GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML

K031419 · Laboratorios Grifols, S.A. · KPE · Nov 24, 2003 · General Hospital

Device Facts

• Record ID: K031419
• Device Name: GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
• Applicant: Laboratorios Grifols, S.A.
• Product Code: KPE · General Hospital
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

GRI-FLEX is a bag with an incorporated 0.2 µm filter for the removal of undesired particulate or microbial matter intended for use as a container in the preparation of drug solutions with the GRI- FILL system.

Device Story

GRI-FLEX is a single-use, sterile, flexible I.V. container with an integrated 0.2 µm polyethersulphone filter. Used in pharmacy settings with the GRI-FILL system for drug solution preparation; the device acts as a container for drug admixtures. The integrated filter removes undesired particulate or microbial matter from the solution. After preparation, the bag is connected to an I.V. administration set for patient infusion. Operated by trained healthcare personnel. The device benefits patients by reducing the risk of administering inadvertent contaminants, including bacteria and particulates, during intravenous therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and ISO DIS 15747. Functional testing conducted per ISO DIS 15747, USP <661>, ISO 8536-4, and ASTM F838-83 to verify correct operation of the bag and filter components.

Technological Characteristics

Flexible I.V. container with integrated 0.2 µm polyethersulphone filter membrane in a polypropylene housing. Available in 100 ml, 250 ml, 500 ml, and 1000 ml volumes. Single-use; sterile (SAL 10⁻⁶) via ETO. Complies with ISO 10993, ISO DIS 15747, ISO 8536-4, ASTM F838-83, and USP <661>.

Indications for Use

Indicated for use by trained healthcare personnel as a flexible I.V. container with an integrated 0.2 µm filter to remove particulate or microbial matter during the preparation of drug solutions using the GRI-FILL system. Restricted to prescription use only.

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Predicate Devices

• VIAFLEX PLASTIC CONTAINER (BAXTER)
• PALL SUPOR AEF

Submission Summary (Full Text)

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K031419

න් පිහිටු පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පි

NOV 2 4 2003

:

| GRIFOLS | | TECHNICAL EVALUATION DOCUMENTATION | # Document: | TED-GRIFLEX-01 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------|----------------|
| | | SECTION 1 - GRI-FLEX: 510(k) SUMMARY | | |
| DATE OF SUBMISSION: | 2003-02-03 | | | |
| SUBMITTER NAME: | Laboratorios Grifols, S.A. | | | |
| SUBMITTER ADDRESS: | C/ Can Guasch, 2 08150 PARETS DEL VALLES BARCELONA SPAIN | | | |
| TELEPHONE: | + 34 93 571 01 00 | | | |
| FAX: | + 34 93 573 09 12 | | | |
| e-mail: | [e-mail] | | | |
| CONTACT: | Sebastián Gascón Technical Director | | | |
| DEVICE TRADE NAME: | GRI-FLEX | | | |
| COMMON NAME: | I.V. BAG with in-line 0.2µm filter | | | |
| CLASSIFICATION NAME: | I.V. CONTAINER (880.5025 KPE and 880.5440, NEP) with in line filter (880.5440, FPB) | | | |
| PREDICATE DEVICE: | (BAG) VIAFLEX PLASTIC CONTAINER (BAXTER) (FILTER) PALL SUPOR AEF | | | |
| DEVICE DESCRIPTION: | GRI-FLEX is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µm filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 rıl. | | | |
| INTENDED USE: | GRI-FLEX is a bag with an incorporated 0.2 µm filter for the removal of undesired particulate or microbial matter intended for use as a container in the preparation of drug solutions with the GRI- FILL system. | | | |

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## SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, the GRI-FLEX device is compared with 2 predicate devices (bag + filter) due to the fact that it is essentially a combination of these 2 devices marketed as a single unit.

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

| # | Characteristic / Feature | GRI-FLEX | PREDICATE | |
|----|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | BAG | FILTER |
| 1. | Filter membrane | Polyethersulphone | N/A | Polyethersulphone |
| 2. | Filter pore | 0.2μm | N/A | 0.2μm |
| 3. | Filter housing | Polypropylene | N/A | Polypropylene |
| 4. | Sterility | SAL 10⁻⁶ ETO | SAL<br>Gamma | SAL 10⁻⁶ ETO |
| 5. | Single-use | YES | YES | YES |
| 6. | Intended use | Bag, with an<br>incorporated 0.2 μm<br>filter for the removal<br>of undesired drug<br>particulate or<br>microbial matter,<br>intended for use as<br>a container in the<br>preparation of drug<br>solutions with the<br>GRI-FILL system. | Bag intended to<br>be used in the<br>preparation of<br>drug admixtures<br>available in sizes<br>from 50 ml - 400<br>ml. | Removal by in-line<br>filtration of<br>inadvertent<br>contaminants<br>(including bacteria,<br>particulates, and<br>entrained air) from<br>infused intravenous<br>fluids. |

The principal differences between the GRI-FLEX device and the predicate devices lie with the fact that the material used for the bag is different and also, the predicate devices are marketed separately whereas the GRI-FLEX is presented as an integral unit combining the two.

## SUMMARY DISCUSSION OF NON-CLINICAL DATA:

According to the biocompatibility test data available for all materials and the biological testing performed on the final product, we have established that the GRI-FLEX device fulfills the requirements set out in ISO 10993 and ISO DIS 15747.

Functional testing performed in accordance with applicable clauses of ISO DIS 15747 and USP <661> (for the bag component) and ISO 8536-4 and ASTM F838-83 (for the filter component) shows correct operation of the device as per its intended use.

2

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## CONCLUSIONS:

We believe the intended use, the indications for use and the design for both GRI-FLEX and the combination of predicate devices are essentially the same. Moreover, the construction materials, although different, are of comparable safety and, hence,
substantial equivalence of GRI-FLEX 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2003

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

Re: K031419

Trade/Device Name: GRI-FLEX Regulation Number: 880.5025, 880.5440 Regulation Name: I.V. Container, Intravascular Administration Set Regulatory Class: II Product Code: KPE, NEP, FPB Dated: November 12, 2003 Received: November 13, 2003

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 affecting 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,

Qurfs

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

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## # Documint TECHNICAL EVALUATION GRIFOLS TED-GRIFLEX-09 DOCUMENTATION SECTION 09 - GRI-FLEX: INDICATIONS FOR USE STATEMENT

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (as required by ODE for all 510(k) received after Jan. 1, 1996)

510(k) Number:

Device Name:

GRI-FLEX

Indications for Use:

All models of GRI-FLEX are flexible I.V. bags, with incorporated 0.2 um filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by cor necting the bag to an I.V. administration set. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physicis n.

(Do not write below this line. Continue on another page in needed) Concurrence od CDRH, Office of Device Eval ration (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Pulitzer Crescent

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K031419

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