(229 days)
Not Found
Not Found
No
The device description focuses on mechanical compression and a predetermined inflation/deflation sequence controlled by a non-AI/ML controller. There is no mention of AI or ML in the text.
Yes.
The device is explicitly described as a "non-invasive therapeutic method" intended to treat several medical conditions such as DVT prophylaxis, edema, extreme pain, leg ulcers, and venous stasis.
No
The device is described as a non-invasive therapeutic method to enhance blood circulation for conditions like DVT prophylaxis and edema, rather than for diagnosing them. It focuses on treatment and prevention by compressing the plantar plexus.
No
The device description clearly outlines a physical garment with compression chambers and fasteners, indicating it is a hardware device, not software-only.
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 Function: The Hygia Health Services Reprocessed Novamedix ImPad® is a physical device that applies external compression to the foot to enhance blood circulation. It does not analyze biological samples.
- Intended Use: The intended use is therapeutic (enhancing circulation, DVT prophylaxis, treating edema, pain, ulcers, and venous stasis/insufficiency) through physical means, not diagnostic testing.
The device description and intended use clearly indicate a therapeutic device that interacts directly with the patient's body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Hygia Health Services Reprocessed Novamedix ImPad® is designed to enhance circulation of blood. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- DVT prophylaxis
- Acute and chronic edema ●
- Extreme pain after trauma or surgery ●
- . Treat leg ulcers and venous stasis/insuffic
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Hygia Health Services Reprocessed Novamedix ImPad® Garment is an intermittent compressible limb device that is placed around the patient's foot with the compression chamber placed under the plantar arch. The garment is constructed out of brushed nylon over a thin layer of closed cell foam. The device is secured using hook and loop fasteners made of polyethylene. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases 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, hold time , and inflation/deflation time is determined by the controller. It is the responsibility of the end user to ensure that the device is connected to an approved controller and to ensure that the controller settings are accurate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's plantar arch, patient's foot, plantar plexus, lower limbs, leg, calf
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 Novamedix ImPad® and the predicate device. All tests found that functional and operational performance characteristics including compression, pressure capabilities, and both safety and operational parameters were substantially equivalent.
In order to ensure that the Hygia Health Service high-level disinfection program did not adversely affect the biocompatibility of the device, a NIH level combination irritation/sensitization human skin patch test was conducted. The detailed protocols of the study are included in the premarket submission. No signs of irritation or sensitization were found.
Nonclinical test results of the Hygia Health Services Reprocessed Novamedix ImPad® indicated substantial equivalence in all aspects to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Novamedix ImPad®
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a black square on the left side with three white curved lines inside, resembling a stylized letter C. To the right of the square is the word "HYGIA" in large, bold, black letters. Below "HYGIA" is the phrase "HEALTH SERVICES" in smaller, black letters.
16021509
510(k) Summary
Summary
Substantial Equivalence Summary for the Hygia Health Services Reprocessed Novamedix ImPad®.
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: April 30, 2002
1. Contact Person
Geoff M. Fatzinger BS, MS Director, Compliance and Regulatory Affairs (205) 943-6670
2. Name of Device
Classification Name: Compressible Limb Sleeve Common or Usual Name: Intermittent Pneumatic Compressible Limb Sleeve Review Panel: Cardiovascular Classification: Class II Proprietary Name: Hygia Health Services Reprocessed Novamedix ImPad®
HYGIA HEALTH SERVICES
MILAN COURT . • SUITE . 25 9 . • BER MEN GHAM . • AL 1 3 5 2 ! 1 2800 2 0 5 - 9 4 3 - 6 6 7 0 - V ○ L C E - - ● - 2 0 5 - 9 4 3 - 6 6 7 } - F A X
1
Image /page/1/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a stylized symbol on the left, resembling concentric circles within a square. To the right of the symbol is the word "HYGIA" in large, bold, sans-serif font. Below "HYGIA" are the words "HEALTH SERVICES" in a smaller font.
Predicate Device
Classification Name: Compressible Limb Sleeve Common Name: Intermittent Pneumatic Compressible Limb Sleeve Classification: Class II Novamedix A-V Impulse System Rigid Sole Foot Cover Proprietary Name:
Statement of Substantial Equivalence 4.
