IV STANDS

K980336 · Clinton Industries, Inc. · FOX · Apr 6, 1998 · General Hospital

Device Facts

• Record ID: K980336
• Device Name: IV STANDS
• Applicant: Clinton Industries, Inc.
• Product Code: FOX · General Hospital
• Decision Date: Apr 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6990
• Device Class: Class 1

Intended Use

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 Story

Device consists of telescoping chrome-plated steel poles mounted on steel or aluminum bases with casters; includes accessories like guidance handles, drainage bag hooks, utility trays, and pump holders. Used in clinical settings (surgery, patient care) to support IV solution bags and infusion pumps. Operated by healthcare staff to provide stable, adjustable-height support for medical equipment. Benefits patient by facilitating organized, mobile delivery of intravenous therapies.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Chrome-plated steel poles, steel or aluminum bases with various coatings. Sensing/Actuation: Mechanical telescoping poles with twist lock or compression knob locking mechanisms. Form factor: Multi-leg base (4, 5, or 6 legs) with casters. Energy source: None (manual).

Indications for Use

Indicated for patients requiring IV administration, surgery, or general patient care support via hanging IV/solution bags or infusion pumps.

Regulatory Classification

Identification

The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

Predicate Devices

• The Brewer Company IV Stands (K823270, K850245)

Submission Summary (Full Text)

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#### 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: .

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.

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# 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:

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.

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

Please see the next two pages of this document.

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# 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 |

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### 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

Chrome Plated Steel

5 Leg, 25", Aluminum

TIV-3254

Knob

4

Base Locking Hooks Height Post Extension Post Casters

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

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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

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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 [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/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

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### INDICATIONS FOR USE STATEMENT

510(K) Number: K 980336

Device Name: IV Stands and Accessories

Indications For Use:

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.

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