Artemis Hand Held Imaging System

K143474 · Quest Medical Imaging · OWN · Jun 30, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143474
• Device Name: Artemis Hand Held Imaging System
• Applicant: Quest Medical Imaging
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Jun 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries. The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.

Device Story

Artemis Handheld Imaging System captures fluorescent images to assess blood flow and tissue perfusion intraoperatively. System components include handheld camera, Artemis Fast Lens, ring light (open procedures), laparoscope (minimally invasive), controller (laptop), and light source (Artemis Light Engine). Operates by detecting fluorescence of dye within circulatory system; provides visual feedback to surgeons. Used in OR settings by surgeons to evaluate tissue viability during plastic, reconstructive, and organ transplant procedures. Output allows real-time observation of blood vessels and perfusion, aiding clinical decision-making regarding tissue health and flap viability.

Clinical Evidence

Bench testing included in vitro sensitivity characterization (ICG in human serum albumin). In vivo evidence included animal models (nude Balb/c mice) and human case series in Germany and the Netherlands, demonstrating perfusion assessment in colon and skin tissue after reconstruction. Comparative qualitative imaging assessments performed against other NIR devices.

Technological Characteristics

System comprises handheld camera, lens, ring light, laparoscope (K945266), laptop controller, and light engine (K141164). Employs fluorescence imaging principle. Complies with IEC 60601-1-2 (EMC) and ISO 14971 (Risk Management).

Indications for Use

Indicated for visual assessment of blood flow and tissue perfusion in tissue and free flaps during plastic, reconstructive, and organ transplant surgeries. Applicable for open procedures via direct visualization or minimally invasive procedures via laparoscope.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• PDE (K110480)
• Fluobeam 800 Clinic Imaging Device (K132475)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Ouest Medical Imaging Mr. Martin Heuvelmans Quality Assurance Manager Industrieweg 41 1775 PW Middenmeer Netherlands

Re: K143474

Trade/Device Name: Artemis Handheld Imaging System Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: May 18, 2015 Received: May 27, 2015

Dear Ms. Heuvelmans:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143474

Device Name Artemis Hand Held Imaging System

#### Indications for Use (Describe)

The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.

The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/0 description: The image shows the logo for Quest Medical Imaging. The logo features a stylized letter "Q" in gray and blue, with the word "Quest" in black next to it. A vertical blue line separates "Quest" from the words "medical imaging" in a cursive font.

## SECTION 6

510(k) Summary (21 CFR 807.92(c))

## Administrative information

| Manufacturer Name: | Quest Medical Imaging<br>Industrieweg 41<br>1775 PW Middenmeer<br>Netherlands |
|--------------------|-------------------------------------------------------------------------------|
| Contact Person: | Martin Heuvelmans, QA Mana<br>Tel: [phone] |

ger Fax: [phone] E-mail: [e-mail]

- Official Correspondent: Quest Medical Imaging Martin Heuvelmans, QA Manager E-mail: [e-mail]
#### FDA Establishment Registration Number: 3010590422

| Date prepared: | December 1st, 2014 |
|----------------|--------------------|
|----------------|--------------------|

- Name of Device: Trade Name: Artemis Handheld Fluorescence Imaging System Common Name: Fluorescent Imaging System Classification Name: 21 CFR 876.1500 Product Code: OWN, GCJ
Identification of Predicate Device(s):

| 510(k)<br>Number | Device | Manufacturer |
|------------------|------------------------------------|---------------------------------------------------|
| K110480 | PDE | Hamamatsu Photonics K.K.<br>Hamamatsu City, Japan |
| K132475 | Fluobeam 800 Clinic Imaging Device | Fluoptics, Grenoble Cedex,<br>France |

## Intended Use Statement

The Artemis Handheld System is a fluorescent imaging system is used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.

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The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.

## Device Description

The Artemis Handheld System is intended for intraoperative and minimal invasive visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue.

The Artemis System consists of a hand held camera, Artemis Fast Lens; ring light for open procedures, and a laparoscope for minimally invasive procedures, controller (lap top) and a light source or Light Engine. The Artemis Light Engine (K141164) is Class II device for illumination of surgical sites for diagnostic purposes. The light Engine has imaging capabilities for fluorescence as well. The laparoscope is an OEM item branded for Quest and cleared via 510(k) Number K945266.

## Performance Testing

The performance testing to verify conformance to the original user / design requirements for both the system overall and the software was successfully conducted. Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness. Software is verification testing was successfully performed. The manufacturer complies with the following voluntary standards:

- IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment Part1-2: . General Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- . ISO 14971 Second edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices.

The Artemis Handheld Imaging System clinical evaluation included in vitro characterization, determining concentration dependent sensitivity of ICG dissolved in human serum albumin, and in in vivo animal models using nude Balb/c mice, as well as comparative imaging qualitative assessments with other NIR imaging devices on various anatomical structures. These studies also included human vital structure imaging performed at a medical research facility in the Netherlands. Further perfusion imaging was assessed in case series studies performed in Germany. satisfactorily demonstrating perfusion in the colon and in skin tissue after skin flap reconstruction.

## Predicate Device Comparison

The Artemis System was compared to the PDE System. K 110480, and the Fluobeam 800, K132475. The systems have similar intended uses and employ the same mechanism of action of fluorescing a dye within the circulatory system. Minor differences are noted between the reference device and the predicates. The reference device does not raise any new questions of safety and effectiveness.

## Conclusion

The Artemis System has similar intended use and technical features as the predicate devices listed above. Therefore, the Artemis System is substantially equivalent to the predicate marketed devices referenced herein.