Laser Speckle Imaging System (RFLSI CZW)

K233076 · Rwd Life Science Co., Ltd. · DPT · May 28, 2024 · Cardiovascular

Device Facts

• Record ID: K233076
• Device Name: Laser Speckle Imaging System (RFLSI CZW)
• Applicant: Rwd Life Science Co., Ltd.
• Product Code: DPT · Cardiovascular
• Decision Date: May 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

Device Story

Laser Speckle Imaging System (RFLSI CZW) measures micro-circulation blood flow; non-patient contacting; no contrast agents required. Device uses laser speckle contrast analysis (LASCA) to capture real-time blood perfusion data of tissues and organs. Operates via infra-red laser diode (785nm); connects to PC via USB 3.0. Used in clinical research settings; operated by trained personnel. System provides visual and quantitative perfusion information (Flux, DC intensity). Healthcare providers use output to assess tissue perfusion; aids in research-based clinical decision-making regarding micro-vascular health.

Clinical Evidence

Bench testing and human volunteer testing performed. Bench testing utilized a 'Flow Model' fluid simulator. Human testing used post-occlusive reactive hyperemia method to compare subject device performance against predicate. Results demonstrate comparable safety and effectiveness.

Technological Characteristics

Infra-red laser diode (785nm ± 10nm); LASCA principle. Measures Flux (0-5000 PU) and DC intensity (0-255 AU). Connectivity via USB 3.0. Power: 100-240V AC. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety).

Indications for Use

Indicated for blood flow measurements in the micro-circulation for clinical research use.

Regulatory Classification

Identification

An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Predicate Devices

• moorFLPI-2 Full-Field Laser Perfusion Imager (K122943)

Submission Summary (Full Text)

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RWD Life Science Co., Ltd. % Eleanor Wu Project Engineer PureID Medical Technology Co., Ltd. Guangzhou International Biology Island Luoxuan Blvd Guanzhou Life Science Innovation Center, Bd.A 3301-3310 & 3316-3318 Guangzhou. China

Re: K233076

Trade/Device Name: Laser Speckle Imaging System (RFLSI CZW) Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II Product Code: DPT Dated: September 26, 2023 Received: September 26, 2023

Dear Eleanor Wu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Yan Fu -S
Date: 2024.05.28 13:35:29
Yan Fu -S
-04'00'

for

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K233076

Device Name Laser Speckle Imaging System (RFLSI CZW)

Indications for Use (Describe)

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| <div style="display:inline-block; vertical-align:middle;"><b> <span style="font-size: 20px;">☑</span> </b></div> | <div style="display:inline-block; vertical-align:middle;">□</div> |

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#### 510(k) Summary Prepared on: 2024-05-15

## 1. Contact Details

Applicant Name: RWD Life Science Co., Ltd. Applicant Address: 19F, Building 9A, Vanke Cloud City III, Liuxin 4 Street, Nanshan District Shenzhen, Guangdong, P.R. China Shenzhen Guangdong 518000 China Applicant Contact Telephone: [phone] Applicant Contact: Mrs. Xuhong Wang Applicant Contact Email: [e-mail] Correspondent Name: PureID Medical Technology Co., Ltd. Correspondent Address: Guangzhou International Biology Island Luoxuan Blvd Guangzhou Life Science Innovation Center, Bd.A 3301-3310 & 3316-3318Guangzhou 510000 China Correspondent Contact Telephone: [phone] Correspondent Contact: Mrs. Eleanor Wu Correspondent Contact Email: [e-mail]

# 2. Device Information

Device Trade Name: Laser Speckle Imaging System (RFLSI CZW) Common Name: Extravascular blood flow probe Classification Name: Probe, Blood-Flow, Extravascular Regulation Number: 870.2120 Product Code: DPT

# 3. Predicate Devices

Predicate #: K122943 Predicate Trade Name: moorFLP1-2 Full-Field Laser Perfusion lmager Product Code: DPT

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## 4. Device Description

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use. It is a measurement tool based on the laser speckle contrast analysis technology and provides real-time blood perfusion information of tissue and organs in a visual and quantitative way. The device is non-patient contacting and does not require the use of contrast agents.

