The medi pneumatic compression system (pcs) - brio is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use

Device Description

The medi pneumatic compression system (pcs) – brio (Model 651) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.
The medi pcs brio (Model 651) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch and a wall power connection for standard 125v AC Power. The PCU provides compression with short cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6 or 8 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs brio (Model 651) is a basic model and is adjustable and limits the different treatment pressures and treatment times according to physician prescription.
The medi pcs brio (Model 651), air hose and sleeves together may only be distributed, sold and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeves, and all pads that are non-sterile, single patient use.
The medi pcs brio (Model 651) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs brio (Model 651)) device, air hoses and air inflatable sleeves together may only be distributed, sold and operated as a prescribed device.

AI/ML Overview

The provided text describes the medi pneumatic compression system (pcs) - brio (Model 651), a Class II medical device intended for treating lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema. The submission is a 510(k) premarket notification, which means the manufacturer is asserting the device is substantially equivalent to a legally marketed predicate device, the CircuFlow 5200 Series Sequential Compression Device (K101523).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the performance tests conducted to demonstrate that the new device is as safe and effective as the predicate device. Unlike a clinical trial with predefined statistical endpoints for efficacy, a 510(k) submission relies on demonstrating substantial equivalence, often through bench testing, adherence to recognized standards, and comparison of technological characteristics.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by the performance specifications of the device itself and the recognized standards it claims to meet. The "reported device performance" is the result of the bench testing demonstrating adherence to these specifications and standards.

Acceptance Criteria (Derived from device specifications & standards)	Reported Device Performance (as demonstrated by testing)
Biocompatibility: Meet ISO 10993 requirements for cytotoxicity, sensitization, and irritation for prolonged skin contact.	Nylon 210D material (used for sleeves) passed Cytotoxicity, Sensitization, and Irritation studies according to AAMI / ANSI / ISO 10993-1, 10993-5, and 10993-10, and GLP (21 CFR Part 58).
Electrical Safety: Conform to general requirements for basic safety and essential performance.	Conforms to ANSI/AAMI 60601-1.
Electrical Safety (Collateral Standard): Conform to collateral standard for electrical safety.	Conforms to ANSI/AAMI 60601-1-11.
Electromagnetic Compatibility (EMC): Meet EMC requirements and tests.	Conforms to IEC 60601-1-2.
Software Verification and Validation: Conform to standard for medical device software (moderate concern level).	Conforms to IEC 62304:2006.
Bench Performance: Meet specifications for various operational parameters.	Inflation and Deflation Time Performance: Assured to meet product specifications. Treatment Time Performance: Assured to meet product specifications. Pressure Performance: Assured to meet product specifications. Burst Pressure Performance: Assured to meet product specifications. Pressure Gradient Performance: Assured to meet product specifications.
Software Integration (GUI Navigation): Assure proper navigation.	GUI Navigation Performance demonstrated to meet specifications.
Software Integration (Pressure Calibration): Assure proper pressure calibration.	Pressure Calibration Performance demonstrated to meet specifications.
Safety (Errors & Alarm): Assure proper error and alarm functionality.	Errors & Alarm Performance demonstrated to meet specifications.
Substantial Equivalence: Demonstrate similar technical and performance characteristics to the predicate device and not raise new safety/effectiveness issues.	Concluded to be substantially equivalent to the CircuFlow 5200 (K101523) based on shared intended use, safety and performance testing results, compliance with standards, and comparison of features and characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The provided text details bench testing and biocompatibility testing. For these types of tests, "sample size" doesn't typically refer to patient data or a clinical test set in the same way it would for a clinical efficacy study.

Biocompatibility Testing: The "test article" was Nylon 210D, which is a material. The "sample size" would relate to the number of material samples subjected to the cytotoxicity, sensitization, and irritation assays. The specific number of samples tested is not provided in the text.
Bench Performance Testing: The "sample size" would refer to the number of medi pcs brio (Model 651) devices or components tested. This information is not specified in the document.
Data Provenance: The data is from laboratory and bench testing conducted by the manufacturer, not from patient data or clinical studies. Therefore, there's no country of origin for clinical data, nor is it retrospective or prospective in that sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is typically relevant for studies involving human interpretation (e.g., medical imaging). Since this submission primarily involves bench and material testing, there's no mention of "experts" establishing ground truth in this context. The "ground truth" for these tests is established by the defined specifications and standards (e.g., a specific pressure reading, a cytotoxicity level).