The Hygia Health Services Reprocessed Novamedix ImPad® 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 Novamedix ImPad® is substantially equivalent to the Novamedix ImPad® 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 device in a predetermined manner and interval.
The Hygia Health Services Reprocessed Novamedix ImPad® is substantially equivalent in function, operating parameters, and intended use to the Novamedix ImPad® that is currently commercially available and in distribution. The predicate device, the Novamedix ImPad®, is marked for "single-patient 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 chemical free high-level disinfection process. The Hygia Health Services highlevel disinfection protocol does not alter the device's efficacy, safety. composition, or intended use. Hygia Health Services also includes the statement "single-patient use only" on the labeling.
Description of the Device 5.
The Hygia Health Services Reprocessed Novamedix ImPad® Garment is an intermittent compressible limb device that is placed around the patient's foot with the compression chamber placed under the plantar arch. The garment is constructed out of brushed nylon over a thin layer of closed cell foam. The device is secured using hook and loop fasteners made of polyethylene. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases 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, hold time , and inflation/deflation time is determined by the controller. It is the responsibility of the end user to ensure that
2
Image /page/2/Picture/0 description: The image contains the logo for Hygia Health Services. The logo features a circular design on the left, followed by the word "HYGIA" in large, bold letters. Below the word "HYGIA" are the words "HEALTH SERVICES" in a smaller font size.
the device is connected to an approved controller and to ensure that the controller settings are accurate.
Intended Use of Device 6.
The Hygia Health Services Reprocessed Novamedix ImPad® operates in the identical manner as the predicate device, the Novamedix ImPad®. 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 devices are used in both the home and institutional settings on patient populations for which a leg or calf compression device would not be applicable. It can be used under a cast or splint.
7. Technological Characteristics
The technological characteristics of the Hygia Health Services Reprocessed Novamedix ImPad® are identical to the predicate device 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 Novamedix ImPad® and the predicate device. All tests found that functional and operational performance characteristics including compression, pressure capabilities, and both safety and operational parameters were substantially equivalent.
9. Biocompatibility
In order to ensure that the Hygia Health Service high-level disinfection program did not adversely affect the biocompatibility of the device, a NIH level combination irritation/sensitization human skin patch test was conducted. The detailed protocols of the study are included in the premarket submission. No signs of irritation or sensitization were found.
Test Conclusions- Nonclinical test results of the Hygia Health Services Reprocessed Novamedix ImPad® indicated substantial equivalence in all aspects to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
DEC 2 4 2002
Hygia Health Services, Inc. c/o Mr. Geoff M. Fatzinger, BS, MS Director of Compliance and Regulatory Affairs 2800 Milan Court, Suite 259 Birmingham, AL 35211
Re: K021509
Trade Name: Hygia Health Services Reprocessed Novamedix ImPad® Regulation Number: 21 CFR. 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 10, 2002 Received: October 11, 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.
4
Page 2 - Mr. Geoff M. Fatzinger, BS, MS
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), 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 vours,
Dna Munkee for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular 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: K 021509
Device Name: Hygia Health Services Reprocessed Novamedix ImPad®
Indications For Use:
The Hygia Health Services Reprocessed Novamedix ImPad® is designed to enhance circulation of blood. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- DVT prophylaxis
- Acute and chronic edema ●
- Extreme pain after trauma or surgery ●
- . Treat leg ulcers and venous stasis/insuffic
PRECAUTIONS AND CONTRAINDIC
Contraindications:
DANGER: DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS AVOID FREEZING AND EXCESSIVE HEAT
Wraps may not be recommended for patients with the following:
-
Congestive heart failure or where an increase of fluid to the heart might be 1 . detrimental
510(k) Num -
- Known or suspected deep vein thrombosis, pre-existing deep vein thrombosis, thrombophlebitis, or pulmonary embolism.
-
ر ب Severe arteriosclerosis or other ischemic vascular disease
-
Any local leg condition in which the wrap would interfere such as 4 dermatitis, gangrene, recent skin graft, or untreated infected wounds
6
Indicațions for Use
:
・
Precautions:
.
- One must ensure that the wrap is applied properly. 1 ..
- One must ensure that the w ectly connected to the pump and that 2. the connection is secure.
- If the patient experiences numbness, tingling, or leg pain, the wrap should 3. be removed.