(245 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The technology described is based on laser speckle contrast analysis.
No
The device is described as a measurement tool for blood flow and is intended for clinical research use, not for treating or rehabilitating patients.
No
The device is described as being for "blood flow measurements" and a "measurement tool" providing "real-time blood perfusion information." It is explicitly stated for "clinical research use," not for diagnosing conditions. While it measures physiological parameters, its stated purpose is not to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "Laser Speckle Imaging System" and describes it as a "measurement tool based on the laser speckle contrast analysis technology." It also mentions conforming to standards related to electrical safety and laser products (IEC 60601-1-2, IEC 60601-1, and IEC 60825-1), which are typically associated with hardware components. The performance studies also include EMC and Electrical Safety Testing and Safety Testing for Laser Products, further indicating the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood flow measurements in the micro-circulation" and "clinical research use." This describes a device used to measure a physiological parameter directly from the body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces this by stating it's a "measurement tool based on the laser speckle contrast analysis technology" that provides "real-time blood perfusion information of tissue and organs." It also explicitly states the device is "non-patient contacting."
- Lack of mention of samples: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physiological process in vivo (within the living body).
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DPT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser Speckle Imaging
Anatomical Site
micro-circulation
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital setting or other appropriate clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the device Laser Speckle Imaging System is conducted to evaluate the functionality, efficiency, and overall performance of it.
EMC and Electrical Safety Testing: The device Laser Speckle Imaging System, has undergone rigorous electromagnetic 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::
- 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::
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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
5
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 | ||
| Imaging System | moorFLPl-2 Full-Field Laser | ||
| Perfusion Imager | N/A | ||
| 510(k)# | N/A | K122943 | N/A |
| Common Name | RFLSI CZW Laser Speckle | ||
| Imaging System | Full-Field | ||
| Laser Perfusion | |||
| Imager | N/A | ||
| Regulation | 21 CFR Part 870.2120 | 21 CFR Part 870.2120 | Same |
| Product Code | DPT | DPT | Same |
6
| Submission &
| Classification | 510(k) Class II | 510(k) Class II | Same | ||
|---|---|---|---|---|---|
| Principle | Laser speckle contrast analysis | ||||
| (LASCA) | Laser speckle contrast analysis | ||||
| (LASCA) | Same | ||||
| Indications for | |||||
| Use | RFLSI CZW Laser Speckle | ||||
| Imaging System is intended for | |||||
| blood flow measurements in the | |||||
| microcirculation. This device is | |||||
| intended for clinical research | |||||
| use. | The moorFLPI-2 Full-Field | ||||
| Laser Perfusion Imager is | |||||
| intended for blood flow | |||||
| measurements in the | |||||
| microcirculation. This device | |||||
| is intended for clinical research | |||||
| use. | Same | ||||
| Laser Type | Infra-red laser | ||||
| diode | Aiming lasers | Infra-red laser | |||
| diode | Aiming | ||||
| lasers | Same | ||||
| Wavelength | 785nm ± 10nm | 650nm | 785nm ± 10nm | 650nm | Same |
| Measured | |||||
| Parameters | Flux (Tissue perfusion) | ||||
| Range: 0-5000 PU | |||||
| Resolution: 1 PU | |||||
| Accuracy: ± 10% |
DC (Intensity)
Range: 0~255 AU
Accuracy: ± 1 AU
Resolution: 1 AU | | Flux (Tissue blood flow)
Range: 0-5000 PU
Resolution: 1 PU
Accuracy: ± 10%
DC (Light Intensity)
Range: 0~255 AU
Accuracy: ± 1 AU
Resolution: 1 AU | | Same |
| Measurement
Algorithms | Spatial algorithm, Step Mode
Spatial algorithm, Sliding Mode
Temporal algorithm | | Spatial algorithm, Step Mode
Spatial algorithm, Sliding
Mode
Temporal algorithm | | Same |
| Working
Distance | 10(±0.5)-40(±1.5) cm (distance
between the front of the scanning
head and the
measurement site) | | 10-38 cm (distance between
the scan head and the
measurement site) | | Different: Slight
design differences
have no direct effect
on the safety and
effectiveness of the
subject device. |
| Power Supply | AC mains, 100-240V, 50-60Hz,
30VA | | AC mains, 100-230V, 50-
60Hz, 30VA | | Different: Different
supply voltage
ranges do not affect
the safety and
efficacy of the
subject device since
they still remain
within safe and
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
7
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.