(190 days)
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.
The Trinity II Single Chamber DVT Pump is a device designed to reduce pooling of blood and increase venous blood flow in the lower extremities of recumbent patients. It uses compressible limb sleeves.
The provided text describes a medical device submission (Trinity II Single Chamber DVT Pump) seeking substantial equivalence to a predicate device. However, it does not contain acceptance criteria for the device's performance, nor does it detail any study proving the device meets specific performance criteria beyond electrical safety, EMI, alarm and timing tests, Y2K compliance, and risk analysis.
The submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump) based on similar indications for use, operating principles, and minor parameter differences (pump pressure range).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it is not present in the provided text.
Here's what I can extract based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the text in the context of clinical or performance acceptance criteria for the device itself. The text mentions "Testing" for electrical safety, EMI, alarm and timing, Y2K, and risk analysis, but these are general safety and engineering tests, not performance acceptance criteria for the DVT pump's therapeutic effect.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. The submission does not detail any clinical performance study with a test set.
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 applicable/Not provided. No clinical performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No clinical performance study is described.
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 provided. This device is a DVT pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This device is a medical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/Not provided. No clinical performance study is described.
8. The sample size for the training set:
Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.
9. How the ground truth for the training set was established:
Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.
Summary of available "testing" information:
| Test Type | Reported Compliance/Finding |
|---|---|
| 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. |
| Substantial Equivalence | Concluded to be equivalent in safety and efficacy to the predicate device (Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump, K881632) based on feature comparison (pump pressure range, default pressure, cycle time, indications). |
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4/28/99
Section 2
510(k) Summary
Delphi Consulting Group
Stafford, Texas 77477
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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.
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| INDICATIONS | The Trinity II Single Chamber DVT Pump is designed toreduce pooling of blood, increase venous blood flow inthe lower extremities of the recumbent patient to reducedeep vein thrombosis and pulmonary embolism. Theintended patient population is adult with theenvironment of use being hospital or clinic. |
|---|---|
| CONTRAINDICATIONS | The Trinity II Single Chamber DVT Pump with sleevesshould not be used during episodes of pulmonaryembolism or in any instance where increased venousreturn or lymphatic return is undesirable. Do not use ona patient with burns, open wound, rash or fracture. Usewith caution on extremities which are not sensitive topain. Do not counter accepted clinical practice orinstitution guidelines. |
| TESTING | Electrical Safety tested to UL 2601. |
| EMI tested to IEC 801-2, -3, -4, -5, IEC 1000-4-11, andEN 61000-4-5, -4-11. | |
| Alarm and Timing tested to Delphi Consulting Groupprotocol. | |
| Y2K -- software has been tested for any problems withyear 2000 problem. Software does not retain dates. | |
| Risk Analysis per EN 1441 and EN 46001. | |
| SAFETY | Preponderance of problems associated with the use of aCompression Sleeve Systems is improper operation ofthe system not system failure. |
| Sleeve problems are: | |
| 1. Puncture or cuts that destroy the integrity of theair chambers. | |
| 2. Dry Cleaning, Steam or Dry Heat Sterilizationthat destroys the sleeves. | |
| Operator Errors are: | |
| 1. Sleeve applied too loose. | |
| 2. Sleeve applied too tight. |
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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 TechnologyPumpK881632 |
|---|---|---|
| Pump pressure range | 20 - 60 mm Hg. | 30 - 60 mm Hg. |
| Default pressure | 40 mm Hg. | 40 mm Hg. |
| Cycle time Approx. | Inflation 12 secondsDeflation 48 seconds | Inflation 12 secondsDeflation 48 seconds |
| Indications | Trinity Single Chamber DVT Pump isdesigned to reduce pooling of blood,increase venous blood flow in thelower extremities of the recumbentpatient to reduce deep veinthrombosis and pulmonaryembolism. | Huntleigh Technology FlowtronPump is designed to reducepooling of blood, increasevenous blood flow in the lowerextremities of the recumbentpatient to reduce deep veinthrombosis and pulmonaryembolism. |
| 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.
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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.
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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 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
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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)
§ 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).