INTRAVASCULAR ADMINISTRATION SET

K993463 · Custom Assemblies, Inc. · FPA · Jan 4, 2000 · General Hospital

Device Facts

• Record ID: K993463
• Device Name: INTRAVASCULAR ADMINISTRATION SET
• Applicant: Custom Assemblies, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated as a single, use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Hospital, Emergency Services, Home settings, wherever I.V. administration is utilized.

Device Story

Extension set functions as an intravascular administration fluid pathway. Device consists of medical-grade tubing of various lengths/diameters, integrated with connectors (luer fittings) and accessories including drip chambers, infusion line filters, clamps, check valves, spikes, and Y-site injection sites. Used in hospital, emergency, and home settings by healthcare providers to extend reach of I.V. therapy. Device is sterile, single-use, and disposable. Benefits include facilitating fluid delivery in clinical environments requiring extended tubing reach.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Tubing composed of Class VI PVC. Accessory components (connectors, drip chambers, clamps, filters, spikes, check valves) composed of polycarbonate, polypropylene, and PVC. Sterile, single-use device. No electronic or software components.

Indications for Use

Indicated for patients requiring I.V. therapy where an extended fluid path is necessary for administration. Suitable for use in hospital, emergency, and home care settings.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• R-Group - K940319
• The Kipp Group - I.V. Administration Set - K991932

Submission Summary (Full Text)

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K993463

JAN - 4 2000

Image /page/0/Picture/2 description: The image shows the logo for "Custom Assemblies, Inc.". The logo features three curved lines on the left side, followed by the company name in a serif font. Below the company name, the tagline "Your Quality Partner" is written in a smaller font.

## Non-Confidential Summary of Safety and Effectiveness

| | page 1 of 2 |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | October 11, 1999 |
| Custom Assemblies, Inc.<br>306 E. Brown St.<br>P.O. Box177<br>Pine Level, NC 27568 | Tel - [phone] |
| | Fax - [phone] |
| Official Contact: | Jack Peacock - President |
| Proprietary or Trade Name: | Extension set |
| Common/Usual Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Device: | Extension set |
| Predicate Devices: | R-Group - K940319<br>The Kipp Group - I.V. Administration Set - K991932 |

## 1000 1000 1000 1000 1000 1000 Device Description: Noveller - A

The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.

| <b>Intended Use:</b> | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | Indicated as a single, use, sterile device for use in I.V. therapy when an<br>extended fluid path is required for administration. |
| Environment of Use -- | Hospital, Emergency Services, Home settings, wherever I.V. administration<br>is utilized. |

Comparison to Predicate Device

Please change our mailing address to:

PO BOX 177 Pine Level, NC 27568

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## Non-Confidential Summary of Safety and Effectiveness

page 2 of 2

October 11, 1999

| Attribute | Custom Assemblies | R. Group<br>K990319 | King Group<br>K991932 |
|------------------------------------------------------------------------------------------------|-------------------|---------------------|-----------------------|
| Indicated for I.V. therapy<br>and administration | Yes | Yes | Yes |
| Used as fluid path way | Yes | Yes | Yes |
| Single patient use | Yes | Yes | Yes |
| Environment where I.V therapy<br>is indicated | Yes | Yes | Yes |
| Tubing of various lengths and<br>diameters | Yes | Yes | Yes |
| Connectors - luer fittings | Yes | Yes | Yes |
| Assembled with - drip<br>chambers, clamps, infusion line filter,<br>spikes, check valves, caps | Yes | Yes | Yes |
| Offered sterile | Yes | Yes | Yes |
| Tubing - PVC Class VI | Yes | Yes | Yes |
| Accessory components<br>Polycarbonate, Polypropylene, PVC | Yes | Yes | Yes |
| None required under Section 514 | Yes | Yes | Yes |

## Differences between 9ther Legally Marketed P Des 人 - 天津

There are no significant differences between the intended device and the predicates - R-Group - K940319 and The Kipp Group - K991932.

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Public Health Service

JAN - 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Custom Assemblies, Inc. c/o Mr. Paul E. Dryden on behalf Custom Assemblies, Inc. Promedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055

Re: K993463 Trade Name: Intravascular Administration Set Class: II Product Code: FPA November 19, 1999 Dated: Received: November 23, 1999

Dear Mr. Dryden:

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 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

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Page 2 - Mr. Dryden

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.

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.gov/cdrh/dsmamain.html".

Sincerely yours;

Timothy A. Ulatowski
Director

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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1 4434463

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Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | (to be assigned) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | I.V. Administration Sets |
| Intended Use: | Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. |
| Environment of use: | Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109)

or

Over-the-counter use

Julien Laurentie

് Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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