(28 days)
K925717/A
Not Found
No
The description focuses on mechanical compression and blood flow, with no mention of AI/ML terms or functionalities.
Yes
The device is designed to prevent DVT and increase venous blood flow, which are therapeutic actions aimed at managing a medical condition.
No
Explanation: The device is a compression sleeve designed to prevent Deep Vein Thrombosis by increasing venous blood flow, not to diagnose a condition or disease.
No
The device description clearly states it is a single chamber inflatable cuff, which is a hardware component. It also mentions being used with pumps, which are also hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow." This is a therapeutic or preventative function, not a diagnostic one.
- Device Description: The device is a compression sleeve that physically compresses the calf to promote blood flow. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of samples, use of reagents, or generation of diagnostic results.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
Product codes
JOW
Device Description
The DVT60 Compression Sleeves are single chamber inflatable cuffs, designed to fit around a patient's calf. They are used with the Huntleigh Flowtron Excel and Universal Pumps. When inflated, they compress the veins in the calf and expel blood out of the leg, promoting circulation and overcoming stasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The determination of Substantial Equivalence is based on non-clinical outcome, inflation performance testing. The sleeves are tested by fitting to a subject's calf and observing the increase in velocity of the blood flow in the veins during compression.
Key Metrics
Not Found
Predicate Device(s)
K925717/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) SUMMARY DVT60 Limb Compression Sleeves
| Company | Huntleigh Healthcare Inc
40 Christopher Way
Eatontown
New Jersey | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Contact | Audrey Witko
Phone
Fax | 732 578 9898
732 460 5809 |
| Summary
Preparation Date | 1ST August 2002 | |
| Trade Name | DVT60 | |
| Common Name | Limb Compression Sleeves | |
| Classification Name | Sleeve, Limb, Compression (JOW) | |
| Predicate Device | Huntleigh Healthcare DVT10(s) K925717/A | |
| Device Description | The DVT60 Compression Sleeves are single chamber
inflatable cuffs, designed to fit around a patient's
calf.
They are used with the Huntleigh Flowtron Excel and
Universal Pumps.
When inflated, they compress the veins in the calf
and expel blood out of the leg, promoting circulation
and overcoming stasis. | |
| Intended Use | DVT60 sleeves are designed to help prevent Deep
Vein Thrombosis (DVT), by increasing venous blood
flow. | |
| Summary of Technological Characteristics | | |
SEP 1 9 2002
The DVT60 compression sleeves have the same technological characteristics as the DVT10 predicate device.
The design characteristics, materials, and method of manufacture are the same,
When compared to the predicate device, the DVT60 sleeves are extended in width, so that are suitable to fit a patient's calf of up to 28 inches circumference.
HEALTH
1
Determination of Substantial Equivalence
The determination of Substantial Equivalence is based on non-clinical outcome, inflation performance testing. The sleeves are tested by fitting to a subject's calf and observing the increase in velocity of the blood flow in the veins during compression.
Equivalence Testing Results
The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures are the same.
The venous blood velocity increase and duration are similar to the predicate device. This increase in blood velocity overcomes venous stasis and so helps to prevent deep vein thrombosis, in the same manner as the predicate device.
Therefore, we propose that the clinical treatment that the patient receives will be equivalent.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
Huntleigh Healthcare, Inc. c/o Ms. Audrey Witko Vice President. Corporate & Clinical Affairs 40 Christopher Way Eatontown, NJ 07724
Re: K022786 Trade Name: DVT60 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: May 23, 2002 Received: August 22, 2002
Dear Ms. Witko:
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. Ilsting 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.
3
Page 2 - Ms. Audrey Witko
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); 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. 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) 594-4646. 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 yours.
V. Prem D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT DVT60 Limb Compression Sleeves
Ver/3-4/24/96
| Applicant: | Huntleigh Healthcare Inc. |
|---|---|
| 510(k) Number (if known): | Not known at present |
| Device Name: | DVT60 |
| Indications For Use: |
The DVT60 Compression Sleeve is designed to help prevent Deep Vein
Thrombosis (DVT), by increasing venous blood flow.
(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) | |
|---|---|
| ------------------------------------------ | ------------------------------------------------------- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K022786 |
|---|---|
| --------------- | --------- |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)