(242 days)
The provided text response template does not contain any Reference Devices, so I am unable to extract a K/DEN number for them.
No
The device description and performance studies focus on mechanical compression and comparison to a predicate device, with no mention of AI or ML.
Yes
The intended use explicitly states the device is designed to enhance circulation and is a therapeutic method to prevent and treat various medical conditions, such as deep vein thrombosis, wound healing, and venous leg ulcers.
No
The device is designed to prevent deep vein thrombosis, reduce wound healing time, treat and assist healing of venous leg ulcers, reduce edema, and decrease compartmental pressures. These are all therapeutic and preventative actions. There is no mention of the device being used to identify or diagnose any medical condition.
No
The device description clearly details physical components like a garment, bladder, tubes, and fasteners, indicating it is a hardware device that provides intermittent pneumatic compression.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic method to prevent and treat conditions related to blood circulation in the lower extremities (DVT, wound healing, venous leg ulcers, edema, compartmental pressures). This involves direct interaction with the patient's body for treatment and prevention.
- Device Description: The device description details a mechanical device that applies intermittent pneumatic compression to the foot. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hygia Health Services Reprocessed NuTech® Foot Wrap is designed to enhance The Hygla Tieann Scivices Reprocessou Aux costs. It to be used by patient's in both the circulation of blood in the venules and artise therapeutic method to prevent:
- Deep vein thrombosis .
- Reduce wound healing time .
- Treat and assist healing of venous leg ulcers .
- Reduce edema caused by venous insufficiency in the lower extremities .
- Decrease compartmental pressures
Product codes
JOW
Device Description
The Hygia Health Services Reprocessed NuTech® Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with polyester foam backing. The single bladder is constructed out of poly vinyl chloride (PVC), which is RF welded at the seams. The inflation/deflation tube is also composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. As the garment compresses the plantar plexus, veins collapse longitudinally, increasing the venous pressure thus ejecting the blood upward. After compression, the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's plantar arch, foot, lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and institutional settings
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed NuTech® Foot Wrap and the predicate device, the NuTech® PlexiPulse Foot Wrap Garment. All tests found that functional and operational performance characteristics including compression, pressure control, timing sequence, and both safety and operational parameters used when connected to a controller were substantially equivalent.
Clinical tests were summarized in support of this pre-market notification submission.
Test Conclusions- Nonclinical and clinical test results of the Hygia Health Services Reprocessed NuTech® Foot Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® PlexiPulse Foot Wrap Garment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
APR 1 2 2002
510(k) Summary
Summary
Substantial Equivalence Summary for the Hygia Health Services Reprocessed NuTech® Foot Wrap.
In accordance with 21 CFR Part 807.92, this summary is submitted by:
Hygia Health Services, Inc. 2800 Milan Court Suite 259 Birmingham, Alabama 35211
Date: August 6, 2001
1. Contact Person
Geoff M. Fatzinger Director, Compliance and Regulatory Affairs (205) 943-6670
Name of Device 2.
Classification Name: Compressible Limb Sleeve Common or Usual Name: Intermittent Pneumatic Compressible Limb Sleeve Cardiovascular Review Panel: Classification: Class II Hygia Health Services Reprocessed NuTech® Foot Wrap. Proprietary Name:
HYGIA HEALTH SERVICES
2 8 0 0 0 m | L A N | C O U R T | ● | S U | T E | 2 5 9 | 3 5 2 1 1 BIRMINGHAM . 2 0 5 - 9 4 3 - 6 6 7 0 V O I 205-943-6671 �
1
Image /page/1/Picture/0 description: The image contains a logo for Hygia Health Services. The logo features a black square with three white concentric circles on the left. To the right of the square, the word "HYGIA" is written in large, bold, black letters. Below "HYGIA", the words "HEALTH SERVICES" are written in smaller letters.
Predicate Device 3.
Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II NuTech® PlexiPulse Foot Wrap Garment Proprietary Name:
Statement of Substantial Equivalence 4.
The Hygia Health Services Reprocessed NuTech® Foot Wrap employs no new technology other than the method used to reprocess the garment in order to allow the device to be utilized more than once. The Hygia Health Services Reprocessed NuTech® Foot Wrap is substantially equivalent to the NuTech® PlexiPulse Foot Wrap in that the basis of operation for both of the devices is the intermittent inflation of a single bladder, which is placed around the patient's plantar arch. The garments are then connected to a controller. Inflation of the device is accomplished using ambient air, and a controller cycle that functions to alternately inflate and deflate the sleeves in a predetermined manner and interval.
