The Compression Care Flight is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (greater than 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Device Description

The Compression Care Flight system is a light weight, portable, prescriptive device that helps stimulate blood flow in the legs through the use of pneumatically controlled, single chamber leg cuff(s), actuated by an electronically controlled pump unit and solenoid valves. All pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 plastic quick disconnects for air tube connection, and an external power supply input jack. The option exists for the unit to be used in single leg or double leg modes. The control unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for mains connection.

AI/ML Overview

The provided text describes a 510(k) submission for the "Compression Care Flight" device, a pneumatic compression device. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DVTcare™ CA5) through non-clinical testing.

Here's an analysis of what information is available and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Not Explicitly Stated but Inferred from Equivalence Claim)	Reported Device Performance (as described in the 510(k))
Pressure Delivery Range: Equivalent to predicate device (up to 65 mmHg)	Pressure Delivery Range: Programmable up to 65 mmHg.
Cycle Time: Equivalent to predicate device (approximately 60-75 seconds/leg)	Cycle Time: Approximately 60 seconds/leg (one inflation/deflation cycle). Configurable cycle time (60-75 seconds).
Inflation Fill Time: Equivalent to predicate device	Inflation Fill Time: Approximately 10-12 seconds.
Cuff (Garment) Fill Time: Equivalent to predicate device	Cuff (Garment) Fill Time: Verified as equivalent to predicate.
Electrical Safety: Meets relevant standards	Electrical Safety: Validated against IEC 60601-1.
System Operation: Equivalent to predicate device	System Operation: Verified as equivalent to predicate.
Intended Use: Matches predicate device	Intended Use: Matches predicate device (DVT prevention, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, aid in treatment of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous and arterial insufficiency, reduction of edema).

Study Details:

The submission does not describe a clinical study in the typical sense with human subjects, control groups, or specific quantitative acceptance criteria for patient outcomes. It relies on non-clinical bench testing to demonstrate performance characteristics are substantially equivalent or superior to the predicate device.

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

Sample Size (Test Set): Not specified. The document refers to "bench testing" and "design validation" without detailing the number of units tested.
Data Provenance: The testing was conducted by Medical Minds LLC. No specific country of origin for the data is mentioned beyond the company's location in Allendale, MI. The testing appears to be retrospective in the sense that it's performed on the device prototypes/pre-production units to demonstrate compliance with design requirements and equivalence.

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

This information is not applicable as the described testing is non-clinical bench testing. There is no "ground truth" in the context of expert medical review. The "ground truth" for non-clinical tests would be the established engineering/performance specifications and standards (e.g., IEC 60601-1 for electrical safety, or the performance specifications of the predicate device).

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

This information is not applicable as the described testing is non-clinical bench testing and does not involve human interpretation or subjective assessment that would require adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a pneumatic compression device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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

This question is not applicable to this device. The "Compression Care Flight" is a physical medical device, not an algorithm, and its performance is assessed directly through its mechanical and electrical functions, not as a standalone algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering specifications, performance standards (like IEC 60601-1), and the known performance characteristics of the predicate device (DVTcare™ CA5). There is no "expert consensus," "pathology," or "outcomes data" ground truth described in this submission for its performance evaluation.

8. The sample size for the training set

Not applicable. This device is hardware; it does not involve a "training set" in the context of machine learning.

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

Not applicable. As above, there is no "training set" for this device.

Summary

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Section 2 Summary

JUL 2 4 2012

Date:

Submitter:

Contact Person:

510(k) Summary of Safety and Effectiveness

April 19, 2011 Medical Minds LLC

11491 78th. Ave Allendale, MI 49401

David Platt Vice President of Quality and Regulatory Medical Minds LLC 616-308-2859

Device: Trade Name: Common/Usual Name:

Compression Care Flight

Compression Limb Sleeve Device

Compression Limb Sleeve

Classification Names:

CFR Reference: 21CFR870.5800

Classification Name: Sieeve, Limb, Compressible

Product Code: JOW

Predicate Device:

K061125 - DVTcare™ CA5

This predicate device submission was made by Doctor's Orders, Inc.

The control unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for mains connection.

The Compression Care Flight is a pneumatic compression device intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (greater than 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous and arterial insufficiency, and reduction of edema in the lower limbs.

Device Description:

Intended Use:

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K121376 2092

Substantial Equivalence of Technological Characteristics:

The Compression Care Flight is similar to the predicate device listed above in the function and operating principles to achieve identical results. The Compression Care Flight offers greater treatment flexibility due to the portability, adjustable pressure, and cycle time capabilities. Our system uses a microprocessor controlled pump to deliver pressurized air (programmable up to 65 mmHg) to bladders that are attached to the patient's lower limbs, using a cycle of approximately 60 seconds / leg as prescribed by a healthcare provider. Each cycle consists of one inflation (fill time approximately 10-12 seconds) followed by deflation. The Compression Care Flight has the capability of allowing a healthcare professional the following feature adjustment options: pressure set point (programmable up to 65 mmHg), hold time (0 seconds, not adjustable), cycle time (60-75 seconds). The cycle time is the length of time for one complete cycle on one leg including fill time, exhaust, and idle time (relaxation).

The Compression Care Flight uses similar means for pressure delivery as the predicate device. Pressurized air is delivered by the pump to the leg cuffs via flexible, plastic air tubes connected to the plastic pump / control unit by locking, quick disconnect couplings. Like the DVT Care CA5, the Compression Care Flight leg cuffs are comprised of a single bladder PVC chambers encased in a soft Nylon material to increase patient comfort and compliance.

Like the DVT Care CAS, the microprocessor and pump units are powered by an internal battery supply and can be connected to the mains power supply for operation and recharging.

Non-Clinical Testing

Non-clinical validation including electrical safety and performance testing have shown that the Compression Care Flight has performance characteristics substantially equivalent to or superseding the listed predicate device. The Compression Care Flight has been validated by Medical Minds at a design validation level based on the requirements of IEC 60601-1. Additional bench testing has verified equivalent pressure delivery, cuff (garment) fill time, cycle time and system operation as the predicate device listed. Test reports can be found in Appendix 1.

Conclusion:

The Compression Care Flight is designed for the same intended use as the predicate device, the DVT Care CA5. This comparison of the specifications demonstrates the functional equivalence of the products. The differences discussed in this section do not raise new issues of safety and effectiveness. Verification and validation testing demonstrated that no adverse effects have been introduced by these differences.

Medical Minds LLC believes that the Compression Care Flight is as safe and effective and performs substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

JUL 2 4 2012

Medical Minds LLC c/o Mr. David Platt Vice President of Quality & Regulation 11491 78th Avenue Allendale, MI 49401

Re: K121376

Trade/Device Name: Compression Care Flight Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 12, 2012 Received: May 8, 2012

Dear Mr. Platt:

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

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Page 2 - Mr. David Platt

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 1 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/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.

M.S. Hilleheme

? 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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K121376

Section 11 Indications for Use

Indications for Use

510(k) Number (if known): 《[2137L

Device Name: Compression Care Flight

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K121376
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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).