The EISCHO Intermittent compression Boot is intended for first aid treatment of minor sportrs injuries. It is intended to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff.

Device Description

This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelops the lower extremity and the lower chamber is located under the foot. The interior panel has been sealed onto the exterior panel. When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue. The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is then inflated by means of the patient placing pressure on the foot. At this point, the pressure in the upper chamber increases which causes a compression of the limb. When the patient lifts his/her foot, the air passes from the upper chamber to inflate the lower chamber, which causes the overall boot pressure to return to nominal pressure. The pressure may be applied while walking, standing, sitting or lying. The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.

AI/ML Overview

The provided document is a 510(k) premarket notification for an Intermittent Compression Boot. It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device, not a study reporting on the performance of the device against specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment) are not applicable as this document does not describe such a study.

However, I can extract information related to the device's intended use which serves as the basis for its acceptance into the market by the FDA as "substantially equivalent."

Here's a breakdown based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implicitly the requirements for demonstrating substantial equivalence to a predicate device. The "performance" is demonstrated by showing that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance (from submission)
Intended Use:	The device is intended for medical purposes, such as to relieve minor aches and
Minor aches and pains relief	pains and to increase circulation in the patient's lower limbs. It simulates
Increased circulation	kneading and stroking of tissues by using an inflatable pressure cuff.
Simulates kneading/stroking	(Specifically for OTC use): First aid treatment of minor sports injuries.
Technological Characteristics:
Inflatable garment/boot	This device is an inflatable garment or boot that is intended for use on patients'
Two chambers	lower limbs. It consists of two chambers. The upper chamber envelops the lower
Air movement mechanism	extremity and the lower chamber is located under the foot. When pressure is
Hand pump inflation	applied to the lower chamber by the patient's foot, air moves from the lower
Patient-driven compression	chamber to the upper chamber through air passageways. Inflated by a hand pump.
Deflation mechanism	Patient places pressure on foot for compression. Deflated by pressing valve stem.
Safety/Effectiveness Profile:
No life-sustaining function	Not life sustaining. Not implanted. No software. Constructed of plastic.
Not implanted	No toxicology implications. Not sterile. For one person. No drug/biological
No software	components.
No new safety/functional issues	"This poses no new safety of functional issues."
Substantial Equivalence:	Comparison indicates they are substantially equivalent to the predicate (EISCHO,
Same as predicate for professional use	Inc.'s Intermittent Compression Boot for professional use, K964957).

The remaining information directly related to a "study" as implied by the questions is not present in this 510(k) document, which generally relies on pre-clinical data, literature review, and comparison to a legally marketed predicate, rather than a de novo clinical trial demonstrating performance against specific numerical acceptance criteria.

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

N/A. This document does not describe a clinical study with a test set of patients/data. It is a regulatory submission for substantial equivalence.

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)

N/A. Ground truth for a test set is not applicable as no such test set is described. The "ground truth" here is the prior FDA clearance of the predicate device.

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

N/A. No test set or adjudication method is described.

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

N/A. This device is a mechanical boot, not an AI or imaging device, and no MRMC study or human reader assistance is relevant or described.

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

N/A. This is a mechanical device, not an algorithm.

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

N/A in the context of a "study." For the purpose of the 510(k), the "ground truth" or standard for comparison is the legally marketed predicate device (EISCHO, Inc.'s Intermittent Compression Boot for professional use, K964957) and its established safety and effectiveness profile.

8. The sample size for the training set

N/A. There is no "training set" as this is not a machine learning device or a clinical study involving data collection for training.

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

N/A. Not applicable for the reasons stated above.

Summary

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991921/

1. Submitter:

Clem Eischen Owner EISCHO, Inc. 1232 S.E. 282 Ave. Grisham, OR 97080 Tel: (503) 2232 Fax: (503) 2232

Device Name 2.

Classification: 2.1
2.2 Common/Usual Name:
Proprietary Name: 2.3

Panel 74, Class II, 890.5650 Power Inflatable Tube Messager Intermittent Compression Boot

Predicate Device: 3.

3.1 EISCO, Inc.'s Intermittent Compression Boot for professional use, K964957

4. Intended Use:

The EISCHO Intermittent compression Boot is intended for medical purposes, such as to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff. The boot is not life sustaining is not implanted and does not use software. It is constructed of plastic that is designed for use over the lower extremity. It appears as an inflated boot. There are no toxicology implications. It is not sterile and is intended for the use of one person. The device is for home, hospital or clinical use. There are no drug or biological components. See also exhibit 6, product labels, for indications for use.

స్ Device Description:

The interior panel has been sealed onto the exterior panel. When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue.

The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is then inflated by means of the patient placing pressure on the foot..

At this point, the pressure in the upper chamber increases which causes a compression of the limb. When the patient lifts his/her foot, the air passes from the upper chamber to inflate the

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EISCHO, Inc. Intermittent Compression Boot Premarket Notification Summary Of Data

lower chamber, which causes the overall boot pressure to return to nominal pressure. The pressure may be applied while walking, standing, sitting or lying.

The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.

6. Substantial Equivalency Comparisons:

The comparison of EISCHO's Intermittent Compression Boot for over the counter use and EISCHO's Intermittent Compression Boot for professional use K964957 are the same The intermittent compression boot for over the counter use is indicated for first aid use on minor sports injuries and the intermittent compression boot for professional use is indicated for post phlebitis syndrome; swelling of foot, ankle and lower leg due to total knee replacement; bruising, swollen knee and ankle; and gravitational edema after cast removal.

7. Conclusions:

Comparison of EISCHO's Intermittent Compression Boot for over the counter use and EISCHO's Intermittent Compression Boot for professional use indicates that they are substantially equivalent. The intermittent compression boot for over the counter use is use for first aid minor injuries. This poses no new safety of functional issues.

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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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

Mr. Clem Eischen President/Sales Eischco, Incorporated 1232 S.E. 282nd Avenue Gresham, Oregon 97080

Re: K991921

Trade Name: Intermittent Compression Boot for OTC Regulatory Class: II Product Code: IRP Dated: May 28, 1999 Received: June 7, 1999

Dear Mr. Eischen:

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 control provisions of the Act. The general control 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Register. 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.

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Page 2 – Mr. Clem Eischen

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 legally 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) 594-4659. 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,

Colin M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K991921 Unknown

510(k) Number (if known):

Intermittent Compression Boot For Over The Counter Use

Device Name:

Indications For Use:

. . .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter USE X

tcaief

Division Sign-Off) ivision of General Restorative Devic 510/k) Number

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).