4. Adjudication Method for the Test Set

As the evaluation primarily consists of objective bench and material testing against predefined criteria and standards, an "adjudication method" involving multiple human reviewers (like 2+1 or 3+1) is not applicable or mentioned. The tests produce measurable results that are compared directly to the specified acceptance criteria.

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

This type of study is not mentioned and is not applicable to the medi pneumatic compression system. This device is not an AI-based diagnostic or assistive reading tool. The submission is for a physical medical device (a pump and sleeves) for compression therapy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is also not applicable. The medi pneumatic compression system is a physical device, not an algorithm. Its "performance" is its mechanical function (pressure delivery, cycle times, safety features), not an algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be characterized as:

Engineering Specifications: For inflation/deflation time, pressure ranges, cycle times, treatment times, and burst pressure, the ground truth is the device's design specifications and performance limits.
Standard Compliance: For biocompatibility, electrical safety, EMC, and software, the ground truth is defined by the specific requirements and limits set forth in the international and national standards (e.g., ISO 10993, ANSI/AAMI 60601 series, IEC 62304).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device is not an AI/machine learning product that requires training data. The "training" in this context would refer to internal development and refinement of the device's design, manufacturing processes, and software, rather than a separate dataset for model training.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML model, this question is not applicable.

Summary

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January 25, 2019

Medi USA, LP % Mark Job Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313

Re: K183631

Trade/Device Name: medi pneumatic compression system (pcs) - brio (Model 651) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: December 19, 2018 Received: December 26, 2018

Dear 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernande Aguel Fernando Aguel -S

for 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) K183631

Device Name

medi pneumatic compression system (pcs) - brio (Model 651)

Indications for Use (Describe)

The medi pneumatic compression system (pcs) - brio is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

-Lymphedema

-Venous stasis ulcers

-Venous insufficiency

-Peripheral edema

The device is intended for home, and hospital use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 510k SUMMARY

This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

し、 SUBMITTER

MEDI USA, LP 6481 Franz Warner Pkwy. Whitsett, NC 27377

Phone: (336) 449 4440

Contact Person: Glenn Anderson Date Prepared: December 5, 2018

II. DEVICE
Name of Device: medi pneumatic compression system (pcs) - brio (Model 651)

Common or Usual Name: Sleeve, Limb, Compressible

Classification Name: Compressible Limb Sleeve (21 CFR 870.5800) Regulatory Class: II, Product Code: JOW

III. PREDICATE DEVICES
Primary- CircuFlow 5200 Series Sequential Compression Device (K101523)

The predicate device has not been subject to a design-related recall

IV. DEVICE DESCRIPTION
The medi pneumatic compression system (pcs) – brio (Model 651) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.

The medi pcs brio (Model 651) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch and a wall power connection for standard 125v AC Power. The PCU provides compression with short cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6 or 8 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs brio (Model 651) is a basic model and is adjustable and limits the different treatment pressures and treatment

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times according to physician prescription.

The medi pcs brio (Model 651), air hose and sleeves together may only be distributed, sold and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeves, and all pads that are non-sterile, single patient use.

The medi pcs brio (Model 651) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs brio (Model 651)) device, air hoses and air inflatable sleeves together may only be distributed, sold and operated as a prescribed device.

V. INDICATIONS FOR USE

The medi pneumatic compression system (pcs)-brio is a compression device based on sequential pneumatic compression technique which is intended for the following conditions:

-Lymphedema -Venous stasis ulcers -Venous insufficiency -Peripheral edema

The device is intended for home, and hospital use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Description	Subject Device-medi pcs brio (Model 651)	Predicate- CircuFlow 5200
510(k)	TBD (assigned by FDA)	K101523
Medical DeviceClassification	Same	Class II
Product Code	Same	JOW
RegulationClassification	Same	870.5800
Review Panel	Same	Cardiovascular
Intended Use	Same	Intermittent Sequential PneumaticCompression
Indications for Use	The medi pcs brio is a compressiondevice based on sequential pneumaticcompression technique which is intendedfor the treatment of the followingconditions:-Lymphedema-Venous stasis ulcers-Venous insufficiency	The CircuFlow 5200 SeriesSequential Compression Pump isa compression device based onsequential pneumaticcompression technique which isintended for the treatment of thefollowing conditions:-Lymphedema

