TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)

K970014 · Delphi Consulting Group · JOW · Aug 6, 1997 · Cardiovascular

Device Facts

• Record ID: K970014
• Device Name: TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
• Applicant: Delphi Consulting Group
• Product Code: JOW · Cardiovascular
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Compressible limb sleeve system; used with Huntleigh Technology, Inc. pump. Device consists of air-filled bladder sleeve applied to patient's lower extremities. Pump provides pneumatic compression to reduce blood pooling and increase venous flow. Used in clinical settings for recumbent patients. Healthcare providers apply sleeve to patient; monitor for proper fit to avoid operator error (too loose/tight). Benefits include reduction of deep vein thrombosis and pulmonary embolism risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compressible limb sleeve; cover made of brushed nylon with Velcro hooks; bladder made of 0.012" gauge clear PVC. Operates via pneumatic compression from external pump (20-60 mmHg range).

Indications for Use

Indicated for recumbent patients 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

• Trinity Sleeve(s) (K954489)
• Pump Flowtron DVT Model AC500DVT (K910188)

Submission Summary (Full Text)

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510(K) SUBMISSION, TRINITY HUNTLEIGH PUMP COMPATIBLE SLEEVES
Delphi Consulting Group

# COPY

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

Signature

Title Owner

Date
Dec 31, 1996

Delphi Consulting Group, P. O. Box 932, Stafford, Texas 77477, 713-723-8169
Fax [phone]

| CLASSIFICATION NAME: | Compressible Limb Sleeves |
| --- | --- |
| COMMON/USUAL NAME: | Extremity Sleeve and Pump |
| PROPRIETARY NAME: | Trinity Huntleigh Pump Compatible Sleeves |
| 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 | 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. |
| INDICATIONS | 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. |

Section 2, Page 1
December, 1996
SUMMAR-1.DOC 12/20/96

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510(k) SUBMISSION, TRINITY HUNTLEIGH PUMP COMPATIBLE SLEEVES
Delphi Consulting Group

# 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.

SUMMAR-1.DOC 12/20/96
Section 2, Page 2
December, 1996

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 6 1997

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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 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 regulation (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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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870.5800 - Jow II - Compressible Limb Sleeve

510(k) SUBMISSION, TRINITY SLEEVES HUNTLEIGH TECHNOLOGY PUMP COMPATIBLE
Delphi Consulting Group

510(k) Number K970014

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)


(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970014

Prescription Use ☐ Yes ☐
OR
Over-The-Counter Use ☐ No ☐

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

INDICA-1.DOC 12/20/96

Section 1, Page 3
December 1996