
| Security | |||||||||||||
| Hardware | |||||||||||||
| Flow Rate | $375 \text{mmHg}$ | $280 \pm 10 \text{mmHg}$ | Substantially equivalent | ||||||||||
| There are 4 flow rates for the Cannula | |||||||||||||
| suction and 4 flow rates for the Shaver | |||||||||||||
| Suction -> displayed by LED (MIN, | |||||||||||||
| LOW, MED and HIGH) | There are 3 flow rates for the Cannula | ||||||||||||
| suction and 3 flow rates for the Shaver | |||||||||||||
| Suction -> displayed by LED | |||||||||||||
| (LOW, MED and HIGH) | |||||||||||||
| Minimum flow | |||||||||||||
| rate | Cannula 100 mL/min | ||||||||||||
| Shaver: 200 mL/min | Cannula flow rates: 100 mL/min | ||||||||||||
| Shaver flow rates: 200 mL/min | Identical | ||||||||||||
| Maximum flow | |||||||||||||
| rate | Cannula 600 mL/min | ||||||||||||
| Shaver: 800mL/min | Cannula flow rates: 600 mL/min | ||||||||||||
| Shaver flow rates: 800 mL/min | Identical | ||||||||||||
| Interfaces | Interface with various shaver systems and | ||||||||||||
| various footswitches | Interface with a Shaver Interface Cable | Substantially | |||||||||||
| equivalent, subject | |||||||||||||
| device has additional | |||||||||||||
| interfaces no more | |||||||||||||
| functionalities |
hemodia
11
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Image /page/10/Picture/4 description: The image shows a logo for Hemodia Medical Partner. The logo features a stylized green letter "H" with a gradient effect, resembling a leaf or a drop. To the right of the "H", the word "hemodia" is written vertically, and below it, the words "Medical Partner" are written in a smaller font size.
| Predicate Devices | Subject Device | Comparison Analysis | |
|---|---|---|---|
| Control with | |||
| Footswitch | Yes, Footswitch (wired) | No | Substantially equivalent, subject |
| device has other control | |||
| such as keyboard (front | |||
| panel interface, and foot | |||
| switch from the shaver | |||
| when connected via | |||
| Shaver Interface Cable) | |||
| Control with | |||
| Remote | No | No | Identical |
| Consumable | Polymer Tubing | Polymer Tubing | Substantially equivalent |
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Image /page/11/Picture/0 description: The image contains the logo for "hemodia Medical Partner". The logo features a stylized green leaf with the letter "H" cut out of the leaf. To the right of the leaf is the word "hemodia" in a sans-serif font. Below "hemodia" is the phrase "Medical Partner" in a smaller font.
The differences in the technological characteristics of both the proposed device ZEOS Aqua Vision Pump and tubing sets and the DOUBLEFLO system is minor and do not raise new questions of safety and effectiveness.
There is no technical characteristics that differs between these devices when considering the clinical and technical support of the intended use.
Both the ZEOS Aqua Vision Pump and tubing sets and the DOUBLEFLO system are designed to be used with compatible shaver systems.
VIII PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Software
The software was developed, tested, and verified in accordance with the FDA quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:
· IEC62304- Medical Device Software - Software Life Cycle Processes.
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
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Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:
- · Unit test reports
- · Integration test reports
- · System test reports
- · Overall software test report
- · Verification test reports
- · Overall software validation report
The software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirement according to the Software Verification Plan.
Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the DOUBLEFLO system.
Design verification testing of the DOUBLEFLO system demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.
Electrical safety and electromagnetic compatibility
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the DOUBLEFLO system.
The device complies with recognized electrical safety standards:
- IEC 60601-1 standard for electrical safety o
- . IEC 60601-1-2 standard for electromagnetic compatibility.
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Image /page/13/Picture/1 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green letter 'H' with a leaf-like shape extending from the top right. To the right of the 'H' is the word 'hemodia' in a sans-serif font, with the words 'Medical Partner' in a smaller font size below it.
Biocompatibility testing
The biocompatibility evaluation for DOUBLEFLO system tubing sets has been conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 -"Biological evaluation of medical devices - Evaluation and testing within a risk management system". These tubing sets are categorized as externally communicating devices in indirect contact with tissue/bone for a limited time (