The IV Stands and accessories are intended for hanging IV and other solution bags which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care.

Device Description

The Clinton Industries, Inc. IV Stands consist of a series of poles that are affixed to a base. The poles can telescope to various heights. The bases come in various sizes, depending on the pole used. The IV Stands are purchased with hooks for holding IV or other solution bags. The are either 2 or 4 hooks that are affixed to the top of the poles. The IV poles are chrome-plated steel. Each IV Stand consists of two poles with one fitting inside the other and telescoping to various heights. The telescoping portion of the poles is held in place by either a twist lock design or a compression knob. The bases are steel or aluminum with various coatings. Casters are affixed to the bases for movement of the stands. The following accessories are marketed with the IV Stands: Guidance Handle, Drainage Bag Hook, Utility Console Tray, Dual Pump Holder, Multi-pump Holder.

AI/ML Overview

This document is a 510(k) premarket notification for IV Stands and Accessories from Clinton Industries, Inc., submitted to the FDA in 1998. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis based on your request, highlighting that this is a medical device substantial equivalence claim, not a study evaluating AI software or diagnostic performance. Therefore, many of your requested fields related to AI performance, ground truth, and expert adjudication are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (IV Stands), "acceptance criteria" are typically met by demonstrating that the device has the same fundamental technological characteristics and intended use as a predicate device already on the market. The "performance" is implicitly accepted if these characteristics are shown to be equivalent and safe. There are no specific quantitative metrics like sensitivity or specificity for an IV Stand.

Characteristic	Acceptance Criteria (Predicate Device K823270 & K850245)	Reported Device Performance (Clinton Industries IV Stands)
Intended Use	Hanging IV/solution bags, supporting infusion pumps/medical items during IV administration, surgery, or patient care.	Same
Base Types	4 Leg, 22" (Epoxy Coated); 5 Leg, 25" (Aluminum); 6 Leg, 26" (Epoxy Coated)	Same
Locking Mechanism	Twist Lock; Knob	Same
Number of Hooks	2 hooks; 4 hooks	Same
Height Ranges	47" to 102" (various models)	Same
Post Material	Chrome Plated Steel	Same
Extension Post Material	Chrome Plated Steel	Same
Casters	Yes	Yes
Accessories	(Not explicitly detailed in predicate, but described for subject device as: Guidance Handle, Drainage Bag Hook, Utility Console Tray, Dual Pump Holder, Multi-pump Holder)	(Available from Clinton Industries)

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

Not Applicable. This is not a study assessing diagnostic performance or AI. The "test set" here refers to the comparison of the new device's specifications against those of existing predicate devices.
The data provenance is from the design specifications of the Clinton Industries IV Stands and the publicly available 510(k) summaries for The Brewer Company's IV Stands (K823270 and K850245).

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

Not Applicable. Ground truth in the context of IV stands refers to their basic engineering and functional specifications, which are objective. There isn't "ground truth" to be established by experts in the same way there would be for image interpretation. The "experts" involved are the design engineers and regulatory professionals from Clinton Industries and potentially FDA reviewers who evaluate the technical specifications against the predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a diagnostic outcome. The comparison is based on objective, verifiable physical and functional characteristics. The FDA's review process serves as the "adjudication" of substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is not a diagnostic device involving human readers or AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is the objective physical and functional specifications of the predicate IV stands as documented in their 510(k) submissions. The new device's specifications are compared directly against these documented characteristics.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI or machine learning device. The design of the Clinton Industries IV Stands is based on established engineering principles and the design of existing, legally marketed IV stands.

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

Not Applicable. As there's no training set, there's no ground truth to be established for it.

Summary

{0}------------------------------------------------

510(k) SUMMARY

APPLICANTS NAME AND ADDRESS:

APR - 6 1998

Clinton Industries, Inc. 545 South Pine Street York, PA 17403

APPLICANTS TELEPHONE NUMBER:

717-848-3519

APPLICANTS FACSIMILE NUMBER:

717-843-5871

APPLICANTS CONTACT PERSON:

Mr. Robert Bohn President

DATE THE SUMMARY WAS PREPARED:

January 23, 1998

DEVICE NAME:

Trade Name: IV Stand and Accessories Common Name: IV Stand and Accessories Classification Name: Stand, Infusion

LEGALLY MARKETED DEVICES TO WHICH CLINTON INDUSTRIES, INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Various IV Stands marketed by The Brewer Company, 13901 Main Street, Menomonee Falls, WI 53051.

DESCRIPTION OF THE DEVICE: .

{1}------------------------------------------------

510(k) SUMMARY CONTINUED

The IV poles are chrome-plated steel. Each IV Stand consists of two poles with one fitting inside the other and telescoping to various heights. The telescoping portion of the poles is held in place by either a twist lock design or a compression knob. The bases are steel or aluminum with various coatings. Casters are affixed to the bases for movement of the stands.

