(33 days)
The HydroBoot device is indicated to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.
The HydroBoot device is intended to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema. The HydroBoot achieves its pressure against the foot and leg from the hydrostatic pressure of water that fills the walls of the boot. The pressure depends only on the depth of the water, so a pressure gradient from the foot to the knee is obtained.
The provided document describes the 510(k) summary for the HydroBoot device (K022233). It is important to note that this document is a summary for regulatory clearance and does not typically contain the detailed raw data, exhaustive study protocols, or statistical analyses that would be found in a full clinical or engineering study report.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the HydroBoot does not present specific quantitative acceptance criteria or a direct performance table in the way a clinical trial detailed report might. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices. The primary performance characteristic discussed is the ability to produce therapeutic pressure levels.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Therapeutic Pressure Level: Produce compressive therapy on the lower legs and feet (implied by "manage chronic swelling and ulceration due to venous insufficiency and lymphedema"). | Pressure levels produced demonstrate equivalence to predicate devices in producing a therapeutic level of pressure on the foot and lower leg. Pressure measurements confirm values predicted from the height of the water column and show the effect of walking on pressure levels. |
| Safety and Effectiveness: Differences in technological characteristics from predicates do not raise new types of questions of safety and effectiveness. | The new technological characteristics (hydrostatic pressure vs. elastic fabric) were deemed not to raise new safety and effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Testing using pressure sensors was carried out on volunteers." However, it does not specify the number of volunteers used in this testing.
- Data Provenance: The document does not explicitly state the country of origin. Given that Incappe, Inc. is located in Vicksburg, MS, and the submission is to the FDA, it is highly probable the testing was conducted in the United States. The study was prospective in nature, as it involved actively "carrying out" testing with pressure sensors on volunteers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The testing appears to be focused on physical pressure measurements, and the "ground truth" seems to be derived from scientific measurements of hydrostatic pressure and objective sensor readings rather than expert clinical assessment of patient outcomes or conditions. If clinical outcomes were being assessed for "ground truth," experts would be mentioned, but this is not the case here.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The testing described is focused on objective pressure measurements (using pressure sensors) rather than subjective assessments or interpretations that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is typically done for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. The HydroBoot is a therapeutic device, and the testing described is focused on objective physical parameters (pressure), not human interpretation of diagnostic data.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Was it done? Yes, in a way. The "testing using pressure sensors" on volunteers, described under "F. TESTING", represents a standalone performance assessment of the device's ability to produce pressure. The device's performance in generating pressure was measured directly on volunteers. This is an assessment of the device's intrinsic mechanical/hydraulic function.
7. Type of Ground Truth Used
- The ground truth used was based on objective physical measurements and scientific principles. Specifically:
- Predicted values from the height of the water column: This relies on established principles of hydrostatics.
- Pressure sensor measurements: These provide objective quantitative data on the actual pressure exerted by the device.
- The comparison was to "demonstrate equivalence... in producing a therapeutic level of pressure," implying that "therapeutic level of pressure" is a known and accepted standard for these types of devices, possibly derived from clinical literature or predicate device performance.
8. Sample Size for the Training Set
The document does not specify a training set sample size. The HydroBoot is a mechanical/hydraulic device, not an AI/machine learning algorithm, so the concept of a "training set" in the context of machine learning is not directly applicable. The "testing" referred to is performance validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of an AI/machine learning algorithm requiring a "training set" as understood in that context. The device's mechanism is based on hydrostatic pressure, a well-understood physical principle.
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AUG 1 2 2002
510(k) Summary
HydroBoot
Common/Classification Name: Medical Support Stocking To Prevent the Pooling of Blood in the Legs, 21 CFR 880.5780(a)
Incappe, Inc. 1529 Walnut Street Vicksburg, MS 39180
Contact: Dr. Henk Kuiper, Prepared: July 5, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The Hydroboot is substantially equivalent to: the Geen Medisox, cleared by FDA as K981296 on May 29, 1998; to the Jobst Elvarex Compression Garment, cleared by FDA as K963573 on October 16, 1996; and, to the Pneumatic Ambulatory Compression System, cleared by FDA as K020538 on May 15, 2002.
DEVICE DESCRIPTION B.
The HydroBoot device is intended to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema. The HydroBoot achieves its pressure against the foot and leg from the hydrostatic pressure of water that fills the walls of the boot. The pressure depends only on the depth of the water, so a pressure gradient from the foot to the knee is obtained.
C. INTENDED USE
The HydroBoot device is indicated to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The Incappe Hydroboot is within a type of device called Medical Support Stocking to Prevent the Pooling of Blood in the Legs. The HydroBoot indications for use is slightly different from those of the legally marketed predicate devices, but the differences do not affect the intended therapeutic use. The HydroBoot has somewhat different technological characteristics from those of the predicate devices. However, the differences do not raise new types of questions of safety and effectiveness. Accepted scientific methods exist to determine the pressure levels produced in the HydroBoot and these methods have demonstrated that the HydroBoot is equivalent to the predicate devices in producing a therapeutic level
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of pressure on the foot and lower leg. This leads to a decision of substantial equivalence. 4
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the HydroBoot are somewhat different from the predicate devices. The predicate devices depend on mechanical forces from an elastic fabric to produce the pressure on the foot and leg. The pressure in the HydroBoot results from the hydrostatic pressure of water that fills the walls of the HydroBoot.
F. TESTING
Testing using pressure sensors was carried out on volunteers as they walked and performed other maneuvers while wearing the HydroBoot or elastic wrap. The pressure measurements confirm the values predicted from the height of the water column and show the effect of walking on the pressure levels.
G. CONCLUSIONS
This pre-market notification demonstrates Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
1 The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(k) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(l)(1) of the Federal Food, Drug, and Cosmetic Act.
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Image /page/2/Picture/2 description: The image shows a black and white logo for the U.S. Department of Health. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo. The logo is simple and recognizable, conveying the department's mission in a clear and concise manner.
AUG 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Incappe, Incorporated C/O Robert Sheridan R. Sheridan Associates 632 Dundee Drive Wilmington, North Carolina 28405
Re: K022233
Trade/Device Name: HydroBoot Regulation Number: 880.5780 (a) Regulation Name: Medical Support Stocking Regulatory Class: I I Product Code: DWL Dated: July 5, 2002 Received: July 11, 2002
Dear Mr. Sheridan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Que L/or
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
. ·
510(k) Number (if known): K022233
Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The HydroBoot provides comprehensive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.
(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)
Steux Cucuate
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
- 510(k) Number: KD222233
OR
Over-The-Counter Use
6
§ 880.5780 Medical support stocking.
Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.