(398 days)
Not Found
No
The summary describes a mechanical compression device and does not mention any AI or ML components or capabilities.
Yes
The device is designed to reduce pooling of blood, increase venous blood flow, and reduce deep vein thrombosis and pulmonary embolism, all of which are therapeutic actions to treat or prevent a medical condition.
No
The "Intended Use / Indications for Use" states the device is "designed to reduce pooling of blood, increase venous blood flow... to reduce deep vein thrombosis and pulmonary embolism." This describes a therapeutic or preventative function, not a diagnostic one.
No
The device description explicitly mentions "Compressible Limb Sleeve and Pump," which are hardware components, indicating it is not a software-only device.
Based on the provided information, the Trinity DVT System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce blood pooling and increase venous blood flow in the lower extremities of recumbent patients to reduce deep vein thrombosis and pulmonary embolism. This is a therapeutic or prophylactic use, not a diagnostic one.
- Device Description: The device is described as a "Compressible Limb Sleeve and Pump." This is a physical device that applies external pressure, not a device that analyzes biological samples (which is the core function of an IVD).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVDs.
In summary, the Trinity DVT System is a medical device used for a therapeutic/prophylactic purpose, not for diagnosing a condition by analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Trinity DVT System(sleeve is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
Product codes
JOW
Device Description
Trinity DVT System Sleeves and Pump
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image is a black and white photograph of what appears to be a handwritten word or phrase. The text is somewhat blurry and difficult to read, but it seems to be written in cursive. The background is white, which makes the dark text stand out.
510(K) SUBMISSION, TRINITY DVT SYSTEM Delphi Consulting Group
Section 2 NOV - 4 1997 Summary & Certification
The following is a Summary & Certification of the Trinity DVT System.
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for a Compressible Limb Sleeve.
Printed Name J. Harvey Knauss
Signature
J. Harvey Knauss
Owner
Title
Date
Sep. 30, 1996
Delphi Consulting Group, P. O. Box 932, Stafford, Texas 77477, 713-723-8169 Fax 713-723-4080
| CLASSIFICATION NAME: | Compressible Limb Sleeves |
|---|---|
| COMMON/USUAL NAME: | Extremity Sleeve and Pump |
| PROPRIETARY NAME: | Trinity DVT System Sleeves and Pump |
| CLASSIFICATION: | 21 CFR Part 870.5800 Compressible |
| Limb Sleeve, Class II | |
| PERFORMANCE STANDARDS: | No Performance Standards for the Compressible |
| Limb Sleeve are in effect. | |
| PREDICATED DEVICE | Sleeves are the same as the sleeves released to |
| market under K954489, 27-SEP-95, Trinity | |
| Sleeve(s), Delphi Consulting Group. The pump is | |
| substantial equivalent to the Huntleigh Technology, | |
| K910188. | |
| INDICATIONS | The Trinity DVT System(sleeve is designed to |
| reduce pooling of blood, increase venous blood | |
| flow in the lower extremities of the recumbent | |
| patient to reduce deep vein thrombosis and | |
| pulmonary embolism. |
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| CONTRAINDICATIONS | The Trinity DVT System Sleeve and pump should
not be used during episodes of pulmonary
embolism or in any instance where increased
venous return or lymphatic return is undesirable.
Do not use on a patient with burns, open wound,
rash or fracture. Use with caution on extremities
which are not sensitive to pain. Do not counter
accepted clinical practice or institution guidelines. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SAFETY | Preponderance of problems associated with the
use of a Compression Sleeve system is improper
operation of the system not system failure. |
| | Sleeve problems are: |
| | 1. Puncture or cuts that destroy the integrity of
the air chambers. |
| | 2. Dry Cleaning, Steam or Dry Heat
Sterilization that destroys the sleeves. |
| | Operator Errors are: |
| | 1. Sleeve applied too loose. |
| | 2. Sleeve applied too tight. |
| | Pump problems are: |
| | 1. Wrong pressure settings. |
| | 2. Air hoses not connected property. |
| | 3. Any of the above listed problems. |
| | SUBSTANTIAL EQUIVALENCE |
ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳ
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle or other bird with three human profiles embedded within the design.
NOV - 4 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. Harvey Knauss Delphi Consulting Group P.O. Box 932 Stafford, Texas 77497-0932
Re: K963957 Trinity DVT System Requlatory Class: II (Two) Product Code: JOW Dated: August 12, 1997 Received: August 13, 1997
Dear Mr. Knauss:
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 Regulations, 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 requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.
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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 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 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. Callahan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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K963957 510(k) Number (if Known)
Device Name: Trinity DV System, Compressible Limb Sleeve and Pump, Single Chamber
Indications for use: The Trinity DVT System is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ben G. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K963957
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)