(399 days)
["K965153"]
Not Found
No
The device description and performance studies focus on mechanical compression and physiological effects, with no mention of AI/ML technologies or data-driven algorithms.
Yes
The device is described as assisting in the healing of cutaneous ulcers, reducing edema and pain, and preventing deep vein thrombosis, which are all therapeutic functions.
No
The device description and intended use indicate it is a therapeutic device for preventing DVT, enhancing circulation, and reducing edema and pain, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a pump and foot wrap garments, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The FP5000 System is an external pneumatic compression system that applies pressure to the foot. It does not analyze any biological samples from the patient.
- Intended Use: The intended uses listed are all related to physical therapy and circulatory support, not diagnostic testing.
Therefore, the FP5000 System falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
JOW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
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
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.
Key Metrics
Not Found
Predicate Device(s)
K965153
A V 5000 system (Kendall), PlexiPulse system (NuTech/KCI)
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
KCa65153
510(k) Summary
FP5000 System
JAN 26 1998
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.
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)