(251 days)
No
The summary describes a micro-processor controlled peristaltic pump for fluid management during arthroscopy. While it mentions software testing and a "moderate" level of concern, there is no mention of AI, ML, image processing, training data, or performance metrics typically associated with AI/ML applications. The focus is on basic pump function, safety, and biocompatibility.
Yes.
The device is intended to provide fluid distension and irrigation of joint cavities and fluid suction during arthroscopy procedures, which is a medical treatment.
No
The device is described as an arthroscopy system intended for fluid distension, irrigation, and suction during arthroscopy procedures. Its function is to transport fluid, not to diagnose conditions.
No
The device description explicitly states it is a "micro-processor controlled pump" and mentions hardware components like cables and connections to accessories/shaver systems. The performance studies also include electrical safety, electromagnetic compatibility, biocompatibility, sterilization validation, and bench testing of the physical pump and tubing sets, all of which relate to hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fluid distension and irrigation of joint cavities and fluid suction during arthroscopy procedures. This involves direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a pump that transports sterile irrigation fluid and provides fluid aspiration. This is a mechanical device used for fluid management within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are typically used to perform tests on samples outside of the body. This device is used within the body during a surgical procedure.
N/A
Intended Use / 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.
Product codes
HRX
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:
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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. Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated include: Unit test reports, Integration test reports, System test reports, Overall software test report, Verification test reports, Overall software validation report. Tests 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. Design verification testing 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. Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate devices. Addition of the RFID (reader and tag) related test requirements.
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 (
§ 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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ☑ 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 PRAStaff(@fda.hhs.gov
"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."
3
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 +33 (0) 5 61 00 03 50
Contact Person :
Anne-Lyse Miard Regulatory Affairs Engineer Anne-Lyse.Miard@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: March 9, 2023
4
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,
accessories and tubing sets |
|------------------------------------------|---------------------------------------------------------------|
| Common Name: | Pump (Arthroscopy pump) |
| Classification Name: | Arthroscope (21 CFR § 888.1100) |
| Classification Panel: | Orthopedic |
| Regulatory Class
(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 |
5
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.
6
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.
7
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
8
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. ●
9
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 (