The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Device Description

The Sensit.ase® PAD-IQ (PAD-IQ) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PAD3000 device. The same methods are applied for measurement of SPP and PVR in the PAD-IQ as are applied in the predicate PAD3000.

The SPP measurement relies on the creation of reactive hyperemia. Reactive hyperemia is the transient increase in blood flow that occurs following a brief period of ischemia. The SPP measurement is performed by applying a pressure cull capable of occluding skin blood flow (perfusion) to a peripheral location (arm, leg, toe. finger, etc.). The pressure cuff is inflated until the skin perfusion, as detected by a laser Doppler signal measured underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP is a test used to evaluate peripheral microcirculation. The SPP neasurement can be useful in identifying patients with peripheral arterial disease (PAD), other alterations in microcirculation, and to aid in the determination of optimum clinical treatment.

The PVR test measures and displays a waveform representing variations in the volume of blood passing through a limb during each cardiac cycle. The PVR test is fully automated and uses a partially inflated pressure cuff to apply slight pressure to the limb. The impact of blood passing through the limb is transferred to the pressure cuff where it is measured as small changes in cuff pressure. The changes are displayed as a PVR waveform. The PVR waveform can be used as a measure of functional severity of occlusive disease and as un objective for later comparisons. The PVR test is sometimes referred to as air plethysmography or volume plethysmography.

The clinical application and interpretation of the SPP measurements and interpretation of the PVR Waveform is the same as the predicate PAD3000.

The differences between the predicate PAD3000 and the PAD-1Q device are summarized as:

Change from one channel of measurement to two channels of measurement, .
Modifying device format for increased portability within a clinical environment of use. .
Inclusion of operation by battery. .

AI/ML Overview

This 510(k) summary describes a device, the SensiLase® PAD-IQ, that is substantially equivalent to a predicate device, the SensiLase® PAD3000. The submission explicitly states that the same methods are applied for measurement of SPP and PVR in the PAD-IQ as are applied in the predicate PAD3000. The differences noted are primarily modifications to the device's physical attributes (two channels of measurement, increased portability, and battery operation) rather than changes to the underlying measurement technology or clinical application.

Therefore, the document does not contain details about a specific clinical study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device, stating: "Qualification of the differences between the predicate PAD3000 and the PAD-IQ device are supported by applicable FDA Recognized Consensus Standards, FDA Guidance and applicable test plans." and "The intended use, technology, features and performance of the PAD-IQ are substantially equivalent to the predicate PAD3000. No new questions of safety or effectiveness are raised."

Thus, for most of your requested points, the answer will be that the information is not provided in this document because the device's performance is assumed to be equivalent to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitely defined as specific numerical acceptance criteria in this document. The submission focuses on substantial equivalence to the predicate device.	The SensiLase® PAD-IQ performs SPP and PVR measurements using the same methods as the predicate PAD3000. The clinical application and interpretation of these measurements are also described as the same as the predicate PAD3000. The submission asserts that no new questions of safety or effectiveness are raised, implying its performance is comparable to the legally marketed predicate.

2. Sample size used for the test set and the data provenance:

Not provided. The document does not describe a new clinical test set for the PAD-IQ. It relies on the established performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. As no new distinct test set is described, this information is not applicable in this context.

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

Not provided. Not applicable due to the absence of a distinct test set described for the PAD-IQ.

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:

No. This device is a measurement instrument, not an AI-assisted diagnostic tool for human readers. An MRMC study is not relevant to its intended use.

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

Yes, implicitly. The device itself performs the measurements (SPP and PVR). The document states, "The PVR test is fully automated." The measurement process is algorithmic and embedded within the device, with clinicians interpreting the output. The performance of these algorithms is considered substantially equivalent to those in the predicate, for which performance would have been established previously.

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

Not provided in this document for a new study. For the original predicate device, the "ground truth" for SPP and PVR measurements would likely have been established through correlation with recognized physiological principles, clinical outcomes, and potentially comparison with other established diagnostic methods for peripheral arterial disease (PAD) and microcirculation assessment.

8. The sample size for the training set:

Not provided. This device is not described as involving a machine learning or AI "training set" in the conventional sense. Its function relies on established physical principles and signal processing, not a trained AI model.

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

Not applicable. As noted above, there is no mention of a "training set" for AI in this document.

Summary

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MAY - 4 2011

510(k) Summary 6.0 Vasamed Incorporated. Company Name: 7615 Golden Triangle Drive Eden Prairie, MN 55344 Dan Bartnik, Chief Technology Officer & Vice President of Operations Contact: (952) 947-9521 Phone: (952) 944-6022 Fax: Summary Date: February 8. 2011 SensiLase® PAD-1Q Trade Name: Common Name: Blood Flowmeter 21 CFR 870.2100, Flowmeter. Blood: Class II. Classification Name: Product Code: DPW Predicate Device: 510(k) Number: K040654 Vasamed Incorporated Manufacture:

Trade Name: SensiLase® PAD3000

Description of Device 1.0

7615 Colden Triange Drive Suito C Ischnology Pork rive Minneapolis, MN 55344 652 ेंद्र को 5827 Phone 9 12 724 007 . 1-0x

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(perfusion) to a peripheral location (arm, leg, toe. finger, etc.). The pressure cuff is inflated until the skin perfusion, as detected by a laser Doppler signal measured underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP is a test used to evaluate peripheral microcirculation. The SPP neasurement can be useful in identifying patients with peripheral arterial disease (PAD), other alterations in microcirculation, and to aid in the determination of optimum clinical treatment.

The clinical application and interpretation of the SPP measurements and interpretation of the PVR Waveform is the same as the predicate PAD3000.

The differences between the predicate PAD3000 and the PAD-1Q device are summarized as:

Change from one channel of measurement to two channels of measurement, .
Modifying device format for increased portability within a clinical environment of use. .
Inclusion of operation by battery. .

2.0 Intended Use

The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

3.0 Technology

The PAD-IO instrument contains a laser diode that is used when performing the skin perfusion pressure measurement. Laser specifications are:

1 . Laser Classification per 21CFR1040.10: Class I
2, Laser Classification per IEC 60825-1: Class 1

The same technology was applied in the predicate PAD3000 device.

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Qualification of the differences between the predicate PAD3000 and the PAD-IQ device are supported by applicable FDA Recognized Consensus Standards, FDA Guidance and applicable test plans.

4.0 Conclusions

The intended use, technology, features and performance of the PAD-IQ are substantially equivalent to the predicate PAD3000. No new questions of safety or effectiveness are raised.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vasamed Incorporated c/o Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

4 2011 MAY

K110438 Re:

Trade/Device Name: SensiLase® PAD-IQ Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: February 8, 2011 Received: February 15, 2011

Dear Mr. Syring:

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 (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. The 1 ou may , morely missions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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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Page 2 - Mr. Syring

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ È 110 438

Device Name: SensiLase® PAD-IQ

Indications for Use:

The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).