LuminScan (TM) Imaging System

K162466 · Micro-Tech (Nanjing) Co., Ltd. · NQQ · Nov 29, 2016 · Radiology

Device Facts

• Record ID: K162466
• Device Name: LuminScan (TM) Imaging System
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: NQQ · Radiology
• Decision Date: Nov 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The LuminScan™ Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.

Device Story

LuminScan™ Imaging System is an endoscopic optical coherence tomography (OCT) device used in hospital settings by clinicians. It consists of a console and a disposable imaging kit. The system uses a swept-source laser (1300 nm) to capture high-resolution, two-dimensional, cross-sectional images of tissue microstructure. The disposable kit features an optical fiber probe and a balloon guide sheath; the balloon is inflated automatically via a system-controlled pump to stabilize the probe within the endoscopic channel (compatible with ≥2.8 mm channels). The clinician operates the system to perform helical scanning (up to 8 cm pullback). Output is displayed on the console, allowing the user to review images, replay sequences, select regions of interest (ROI) for zoom, place markers, and take snapshots. This real-time visualization assists in the evaluation of tissue microstructure, potentially aiding clinical decision-making during endoscopic procedures.

Clinical Evidence

No human clinical data provided. Bench testing included software verification/validation, balloon performance (burst, fatigue, inflation/deflation, airtightness), tensile strength, endoscopic compatibility, retraction, sterilization, shelf life, and biocompatibility. Reliability testing covered environmental factors and vibration. Animal testing (n=2 Bama miniature pigs) evaluated imaging procedure and quality in the esophagus, confirming the ability to capture, replay, zoom, mark, and snapshot OCT images.

Technological Characteristics

Swept-source OCT imaging system; 1300 nm center wavelength; 120 nm bandwidth; Class 1M laser. Components: console and disposable kit (silica/borosilicate glass fiber, 304 SS torque cable, nylon guide sheath/balloon). Automatic balloon inflation system. Connectivity: standalone console. Sterilization: Ethylene Oxide. Software: Minor level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60825-1, ISO 10993, ISO 14971.

Indications for Use

Indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Nvision VLE Imaging System (K112770)

Submission Summary (Full Text)

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

November 29, 2016

Micro-Tech (Nanjing) Co., Ltd. Ms. Becky Li Quality Director No. 10 Gaoke Third Road Nanjing National Hi-Tech, Industrial Development Zone Nanjing, 210032 CN

Re: K162466

Trade/Device Name: LuminScan™ Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NQQ Dated: August 31, 2016 Received: September 2, 2016

Dear Ms. Li:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (21 CFR 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, Jennifer R. Stevenson -A

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K162466

Device Name

LuminScan(TM) Imaging System

Indications for Use (Describe)

The LuminScan(TM) Imaging System is is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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Image /page/3/Picture/0 description: The image shows a logo for Micro-Tech. The logo consists of a blue 3D block letter "MT" on the left, and the text "MICRO-TECH" on the right. Below the text "MICRO-TECH" are two Chinese characters.

510K Summary

# 510 (K) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _

# 510 (K) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __

- 1. Date of Preparation: 11/24/2016
- 2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality Director Tel: [phone] Fax: [phone] Email: [e-mail]

# 3. Identification of Proposed Device

Product Name: LuminScan™ Imaging System Common Name: Endoscopic Optical Coherence Tomography Imaging System (EOCT Imaging System) Model: C1 Regulatory Information: Classification Name: Ultrasonic pulsed echo imaging system Classification: Class II Product Code: NQQ Regulation Number: 21 CFR892.1560 Review Panel: General & Plastic Surgery

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Image /page/4/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font. The letters are blue and appear to be made of blocks. To the right of the letters is the word "MICRO-TECH" in a simple, sans-serif font. Below the word "MICRO-TECH" are two Chinese characters.

### 4. Identification of Predicate Device

510(k) Number: K112770

Product Name: Nvision VLE Imaging System (OCT)

#### 5. Device Description

LuminScan™ Imaging System is a general imaging system comprised of LuminScan™ Imaging System Console and LuminScan™ Disposable Imaging Kit.

#### 6. Indications for Use

LuminScan™ Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.