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	-Peripheral edemaThe device is intended for home, andhospital use	-Venous stasis ulcers-Venous insufficiency-Peripheral edemaThe device is intended for home, and hospital use
Prescription Use Only	Same	Yes
Compression Type	Same	Adjustable Distal Pressure,Gradient, SequentialCompressible Limb Sleeve
Regulation Description	Same	Continuous
Mode	Same	Continuous
# of Inflatable SleeveChambers	6 or 8 per sleeve	4 or 8 per sleeve
Pump Distal SleeveChamber PressureRange	20 - 80 mm Hg	25 – 120 mm Hg
Default Distal SleeveChamber Pressure	50 mmHg Distal	45 mmHg Distal
Inflation time	3-5 seconds per chamber, dependent onpressure setting & sleeve size	Adjustable5- 20 seconds per chamber
Deflation time	10 seconds	12 seconds
Cycle Time	28-46 seconds, dependent on pressuresettings and sleeve model.	Adjustable32 – 92 seconds
Therapy Time	Adjustable, 10 – 180 minutes	Adjustable 15 – 180 minutes
UL Mark	Applied Part Type BFProtection against Electrical Shock: Class II	Applied Part Type BProtection against ElectricalShock: Class I
Standards	IEC 60601-1IEC 60601-1-2IEC 60601-11ISO 10993ISO 14971IEC 62304ISO 13485	IEC 60601-1-1IEC 60601-1-2UL 60601-1ISO 10993ISO 14971
Single Patient Use	Same	Yes

Adjustable Distal Pressure, Gradient, Sequential compression is the technological principle for both the subject and predicate device. Both compression systems are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Both compression systems are adjustable distal pressure, gradient, sequential type and enables different treatment pressures and treatment times according to physician prescription.

At a high level, the subject and predicate device are based on the following same technological features and operational elements:

Similar pump with similar principals of operation

Similar sleeve design and materials

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All devices consist of electrically generated sources of compressed air, tubing to convey the pressurized air to the sleeve and pressure is applied cyclically for a specified period of time.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence

Biocompatibility testing

Biocompatibility tests were selected based on the 510(k) Memorandum - #G95-1 "Use of International

Standard ISO-10993", Table 1 Initial Evaluation Tests for Consideration. The test article of Nylon 210D (ID 07082016) is used for manufacturing all sleeves. Based on intended use and contact, this nylon 210D material is considered a "Surface Device" for "Skin" and has a prolonged contact duration of 24h to 30 days.

Based on the ISO 10993-1 testing matrix, Cytotoxicity, Sensitization, and Irritation studies were required according to the following ISO standards and Good Laboratory Practices (GLP), (21 CFR Part 58).

AAMI / ANSI / ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing AAMI / ANSI / ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity AAMI / ANSI / ISO 10993-10: Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization

Electrical safety and electromagnetic compatibility (EMC)

The medi pcs brio (Model 651) conforms to the following standards

Electrical Safety General Requirements for basic safety and essential performance per ANSI/AAMI 60601-1 Electrical Safety Collateral Standard per ANSI/AAMI 60601-1-11 EMC requirements and tests per IEC 60601-1-2

Software Verification and Validation

The medi pcs brio (Model 651) conforms to the following standard, based on its identified level of moderate concern

IEC 62304:2006 Medical Device Software

Bench Performance

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Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the medi pcs brio (Model 651) are substantially similar to those of the predicate device. The performance tests performed include assessment of:

Inflation and Deflation Time Performance Treatment time Performance Pressure Performance Burst Pressure Performance Pressure Gradient Performance Software Integration - Graphical User Interface Navigation Performance Software Integration - Pressure Calibration Performance Safety - Errors & Alarm Performance

CONCLUSION VIII.

Based on their same intended use, safety and performance testing results and the compliance with the acceptable voluntary standards and comparison to the predicate in terms of features and characteristics; we conclude that the proposed subject device, the medi pcs brio (Model 651) is substantially equivalent to the identified predicate, since the subject device has the same technical and performance characteristics as the predicate device. Performance testing results for the proposed devices do not raise any new safety and/or effectiveness issues.

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).