(216 days)
No
The summary describes a mechanical device (compressible limb sleeves) and does not mention any AI or ML terms, image processing, or data analysis related to AI/ML.
Yes
The device is described as reducing pooling of blood and increasing venous blood flow to reduce deep vein thrombosis and pulmonary embolism, which are therapeutic actions aimed at treating or preventing a medical condition.
No
Explanation: The device is described as reducing blood pooling and increasing venous blood flow to prevent deep vein thrombosis and pulmonary embolism, which are therapeutic actions rather than diagnostic ones.
No
The device description explicitly states "Compressible Limb Sleeves," which are hardware components. The intended use also describes a physical action (reducing pooling of blood, increasing venous blood flow) achieved through these sleeves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Trinity Huntleigh Pump Compatible Sleeves clearly indicate it is a physical device applied externally to the lower extremities to reduce blood pooling and increase venous blood flow. It does not involve the analysis of any biological specimens.
Therefore, this device falls under the category of a therapeutic or preventative medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Trinity Huntleigh Pump Compatible Sleeves 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
74JOW
Device Description
The Trinity Huntleigh Pump Compatible Sleeves are the same as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group. The Trinity Huntleigh Pump Compatible Sleeves 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.
Cover is made from soft brushed nylon with hooks of Velcro. Bladder is made from PVC clear 0.012" GA.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/17 description: The image shows the word "COPY" in large, outlined block letters. Each letter is formed by two parallel lines, creating a hollow effect. The letters are bold and stand out against the white background.
Section 2 Summary & Certification
AUG -6 1997
The following is a Summary & Certification of the Trinity Huntleigh Pump Compatible Sleeves.
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
Printed Name of Harvey Knauer
Signature
Title Owner
Title
Date
Dec 31, 1996
Delphi Consulting Group, P. O. Box 932, Stafford, Texas 77477, 713-723-8169 Fax 713-723-4080
Compressible Limb Sleeves CLASSIFICATION NAME: Extremity Sleeve and Pump COMMON/USUAL NAME: Trinity Huntleigh Pump Compatible Sleeves PROPRIETARY NAME: 21 CFR Part 870.5800 Compressible CLASSIFICATION: Limb Sleeve, Class II PERFORMANCE STANDARDS: No Performance Standards for the Compressible Limb Sleeve are in effect. Trinity Huntleigh Pump Compatible Sleeves are the PREDICATED DEVICE same as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group. The Trinity Huntleigh Pump Compatible Sleeves is INDICATIONS 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.
1
| CONTRAINDICATIONS | The Trinity Huntleigh Pump Compatible Sleeves
with a Huntleigh Technology, Inc. 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. |
| SUBSTANTIAL EQUIVALENCE | The Trinity Huntleigh Pump Compatible Sleeve are the
same as the sleeves released to market under K954489,
27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group
and sleeve tubing pump connector same as Huntleigh
Technology, K910188, Pump Flowtron DVT Model
AC500DVT with pressure range of 20-60 mmHg. |
| MATERIALS | Cover is made from soft brushed nylon with hooks
of Velcro. Bladder is made from PVC clear 0.012"
GA. |
| CONCLUSIONS | The conclusion drawn from the above is that the
Trinity Huntleigh Pump Compatible Sleeves is
equivalent in safety and efficacy to its predicate
device. |
(
… ..
.. .
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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 a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
:
6 1997 AUG
Mr. J. Harvey Knauss Delphi Consulting Group P.O. Box 932 Stafford, Texas 77477
Re: K970014 Trade Name: Trinity Sleeves, Huntleigh Pump Compatible Regulatory Class: II Product Code: 74JOW Dated: April 30, 1997 Received: May 8, 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht 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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Page 2 - Mr. J. Harvey Knauss
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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) SUBMISSION, TRINITY SLEEVES HUNTLEIGH TECHNOLOGY PUMP COMPATIBLE Delphi Consulting Group
510(k) Number_K9700|4
Device Name: Trinity Sleeve(s), Huntleigh Technology Pump Compatible
Indications for use: The Trinity Sleeve(s), Huntleigh Technology Pump Compatible 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)
Sete Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_K970014
Prescription Use
GR
Over-The-Counter Use No
(Per 21 CFR 801.109)
(Optional Format 1-2-96)