(190 days)
No
The 510(k) summary describes a mechanical pump and sleeves for DVT prevention and does not mention any AI or ML capabilities.
Yes
The device is designed to reduce deep vein thrombosis and pulmonary embolism, which are medical conditions, thereby providing a therapeutic effect.
No
The device description and intended use state that it is designed to reduce pooling of blood and increase venous blood flow, which are therapeutic actions, not diagnostic ones. It does not mention identifying, detecting, or measuring a medical condition.
No
The device description explicitly mentions a "Pump" and "compressible limb sleeves," which are hardware components. The performance studies also include electrical safety and EMI testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed to reduce pooling of blood 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 purpose, not a diagnostic one.
- Device Description: The description reinforces the therapeutic nature by mentioning the use of compressible limb sleeves to achieve the intended effect.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Trinity II Single Chamber DVT System Pump does not fit this definition.
N/A
Intended Use / Indications for Use
The Trinity II Single Chamber DVT Pump 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. The intended patient population is adult with the environment of use being hospital or clinic.
Product codes
74 JOW
Device Description
Not Found
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
adult
Intended User / Care Setting
hospital or clinic / hospital or clinic
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)
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
4/28/99
Section 2
510(k) Summary
Delphi Consulting Group
Stafford, Texas 77477
1
J. Harvey Knauss (713) 723-8169
Summary
The following is a Summary of the Trinity II Single Chamber DVT Pump 510(k) submission.
Delphi Consulting Group P. O. Box 932 Stafford, Texas 77477 713-723-8169 Fax 713-723-4080
Printed Name J. Harvey Knauss
Signature
J. Harvey Knouse
Owner
Date
Title
16,1998
CLASSIFICATION NAME:
COMMON/USUAL NAME:
PROPRIETARY NAME:
CLASSIFICATION:
PERFORMANCE STANDARDS:
PREDICATED DEVICE
Compressible Limb Sleeves
Extremity Sleeve and Pump
Trinity II Single Chamber DVT Pump
21 CFR Part 870.5800 Compressible Limb Sleeve, Class II
No Performance Standards for the Compressible Limb Sleeve are in effect.
Trinity II Single Chamber DVT Pump is the same as the Pump released to market under K881632, Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump.
2
| INDICATIONS | The Trinity II Single Chamber DVT Pump 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. The
intended patient population is adult with the
environment of use being hospital or clinic. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTRAINDICATIONS | The Trinity II Single Chamber DVT Pump with sleeves
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. |
| TESTING | Electrical Safety tested to UL 2601. |
| | EMI tested to IEC 801-2, -3, -4, -5, IEC 1000-4-11, and
EN 61000-4-5, -4-11. |
| | Alarm and Timing tested to Delphi Consulting Group
protocol. |
| | Y2K -- software has been tested for any problems with
year 2000 problem. Software does not retain dates. |
| | Risk Analysis per EN 1441 and EN 46001. |
| SAFETY | Preponderance of problems associated with the use of a
Compression Sleeve Systems 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. |
3
SUBSTANTIAL EQUIVALENCE
The Trinity II Single Chamber DVT Pump is identical in every feature to the K881632, Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump. The Sleeves are released to market via K954489, Trinity Sleeve(s).
Comparison of features and principles of operation between the Trinity II Single Chamber DVT Pump and predicate device in the market via Section 510(k) of the "Act."
| Parameter | Trinity II DVT Pump | Huntleigh Technology
Pump
K881632 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pump pressure range | 20 - 60 mm Hg. | 30 - 60 mm Hg. |
| Default pressure | 40 mm Hg. | 40 mm Hg. |
| Cycle time Approx. | Inflation 12 seconds
Deflation 48 seconds | Inflation 12 seconds
Deflation 48 seconds |
| Indications | Trinity Single Chamber DVT Pump 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. | Huntleigh Technology Flowtron
Pump 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. |
| CE Mark | No | Yes |
- CONCLUSIONS The conclusion drawn from the above is that the Trinity II Single Chamber DVT Pump is equivalent in safety and efficacy to its predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 19:00
Mr. J. Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071
K983680 Re : Trinity II Single Chamber DVT System Pump Requlatory Class: II (Two) Product Code: 74 JOW January 29, 1999 Dated: February 1, 1999 Received:
Dear Mr. Knauss:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 You may, the Federal Food, Drug, and Cosmetic Act (Act). 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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (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 In addition, FDA may publish further regulatory action. 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.
5
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 requlation (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" Other general information on your (21CFR 807.97). 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
6
510(k) Number_ K983680
Trinity II Single Chamber DVT System Pump Device Name:
Indications for use: The Trinity II Single Chamber DVT System Pump (with 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. The intended patient population is adult with the environment of use being hospital, clinic.
Prescription Device: Federal Law (US) restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zee L. Bemyer Ce
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K983635)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)