The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor) .
Angioplasty/stent failure .
Arteriopathic wounds .
Graft failure .
Intermittent claudication .
Ischemia .
Night Pain .
Rest Pain .
Small vessel disease .
Ulcers .
The device is intended for home and hospital use.

Device Description

The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "ArterioFlow 7500 Sequential Compression Device." This device is a sequential compression device used to improve blood circulation in the lower extremities. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria for an AI/ML device or a new type of therapeutic device.

Therefore, many of the requested points from the prompt (related to AI performance, ground truth, expert adjudication, MRMC studies, sample sizes for training/test sets, etc.) are not applicable to this type of medical device submission. The device is a physical medical device (pump, garments, tubing) and its performance is assessed through bench and laboratory testing against specifications, not through an AI model's predictive accuracy.

Here's the information that can be extracted relevant to the prompt, with explanations for why other points are not present:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specification)	Reported Device Performance (Conformity)
Pressure Calibration for Pressure Sensor	Meets specifications (Implied by "assures that the product meets its specifications")
Cycle Time Performance	Meets specifications (Implied by "assures that the product meets its specifications")
Treatment Time Performance	Meets specifications (Implied by "assures that the product meets its specifications")
Pressure Performance of Arterial Garment	Meets specifications (Implied by "assures that the product meets its specifications")
Tensile Strength of Arterial Garment	Meets specifications (Implied by "assures that the product meets its specifications")
Conformance to UL 60601-1-2	Conforms
Conformance to ISO 14971	Conforms

Study Proving Acceptance Criteria:
The document states, "Bench and laboratory testing was performed and assures that the product meets its specifications." This indicates that the performance tests listed (PQ-03 to PQ-07) were conducted as part of this bench and laboratory testing.

Non-Applicable or Unknown Information (based on the provided text)

Since this is not an AI/ML device or a diagnostic device requiring clinical accuracy studies, the following information is not present or relevant in this 510(k) summary:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Test set" refers to data for evaluating an algorithm, which is not relevant here. The testing involved physical device performance. The sample size for bench/laboratory tests of physical parts is not specified, but it would typically be a limited number of devices or components tested to engineering specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. Device specifications (e.g., pressure, cycle time, tensile strength) are engineering parameters.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication of expert opinions is relevant as there's no clinical "ground truth" being established by experts for algorithmic performance.
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: Not applicable. This device does not involve human readers interpreting data with or without AI assistance. It is a therapeutic physical device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device like this is its engineering specifications and its ability to meet those during manufacturing and operation, confirmed by bench testing.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable. No training set is involved.

Summary

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510(K) SUMMARY

Submitter:

· Devon Medical, Inc.

Contact Person:

Ruth Wu, COO

1100 First Avenue, Suit 100

King of Prussia, PA 19406

800.571.3135 Phone:

484.636.3380 Fax:

Common Classification & Proprietary Names:

Common Names:	Sequential Compression Device
Proprietary Name:	ArterioFlow 7500

Date Prepared:

July 22, 2010

Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the ArterioFlow 7500.

- - - - - - - - - - - -Production Article1995 - 1997 - 1997 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -11:40 PM 11	Submit Comments of Children Research Comments of the Comments of Children- + 2435 × 12 × - - -
. Imh SIPPVP	870 5800	IOW

Predicate Devices:

The ArterioFlow 7500 Sequential Compression Device is substantially equivalent to the following.

Predicate Device	Manufacturer	510(k)#
CircuFlow 5200	Devon Medical, Inc.	K101523
BioArterial Plus	Bio Compression Systems Inc.	K072666

Device Description

The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.

1402582

OCT. 7 2010

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SECTION 5

Intended Use:

The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor) .
Angioplasty/stent failure .
Arteriopathic wounds .
Graft failure .
Intermittent claudication .

The device is intended for home and hospital use.

Technological Characteristics:

The manufacturer believes that the technological characteristic of the ArterioFlow 7500 are substantially similar to those of the predicate devices. The ArterioFlow 7500 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.

Performance Testing

Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the ArterioFlow 7500 are substantially similar to those of the predicate devices.

List of Performance Tests
PQ-03	Pressure Calibration for Pressure Sensor
PQ-04	Cycle Time Performance
PQ-05	Treatment Time Performance
PQ-06	Pressure Performance of Arterial Garment
PQ-07	Tensile Strength of Arterial Garment

Standards

The ArterioFlow 7500 conforms to the following standards: UL 60601-1-2 and ISO 14971

Statement of Substantial Equivalence

The ArterioFlow 7500 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, believes that the ArterioFlow 7500, is safe and effective and substantially equivalent to the predicate devices as described herein.

Ischemia
Night Pain
Rest Pain
Small vessel diseas
Ulcers

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

DCT 7 2010

Devon Medical Inc. c/o Mr. Mark Job Regulatory Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K102582

ArterioFlow 7500 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 7, 2010 Received: September 8, 2010

Dear Mr. Mark Job:

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 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

{3}------------------------------------------------

Page 2 - Mr. Mark Job

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.

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/ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dmah R. Vahner

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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SECTION 4

INDICATIONS FOR USE STATEMENT

(102582 510(k) Number (if known):

Device Name: ArterioFlow 7500 Sequential Compression Device

The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor) .
Angioplasty/stent failure .
Arteriopathic wounds .
Graft failure .
Intermittent claudication .
Ischemia .
Night Pain .
Rest Pain .
Small vessel disease .
Ulcers .

The device is intended for home and hospital use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) 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)

AND/OR

brune R. lehner
(D:vi:s

iovascular Devices ( arc

510(k) Number K102582

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).