DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

K221919 · Hemodia Sas · HRX · Mar 9, 2023 · Orthopedic

Device Facts

• Record ID: K221919
• Device Name: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
• Applicant: Hemodia Sas
• Product Code: HRX · Orthopedic
• Decision Date: Mar 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets 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.

Device Story

Micro-processor controlled peristaltic pump; transports sterile saline for joint cavity distension/irrigation and aspiration during arthroscopy. Operated by clinical staff in surgical settings. Features RFID-based tubing recognition system for traceability, usage control, and anti-counterfeiting; RFID reader on pump interfaces with encrypted tags on tubing. Includes remote, foot-control, and hand-control interfaces. Software manages pump operation, tubing validation, and pressure loss compensation. Output provides controlled fluid flow to surgical site; assists visualization and joint management during orthopedic procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including functional performance, usability, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and sterilization validation (ISO 11135).

Technological Characteristics

Peristaltic roller pump; microprocessor-controlled. Connectivity via cable to interfaces (remote, foot/hand controls). RFID reader for tubing authentication. Materials meet ISO 10993 standards. Sterilization via Ethylene Oxide (EO). Software-controlled pressure loss compensation. Form factor: pump unit with associated tubing sets.

Indications for Use

Indicated for fluid distension, irrigation, and suction of knee, shoulder, hip, elbow, ankle, and wrist joint cavities during arthroscopy procedures using 0.9% NaCl saline.

Regulatory Classification

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.

Predicate Devices

• DOUBLEFLO System (K203480)

Reference Devices

• ZEOS Aqua Vision Pump and tubing sets (K192921)

Submission Summary (Full Text)

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March 9, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue font.

Hemodia SAS % Arne Briest Managing Director VisaMed GmbH Kastellstr. 8 Karlsruhe, 76227 Germany

Re: K221919

Trade/Device Name: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 7, 2023 Received: February 7, 2023

Dear Arne 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/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.

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sara S. Thompson -S

For

Laurence D. Coyne, Ph.D. 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

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## Indications for Use

510(k) Number (if known) K221919

Device Name DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

Indications for Use (Describe)

The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets 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) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows a logo for a company called "hemodic Medical Partner". The logo features a stylized green shape resembling a leaf or a drop, with the letter "H" embedded within it. The word "hemodic" is written in a simple, sans-serif font to the right of the green shape, and the words "Medical Partner" are written in a smaller font size below "hemodic".

TRADITIONAL 510(k) PREMARKET NOTIFICATION ⁄ 221919 DOUBLEFLO INFLOW/OUTFLOW PUMP,

accessories and tubing sets

# K221919

#### 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 [phone]

#### Contact Person :

Anne-Lyse Miard Regulatory Affairs Engineer [e-mail]

#### B. APPLICATION CORRESPONDANT

VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe-Germany www.visamed.com Tel [phone]

Contact Person : Arne Briest CEO [e-mail]

#### II. Dated prepared: March 9, 2023

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Image /page/4/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a green abstract shape resembling a stylized leaf or droplet, with the letter 'H' embedded within it. To the right of the symbol, the word 'hemodia' is written in a lowercase, sans-serif font. Below 'hemodia', the words 'Medical Partner' are written in a smaller, sans-serif font.

#### lll DEVICE IDENTIFICATION

| Name of Device: | DOUBLEFLO INFLOW/OUTFLOW PUMP,<br>accessories and tubing sets |
|------------------------------------------|---------------------------------------------------------------|
| Common Name: | Pump (Arthroscopy pump) |
| Classification Name: | Arthroscope (21 CFR § 888.1100) |
| Classification Panel: | Orthopedic |
| Regulatory Class<br>(pump and tubings) : | II |
| Product Code: | HRX |
| 510k #: | K221919 |

#### IV PREDICATE DEVICE

| Predicate Device | K203480 - DOUBLEFLO System |
|------------------|-------------------------------------------------|
| Reference Device | K192921 - ZEOS Aqua Vision Pump and tubing sets |

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Image /page/5/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a green, stylized leaf shape with the letter 'H' embedded within it. To the right of the leaf is the word 'hemodia' in a lowercase, sans-serif font. Below 'hemodia' are the words 'Medical Partner' in a smaller font size.

#### > DEVICE DESCRIPTION

The DOUBLEFLO INFLOW/OUTFLOW PUMP is a micro-processor 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 accessories / shaver systems.

The pump has to be used with the following tube sets:

| Product Category | Model Designation | Part Number |
|------------------|----------------------------|-------------|
| Tubing Set | DOUBLEFLO DAY TUBE SET | 72205772 |
| Tubing Set | DOUBLEFLO PATIENT TUBE SET | 72205773 |
| Tubing Set | DOUBLEFLO INFLOW TUBE SET | 72205774 |
| Tubing Set | DOUBLEFLO OUTFLOW TUBE SET | 72205765 |

## VI INDICATIONS FOR USE

The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets 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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Image /page/6/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' embedded within it, and the word 'hemodia' is written in a simple, sans-serif font to the right of the leaf. Below 'hemodia' are the words 'Medical Partner' in a smaller font size.

#### VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The DOUBLEFLO system (K203480) is the predicate device for the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets.

Each pump systems mentioned above 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, each predicates devices and DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets are for use during arthroscopic procedures to provide fluid irrigation and aspiration. They are roller pumps that function according to the peristaltic principle and are to be used with specially designed tube sets.

The DOUBLEFLO System, and the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets are designed to be used with compatible accessories.

The features and technical characteristics that differ from the previous version of DOUBLEFLO system (K203480 - pump, with associated accessories and tubing sets) manufactured by HEMODIA SAS, and that are considered in this 510(k) submission are:

- Addition of compatible pump accessories: addition of a Remote, Foot -Control Interfaces, Hand Control Interfaces, Footswitch, and Power Cords,
- The DOUBLEFLO INFLOW/OUTFLOW PUMP is now equipped with a tubing recognition system. This system allows precise traceability of the tubing, allows the control of the use of the tubing (e.g. the pump use a preprogrammed algorithm according to the tubing used: DOUBLEFLO DAY TUBE SET or DOUBLEFLO INFLOW TUBE SET or the pump discard outdated tubing), but also allows protection against copying. This technical solution is made possible by the addition of an RFID (Radio Frequency ldentification) reader on the DOUBLEFLO INFLOW/OUTFLOW PUMP and a label on each tubing (RFID Tag containing encrypted data),
- Software revision, to implement the tubing recognition using RFID system -(reader and RFID tag), to correct anomalies, and a further improved compensation of pressure losses,
- Modification of the design of the pinch valve of the DOUBLEFLO -INFLOW/OUTFLOW PUMP,
- Addition of new components (RFID label) and raw material changes for the tubing.

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Image /page/7/Picture/1 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' inside. To the right of the leaf is the word 'hemodia' in a sans-serif font. Below 'hemodia' are the words 'Medical Partner' in a smaller font size.

- Packaging change for the tubing sets -
- -Adjusted shelf-life for the OUTFLOW TUBING SETS (Ref: 72205765)

These new technical characteristics do not lead to differences between these predicate devices and subject device considering the clinical and technical support of the intended use. The functionalities of the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets remain the same.

Conclusion: The differences in the technological characteristics of the predicate device, DOUBLEFLO system and the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets are minor and do not raise different questions of safety and effectiveness.

#### 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 guidance 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.

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

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Image /page/8/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' cut out in white. To the right of the leaf is the word 'hemodia' in a lowercase, sans-serif font. Below 'hemodia' are the words 'Medical Partner' in a smaller, sans-serif font.

- · 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 INFLOW/OUTFLOW PUMP, accessories and tubing sets.

Design verification testing of the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets demonstrates that the device performs as intended and that the performance does not raise different questions of safety and effectiveness.

#### Electrical safety and electromagnetic compatibility

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the DOUBLEFLO INFLOW/OUTFLOW PUMP, and associated accessories.

The device complies with recognized electrical safety standards:

- IEC 60601-1 standard for electrical safety ●
- IEC 60601-1-2 standard for electromagnetic compatibility. ●

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Image /page/9/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green letter 'H' that resembles a leaf or a drop. To the right of the 'H' is the word "hemodia" in a smaller, sans-serif font. Below "hemodia" are the words "Medical Partner" in an even smaller font.

### Biocompatibility testing

The biocompatibility evaluation for DOUBLEFLO 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 (<24h) per ISO 10993-1. The evaluation reveals that biocompatibility requirements are met by the DOUBLEFLO INFLOW/OUTFLOW PUMP tubing sets.

Biocompatibility testing was performed on the tube sets in accordance with:

- · ISO 10993-1 Biological evaluation of medical devices- Evaluation and testing within a risk management system;
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity; and
- · ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
- ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.
- · European Pharmacopeia ISO 10993-12
- United States Pharmacopoeia 42 National Formulary 37 (USP 42-NF 37 ISO 10993-12)

#### Sterilization Validation

In addition, the sterilization validation on the tube sets has been performed in accordance with:

- · ISO 11135 Sterilization of health care products Ethylene Oxide -Requirements for the development, validation and routine control of a sterilization process for medical device
- ISO 11135-1 Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
- · ISO 14937 Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
- ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.

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Image /page/10/Picture/0 description: The image shows the logo for Hemodic Medical Partner. The logo features a stylized green letter 'H' with diagonal stripes, resembling a leaf or a drop. To the right of the 'H' is the word "hemodic" in a simple, sans-serif font. Below "hemodic" are the words "Medical Partner" in a smaller font size.

## TRADITIONAL 510(k) PREMARKET ΝΟΤΙΕΙΟΑΤΙΟΝΎ221919
ΑΙΑ - ΒΟΗΡΙ ΤΕΙ Ο ΙΝΤΙ ΟΥΚΟΗΤΕΙ ΟΥΚΟΗΤΕΙ ΟΥΥ ΒΗΜΙΣ DOUBLEFLO INFLOW/OUTFLOW PUMP,

accessories and tubing sets

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 3 days of aeration (gas release) that remain on the tube set will not be exceeded. The sterility assurance level (SAL) was 10-6. Package and product integrity of the tube sets were tested in accordance with ISO11607-1 - Packaging for terminally sterilized medical devices and ASTM-F- 1980:2002 - Standard for accelerated aging of sterile medical device packages.

