(68 days)
No
The device description details a mechanical IV stand with accessories, and there is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.
No
The device is described as an IV stand, intended for hanging IV bags and supporting infusion pumps, which are accessories to patient care rather than directly performing a therapeutic function on the patient.
No
The device, an IV stand, is described as equipment for holding IV bags and pumps. Its function is purely supportive and does not involve detecting, monitoring, or assessing health conditions, which are characteristics of a diagnostic device.
No
The device description clearly outlines a physical medical device consisting of poles, bases, hooks, and casters, with no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the IV Stands and accessories are for "hanging IV and other solution bags" and "hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care." This describes a device used to physically support and position items during medical procedures.
- Device Description: The description details the physical components of the IV stand (poles, base, hooks, casters) and its accessories (handles, hooks, trays, pump holders). This aligns with a physical support device.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or any diagnostic function.
The device described is a medical device used for patient care, but it falls under the category of a supportive or accessory device rather than an IVD.
N/A
Intended Use / 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.
Product codes
FOX
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 -- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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: .
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.
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:
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.
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
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
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:
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