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.

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: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.

AI/ML Overview

The provided text is a 510(k) summary for the DOUBLEFLO system, an arthroscopy system. It describes the device, its intended use, a comparison with a predicate device, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based only on the provided text. Many of the requested fields are not applicable or not explicitly stated in this type of FDA submission.

Acceptance Criteria and Device Performance

The provided document describes various performance tests rather than specific acceptance criteria with numerical targets. The "Results" column largely states that the device "demonstrated to be substantially equivalent to the predicate device." Therefore, numerical acceptance criteria are inferred from the predicate device's performance or general safety/effectiveness standards.

Test Category	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Software	Conformity with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304 standard (Medical Device Software - Life Cycle Process) for a "moderate" level of concern. Software should perform as intended, without directly or indirectly causing minor injury.	Software was developed, tested, and verified according to specified FDA guidance and IEC 62304. Unit, integration, system, and verification tests were performed. Overall software validation report confirmed conformity with user needs and intended use. Demonstrated intended performance without raising new safety/effectiveness questions.
Electrical Safety and Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.	The device complies with IEC 60601-1 and IEC 60601-1-2. Evaluation and testing demonstrated substantial equivalence to the predicate device.
Biocompatibility	Compliance with FDA Guidance Document: Use of International Standard ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for externally communicating devices in indirect contact with tissue/bone for a limited time (<24h). No cytotoxicity, sensitization, irritation, or acute systemic toxicity.	Biocompatibility requirements were met. Tests performed: Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity. Demonstrated substantial equivalence to the predicate device.
Sterilization Validation	Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7. Ethylene oxide (EO) < 4 mg, ethylene chlorohydrin (ECH) < 5 mg after 3 days aeration. Sterility Assurance Level (SAL) of 10^-6. Package and product integrity per ISO 11607-1 and ASTM-F-1980:2002.	Validation performed according to standards. EO < 4 mg and ECH < 5 mg after 3 days of aeration. SAL was 10^-6. Package and product integrity tested. Demonstrated substantial equivalence to the predicate device.
Performance Testing - Bench (Functional and Usability)	Device performs as intended for fluid distension, irrigation, and suction in specified joint cavities. Tubing sets maintain strength and leak integrity at t0 and after 3 years accelerated aging. Usability meets IEC 62366-1.	Functional tests of the DOUBLEFLO system and accessories were conducted. Usability tests were conducted per IEC 62366-1. Functional tests of tubing sets (strength, leak, and tensile) at t0 and after 3 years of accelerated aging were performed. Demonstrated intended performance and substantial equivalence.
Pressure Regulation	Maintain constant pressure when flow rate is changed. Max allowable pressure of 150 mmHg. Min allowable pressure of 5 mmHg. Default pressure at start of pump of 50 mmHg.	The subject device maintains pressure constant when flow rate is changed. Max allowable pressure: 150 mmHg. Min allowable pressure: 5 mmHg. Default pressure at start: 50 mmHg. These values are lower than or substantially equivalent to the predicate.
Flow Rates (Cannula & Shaver Suction)	Cannula: Min 100 mL/min, Max 600 mL/min. Shaver: Min 200 mL/min, Max 800 mL/min.	Cannula flow rates: 100 mL/min to 600 mL/min. Shaver flow rates: 200 mL/min to 800 mL/min. Identical to predicate device.

Study Details

Sample size used for the test set and the data provenance:
- Software, Biocompatibility, Sterilization, Electrical Safety/EMC: Not explicitly mentioned as a "test set" in the context of clinical or image data. The tests were performed on the device and its components (tubing sets). The provenance of these components is not stated.
- Bench Tests: The functional tests, usability tests, and strength/leak/tensile tests were conducted on the DOUBLEFLO system and its tubing sets. The number of samples for these tests is not specified in the document.
- Data Provenance: The document does not describe the origin of data in terms of retrospective/prospective or country of origin, as these were non-clinical bench and lab studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to non-clinical, performance-based testing in a laboratory setting, not studies requiring expert interpretation for ground truth.
Adjudication method for the test set: Not applicable. This refers to non-clinical, performance-based testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an arthroscopy fluid management system, not an AI-powered diagnostic tool for interpretation by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone performance testing of the device itself (pump, tubing sets), without a human-in-the-loop, for aspects like fluid flow, pressure, electrical safety, etc. There is no "algorithm only" performance study in the context of AI, as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Software, the ground truth was the defined software requirements and intended functionality, validated against user needs.
- For Electrical Safety, EMC, Biocompatibility, Sterilization, and Bench Tests, the ground truth was adherence to established international standards (IEC, ISO, ASTM) and the specified performance parameters (e.g., pressure, flow rates, material properties, sterility levels).
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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)

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a green leaf-like shape with the letter 'H' inside it on the left side. To the right of the leaf shape, the word 'hemodia' is written in a sans-serif font, with the words 'Medical Partner' written in a smaller font size below it.

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 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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Image /page/6/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with a white "H" inside it. To the right of the leaf is the word "hemodia" in a sans-serif font, and below that are the words "Medical Partner" in a smaller font size.