The following accessories are marketed with the IV Stands:

Guidance Handle -- for grasping and moving the IV Stand

Drainage Bag Hook - for holding the IV or solution bags

Utility Console Tray -- for holding other medical items

Dual Pump Holder - for holding multiple infusion pumps

Multi-pump Holder -- for holding up to four infusion pumps

INTENDED USE OF THE DEVICE:

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:

Please see the next two pages of this document.

{2}------------------------------------------------

SUBSTANTIAL EQUIVALENCE DATA

The IV Stands to be marketed by Clinton Industries, Inc. are substantially equivalent to a product line of IV Stands marketed by The Brewer Company. We believe that these Stands are covered in the E. F. Brewer 510(k) numbers K823270 and K850245.

Both the Clinton Industries, Inc. and The Brewer Company IV Stands are used for hanging IV and other solutions, which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, and patient care.

The following is a description of the physical similarities between the Clinton Industries, Inc. and The Brewer Company IV Stands:

CLINTON CODE	BREWER CODE
TIV-300	11300
Base	4 Leg, Epoxy Coated	4 Leg, Epoxy Coated
Locking	Twist Lock	Twist Lock
Hooks	2	2
Height	47" to 84-1/2"	47" to 84-1/2"
Post	Chrome Plated Steel	Chrome Plated Steel
Extension Post	Chrome Plated Steel	Chrome Plated Steel
Casters	Yes	Yes
	CLINTON CODE	BREWER CODE
	TIV-310	43403
Base	4 Leg, 22", Epoxy Coated	4 Leg, 22", Epoxy Coated
Locking	Knob	Knob
Hooks	2	2
Height	51-3/4" to 94"	51-3/4" to 94"
Post	Chrome Plated Steel	Chrome Plated Steel
Extension Post	Chrome Plated Steel	Chrome Plated Steel
Casters	Yes	Yes
	CLINTON CODE	BREWER CODE
	TIV-3104	43406
Base	4 Leg, 22", Epoxy Coated	4 Leg, 22", Epoxy Coated
Locking	Knob	Knob
Hooks	4	4
Height	51-3/4" to 94"	51-3/4" to 94"
Post	Chrome Plated Steel	Chrome Plated Steel
Extension Post	Chrome Plated Steel	Chrome Plated Steel
Casters	Yes	Yes

{3}------------------------------------------------

SUBSTANTIAL EQUIVALENCE DATA CONTINUED

Base Locking Hooks Height Post Extension Post Casters

CLINTON CODE TIV-325 5 Leg, 25", Aluminum Knob 2 52-1/2" to 93-3/4" Chrome Plated Steel Chrome Plated Steel Yes

CLINTON CODE

52-1/2" to 93-3/4"

Chrome Plated Steel

5 Leg, 25", Aluminum

TIV-3254

Knob

Base Locking Hooks Height Post Extension Post Casters

Yes CLINTON CODE TIV-330 6 Leg, 26", Epoxy Coated Knob 2 58 to 102'' Chrome Plated Steel Chrome Plated Steel Yes

Base Locking Hooks Height Post Extension Post Casters

CLINTON CODE TIV-3304 6 Leg, 26", Epoxy Coated Knob 4 58 to 102" Chrome Plated Steel Chrome Plated Steel Yes

BREWER CODE 1350 5 Leg, 25", Aluminum Knob 2 52-1/2" to 93-3/4" Chrome Plated Steel Chrome Plated Steel Yes

BREWER CODE I 1360 5 Leg, 25", Aluminum Knob 4 52-1/2" to 93-3/4" Chrome Plated Steel Chrome Plated Steel Yes

BREWER CODE 43408 6 Leg, 26", Epoxy Coated Knob . 2 58" to 102" Chrome Plated Steel Chrome Plated Steel Yes

BREWER CODE 43409 6 Leg, 26", Epoxy Coated Knob 4 58" to 102" Chrome Plated Steel Chrome Plated Steel Yes

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 1998

Clinton Industries, Incorporated ·C/O James R. Collie, RAC Consultant to Clinton Industries, Inc. J.R. Collie Associates, Incorporated 3030 Antler Drive Doylestown, Pennsylvania 18901

Re : K980336 IV Stands Trade Name: Requlatory Class: Unclassified Product Code: FOX Dated: January 26, 1998 Received: January 28, 1998

Dear Mr. Collie:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 40,000 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 requlation 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

{5}------------------------------------------------

Page 2 - Mr. Collie

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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) 594-4692. 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/lgov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Wlatsky

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(K) Number: K 980336

Device Name: IV Stands and Accessories

Indications For Use:

Patraux Crescente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980836

Prescription Use
(Per 21 CFR 801.109)

Over--The Counter Use

Regulation Number and Section

§ 880.6990 Infusion stand.

(a)
Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.