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 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: DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, DOUBLEFLO INFLOW TUBE SET, DOUBLEFLO OUTFLOW TUBE SET.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets." It concerns a pump used in arthroscopic procedures.

It is crucial to understand that this document does NOT describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-driven medical device.

Instead, this is a traditional 510(k) summary for a physical medical device (a pump). The "software" mentioned refers to the embedded software controlling the pump's mechanical functions, not an AI/ML algorithm that interprets medical data (like images) or assists in diagnosis/treatment decisions.

Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML is not applicable to this document.

The document discusses performance in terms of safety and effectiveness of the traditional medical device (the pump and its accessories/tubing sets), primarily through:

Software verification and validation: Ensuring the pump's control software functions correctly and safely.
- Acceptance Criteria (Implied for Software): Software performs as intended, no anomalies, compliant with relevant standards (IEC 62304, FDA guidance for software in medical devices).
- Reported Performance (Software): Unit, integration, system, and validation tests performed; successfully covers RFID-related requirements; software considered "moderate" level of concern.
Electrical safety and electromagnetic compatibility (EMC): Ensuring the device operates safely in its electromagnetic environment.
- Acceptance Criteria: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- Reported Performance: Complies with recognized standards, demonstrated substantial equivalence.
Biocompatibility testing: Ensuring the tubing sets are safe for contact with the body.
- Acceptance Criteria: Compliance with ISO 10993 series standards and FDA guidance.
- Reported Performance: Tests performed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity), met requirements, demonstrated substantial equivalence.
Sterilization validation: Ensuring the tubing sets can be effectively sterilized.
- Acceptance Criteria: Compliance with ISO 11135, ISO 14937, ISO 10993-7. Residual EO/ECH limits met. SAL of 10^-6. Package integrity confirmed.
- Reported Performance: Validation performed, met requirements, demonstrated substantial equivalence.
Bench Performance Testing: Functional and usability tests of the pump and tubing sets (e.g., leak, tensile strength, accelerated aging).
- Acceptance Criteria (Implied): Device performs as intended for fluid distension, irrigation, and suction; tubing sets maintain integrity over shelf life.
- Reported Performance: Tests performed, demonstrated substantial equivalence.

In summary, this document is not about an AI/ML device, and thus cannot provide the specific details requested for such a system. The performance data provided relates to the physical and software functionalities of a medical pump, not an AI's analytical or diagnostic capabilities.

Summary

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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 (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

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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)

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)

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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 +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

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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,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

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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 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 andelectromagneticcompatibility(EMC)	Testing in compliance withthe IEC 60601-1 and IEC60601-1-2	Evaluation and testing wereperformed on the subject deviceand demonstrated to besubstantially equivalent to thepredicate devices. Addition of theRFID (reader and tag) related testrequirements.
Biocompatibilitytesting	Testing in compliance withFDA Guidance "Use ofInternational Standard ISO10993, Biological evaluationof medical Devices Part 1"and ISO 10993-1	The following non clinical testswere performed on the subject orequivalent devices: Cytotoxicity,Sensitization, Irritation, Acutesystemic toxicity and Pyrogenicityand demonstrated to besubstantially equivalent to thepredicate devices.
SoftwareVerification andValidationTesting	Software verification testingin compliance with FDAguidance "General Principlesof Software Validation" andIEC 62304	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performance toidentified predicate devices. Thetesting successfully cover RFID(reader and tag) related testrequirements.
SterilizationValidation	The sterilization validationwas performed according toISO 11135 and ISO 11135-1Sterilization of health careproducts - Ethylene oxide -Part 1:Requirements for thedevelopment, validation androutine control of asterilizationprocess for medical devices;and• ISO 10993-7 - Biologicalevaluation of medicaldevices - Part 7: Ethyleneoxidesterilization residuals.	Validation was performed on thesubject device and demonstratedto be substantially equivalent tothe identified predicate devices.
Bench Tests	The functional and usabilitytests on DOUBLEFLOINFLOW/OUTFLOW PUMP,accessories and tubing setswere performed according to	Evaluation and testing wereperformed on the subject deviceand demonstrated substantially
	IEC 62366 – MedicalDevices – Part 1: Applicationof Usability Engineering toMedical to Medical Devices.The functional test includedtest on the strength of thetubing sets at to andfollowing three years and 3months of accelerated aging.	equivalent performance toidentified 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.

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.