K Number

Device Name

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

Manufacturer

LABORATORIOS GRIFOLS, S.A.

Date Cleared

2003-11-24

(203 days)

Product Code

KPE FPB NEP

Regulation Number

880.5025

Intended 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 connecting 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 physician.

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 ml.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a flexible I.V. bag with a filter, a purely physical device for containing drug solutions. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.

Therapeutic

No.
The device is described as an "empty container" used for the "preparation of drug solutions" and later connected to an "I.V. administration set" for patient administration. It does not directly provide therapy but rather serves as a container for administering therapeutic agents.

Diagnostic

Explanation: The GRI-FLEX device is described as an I.V. bag with an incorporated filter for preparing drug solutions, and its function involves containing and filtering drug solutions for administration to a patient. There is no mention of it being used to diagnose conditions or process diagnostic data.

SaMD (Software as a Medical Device)

The device description clearly states it is a flexible I.V. bag with an incorporated filter, which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a container for preparing drug solutions that are later administered to the patient. This is a direct interaction with the patient's body (intravenous administration), not an in vitro test performed on a sample taken from the body.
Device Description: The description reinforces that it's an empty container with a filter for preparing solutions for administration.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the preparation and administration of medication, which falls outside the scope of IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

KPE, NEP, FPB

Device Description

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

trained health-care personnel

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

(BAG) VIAFLEX PLASTIC CONTAINER (BAXTER), (FILTER) PALL SUPOR AEF

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Regulation Number and Section

§ 880.5025 I.V. container.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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
		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:	sebastian.gascon@grifols.com
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.

Page 18 of 32

KO3/419

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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
Gamma	SAL 10⁻⁶ ETO
5.	Single-use	YES	YES	YES
6.	Intended use	Bag, with an
incorporated 0.2 μm
filter for the removal
of undesired drug
particulate or
microbial matter,
intended for use as
a container in the
preparation of drug
solutions with the
GRI-FILL system.	Bag intended to
be used in the
preparation of
drug admixtures
available in sizes
from 50 ml - 400
ml.	Removal by in-line
filtration of
inadvertent
contaminants
(including bacteria,
particulates, and
entrained air) from
infused intravenous
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 (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.

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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.

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.

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

# 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)

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

Page 17 of 32