(241 days)
To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: - Lymphedema. - · Primary and secondary (including post-surgery, radio or chemotherapy). - . Chronic Edema of Venous Origin - Chronic venous insufficiency. . - Acute and chronic wounds including venous leg ulcers and post- surgical wounds. . IPC may also be beneficial in the management of: - . Lipoedema. - Varicose veins . - Postoperative Venous Ligation or Stripping . - . Sports injuries - Post Traumatic Edema . - . Lymphatic Filariasis
The Hydroven 12 system comprises of a range of inflatable sleeves. inserts and a compatible air pump. The sleeves fit around patients' upper and lower limbs. The sleeves contain separate but overlapping air chambers that intermittently compress the limbs in a specific sequence. The resultant pressure on the patient's limb tissues promotes the transport of fluids and proteins. The inflatable inserts can be added to allow large circumference limbs to be treated. The pump provides the compressed air to the sleeves with user selected pressures and sequence of operation.
The provided text is a 510(k) summary for the Hydroven 12 Pump and Garments, a medical device for intermittent pneumatic compression therapy. This document aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not available in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy thresholds) for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Lympha Press Plus and compression Garments, K013331) through various engineering and performance tests. The "acceptance criteria" are implied to be "compliance with standard" or "Passed" for functional and safety tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Full validation of pump software / hardware functionality, including User Interface and Therapy delivery | Passed |
| Performance testing garments - Pressure cyclic test (with Leg and Arm garments) | Passed |
| Electrical Testing to Standard ANSI/AAMI ES60601-1:2005/(R)2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Complies with Standard |
| EMC testing to Standard IEC 60601-1-2, 2007 | Complies with Standard |
| Environmental Stability testing (Storage / Distribution Test, Operational Temperature / Humidity Test) | Passed |
| Equivalent pressure profiles to predicate device | Achieved |
| Similar garment construction and substantially equivalent therapy delivery to predicate device | Achieved |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests mentioned (software/hardware validation, pressure cyclic test, electrical, EMC, environmental) are typically engineering and bench tests, not clinical studies with human subjects that would have a "test set" in the context of AI or diagnostic device evaluation.
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 information is not provided. As explained above, this document is focused on engineering testing and substantial equivalence, not clinical validation requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 is not applicable and not provided. The Hydroven 12 is a physical therapy device (intermittent pneumatic compression pump and garments), not an AI-powered diagnostic or interpretive device that would involve human "readers" or AI assistance in that sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. The device is an electro-mechanical system, not an algorithm in the AI sense. Its standalone performance is assessed by the "Passed" or "Complies with Standard" results for its functional and safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering tests would be the established specifications, performance requirements, and regulatory standards (e.g., pressure output accuracy, electrical safety limits, EMC compliance). It is not expert consensus, pathology, or outcomes data in the clinical sense because it's not a diagnostic device.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" in the context of machine learning or AI, as this is not an AI device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
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Image /page/0/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 04, 2016
Huntleigh Healthcare Ltd Greg Baily Technical Director 35 Portmanmoor Road Cardiff, CF24 5HN United Kingdom
Re: K15228
Trade/Device Name: Hydroven 12 Pump and Garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 22, 2016 Received: February 24, 2016
Dear Greg Baily:
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 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrenner
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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510(k) Number: K152228
Device Name: Hydroven 12 Pump and Garments.
Indications for Use:
To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders.
As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme:
- Lymphedema.
- · Primary and secondary (including post-surgery, radio or chemotherapy).
- . Chronic Edema of Venous Origin
- Chronic venous insufficiency. .
- Acute and chronic wounds including venous leg ulcers and post- surgical wounds. .
IPC may also be beneficial in the management of:
- . Lipoedema.
- Varicose veins .
- Postoperative Venous Ligation or Stripping .
- . Sports injuries
- Post Traumatic Edema .
