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

Device Description

Compressible Limb Sleeves

AI/ML Overview

The provided text indicates that the device, Trinity Huntleigh Pump Compatible Sleeves, is substantially equivalent to a previously marketed predicate device (K954489, Trinity Sleeve(s), Delphi Consulting Group) and sleeve tubing pump connector (K910188, Pump Flowtron DVT Model AC500DVT from Huntleigh Technology). This substantial equivalence determination serves as the primary basis for meeting the acceptance criteria, as there are no specific performance standards for Compressible Limb Sleeves mentioned.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Safety	"The Trinity Huntleigh Pump Compatible Sleeves is equivalent in safety and efficacy to its predicate device." Concerns listed relate to improper operation (puncture/cuts, improper sterilization, sleeve applied too loose/tight) rather than inherent system failure.
Efficacy	"The Trinity Huntleigh Pump Compatible Sleeves is equivalent in safety and efficacy to its predicate device." Indications for Use: 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.
Substantial Equivalence to Predicate Device (K954489)	Confirmed: "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."
Substantial Equivalence to Predicate Device (K910188)	Confirmed: "...and sleeve tubing pump connector same as Huntleigh Technology, K910188, Pump Flowtron DVT Model AC500DVT with pressure range of 20-60 mmHg."
Material Composition	Cover: soft brushed nylon with Velcro hooks. Bladder: PVC clear 0.012" GA. (This isn't an acceptance criterion per se, but rather a descriptive element of the device that aligns with the predicate.)

2. Sample Size Used for the Test Set and Data Provenance

The text does not explicitly describe a formal "test set" or a new study in the way a clinical trial would. The basis for acceptance is stated as substantial equivalence to existing predicate devices. Therefore, information regarding a "sample size for the test set" or "data provenance" for a new study is not provided. The acceptance hinges on the comparison to already marketed and accepted devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since no new clinical study or test set is described, there's no mention of experts establishing a ground truth for a new dataset. The "ground truth" for acceptance is effectively the established safety and efficacy of the predicate devices.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no new test set or study is described. The adjudication method would be the regulatory review process by the FDA to determine substantial equivalence.

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. This device is a medical sleeve and pump system aiming to prevent DVT/PE, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's acceptance is based on the established safety and efficacy of its predicate devices (K954489 and K910188), which were previously cleared by the FDA. This implies that the predicate devices had already demonstrated acceptable performance based on historical data, clinical experience, and potentially their own submission data (though not detailed here for the predicates). The current submission relies on the direct comparison of the new device's design, materials, and intended use to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that would require a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an algorithm is relevant to this device.

Summary

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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.

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CONTRAINDICATIONS	The Trinity Huntleigh Pump Compatible Sleeveswith a Huntleigh Technology, Inc. Pump should notbe used during episodes of pulmonary embolism orin any instance where increased venous return orlymphatic return is undesirable. Do not use on apatient with burns, open wound, rash or fracture.Use with caution on extremities which are notsensitive to pain. Do not counter accepted clinicalpractice or institution guidelines.
SAFETY	Preponderance of problems associated with theuse of a Compression Sleeve system is improperoperation of the system not system failure.
	Sleeve problems are:
	1. Puncture or cuts that destroy the integrity ofthe air chambers.
	2. Dry Cleaning, Steam or Dry HeatSterilization 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 thesame as the sleeves released to market under K954489,27-SEP-95, Trinity Sleeve(s), Delphi Consulting Groupand sleeve tubing pump connector same as HuntleighTechnology, K910188, Pump Flowtron DVT ModelAC500DVT with pressure range of 20-60 mmHg.
MATERIALS	Cover is made from soft brushed nylon with hooksof Velcro. Bladder is made from PVC clear 0.012"GA.
CONCLUSIONS	The conclusion drawn from the above is that theTrinity Huntleigh Pump Compatible Sleeves isequivalent in safety and efficacy to its predicatedevice.

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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

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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

Over-The-Counter Use No

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).