#### Performance Testing - Bench

The following performance tests were conducted:

- Functional tests of the DOUBLEFLO INFLOW/OUTFLOW PUMP ●
- Functional tests of the DOUBLEFLO INFLOW/OUTFLOW PUMP, ● accessories
- . Usability Tests of the DOUBLEFLO INFLOW/OUTFLOW PUMP accessories and tubing.
- . Functional tests of the tubing sets at to and after 18 months (for the DOUBLEFLO OUTFLOW TUBE SET, Ref: 72205765) and 3 years of accelerated aging (for the DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, AND DOUBLEFLO INFLOW TUBE SET)
- Leak and Tensile (Strength) tests of the tubing sets at to and after 18 months ● (for the DOUBLEFLO INFLOW/OUTFLOW PUMP OUTFLOW TUBE SET. Ref: 72205765) and 3 years of accelerated aging (for the DOUBLEFLO DAY TUBE SET, DOUBLEFLO INFLOW/OUTFLOW PUMP PATIENT TUBE SET, AND DOUBLEFLO INFLOW/OUTFLOW PUMP INFLOW TUBE SET)

#### Animal studies

Data from animal studies were not required to support the safety and effectiveness of the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets.

#### Clinical Studies

Clinical data were not required to support the safety and effectiveness of the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets. All validation was performed based on non-clinical performance tests.

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Image /page/11/Picture/0 description: The image shows the logo for Hemodic Medical Partner. The logo features a stylized green leaf shape with the letter 'H' embedded within it. To the right of the leaf is the word 'hemodic' in a simple, sans-serif font, and below that, in smaller letters, are the words 'Medical Partner'.

### IX SUMMARY OF NON CLINICAL PERFORMANCE TESTING - Bench

| Test | Test Method Summary | Results |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety and<br>electromagnetic<br>compatibility<br>(EMC) | Testing in compliance with<br>the IEC 60601-1 and IEC<br>60601-1-2 | Evaluation and testing were<br>performed on the subject device<br>and demonstrated to be<br>substantially equivalent to the<br>predicate devices. Addition of the<br>RFID (reader and tag) related test<br>requirements. |
| Biocompatibility<br>testing | Testing in compliance with<br>FDA Guidance "Use of<br>International Standard ISO<br>10993, Biological evaluation<br>of medical Devices Part 1"<br>and ISO 10993-1 | The following non clinical tests<br>were performed on the subject or<br>equivalent devices: Cytotoxicity,<br>Sensitization, Irritation, Acute<br>systemic toxicity and Pyrogenicity<br>and demonstrated to be<br>substantially equivalent to the<br>predicate devices. |
| Software<br>Verification and<br>Validation<br>Testing | Software verification testing<br>in compliance with FDA<br>guidance "General Principles<br>of Software Validation" and<br>IEC 62304 | Evaluation and testing were<br>performed on the subject device<br>and demonstrated substantially<br>equivalent performance to<br>identified predicate devices. The<br>testing successfully cover RFID<br>(reader and tag) related test<br>requirements. |
| Sterilization<br>Validation | The sterilization validation<br>was performed according to<br>ISO 11135 and ISO 11135-1<br>Sterilization of health care<br>products - Ethylene oxide -<br>Part 1:<br>Requirements for the<br>development, validation and<br>routine control of a<br>sterilization<br>process for medical devices;<br>and<br>• ISO 10993-7 - Biological<br>evaluation of medical<br>devices - Part 7: Ethylene<br>oxide<br>sterilization residuals. | Validation was performed on the<br>subject device and demonstrated<br>to be substantially equivalent to<br>the identified predicate devices. |
| Bench Tests | The functional and usability<br>tests on DOUBLEFLO<br>INFLOW/OUTFLOW PUMP,<br>accessories and tubing sets<br>were performed according to | Evaluation and testing were<br>performed on the subject device<br>and demonstrated substantially |
| | IEC 62366 – Medical<br>Devices – Part 1: Application<br>of Usability Engineering to<br>Medical to Medical Devices.<br>The functional test included<br>test on the strength of the<br>tubing sets at to and<br>following three years and 3<br>months of accelerated aging. | equivalent performance to<br>identified predicate devices. |
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |

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Image /page/12/Picture/0 description: The image shows the logo for Hemodica Medical Partners. The logo features a stylized green letter 'H' with a rounded top, resembling a water droplet. The word "hemodica" is written in a simple, sans-serif font to the right of the 'H', and below it, in a smaller font, are the words "Medical Partners".

# TRADITIONAL 510(k) PREMARKET NOTIFICATIONK221919
TRADITIONAL 510(k) PREMARKET OW BUYE DOUBLEFLO INFLOW/OUTFLOW PUMP,

accessories and tubing sets

#### × CONCLUSIONS

Based on the same intended use, the same basic technological characteristics and performance testing, the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is substantially equivalent to the predicate device DOUBLEFLO System (K203480). The differences between the proposed device and the predicate device do not raise different questions of safety and effectiveness.