- . Lymphatic Filariasis
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (Part 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)
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HUNTLEIGH
510K Summary Hydroven 12 Pump and Garments
| Name & Address: | Huntleigh Healthcare LtdDiagnostic Products Division35 Portmanmoor RoadCardiff, UKCF24 5HN | ||
|---|---|---|---|
| Telephone: | +(44) 2920 485885 | ||
| Fax: | +(44) 2920 447142 | ||
| Prepared: | July 2015 | ||
| Contact: | Greg Baily - Technical Director | ||
| Device Name: | Hydroven 12 Pump and Garments | ||
| Common Name | Compressible Limb Sleeve | ||
| Classification | Class | Product Code | Classification Regulation |
| II | JOW | 870.5800 | |
| Classification Name: | Sleeve, Limb, Compressible | ||
| Predicate Device: | Lympha Press Plus and compression Garments (K013331) manufactured by Mego Afek AC Ltd. Kibbutz Afek, 30042, Israel | ||
| Indications for Use: | Indications for Use:To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: | ||
| Lymphedema. Primary and secondary (including post-surgery, radio or chemotherapy). Chronic Edema of Venous Origin Chronic venous insufficiency. Acute and chronic wounds including venous leg ulcers and post-surgical wounds. | |||
| IPC may also be beneficial in the management of: Lipoedema. Varicose veins Postoperative Venous Ligation or Stripping Sports injuries Post Traumatic Edema Lymphatic Filariasis | |||
| Description : | The Hydroven 12 system comprises of a range of inflatable sleeves. |
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inserts and a compatible air pump.
The sleeves fit around patients' upper and lower limbs. The sleeves contain separate but overlapping air chambers that intermittently compress the limbs in a specific sequence.
The resultant pressure on the patient's limb tissues promotes the transport of fluids and proteins.
The inflatable inserts can be added to allow large circumference limbs to be treated.
The pump provides the compressed air to the sleeves with user selected pressures and sequence of operation.
| Models: | |
|---|---|
| --------- | -- |
| Model REF | Device | Features |
|---|---|---|
| 316003US | Hydroven 12 | AC powered pump |
| 316A68, 316A78,316AI68, 316AI78,316L76S, 316L76W,316L84S, 316L84W,315LI76, 316LI84 | Hydroven 12 garments. | Sequential inflation providing activecompression. |
Comparison of Intermittent Pneumatic Compression Therapy is the technological Technological principle for both the subject and predicate devices. It is based on a Characteristics with pump and pneumatic garment combination. Whereby a garment with Predicate Device multiple internal air chambers is applied to the limb requiring therapy, the pump supplies air to inflate and deflate the garment chambers in sequence which compresses the limb. Applying a sequential compression to a limb takes over the permanently missing function of compromised lymphatics by squeezing edema tissue fluid to regions with normal lymphatic drainage. The subject and predicate are based on the following same technological elements: · An internal air source (air compressor) • An electronic pressure control system • A valve system to route air to the appropriate garment chamber • A multiway pneumatic 'garment to pump' connection system • PU Coated Nylon Garments • Limb Garments with Multiple internal chambers • Limb Garments with Zipper closures • Front panel display indicating device settings The following technological difference exist between the subject and predicate devices · Subject uses low voltage compressor - predicate uses AC line powered compressor • Subject uses motor driven rotary air valve – predicate uses a series of solenoid driven air valves
- · Subject uses multiple LED displays predicate uses a single LCD display
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HUNTLEIGH
Substantial Equivalence: The Hydroven 12 Pump and Garments is substantially equivalent to cleared device Lympha Press Plus and compression garments (K013331). The Hydroven 12 pump provides equivalent pressure profiles. The Hydroven 12 garments have similar construction and deliver substantially equivalent therapy.
| Testing to demonstrate equivalence included: |
|---|
| Testing to demonstrate equivalence included: | |
|---|---|
| Testing conducted | Result |
| Full validation of pump software / hardware functionality, including- User Interface- Therapy delivery | Passed |
| Performance testing garments - Pressure cyclic test.with Leg garmentswith Arm garments | Passed |
| Electrical Testing to Standard ANSI/AAMIES60601-1:2005/(R)2012, C1:2009/(R)2012 andA2:2010/(R)2012 | Complies withStandard |
| EMC testing to Standard IEC 60601-1-2, 2007 | Complies withStandard |
| Environmental Stability testing.-Storage / Distribution Test.-Operational Temperature /Humidity Test. | Passed |
| Technologies Summary: | The Hydroven 12 pump consists of an air compressor, distribution valve and a microcontroller based control and monitoring system, all housed in a portable enclosure.Options of pressure settings and cycle sequences can be selected by the user.The system is powered by standard 60Hz AC line supply. The monitoring system can alert the user to faults. |
| The Hydroven 12 garments comprise of 12 separate air bladders constructed from RF welded polyurethane sheet material.The cells are located in between the inner and outer covers, which are made from woven nylon/PU laminate materials.The sleeve is fastened around the patient's limb by a zipper.The cells overlap, in order to apply a continuous area of force along the limb. | |
| Conclusion: | The data detailed within this submission demonstrates that the device is substantially equivalent to the legally marketed predicate device, identified in this summary. |
§ 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).