FLEBOSET MULTIPLE

K040456 · Laboratorios Grifols, S.A. · LHI · Mar 9, 2004 · General Hospital

Device Facts

• Record ID: K040456
• Device Name: FLEBOSET MULTIPLE
• Applicant: Laboratorios Grifols, S.A.
• Product Code: LHI · General Hospital
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for: (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set. The device should not be used with lipids. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Device Story

Fluid transfer tubing set; enables continuous delivery of drug solutions from 6 glass source containers. Device consists of 6 spikes connected in series with flexible tubing segments; each segment includes individual clamp; terminal features spikeable twist-off valve connector. Used in pharmacy compounding (with GRI-FILL 2.0 device) or I.V. administration (with gravity/pump infusion sets). Operated by trained healthcare personnel in clinical or pharmacy settings. Minimizes tubing manipulation during small volume source container handling. Provides fluid pathway to infusion sets; facilitates uninterrupted solution delivery. Benefits patient by reducing manual intervention and maintaining continuous fluid supply.

Clinical Evidence

Bench testing only. No clinical data provided. Materials underwent chemical and biological testing per requirements. Functional laboratory testing confirmed correct operation under foreseeable conditions.

Technological Characteristics

Materials: PVC with DEHP plasticizer. Configuration: 6 spikes in series with flexible tubing, individual clamps, and twist-off valve connector. Sterilization: Ethylene Oxide. Connectivity: Standalone fluid pathway. Energy: None (gravity/pump driven).

Indications for Use

Indicated for continuous delivery of identical solutions from 6 glass source flasks for pharmacy compounding or I.V. administration. Intended for use by trained healthcare personnel. Contraindicated for use with lipids.

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

• Automix 3+3 Compounder Transfer Set (K894827)
• Medrad Transfer Set (K022431)
• Merit Medical Contrast Management System (K961794)

Submission Summary (Full Text)

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K040456

3/9/04

## TECHNICAL EVALUATION DOCUMENTATION multiple-01 GRIFOLS SECTION 1 - FLEBOSET MULTIPLE: 510(k) SUMMARY

: 上一

| DATE OF SUBMISSION: | 2004-02-06 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER NAME:<br>SUBMITTER ADDRESS: | Laboratorios Grifols, S.A.<br>C/ Can Guasch, 2<br>08150 PARETS DEL VALLES<br>BARCELONA<br>SPAIN |
| TELEPHONE:<br>FAX:<br>e-mail: | + 34 93 571 01 00<br>+ 34 93 573 09 12<br>[e-mail] |
| CONTACT: | Sebastián Gascón<br>Technical Director |
| DEVICE TRADE NAME:<br>COMMON NAME: | FLEBOSET MULTIPLE<br>I.V. FLUID TRANSFER SETS<br>FLUID DELIVERY TUBING |
| CLASSIFICATION NAME: | SET, I.V. FLUID TRANSFER (21 CFR 880.5440, LHI)<br>TUBING. FLUID DELIVERY (21 CFR 880.5440, FPK) |
| PREDICATE DEVICE: | Automix 3+3 Compounder Transfer Set (BAXTER<br>HEALTHCARE CORP.)<br>Medrad Transfer Set (MEDRAD INC.)<br>Merit Medical Contrast Management<br>System<br>(MERIT MEDICAL SYSTEMS, INC.) |
| DEVICE DESCRIPTION: | FLEBOSET MULTIPLE is a fluid transfer tubing set<br>used to enable continuous (uninterrupted) delivery<br>of drug solutions from 6 glass source containers. It<br>is used in pharmacy compounding or for I.V. fluid<br>transfer to minimize tubing manipulation when<br>working with small volume source containers. The<br>device is made up of 6 spikes connected in series<br>with flexible tubing segments, each segment with an<br>individual clamp. The set terminal, for connection to<br>pharmacy compounding device sets or<br>the<br>administration sets (gravity or pump) consists of a<br>spikeable twist-off valve connector. |

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Image /page/1/Picture/0 description: The image is a document header with the word GRIFOLS on the left side. The header also contains the words TECHNICAL EVALUATION DOCUMENTATION. The document number is TED-FLEBOSET MULTIPLE-01. The section is titled SECTION 1 - FLEBOSET MULTIPLE: 510(k) SUMMARY.

#### INTENDED USE:

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for.

Pharmacy compounding, (a) when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and

I.V. administration, when used in conjunction with (b) a gravity or pump infusion set to channel the solution from the source containers to the infusion set. The device should not be used with lipids.

#### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, FLEBOSET MULTIPLE is compared with other fluid delivery tubing used in pharmacy compounding and I.V. administration. The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.

| | | | PREDICATES | | |
|----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| # | Characteristic /<br>Feature | FLEBOSET<br>MULTIPLE | BAXTER<br>Automix 3+3<br>(transfer set<br>presented<br>together with<br>compounder)<br>K894827 | MEDRAD<br>Transfer Set<br>K022431 | MERIT MEDICAL<br>Transfer Sets<br>K961794 |
| 1. | Intended use / Claims | FLEBOSET MULTIPLE is<br>an ancillary device used<br>as fluid pathway through<br>which substances from 6<br>glass<br>source<br>flasks<br>containing<br>the<br>same<br>solution<br>may<br>be<br>continuously delivered for.<br>(a) Pharmacy compoun-<br>ding, when<br>used<br>in<br>conjunction with the GRI-<br>FILL<br>2.0 pharmacy<br>compounding device and<br>associated transfer sets,<br>and (b) I.V. administration,<br>when used in conjunction<br>with a gravity or pump<br>infusion set to channel the<br>solution from the source<br>containers to the infusion | Positive<br>displacement<br>fluid<br>compounding<br>system employing the<br>3+3<br>compounder,<br>TRANSFER<br>SETS,<br>empty<br>Viaflex<br>or<br>Travamulsion containers<br>with<br>connectors and<br>multitask<br>computer<br>software to provide<br>compounding of a wide<br>variety of fluids | The Medrad Transfer<br>Set is medical<br>disposable device used<br>to transfer intravascular<br>contrast media and<br>saline from a spikeable<br>container to a power<br>injector syringe. The<br>device components<br>consist of a vented<br>spike, connector tube, a<br>means of manually<br>stopping flow, female<br>luer, and individually<br>packaged sterile caps. | Contrast media delivery<br>systems used to transfer<br>I.V. contrast media from<br>a spikeable container to<br>a syringe. |

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# 230SET MULTIPLE: 510(k) S

| # | Characteristic /<br>Feature | FLEBOSET<br>MULTIPLE | PREDICATES | | |
|----|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | | | BAXTER<br>Automix 3+3<br>(transfer set<br>presented<br>together with<br>compounder)<br>K894827 | MEDRAD<br>Transfer Set<br>K022431 | MERIT MEDICAL<br>Transfer Sets<br>K961794 |
| | | set. The device should not<br>be used with lipids. | | | |
| 2. | Technological<br>features:<br>-Sterilization<br>-Contact with patient | Ethylene Oxide<br>NO- Intended for use<br>with the pharmacy<br>compounding device or<br>INDIRECT - May be used<br>on-line with patient,<br>upstream of the gravity or<br>pump administration sets. | Radiation<br>NO - Intended for use<br>with the pharmacy<br>compounding device. | Ethylene Oxide<br>NO- Must be removed<br>from the syringe before<br>the syringe can be<br>connected to the<br>patient. | Ethylene Oxide<br>INDIRECT - May be<br>used on-line with the<br>patient through a<br>syringe with stopcock or<br>a manifold port. |
| | -Source solutions | 6 | 3 or 6. | 2 | 1 |
| 3. | Principle Materials | PVC with DEHP plasticizer | PVC with DEHP<br>plasticizer | PVC | Flexible plastic |
| 4. | Sterility | Sterile | Sterile | Sterile | Sterile |

From the above table, it can be established that the new device and the predicate devices are very similar.

# SUMMARY DISCUSSION OF NON-CLINICAL DATA:

All materials used in the construction of FLEBOSET MULTIPLE have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use.

#### CONCLUSIONS:

We believe the intended use, the indications for use, the functionality and the operation of FLEBOSET MULTIPLE and the predicate devices for fluid transfer both in pharmacy compounding and for 1.V. administration are essentially the same. Hence, substantial equivalence of FLEBOSET MULTIPLE with the legally marketed devices may be established.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The profiles are arranged to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

MAR - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laboratorios Grifols, S.A. C/O Ms. Susan Gill Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K040456

Trade/Device Name: Fleboset Multiple Regulation Number: 880.5440 Regulation Name: Set, Intravenous Fluid Transfer Regulatory Class: II Product Code: LHI Dated: February 20, 2004 Received: February 23, 2004

Dear Ms. Gill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations offecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Ms. Gill

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

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

Enclosure

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## ECHNICAL EVALUATION DOCUMENTATION ON 09 FLEBOSET MULTIPLE: INDICATIONS FO A CHE CHENE

### PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(as required by ODE for all 510(k) received after Jan. 1, 1996)

510(k) Number:

K040456

Device Name:

FLEBOSET MULTIPLE

Indications for Use:

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:

- (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
- (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.

The device should not be used with lipids.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

(Do not write below this line. Continue on another page in needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arne Nannestad, Interim Branch Chief
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040456

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use