SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE

K050339 · Laboratorios Grifols, S.A. · LHI · Feb 25, 2005 · General Hospital

Device Facts

• Record ID: K050339
• Device Name: SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
• Applicant: Laboratorios Grifols, S.A.
• Product Code: LHI · General Hospital
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

SETS GRI-FILL 3.0 1 WAY and 2 WAYS are disposable components of the GRI-FILL 3.0 pharmacy compounding system used to provide a fluid pathway through which one or two source substances are channeled to an IV container or syringe. SETS GRI-FILL 3.0 MULTIPLE are ancillary devices connected to SETS GRI-FILL 3.0 1 WAY or 2 WAYS used to provide a fluid pathway through which the same substance in up to 6 source containers may be delivered into a final IV container. The device is NOT intended to be connected directly to the patient.

Device Story

SETS GRI-FILL 3.0 are disposable fluid transfer sets used exclusively with the GRI-FILL 3.0 pharmacy compounding system. The system facilitates the mixing of multi-ingredient solutions and reconstitution of powder drugs. The 1WAY/2WAY sets consist of a syringe, distributor, tubing, and an integrated waste/residue bag; the MULTIPLE model acts as an ancillary connector for up to six source containers. Operated by trained pharmacy personnel in a hospital pharmacy setting, the device provides a closed-system fluid pathway. It does not connect directly to patients. By automating the transfer of source substances into final IV containers, the device improves compounding efficiency and accuracy, reducing manual handling risks for pharmacy staff.

Clinical Evidence

Bench testing only. Functional laboratory testing performed under normal and stress conditions verified accurate delivery of source solutions and confirmed fluid/air leakage prevention. No clinical data was required or provided.

Technological Characteristics

Materials: PVC with DEHP plasticizer. Components: Syringe, distributor, tubing, waste bag, Luer adapters. Sterilization: Ethylene Oxide. System: Closed-system fluid pathway. Connectivity: Standalone disposable component for GRI-FILL 3.0 pharmacy compounding system.

Indications for Use

Indicated for use by trained healthcare personnel in hospital pharmacies as a fluid pathway for compounding or mixing multi-ingredient solutions into a final IV container or syringe using the GRI-FILL 3.0 pharmacy compounder. Contraindicated for use with lipids. Restricted to sale by or on the order of a physician.

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

• SETS GRI-FILL 2.0 1WAY / 2WAY / LUER (K033682)
• FLEBOSET MULTIPLE (K040456)

Submission Summary (Full Text)

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# K454339 (P. 10f 3)

#### TECHNICAL EVALUATION # Document CRIFOLS TED-SETS GRI-FIL DOCUMENTATION SECTION 1 - SETS GRI-FILL 3.0: 510(k) SUM

| DATE OF SUBMISSION: | 2004-11-30 |
|----------------------|-------------------------------------------------------------------------------|
| SUBMITTER NAME: | Laboratorios Grifols, S.A. |
| SUBMITTER ADDRESS: | C/ Can Guasch, 2<br>08150 PARETS DEL VALLES<br>BARCELONA<br>SPAIN |
| TELEPHONE: | + 34 93 571 01 00 |
| FAX: | + 34 93 573 09 12 |
| e-mail: | [e-mail] |
| CONTACT: | Sebastian Gascón<br>Technical Director |
| DEVICE TRADE NAME: | SETS GRI-FILL 3.0 |
| COMMON NAME: | I.V. FLUID TRANSFER SETS |
| CLASSIFICATION NAME: | I.V. FLUID TRANSFER SETS (21 CFR 880.5440) |
| PREDICATE DEVICE: | SETS GRI-FILL 2.0 1WAY / 2WAY / LUER (K033682)<br>FLEBOSET MULTIPLE (K040456) |

#### DEVICE DESCRIPTION:

SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1WAY / 2WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1WAY / 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

#### INTENDED USE:

SETS GRI-FILL 3.0 1 WAY and 2 WAYS are disposable components of the GRI-FILL 3.0 pharmacy compounding system used to provide a fluid pathway through which one or two source substances are channeled to an IV container or syringe. SETS GRI-FILL 3.0 MULTIPLE are ancillary devices connected to SETS GRI-FILL 3.0 1 WAY or 2 WAYS used to provide a fluid pathway through which the same substance in up to 6 source containers may be delivered into a final IV container. The device is NOT intended to be connected directly to the patient.

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# KAS4339 (P.2 aP3)

#### TECHNICAL EVALUATION # Document; GRIFOLS TED-SETS GRI-FILL 3.0-01 DOCUMENTATION SECTION 1 -- SETS GRI-FILL 3.0: 510(k) SUMMARY

#### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, SETS GRI-FILL 3.0 are compared with other transfer sets used in pharmacy compounding.