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	Technical Characteristics	Comparison Analysis
	ZEOS Aqua Vision Pump(K192921)	DOUBLEFLO system(K203480)
Illustration	Image: ZEOS Aqua Vision Pump	Image: DOUBLEFLO system
General DeviceDescription	Dual Pump Arthroscopic System, theirrigation/aspiration system has a commoncontrol system with two separate pumps, onepump dedicated to irrigation and one pumpdedicated to aspiration.	Dual Pump Arthroscopic System, theirrigation/aspiration system has a commoncontrol system with two separate pumps, onepump dedicated to irrigation and one pumpdedicated to aspiration.		Similar overall set up anduser interface, identicalprinciple of operations
Principle ofoperation			Microprocessor controlled	Identical
			Roller Pump and automatic fluid management
Irrigation andsuction in oneunit:Independentinflow/outflowcontrol			Yes, two separate irrigation / aspirationpumps	Identical

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	Predicate Devices	Subject Device	Comparison Analysis
Regulatespressure andflow	yes	yes	Substantiallyequivalent, the onlydifference is that thesubject device maintainsthe pressure constantwhen the flow rate ischanged.
Maximumallowablepressure	280 mmHg	150 mmHg	The maximum presetpressure allowable by theDOUBLEFLO systemsoftware is lower than thatof the ZEOS AQUAVISION pump.Substantiallyequivalent.
Minimumallowablepressure	20 mmHg	5 mmHg
Default pressureatstart of thepump	60 mmHg	50 mmHg	Substantiallyequivalent.The default pressuresdefined by theDOUBLEFLO systemsoftware is lower thanthat of the ZEOSAQUA VISIONpump

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	Predicate Devices			Subject Device		Comparison Analysis
RecommendedInitialpressure setting	Joint	Pressure levelwith tourniquet	Pressure levelwithouttourniquet	FLUSH RATE	Shaversuction	Joint	Pressure level withtourniquet	Pressure levelwithouttourniquet	RINSE SUCTION	SHAVERSUCTION
		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 RateSecurityHardwareFlow Rate				$375 \text{mmHg}$					$280 \pm 10 \text{mmHg}$				Substantially equivalent
				There are 4 flow rates for the Cannulasuction and 4 flow rates for the ShaverSuction -> displayed by LED (MIN,LOW, MED and HIGH)					There are 3 flow rates for the Cannulasuction and 3 flow rates for the ShaverSuction -> displayed by LED(LOW, MED and HIGH)
Minimum flowrate				Cannula 100 mL/minShaver: 200 mL/min					Cannula flow rates: 100 mL/minShaver flow rates: 200 mL/min				Identical
Maximum flowrate				Cannula 600 mL/minShaver: 800mL/min					Cannula flow rates: 600 mL/minShaver flow rates: 800 mL/min				Identical
Interfaces				Interface with various shaver systems andvarious footswitches					Interface with a Shaver Interface Cable				Substantiallyequivalent, subjectdevice has additionalinterfaces no morefunctionalities

hemodia

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	Predicate Devices	Subject Device	Comparison Analysis
Control withFootswitch	Yes, Footswitch (wired)	No	Substantially equivalent, subjectdevice has other controlsuch as keyboard (frontpanel interface, and footswitch from the shaverwhen connected viaShaver Interface Cable)
Control withRemote	No	No	Identical
Consumable	Polymer Tubing	Polymer Tubing	Substantially equivalent

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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 (<24h) per ISO 10993-1. The evaluation reveals that biocompatibility requirements are met by the DOUBLEFLO system 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.

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/14/Picture/1 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with a white "H" inside it, followed by the word "hemodia" in a sans-serif font. Below "hemodia" are the words "Medical Partner" in a smaller, lighter font.

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 system 9
Functional tests of the DOUBLEFLO system accessories .
. Usability Tests of the DOUBLEFLO system
Functional tests of the tubing sets at to and after 3 years of accelerated . aqing
. Leak and Tensile (Strength) tests of the tubing sets at to and after 3 years of accelerated aging

Animal studies

Data from animal studies were not required to support the safety and effectiveness of the DOUBLEFLO system.

Clinical Studies

Clinical data were not required to support the safety and effectiveness of the DOUBLEFLO system. All validation was performed based on non-clinical performance tests.

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IX SUMMARY OF NON CLINICAL PERFORMANCE TESTING - Bench

Test	Test Method Summary	Results
Electrical safety andelectromagneticcompatibility(EMC)	Testing in compliancewith the IEC 60601-1and IEC 60601-1-2	Evaluation and testing wereperformed on the subject deviceand demonstrated to besubstantially equivalent to thepredicate device.
Biocompatibilitytesting	Testing in compliancewith FDA Guidance"Use of InternationalStandard ISO 10993,Biological evaluation ofmedical Devices Part 1"and ISO 10993-1	The following non clinical testswere performed on the subject orequivalent devices: Cytotoxicity,Sensitization, Irritation and Acutesystemic toxicity anddemonstrated to be substantiallyequivalent to the predicatedevice.
Software VerificationandValidation Testing	Software verificationtesting in compliancewith FDA guidance"General Principles ofSoftware Validation"and IEC 62304	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performance toidentified predicate device
SterilizationValidation	The sterilizationvalidation wasperformed according toISO 11135 and ISO11135-1 Sterilization ofhealth care products –Ethylene oxide - Part 1:Requirements for thedevelopment, validationand routine control of asterilizationprocess for medicaldevices; and• ISO 10993-7 -Biological evaluation ofmedical devices - Part7: Ethylene oxidesterilization residuals.	Validation was performed on thesubject device and demonstratedto be substantially equivalent tothe identified predicate devices.
Bench Tests	The functional andusability tests on theDOUBLEFLO systemwas performedaccording to IEC 62366– Medical Devices –	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performance toidentified predicate device.

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	Part 1: Application ofUsability Engineering toMedical to MedicalDevices. The functionaltest included test on thestrength of the tubingsets at t₀ and followingthree years and 3months of acceleratedaging.
Animal studies	Not applicable	Not applicable
Clinical Studies	Not applicable	Not applicable

CONCLUSIONS ×

Based on the similar intended use, the same basic technological characteristics and performance testing, the DOUBLEFLO system (pump, tubing sets and accessories) is substantially equivalent to the predicate device ZEOS Aqua Vision Pump and tubing sets (K192921). The differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 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.