#### 7. Clinical Test Conclusion

This section is not applicable because there is not including any clinical performance data with this 510(k) Submission.

#### 8. Comparison of Technological Characteristics

LuminScan™ Imaging System is an optical coherence tomography (OCT) imaging device, which has similar technological characteristics as the predicate device cleared under 510(k) K112770 of NinePoint Medical Inc. Both devices use the principles of swept source OCT to generate high-resolution, two-dimensional, cross-sectional images of tissue microstructures in real time.

The main technological differences between the proposed device and the predicate device are the inflation method of accessory and the parameters of the accessory. The proposed device use automatic pump to inflate balloon of accessory, and controlled by system software. The predicate device use manual method to inflate balloon. In additional, the diameter of the inflation balloon in the proposed device is 16 mm whereas the diameter in the predicated device is 25 mm. Moreover, the inflated pressure of the inflation balloon in the proposed device is 3 atm whereas the pressure in the predicate device is 0.34 atm. Furthermore, the accessory in the proposed device can pass through the endoscopic channel as small as 2.8 mm. The predicate device

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Image /page/5/Picture/1 description: The image shows a logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the words "MICRO-TECH" written in a simple font to the right of the letters. Below the words "MICRO-TECH" are two Chinese characters.

requires an endoscopic channel of no less than 3.7 mm.

With risk mitigation mechanisms in the proposed device, however, these differences

between the proposed device and the predicate device in the technological

characteristics are minor and would not raise any questions of safety or effectiveness.

## Comparison to predicate Device:

| Technological<br>Characteristics | Nvision VLE® Imaging System<br>(K112770) | LuminScan™ Imaging System |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and compatibility: | | |
| Product Code | NQQ | NQQ |
| Regulation No. | 21CFR892.1560 | 21CFR892.1560 |
| Class | 2 | 2 |
| Supplied Sterile | Yes | Yes |
| Configuration | Imaging tool and accessory | Imaging tool and accessory |
| Where Used | Hospital Setting | Hospital Setting |
| Indications for Use | Imaging tool in the evaluation of<br>human tissue microstructure by<br>providing two-dimensional ,cross<br>sectional , real- time depth<br>visualization | Imaging tool in the evaluation of<br>human tissue microstructure by<br>providing two-dimensional ,cross<br>sectional , real- time depth<br>visualization |
| Console: | | |
| Radiation Type | Near Infrared | Near Infrared |
| Optical Source | Swept source laser | Swept source laser |
| Center Wavelength | 1300 nm | 1300 nm |
| Optical Bandwidth | 110 nm | 120 nm |
| Optical Radiation<br>Safety | Safe for indicated use, Class 1M<br>laser source | Safe for indicated use, Class 1M<br>laser source |
| Measurement<br>Technique | OCT, Fourier domain | OCT, Fourier domain |
| Scanning Mode | Helical pitch (360 degree + 6 cm<br>pullback length) | Helical pitch (360 degree, up to 8<br>cm pullback length) |
| Frame Rate | 12.5 frames/sec | 24.4 frames/sec |
| Inflation Method | manual | automatic |
| Optical Probe: | | |
| Optical Fiber Probe<br>Material | Silica and borosilicate glass | Silica and borosilicate glass |
| Torque Cable and<br>Hypo tube Cap<br>Material | 316 SS | 304 SS |
| Optical Probe | Single mode optical fiber with distal<br>optics | Single mode optical fiber with distal<br>optics |
| | | 510K Summary |
| Technological<br>Characteristics | Nvision VLE® Imaging System<br>(K112770) | LuminScan™ Imaging System |
| Probe Dimensions | 2.5 m nominal | 2.5 m nominal |
| Guide Sheath: | | |
| Shaft Material | Nylon | Nylon |
| Balloon Material | PET | Nylon |
| Guide Sheath | Balloon guide sheath , polymer<br>tubing with closed end | Balloon guide sheath , polymer<br>tubing with closed end |
| Inflated Diameter | 25 mm | 16 mm |
| Inflated Length | 72 mm | 30/55/80 mm |
| Inflated Pressure | 5 psi (0.34 atm) | 3 atm |
| Sheath Assembly<br>will be Inflated and<br>Deflated Multiple<br>Times | >10 cycles | >20 cycles |
| Balloon Inflation<br>and Deflation Time | <60 sec | <60 sec |
| Endoscopic<br>Channel | 3.7mm | ≥2.8 mm |
| Tip structure | Atraumatic tip | Atraumatic tip |
| Biocompatibility<br>(Body contacting<br>components) | ISO 10993 compatible | ISO 10993 compatible |
| General Use | Single use and sterile guide sheath<br>and optical probe | Single use and sterile guide sheath<br>and optical probe |
| Shelf life | 6 months | 12 months |

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Image /page/6/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text "MICRO-TECH" are two Chinese characters.

