The FP5000 System is an external pneumatic compression system comprised of a pump which supplies compressed air to a pair of foot wrap garments. The garments alternately inflate to provide compression to the venous plantar plexus of the foot. Venous plantar plexus compression move blood out of the leg, and may be used to prevent deep vein thrombosis (DVT), and as part of the treatment regimen for venous and arterial conditions of the lower limbs.

AI/ML Overview

The provided text for KCa65153 is a 510(k) summary for the FP5000 System, a device for external pneumatic compression. The summary focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and a study to prove the device meets these criteria in the traditional sense of a clinical trial with specific performance metrics.

Based on the provided document, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific quantitative targets (e.g., "sensitivity > X%", "accuracy > Y%"). Instead, it states:

| Acceptance Criteria (Implied) | Reported Device Performance |
| A. Comparable therapy/performance to existing marketed devices | "Laboratory evaluation on healthy subjects documented that the venous outflow velocity, as measured at the common femoral vein, is comparable between the FP5000 System and the two predicate systems (A V 5000 system (Kendall) and the PlexiPulse system (NuTech/KCI))." |
| B. No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation compared to predicate devices. | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| C. Meet voluntary standards (e.g., UL listing, European Medical Directive for electromagnetic compatibility). | "Voluntary standards met include UL listing and compliance with the European Medical Directive for electromagnetic compatability." |
| D. Raise no new safety or effectiveness concerns. | "The FP5000 System raises no new safety or effectiveness concerns." (This is a general statement required for 510(k) clearance, rather than a quantifiable performance metric). |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size: The document only mentions "healthy subjects" for the laboratory evaluation. It does not specify the number of subjects (the sample size) used in this evaluation.
Data provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the study was conducted within the US or under internationally recognized standards accepted by the FDA. The nature of a "laboratory evaluation on healthy subjects" implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to the type of device and study described. The study cited measured physiological parameters (venous outflow velocity) directly, rather than relying on expert interpretation of images or other subjective assessments that would require ground truth established by experts.

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

Not applicable. As the study measured objective physiological parameters directly, no adjudication method for expert consensus was required.

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

Not applicable. This device is an external pneumatic compression system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical medical device, not a software algorithm. Its performance is evaluated through its mechanical action and physiological effects.

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

The ground truth or comparison standard was the direct measurement of venous outflow velocity in healthy subjects, using established methods to quantify the physiological effect of the device and comparing it to the same measurements obtained with predicate devices. This relies on quantitative physiological data rather than a subjective "ground truth" derived from expert consensus, pathology, or outcomes data in the traditional sense for diagnostic algorithms.

8. The sample size for the training set

Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Summary

{0}------------------------------------------------

KCa65153

510(k) Summary

FP5000 System

JAN 26 1998

The system is designed to provide therapy comparable to existing marketed devices such as the A V 5000 system (Kendall) and the PlexiPulse system (NuTech/KCI). There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. Laboratory evaluation on healthy subjects documented that the venous outflow velocity, as measured at the common femoral vein, is comparable between the FP5000 System and the two predicate systems.

There are no performance standards established for this category of medical device (Class II -Compressible Limb Sleeves). Voluntary standards met include UL listing and compliance with the European Medical Directive for electromagnetic compatability.

The FP5000 System raises no new safety or effectiveness concerns.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Audrey Witko Director of Corporate Affairs Huntleigh Healthcare Inc. 227 Route 33 East Manalapan, NJ 07726

JAN 26 1998

Re: K965153 Huntleigh FP5000 System Model FP5000 Regulatory Class: II (Two) Product Code: JOW October 30, 1997 Dated: October 31, 1997 Received:

Dear Ms. Witko:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Audrey Witko

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):

Device Name: Huntleigh FP5000 System

Indications For Use:

Prevention of deep vein thrombosis 1.
Enhancement of venous & arterial circulation 2.
Preventionof venous stasis 3 .
Assist healing of cutaneous ulcers 4 ,
-5 . Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma 6.
7 . Reduction of compartmental pressures

(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, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________ ¥965153.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

000005

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).