Laminar P1 (LDH-HW-001)

K242487 · Laminar Digital Health, Inc. · JAF · Dec 13, 2024 · Radiology

Device Facts

• Record ID: K242487
• Device Name: Laminar P1 (LDH-HW-001)
• Applicant: Laminar Digital Health, Inc.
• Product Code: JAF · Radiology
• Decision Date: Dec 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1540
• Device Class: Class 2

Intended 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.

Device Story

Laminar P1 is a wearable, ultrasound-based sensor patch for peripheral blood flow detection. System comprises a single-use sensor patch, adhesive patch frame, and reusable battery-operated processing unit. Device utilizes 4.5 MHz piezoelectric transducers in continuous-wave Doppler mode to detect blood flow in veins and arteries. Medical professionals (physicians/nurses) apply the patch to the patient; the processing unit controls the transducer and provides audio output via a built-in speaker. Users can adjust volume levels and select between three receiver options (shallow, medium, deep) to optimize signal quality. Output is an audible Doppler signal, similar to traditional handheld Doppler devices, used by clinicians to assess peripheral vascular status and assist in diagnosing peripheral vascular disease. Benefits include a lightweight, body-worn form factor facilitating monitoring over time compared to traditional handheld probes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), software (IEC 62304), electrical/EMC safety (IEC 60601-1/1-2), and acoustic output (IEC 60601-2-37, IEC 62359).

Technological Characteristics

Wearable ultrasound patch; 4.5 MHz continuous-wave piezoelectric transducer. Components: single-use sensor patch, adhesive frame, reusable battery-operated processing unit (3.7V Li-polymer). Dimensions: 52x38x22 mm; weight: 44g. Features adjustable volume and three receiver depth settings. Standards: ISO 10993-1 (biocompatibility), IEC 62304 (software), IEC 60601-1/1-2 (electrical/EMC), IEC 60601-2-37/62359 (acoustic).

Indications for Use

Indicated for adults 18+ in clinical settings to detect peripheral blood flow and assist in peripheral vascular disease diagnosis.

Regulatory Classification

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.

Predicate Devices

• FloPatch (FP110) (K191388)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K242487

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)

< | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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: [phone] Email: [e-mail]@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<br>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<br>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

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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<br>use by medical professionals. The device | |
| | assist in the detection of peripheral<br>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<br>Width x Height) | 52 x 38 x 22 mm | 135 x 108 x 43.3 mm | |
| Weight | 44 grams | <450 grams | |
| Principle of Operation | Doppler effect to detect blood flow in | Doppler effect to detect blood flow in | |
| | peripheral vasculature | peripheral vasculature | |
| Modes of Operation | One mode, continuous | One mode, continuous | |
| Transducers | 4.5 MHz probe | 4 MHz probe | |
| | | Subject Device | Predicate Device |
| | | Laminar P1 | FloPatch (FP110) |
| | | | K191388 |
| Global<br>Maximum | ISPTA, $\alpha$<br>(mW/cm²) | 204.89 | 21.47 |
| Outputs | MI | 0.0537 | 0.01 |
| Operational Modes | | • Volume levels (silent, low, medium, high)<br>• Receiver options for signal strength (shallow, medium, deep) | No Volume slider |
| Audio Bandwidth | | 150 Hz – 2 KHz | N/A |
| Audio Power | | 0.8 W | N/A |
| Power Source | | Rechargeable 3.7V lithium-polymer battery | Internal AA alkaline batteries |
| Maintenance | | • Reusable processing unit<br>• Single use sensor patch and patch frame | Single use transducer |

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#### SUMMARY OF NON-CLINICAL TESTING

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.

#### SUMMARY OF CLINICAL TESTING

No clinical testing was provided to support the demonstration of substantial equivalence.

#### CONCLUSION

Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The indications for use, technological characteristics, and performance characteristics for the proposed Laminar P1 are assessed to be substantially equivalent to the predicate device.