TRINITY II SINGLE CHAMBER DVT PUMP

K983680 · Delphi Consulting Group · JOW · Apr 28, 1999 · Cardiovascular

Device Facts

• Record ID: K983680
• Device Name: TRINITY II SINGLE CHAMBER DVT PUMP
• Applicant: Delphi Consulting Group
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Trinity II Single Chamber DVT Pump is a pneumatic compression device for hospital/clinic use. It connects to compressible limb sleeves to provide intermittent pneumatic compression. Device inflates sleeves to a default pressure of 40 mmHg (range 20-60 mmHg) with a cycle of 12 seconds inflation and 48 seconds deflation. Operation is managed by clinical staff. By increasing venous blood flow in lower extremities of recumbent patients, it reduces risk of deep vein thrombosis and pulmonary embolism. System includes alarms and timing controls. Device is intended to be used per physician order.

Clinical Evidence

Bench testing only. 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 functionality verified via internal protocol. Risk analysis performed per EN 1441 and EN 46001. Y2K compliance testing confirmed.

Technological Characteristics

Pneumatic compression pump for limb sleeves. Pressure range: 20-60 mmHg; default: 40 mmHg. Cycle: 12s inflation, 48s deflation. Electrical safety: UL 2601. EMI compliance: IEC 801/1000 series, EN 61000. Risk management: EN 1441, EN 46001. Software is non-date-retaining.

Indications for Use

Indicated for adult patients in hospital or clinic settings to reduce blood pooling and increase venous blood flow in lower extremities to prevent deep vein thrombosis and pulmonary embolism. Contraindicated for patients with pulmonary embolism, conditions where increased venous/lymphatic return is undesirable, burns, open wounds, rashes, or fractures. Use with caution on extremities insensitive to pain.

Regulatory Classification

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.

Predicate Devices

• Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump (K881632)

Reference Devices

• Trinity Sleeve(s) (K954489)

Submission Summary (Full Text)

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4/28/99

K983680

Section 2

510(k) Summary

Delphi Consulting Group
Stafford, Texas 77477

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J. Harvey Knauss [phone]

## 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 [phone]

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 to<br>reduce pooling of blood, increase venous blood flow in<br>the lower extremities of the recumbent patient to reduce<br>deep vein thrombosis and pulmonary embolism. The<br>intended patient population is adult with the<br>environment of use being hospital or clinic. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTRAINDICATIONS | The Trinity II Single Chamber DVT Pump with sleeves<br>should not be used during episodes of pulmonary<br>embolism or in any instance where increased venous<br>return or lymphatic return is undesirable. Do not use on<br>a patient with burns, open wound, rash or fracture. Use<br>with caution on extremities which are not sensitive to<br>pain. Do not counter accepted clinical practice or<br>institution guidelines. |
| TESTING | Electrical Safety tested to UL 2601. |
| | EMI tested to IEC 801-2, -3, -4, -5, IEC 1000-4-11, and<br>EN 61000-4-5, -4-11. |
| | Alarm and Timing tested to Delphi Consulting Group<br>protocol. |
| | Y2K -- software has been tested for any problems with<br>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<br>Compression Sleeve Systems is improper operation of<br>the system not system failure. |
| | Sleeve problems are: |
| | 1. Puncture or cuts that destroy the integrity of the<br>air chambers. |
| | 2. Dry Cleaning, Steam or Dry Heat Sterilization<br>that 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 Technology<br>Pump<br>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<br>Deflation 48 seconds | Inflation 12 seconds<br>Deflation 48 seconds |
| Indications | Trinity Single Chamber DVT Pump is<br>designed to reduce pooling of blood,<br>increase venous blood flow in the<br>lower extremities of the recumbent<br>patient to reduce deep vein<br>thrombosis and pulmonary<br>embolism. | Huntleigh Technology Flowtron<br>Pump is designed to reduce<br>pooling of blood, increase<br>venous blood flow in the lower<br>extremities of the recumbent<br>patient to reduce deep vein<br>thrombosis and pulmonary<br>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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)