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 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Laser Speckle Imaging System (RFLSI CZW) and its comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance or diagnostic accuracy. The document focuses on technological comparison, electrical safety, EMC, and laser safety testing.

Here's a breakdown of the information that is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document provides the following performance parameters for the subject device:

Feature	Acceptance Criteria (Subject Device)	Reported Device Performance (Subject Device)
Flux (Tissue perfusion)	Range: 0-5000 PU	Range: 0-5000 PU
	Resolution: 1 PU	Resolution: 1 PU
	Accuracy: ± 10%	Accuracy: ± 10%
DC (Intensity)	Range: 0~255 AU	Range: 0~255 AU
	Accuracy: ± 1 AU	Accuracy: ± 1 AU
	Resolution: 1 AU	Resolution: 1 AU

Note: The document states that "Differences in device parameters do not raise new concerns regarding safety and effectiveness" and that "Verification and validation testing for the subject device demonstrate safety and effectiveness." It also mentions "Comparison tests to verify the substantial performance of the device and the predicate device were conducted... and the results conclude that the device shows comparable performance, safety, and effectiveness to the predicate device." However, specific numerical acceptance criteria for comparability in these comparison tests are not explicitly stated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For the "laboratory testing model 'Flow Model' using a fluid simulator," the sample size is not specified.
- For the "volunteer test on the human body using post-occlusive reactive hyperemia method," the sample size is not specified.
Data Provenance: Not specified. The document indicates the applicant and correspondent are in China, but it doesn't state where the testing data originated.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance tests described (flow model and volunteer test) likely use objective physical measurements rather than expert assessment for ground truth, but the details are missing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

This type of study is not mentioned in the document. The device is a Laser Speckle Imaging System for blood flow measurement, which typically outputs quantitative data directly, rather than images requiring human interpretation that AI might assist.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance testing described ("test with laboratory testing model 'Flow Model' using a fluid simulator" and "volunteer test on the human body") appears to evaluate the device's standalone performance in measuring blood flow. The document states that the testing demonstrated that "the device performs its intended purpose, and it meets the specified requirements and standards" and showed "comparable performance, safety, and effectiveness to the predicate device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Flow Model" testing, the ground truth would likely be the known flow rates or parameters of the fluid simulator.
For the "volunteer test on the human body using post-occlusive reactive hyperemia method," the ground truth would be established by the physiological changes induced by the post-occlusive reactive hyperemia method, which creates a temporary blood flow cessation followed by a reactive increase. The device's measurements would be compared against the expected physiological response. The precise method of establishing 'ground truth' for comparison during these physiological tests is not detailed, but it's not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The device described is a measurement system and not an AI/ML device that typically requires a large training set in the way a diagnostic imaging algorithm might. The document does not mention any machine learning components that would necessitate training data.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the reasons stated in point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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: 0755-86111286 Applicant Contact: Mrs. Xuhong Wang Applicant Contact Email: wangxuhong@rwdls.com 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: 0086-1807069013 Correspondent Contact: Mrs. Eleanor Wu Correspondent Contact Email: raq@cn.purefda.com

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

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 SpeckleImaging System	moorFLPl-2 Full-Field LaserPerfusion Imager	N/A
510(k)#	N/A	K122943	N/A
Common Name	RFLSI CZW Laser SpeckleImaging System	Full-FieldLaser PerfusionImager	N/A
Regulation	21 CFR Part 870.2120	21 CFR Part 870.2120	Same
Product Code	DPT	DPT	Same

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Submission &Classification	510(k) Class II		510(k) Class II		Same
Principle	Laser speckle contrast analysis(LASCA)		Laser speckle contrast analysis(LASCA)		Same
Indications forUse	RFLSI CZW Laser SpeckleImaging System is intended forblood flow measurements in themicrocirculation. This device isintended for clinical researchuse.		The moorFLPI-2 Full-FieldLaser Perfusion Imager isintended for blood flowmeasurements in themicrocirculation. This deviceis intended for clinical researchuse.		Same
Laser Type	Infra-red laserdiode	Aiming lasers	Infra-red laserdiode	Aiminglasers	Same
Wavelength	785nm ± 10nm	650nm	785nm ± 10nm	650nm	Same
MeasuredParameters	Flux (Tissue perfusion)Range: 0-5000 PUResolution: 1 PUAccuracy: ± 10%DC (Intensity)Range: 0~255 AUAccuracy: ± 1 AUResolution: 1 AU		Flux (Tissue blood flow)Range: 0-5000 PUResolution: 1 PUAccuracy: ± 10%DC (Light Intensity)Range: 0~255 AUAccuracy: ± 1 AUResolution: 1 AU		Same
MeasurementAlgorithms	Spatial algorithm, Step ModeSpatial algorithm, Sliding ModeTemporal algorithm		Spatial algorithm, Step ModeSpatial algorithm, SlidingModeTemporal algorithm		Same
WorkingDistance	10(±0.5)-40(±1.5) cm (distancebetween the front of the scanninghead and themeasurement site)		10-38 cm (distance betweenthe scan head and themeasurement site)		Different: Slightdesign differenceshave no direct effecton the safety andeffectiveness of thesubject device.
Power Supply	AC mains, 100-240V, 50-60Hz,30VA		AC mains, 100-230V, 50-60Hz, 30VA		Different: Differentsupply voltageranges do not affectthe safety andefficacy of thesubject device sincethey still remainwithin safe andreasonable 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.

Regulation Number and Section

§ 870.2120 Extravascular blood flow probe.

(a)
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.(b)
Classification. Class II (performance standards).