The Hygia Health Services Reprocessed NuTech® Foot Wrap is substantially equivalent in function, operating parameters, and intended use to the NuTech® PlexiPulse Foot Wrap that is currently commercially available and in distribution. The predicate device, the NuTech® PlexiPulse Foot Wrap, is marked for "singlepatient use only". Hygia Health Services does not change the device in any way except to render the device "reusable" by placing it through a scientifically validated thermal kill pasteurization process. The Hygia Health Services HLD protocol does not alter the device s efficacy, safety, composition, or intended use.
Description of the Device 5.
The Hygia Health Services Reprocessed NuTech® Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with polyester foam backing. The single bladder is constructed out of poly vinyl chloride (PVC), which is RF welded at the seams. The inflation/deflation tube is also composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. As the garment compresses the plantar plexus, veins collapse longitudinally, increasing the venous pressure thus ejecting the blood upward. After compression, the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
2
Image /page/2/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a black square with three white concentric circles on the left, followed by the word "HYGIA" in large, bold, black letters. Below the word "HYGIA" are the words "HEALTH SERVICES" in smaller, lighter letters.
Intended Use of Device 6.
The Hygia Health Services Reprocessed NuTech® Foot Wrap operates in the identical manner as the predicate device, the NuTech® PlexiPulse Foot Wrap Garment. It is designed to apply compression to a patient's plantar plexus for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The device may be used in both the home and institutional settings on patient populations for which a leg or calf compression device would not be applicable.
Technological Characteristics 7.
The technological characteristics of the Hygia Health Services Reprocessed NuTech® Foot Wrap are identical to the original NuTech® PlexiPulse Foot Wrap Garment in overall design, materials, energy source. mode of operation, and performance characteristics.
8. Performance Data
Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed NuTech® Foot Wrap and the predicate device, the NuTech® PlexiPulse Foot Wrap Garment. All tests found that functional and operational performance characteristics including compression, pressure control, timing sequence, and both safety and operational parameters used when connected to a controller were substantially equivalent.
9. Clinical Data
Clinical tests were summarized in support of this pre-market notification submission.
Test Conclusions- Nonclinical and clinical test results of the Hygia Health Services Reprocessed NuTech® Foot Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® PlexiPulse Foot Wrap Garment.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract caduceus symbol, featuring three curved lines that resemble a bird or a flowing design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Mr. Geoff M. Fatzinger, BS MS Director, Compliance and Regulatory Affairs c/o Hygia Health Services, Inc. 2800 Milan Court, Suite 259 Birmingham, AL 35211
K012650 Re:
Trade Name: Hygia Health Services Reprocessed NuTech® Foot Wrap Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 7, 2002 Received: February 8, 2002
Dear Mr. Fatzinger:
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. 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
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Page 2 . - Mr. Geoff M. Fatzinger, BS MS
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) 594-4648. 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" (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,
onna-Bea Tillman Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Indications For Use
Applicant: Hygia Health Services, Inc.
510(k) Number: · ·
Device Name: Hygia Health Services Reprocessed NuTech® Foot Wrap
01265()
Indications For Use:
The Hygia Health Services Reprocessed NuTech® Foot Wrap is designed to enhance The Hygla Tieann Scivices Reprocessou Aux costs. It to be used by patient's in both the circulation of blood in the venules and artise therapeutic method to prevent:
- Deep vein thrombosis .
- Reduce wound healing time .
- Treat and assist healing of venous leg ulcers .
- Reduce edema caused by venous insufficiency in the lower extremities .
- Decrease compartmental pressures
PRECAUTIONS AND CONTRAINDICATIONS
Contraindications:
Wraps may not be recommended for patients with the following:
- Congestive heart failure 1.
- Known or suspected deep vein thrombosis 2.
- Severe arteriosclerosis or other ischemic vascular disease 3.
- Any local leg condition in which the wrap would interfere such as 4. dermatitis, gangrene, recent skin graft, or untreated infected wounds
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p2/2
Precautions:
One must ensure that the wrap is applied properly. ・1.
- One must ensure that the wrap is correctly connected to the pump and that 2. the connection is secure.
- If numbness, tingling, or leg pain is experienced by the patient, the wrap 3. should be removed.
Division of Cardiovascular & Respiratory Devices
510(k) Number 2012650
Prescription Use
(Per 21 CFR 801.109)