## 5. Intended Use/Indications for Use

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

## 6. Technological Comparison to Predicate Device

The subject device Laser Speckle Imaging System (RFLSI CZW) of this Traditional 510(k) uses the same laser speckle technology as that used by the predicate device. Differences in device parameters do not raise new concerns regarding safety and effectiveness. Verification and validation testing for the subject device demonstrate safety and effectiveness. The Laser Speckle Imaging System (RFLSI CZW) has shown to be substantially equivalent to the predicate device for its intended use in a hospital setting or other appropriate clinical environment.

| Technological Comparison | | | |
|--------------------------|-------------------------------------------|-------------------------------------------------|-------------|
| | Subject Device | Predicate Device | Equivalence |
| Feature | RFLSI CZW Laser Speckle<br>Imaging System | moorFLPl-2 Full-Field Laser<br>Perfusion Imager | N/A |
| 510(k)# | N/A | K122943 | N/A |
| Common Name | RFLSI CZW Laser Speckle<br>Imaging System | Full-Field<br>Laser Perfusion<br>Imager | N/A |
| Regulation | 21 CFR Part 870.2120 | 21 CFR Part 870.2120 | Same |
| Product Code | DPT | DPT | Same |

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| Submission &<br>Classification | 510(k) Class II | | 510(k) Class II | | Same |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle | Laser speckle contrast analysis<br>(LASCA) | | Laser speckle contrast analysis<br>(LASCA) | | Same |
| Indications for<br>Use | RFLSI CZW Laser Speckle<br>Imaging System is intended for<br>blood flow measurements in the<br>microcirculation. This device is<br>intended for clinical research<br>use. | | The moorFLPI-2 Full-Field<br>Laser Perfusion Imager is<br>intended for blood flow<br>measurements in the<br>microcirculation. This device<br>is intended for clinical research<br>use. | | Same |
| Laser Type | Infra-red laser<br>diode | Aiming lasers | Infra-red laser<br>diode | Aiming<br>lasers | Same |
| Wavelength | 785nm ± 10nm | 650nm | 785nm ± 10nm | 650nm | Same |
| Measured<br>Parameters | Flux (Tissue perfusion)<br>Range: 0-5000 PU<br>Resolution: 1 PU<br>Accuracy: ± 10%<br><br>DC (Intensity)<br>Range: 0~255 AU<br>Accuracy: ± 1 AU<br>Resolution: 1 AU | | Flux (Tissue blood flow)<br>Range: 0-5000 PU<br>Resolution: 1 PU<br>Accuracy: ± 10%<br><br>DC (Light Intensity)<br>Range: 0~255 AU<br>Accuracy: ± 1 AU<br>Resolution: 1 AU | | Same |
| Measurement<br>Algorithms | Spatial algorithm, Step Mode<br>Spatial algorithm, Sliding Mode<br>Temporal algorithm | | Spatial algorithm, Step Mode<br>Spatial algorithm, Sliding<br>Mode<br>Temporal algorithm | | Same |
| Working<br>Distance | 10(±0.5)-40(±1.5) cm (distance<br>between the front of the scanning<br>head and the<br>measurement site) | | 10-38 cm (distance between<br>the scan head and the<br>measurement site) | | Different: Slight<br>design differences<br>have no direct effect<br>on the safety and<br>effectiveness of the<br>subject device. |
| Power Supply | AC mains, 100-240V, 50-60Hz,<br>30VA | | AC mains, 100-230V, 50-<br>60Hz, 30VA | | Different: Different<br>supply voltage<br>ranges do not affect<br>the safety and<br>efficacy of the<br>subject device since<br>they still remain<br>within safe and<br>reasonable limits. |
| PC Connection | USB 3.0 cable | | USB 3.0 cable | | Same |

# 7. Performance Testing

Performance testing of the device Laser Speckle Imaging System is conducted to evaluate the functionality, efficiency, and overall performance of it. The following tests have demonstrated that the device performs its intended purpose, and it meets the specified requirements and standards:

### EMC and Electrical Safety Testing

The device Laser Speckle Imaging System, has undergone rigorous electromagnetic

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### K233076

compatibility testing, including radiated emission, radiated immunity, conducted emission and conducted immunity tests. The test results show that the device conforms to the following performance standards::

- 0 IEC 60601-1-2 Edition 4.0 2014-02 +A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2015+A1: 2012+A2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

#### Safety Testing for Laser Products

Laser safety testing was conducted and shows that the device conforms to following performance standard::

- O IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification and requirements
#### Performance Comparison Testing

Comparison tests to verify the substantial performance of the device and the predicate device were conducted, using two kinds of methods: (1) test with laboratory testing model "Flow Model" using a fluid simulator and (2) volunteer test on the human body using post-occlusive reactive hyperemia method, and the results conclude that the device shows comparable performance, safety, and effectiveness to the predicate device.

## 8. Conclusions

The technological comparison and performance testing demonstrate that the RFLSI CZW Laser Speckle Imaging System is substantially equivalent to its predicate device when used as intended.