(242 days)
The Hygia Health Services Reprocessed NuTech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order 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 .
The Hygia Health Services Reprocessed NuTech® Calf Wrap is a compressible limb device for the lower limb, that when attached to an approved controller, provides intermittent pneumatic compression of the gastrocnemius muscle. The garment is constructed out of brushed nylon with an elastic lining. The single inflation chamber is constructed from the garment itself. The device has an internal coating of a latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The inflation tube is constructed of poly vinyl chloride (PVC), which terminates in a snap-lock connector. The hook fasteners are made of polyethylene. The garments are placed around the gastrocnemius muscle of the calf and secured with a hook and loop fastener. As the garment compress the muscle, venous pressure is increased, ejecting the blood upward toward the heart. After a rapid compression, the garment deflates allowing the veins to refill and bring oxygenated blood to the lower limbs. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
The provide text is a 510(k) summary for the Hygia Health Services Reprocessed NuTech® Calf Wrap, a device intended to prevent deep vein thrombosis (DVT) and treat edema. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the requested table and answer all questions regarding acceptance criteria and a study proving device performance.
The document states:
- Performance Data: "Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed NuTech® Calf Wrap and the predicate device, the NuTech® Universal Calf Wrap. All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be equivalent. Clinical Tests- Clinical tests were summarized in support of the premarket notification submission. Test Conclusions- Clinical and nonclinical test results of the Hygia Health Services Reprocessed NuTech® Calf Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® Universal Calf Wrap."
This indicates that studies were performed, but the document lacks the detailed quantitative acceptance criteria and specific results for device performance, sample sizes, ground truth establishment, expert involvement, and comparative effect sizes that you requested.
Therefore, I cannot populate the table or answer most of your questions based on the provided text.
Based on the available information, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated with numeric values in the document. The general criteria seem to be "substantial equivalence" in functional and operational performance characteristics to the predicate device.
- Reported Device Performance: "All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be equivalent." No specific quantitative performance metrics are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective).
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)
- Not specified. The document refers to "bench testing" and "clinical tests" but does not detail the methodology for establishing ground truth or expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable/Not specified. This device is a physical medical device (calf wrap), not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not specified, as this is a physical device and not an algorithm. Bench tests would represent standalone performance of the device without a human in the loop, but detailed results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "nonclinical tests," the ground truth was likely established by comparing the reprocessed device's physical and operational characteristics (compression, pressure control, timing sequence, safety, controller connections) against the known/expected characteristics of the original predicate device.
- For "clinical tests," the ground truth or endpoints evaluated are not detailed, but generally for DVT prevention and edema reduction, these would involve clinical outcomes, physiological measurements, or imaging.
8. The sample size for the training set
- Not applicable for this type of device (physical reprocessed device, not a machine learning algorithm).
9. How the ground truth for the training set was established
- Not applicable for this type of device.
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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 concentric circles inside. To the right of the square is the word "HYGIA" in large, bold, black letters, and below that is the phrase "HEALTH SERVICES" in smaller, thinner, black letters.
1012657
APR 1 2 2002
510(k) Summary
Summary
Substantial Equivalence Summary for the Hygia Health Services Reprocessed NuTech® Calf 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: July 31, 2001
.
Contact Person 1.
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: Class II Classification: Hygia Health Services Reprocessed NuTech® Calf Wrap. Proprietary Name:
HYGIA HEALTH SERVICES
MILAN COURT · · SUITE · 259 · · BIRMINGHAM , AL 35211 2800 2 0 5 - 9 4 3 - 6 6 7 0 - V O I C E
8-1
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Image /page/1/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a square with three concentric circles on the left and the word "HYGIA" in large, bold letters on the right. Below the word "HYGIA" are the words "HEALTH SERVICES" in smaller letters.
3. Predicate Device
Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: NuTech® Universal Calf Wrap Proprietary Name:
Statement of Substantial Equivalence 4.
The Hygia Health Services Reprocessed NuTech® Calf Wrap employs no new technology other than the method used to reprocess the sleeve in order to allow the device to be utilized more than once. The Hygia Health Services Reprocessed als aon® Calf Wrap is substantially equivalent to the NuTech® Universal Calf Wrap in that the basis of operation for both of the devices is the intermittent inflation of a single inflation chamber, which is placed around the patient's mination on a muscle. The garments are then connected to a controller via a snap-lock connector. Inflation of the garment 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 NuTech® Calf Wrap is substantially equivalent in function, operating parameters, and intended use to the NuTech® Universal Calf Wrap that is currently commercially available and in distribution. The predicate device, the NuTech® Universal Calf 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® Calf Wrap is a compressible limb device for the lower limb, that when attached to an approved controller, provides intermittent pneumatic compression of the gastrocnemius muscle. The garment is constructed out of brushed nylon with an elastic lining. The single inflation chamber is constructed from the garment itself. The device has an internal coating of a latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The inflation tube is constructed of poly vinyl chloride (PVC), which terminates in a snap-lock connector. The hook fasteners are made of polyethylene. The garments are placed around the gastrocnemius muscle of the calf and secured with a hook and loop fastener. As the garment compress the muscle, venous pressure is increased, ejecting the blood upward toward the heart. After a rapid compression, the garment deflates
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Image /page/2/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a series of concentric circles on the left, followed by the word "HYGIA" in large, bold letters. Below the word "HYGIA" is the phrase "HEALTH SERVICES" in smaller letters. The logo is simple and professional, and it conveys a sense of health and well-being.
allowing the veins to refill and bring oxygenated blood to the lower limbs. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
Intended Use of Device 6.
The Hygia Health Services Reprocessed NuTech® Calf Wrap is designed to operate in the identical manner as the predicate device, the NuTech® Universal Calf Wrap. It is designed to apply compression to a patient's gastrocnemius muscle for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The device is used in both the home and institutional settings on patient populations for which this device applicable.
Technological Characteristics 7.
The technological characteristics of the Hygia Health Services Reprocessed NuTech® Calf Wrap are identical to the original NuTech® Universal Calf Wrap in overall design, materials, energy source, mode of operation, and performance characteristics. Hygia Health Services employs no new technological characteristics other than the scientifically validated thermal high-level disinfection process.
Performance Data 8.
Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed NuTech® Calf Wrap and the predicate device, the NuTech® Universal Calf Wrap. All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be equivalent.
Clinical Tests- Clinical tests were summarized in support of the premarket notification submission.
Test Conclusions- Clinical and nonclinical test results of the Hygia Health Services Reprocessed NuTech® Calf Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® Universal Calf Wrap.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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
K012657 Re:
Trade Name: Hygia Health Services Reprocessed NuTech® Calf 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 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.
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) I mis letter will and w yourse finding of substantial equivalence of your device to a legally premance notification. The 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 additionally 21 CF 1 1 1 1 - 1 - 4648. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation on 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, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Indications For Use
Applicant: Hygia Health Services, Inc.
510(k) Number: ·
Device Name: Hygia Health Services Reprocessed NuTech® Calf Wrap
Indications For Use:
The Hygia Health Services Reprocessed NuTech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order 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 .
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
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 K012654
Prescrinting !! (Per 21 CFK 801.109)
§ 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).