(114 days)
Not Found
No
The summary describes a device that functions like a traditional continuous-wave Doppler ultrasound, producing an audible signal based on blood flow. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a sensor to detect blood flow to assist in the detection of peripheral vascular disease, which is a diagnostic function, not a therapeutic one.
Yes
The device is designed to "detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease," which clearly indicates its role in identifying or characterizing a medical condition.
No
The device description explicitly states that the Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit, all of which are hardware components. The performance studies also include testing for biocompatibility, electrical and EMC safety, and acoustic output levels, which are relevant to hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Laminar P1 Function: The Laminar P1 device uses ultrasound to directly detect blood flow within the body (in vivo). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease by being placed on the patient's body.
Therefore, based on its mechanism of action and intended use, the Laminar P1 is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.
Product codes
DPW
Device Description
The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral vessels/vasculature
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities.
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
The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards:
- Biocompatibility per ISO 10993-1 and FDA's guidance Use of International Standard . ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- . Software per IEC 62304 and FDA's guidance Content of Premarket Submissions for Device Software Functions
- Electrical and EMC safety per IEC 60601-1 and IEC 60601-1-2 .
- . Acoustic output levels per IEC 60601-2-37 and IEC 62359
- . Bench performance testing (functional testing, audio performance testing, mechanical testing)
The results of these tests indicate that the Laminar P1 is substantially equivalent to the predicate device.
No clinical testing was provided to support the demonstration of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2024
Laminar Digital Health, Inc. % Pierre Bounaud Principal Consultant Ram+ 2790 Mosside Blvd, Suite 800 Monroeville, Pennsylvania 15146
Re: K242487
Trade/Device Name: Laminar P1 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: November 12, 2024 Received: November 12, 2024
Dear Pierre Bounaud:
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.
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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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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assistance/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,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Laminar P1
Indications for Use (Describe)
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) SUMMARY
DATE PREPARED
December 11, 2024
MANUFACTURER AND 510(k) OWNER
Laminar Digital Health, Inc. 440 N Wolfe Road, Sunnyvale, CA 94085, USA Telephone: Official Contact: Jess Lee, CEO
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D. Allison Komiyama, Ph.D., RAC ROM+ Telephone: +1 (412) 816-8139 Email: pbounaud@rqmplus.com.akomiyama@rgmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Laminar P1 |
|---|---|
| Common Name: | Ultrasound Sensor Patch |
| Regulation Number: | 21 CFR 870.2100 |
| Class: | II |
| Product Code: | DPW |
| Premarket Review: | OHT2/Division of Cardiac Electrophysiology, Diagnostics |
| and Monitoring Devices (DHT2A) | |
| Review Panel: | Cardiovascular |
PREDICATE DEVICE IDENTIFICATION
The Laminar P1 is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|--------------------------------------|----------------------|
| K191388 | FloPatch (FP110) / Flosonics Medical | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the
5
traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.
INDICATIONS FOR USE
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuouswave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease.
The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on patients, ages 18 years and older.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Laminar Digital Health, Inc. believes that the Laminar P1 is substantially equivalent to the predicate device based on the information summarized here:
Both devices have the same intended use, i.e., to detect blood flow in peripheral vessels for assisting in the detection of peripheral vascular disease. Both devices are intended for the same patient population and the same use environments.
The subject device shares similar technological characteristics with the predicate device. Both devices use the Doppler effect to detect blood flow in peripheral vasculature via piezoelectric transducers and one continuous wave mode.
Main differences in technological characteristics include:
- Smaller form factor The subject device is smaller and lighter than the predicate. This . difference has undergone testing to ensure the subject device is as safe and effective as the predicate.
- . Transducer frequency - The subject device operates at 4.5 MHz while the predicate device features a flat face probe at 4 MHz. This does not raise different questions of safety or effectiveness.
- Global maximum outputs – Global maximum outputs for the subject device are higher than the predicate. This difference has undergone testing to ensure the subject device is as safe and effective as the predicate.
- . Volume level and receiver options – The subject device offers a choice of volume levels and three ultrasound receiver options (shallow, medium, and deep) to boost signal quality. The user can cycle between the three options to pick the best audio sound quality and amplitude. This does not raise different questions of safety or effectiveness.
These differences have undergone testing to ensure the subject device is as safe and effective as the predicate device.
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| Subject Device | Predicate Device | ||
|---|---|---|---|
| Laminar P1 | FloPatch (FP110) | ||
| K191388 | |||
| Indications for Use | The Laminar P1 device is a wearable and | The FloPatch(FP110) is intended for the | |
| disposable, ultrasound-based (4.5 MHz, | detection of blood flow in peripheral | ||
| continuous-wave) patch sensor designed | vasculature. | ||
| to detect blood flow in peripheral vessels | The device is intended to be used by | ||
| and assist in the detection of peripheral | medical professionals, such as | ||
| vascular disease. | physicians and nurses, in hospitals and | ||
| The Laminar P1 device is intended to be | professional environments. The device is | ||
| used by medical professionals, such as | intended for prescription use only. | ||
| physicians and nurses, in hospitals, clinics | |||
| and private offices and healthcare | |||
| facilities. It is to be used on patients, ages | |||
| 18 years and older. | |||
| Product Code | DPW | DPW | |
| Use Environment | Healthcare settings | Healthcare settings | |
| Patient Population | 18 years and older | 18 years and older | |
| Installation and Use | Body Worn | Body Worn | |
| Applications | Peripheral vascular | Peripheral vascular | |
| Device Description | The Laminar P1 is an ultrasound-based | The FloPatch (FP110) is a non-invasive | |
| battery-powered sensor patch designed to | blood flow detection device intended to | ||
| detect blood flow in veins and arteries to | be used in a medical/hospital setting for | ||
| use by medical professionals. The device | |||
| assist in the detection of peripheral | |||
| vascular disease. The sensor patch is | uses ultrasound and the Doppler effect to | ||
| designed to have the same performance | evaluate the flow of blood. The device | ||
| characteristics as traditional ultrasound | consists of signal processing box (main | ||
| transducer probes (4.5 MHz frequency) | unit) and an ultrasonic vascular flow | ||
| but in a patch form factor that is easy to | transducer. The device transmits | ||
| place on the patient's body for a given | ultrasonic waves from the vascular flow | ||
| time period. | transducer to a peripheral vessel such as | ||
| the carotid artery. The Doppler shifted | |||
| ultrasonic waves are reflected by moving | |||
| blood cells back to the ultrasonic flow | |||
| transducer. The reflected signal is | |||
| received by the signal processing box | |||
| (main unit) which outputs the doppler | |||
| signal to the device speaker. | |||
| Device Components | • Processing Unit | • Main Unit (signal processing box) | |
| • Sensor Patch with Patch Frame | • Ultrasonic transducer | ||
| • Power Cable | |||
| Dimensions (Length x | |||
| Width x Height) | 52 x 38 x 22 mm | 135 x 108 x 43.3 mm | |
| Weight | 44 grams |