# 9. Performance Data

# Safety Testing

The product development processes have been shown to conform to product safety

| Safety Testing | Recognized Standard or Guidance |
|--------------------------------------------------------------------------------------|---------------------------------|
| Risk Management | ISO 14971 |
| Medical Electrical Equipment | IEC 60601-1 |
| Electromagnetic Compatibility | IEC 60601-1-2 |
| Application of Usability | IEC 60601-1-6 and IEC62366 |
| Safety of Endoscopic Equipment | IEC 60601-2-18 |
| Laser Safety | IEC 60825-1 |
| Biological Evaluation Of Medical Devices -<br>Ethylene Oxide Sterilization Residuals | ISO 10993-7 |
| Validation and Routine Control of Ethylene<br>Oxide Sterilization process | ISO 11135-1 |

standard including:

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Image /page/7/Picture/0 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional blue font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text is a line, and below the line are two Chinese characters.

| Safety Testing | Recognized Standard or Guidance |
|---------------------|---------------------------------|
| Transport Packaging | ISTA 2A and 2B |

510K Summary

# Bench Testing

## Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for the LuminScan™ Imaging System was considered as a "Minor" level of concern, since failures or latent design flaws in the software are unlikely to cause any injury to the patient or operator.

## Disposable Imaging Kit Testing

The following in-vitro performance tests were completed on the Disposable Imaging

Kit; all the tests were found to be within their test acceptance criteria (passing test

result):

| Balloon Diameter | Balloon length |
|-------------------------------------|--------------------------------------|
| Balloon Burst Testing | Balloon Fatigue Testing |
| Balloon Inflation/Deflation Testing | Tensile Strength |
| Endoscopic Compatibility Testing | Airtightness |
| Retraction testing | Sterilization and Shelf Life Testing |
| Biocompatibility Testing | |

# Reliability Testing

Device reliability was evaluated against several environments factors (e.g., temperature, humidity) when the product was in operation or was properly stored. In additional, vibration testing was performed to evaluate the device reliability when the product was power off. Both tests yielded passing results.

### System Performance Testing

High-level product design requirements of the LuminScan™ Imaging System were evaluated in system performance testing. System performance yielded a passing test result.

### Animal Testing

Animal testing was performed to evaluate imaging procedure as well as image quality

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Image /page/8/Picture/1 description: The image contains a logo for Micro-Tech. The logo features a stylized blue "MT" symbol on the left. To the right of the symbol, the words "MICRO-TECH" are written in blue, with a thin blue line underneath. Below "MICRO-TECH", there are two Chinese characters, also in blue.

to ensure that the device meets the design requirements as intended.

An animal testing summary is provided in the following table:

| Item | Description |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Species | Bama miniature pig ( <i>Sus scrofa domesticus</i> ) |
| Quantity | 2 |
| Sex | One male and one female |
| Age | 8-9 months |
| Weight | 35-40 kg |
| Imaging Anatomical Area | Esophagus |
| Obtained Images | Two-dimensional and cross-sectional OCT images of animal<br>esophagus were captured by the device. User could review the<br>images with replay function. User could select region of interest<br>(ROI) on the cross-sectional images and show zoomed-in image<br>of ROI. User could make marker on the images and take a<br>snapshot of it. |

#### 10. Substantially Equivalent (SE) Conclusion

Third Party safety testing, adherence to U.S. FDA design control guidance and ISO 14971, as well as thorough in-house, non-clinical (bench) testing and software validation provide reasonable assurance that the LuminScan™ Imaging System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device, the Nvsion VLE Imaging System under K112770.