The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.

| # | Characteristic /<br>Feature | PROPOSED DEVICE | PREDICATE DEVICES | |
|----|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | SETS GRI-FILL 3.0 | SETS GRI-FILL 2.0 | FLEBOSET<br>MULTIPLE |
| 1 | Intended use<br>Claims | SETS GRI-FILL 3.0 1 WAY<br>and 2 WAYS are disposable<br>components of the GRI-FILL<br>3.0 pharmacy compounding<br>system used to provide a fluid<br>pathway through which one<br>or two source substances are<br>channeled to an IV container<br>or syringe. SETS GRI-FILL<br>3.0 MULTIPLE are ancillary<br>devices connected to SETS<br>GRI-FILL 3.0 1 WAY or 2<br>WAYS used to provide a fluid<br>pathway through which the<br>same substance in up to 6<br>source containers may be<br>delivered into a final IV<br>container. The device is NOT<br>intended to be connected<br>directly to the patient. | SETS GRI-FILL 2.0 are<br>disposable components of the<br>GRI-FILL 2.0 pharmacy<br>compounding system used to<br>provide a fluid pathway<br>through which 1 or more<br>source solutions are delivered<br>into a single final solution.<br>The device is NOT intended<br>to be connected directly to<br>the patient. | FLEBOSET MULTIPLE is<br>an ancillary device used as<br>fluid pathway through<br>which substances from 6<br>glass source flasks<br>containing the same<br>solution may be<br>continuously delivered for:<br>(a) Pharmacy<br>compounding, when used<br>in conjunction with the<br>GRI-FILL 2.0 pharmacy<br>compounding device and<br>associated transfer sets,<br>and<br>(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<br>set.<br>The device should not be<br>used with lipids. |
| 2. | Technological<br>features: | | | |
| | -<br>Sterilization<br>- Direct<br>- patient<br>hook-up | Ethylene Oxide<br>NO | Ethylene Oxide<br>NO | 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. |
| | - Source | 1(1WAY Set) 2(2WAY Set) | 1 (1WAYSet) or 2 (2WAY | 6 |

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## TECHNICAL EVALUATION GRIFOLS DOCUMENTATION . ECTION 1 - SETS GRI-FILL 3.0: 510(k) SU

| # | Characteristic /<br>Feature | PROPOSED DEVICE | PREDICATE DEVICES | |
|----|-----------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------|------------------------------|
| | | SETS GRI-FILL 3.0 | SETS GRI-FILL 2.0 | FLEBOSET<br>MULTIPLE |
| | containers | up to 6 with MULTIPLE<br>ancillary device. | Set) | |
| 3. | Main Transfer Set<br>Material | PVC with DEHP<br>plasticizer | PVC with DEHP<br>plasticizer | PVC with DEHP<br>plasticizer |
| 4. | Physical, Mechanical<br>and Biological<br>Specifications | Sterile / Non pyrogenic | Sterile / Non pyrogenic | Sterile / Non<br>pyrogenic |
| 5. | Closed system (fluid<br>not in contact with<br>any resusable part of<br>the compounding<br>device). | YES | YES | YES |
| 6. | Integrated waste<br>container | YES | NO | NO |

From the above table, it can be established that the new device and the predicate devices are very similar. In fact, the proposed device is a newer version of the SETS GRI-FILL 2.0. As a new feature, the proposed SETS GRI-FILL 3.0 incorporate a waste bag as a permanently attached COMPONENT. The 3.0 version has been designed specifically to be used in conjunction with the GRI-FILL 3.0 pharmacy compounder which also allows the addition of a determined amount of solution to a pre-filled container as well as the reconstitution of powder drugs previous to their being used in subsequent pharmacy compounding

### SUMMARY DISCUSSION OF NON-CLINICAL DATA:

All materials used in the construction of SETS GRI-FILL 3.0 have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use as a parenteral drug solution fluid pathway.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:

- accurate delivery of specified source solutions under normal conditions and stress conditions
- fluid / air leakage checking -

#### CONCLUSIONS:

We believe the intended use, the indications for use, the functionality and the operation of both SETS GRI-FILL 3.0 and the predicate devices for fluid transfer in pharmacy compounding are essentially the same. Hence, substantial equivalence in pharmacy contpolining allering allering marketed device may be established.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laboratorios Grifols, S.A. C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 1655 Scott Boulevard Santa Clara, California 95050-4169

Re: K050339

Trade/Device Name: Sets Gri-Fill 3.0 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: February 10, 2005 Received: February 11, 2005

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becales as a section is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use batter to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to de views martic Act (Act) that do not require approval of a premarket the Federal I ood, Drug, and Ocomette , therefore, market the device, subject to the general approvincianon (Included to the general controls provisions of the Act include condivis provisions of the rion i 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 If your device to subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the evas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Christensen

Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticase be auvrisod that 1 DTF o lection of that your device complies with other requirements mean that I Drima mass statutes and regulations administered by other Federal agencies. or the Act of ally I oderal blance and by sequirements, including, but not limited to: registration 1 ou intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 CF rear 807), aquality systems (QS) regulation (21 CFR Part 820); and if requirements us sectionic 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) This retter wifi and in your finding of substantial equivalence of your device to a premarket notification. - The PDF 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), 11 you desire specific at no 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 may other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

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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## Indications for Use

510(k) Number (if known): _ LOSU33 S

Device Name: SETS GRI-FILL 3.0

Indications for Use:

SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in SETS OFF I the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to confulletion will the Orthway through which one or two source substances are delivered into a final IV container or syringe.

SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated 1 WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.

This 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 the order of a physician.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Kunn

Frion Sign-Off) Invision of Anesthesiology, General Hospital, Infection Control, Dental Devices

长45.033 110(k) Number ._______________________________________________________________________________________________________________________________________________________________

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