GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML by LABORATORIOS GRIFOLS, S.A.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GRI-FLEX device:

Important Note: The provided document is a 510(k) summary for a medical device. These summaries primarily focus on demonstrating substantial equivalence to existing predicate devices, rather than comprehensive standalone performance studies that would typically be conducted for a novel device or to establish specific performance metrics against clinical endpoints. Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC studies, ground truth for training data) are not typically detailed in these types of submissions because the study design is geared towards showing equivalence based on known performance of the predicate.

Acceptance Criteria and Device Performance for GRI-FLEX

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device demonstrating substantial equivalence to predicates, the "acceptance criteria" are primarily based on meeting the established performance characteristics and safety profiles of the predicate devices. The study conducted is a non-clinical evaluation to demonstrate these equivalences.

Characteristic / Feature	Acceptance Criteria (Implied by Predicate Performance)	Reported GRI-FLEX Performance
Filter membrane	Polyethersulphone (matching predicate filter)	Polyethersulphone
Filter pore size	0.2µm (matching predicate filter)	0.2µm
Filter housing	Polypropylene (matching predicate filter)	Polypropylene
Sterility	SAL 10⁻⁶ (matching predicate filter)	SAL 10⁻⁶ ETO (Ethylene Oxide sterilization)
Single-use	Yes (matching both predicates)	Yes
Intended Use	Comparable to predicate bag + filter	Bag with incorporated 0.2µm filter for removal of particulate/microbial matter in drug solution preparation with GRI-FILL system.
Biocompatibility	Fulfillment of ISO 10993 and ISO DIS 15747 (implied)	Fulfills ISO 10993 and ISO DIS 15747
Functional Testing	Correct operation per intended use (implied)	Shows correct operation per intended use based on ISO DIS 15747, USP <661>, ISO 8536-4, ASTM F838-83.

Study That Proves the Device Meets the Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a "Summary Discussion of Non-Clinical Data." This involves a series of tests to demonstrate material compatibility, sterility, and functional performance, benchmarking against relevant international standards and the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided text. For non-clinical functional and biological testing of a device like this, sample sizes would typically be determined by statistical methods or regulatory standards for engineering tests, but are not specified here.
Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM), implying that the data was generated specifically for this device submission within a controlled testing environment, likely by the manufacturer (Laboratorios Grifols, S.A.) or a contracted testing laboratory. The country of origin for the data is not explicitly stated, but the manufacturer is based in Spain. The data is prospective in that it was generated for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided in the document. For non-clinical device performance and safety testing, "ground truth" is established by adherence to physical, chemical, and biological testing standards and specifications, not by expert human interpretation in the way it would be for diagnostic imaging or clinical studies.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies for human interpretation of data where there might be disagreement (e.g., radiologists reviewing images). This document describes non-clinical engineering and biological tests which do not involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical studies evaluating human reader performance for diagnostic devices, often with and without AI assistance. This submission focuses on the non-clinical performance and safety of a medical container with an integrated filter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical component (an IV bag with a filter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The functional tests performed (e.g., filter efficacy, material integrity) are analogous to "standalone" performance for a physical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's non-clinical evaluation is based on:

Reference Standards and Specifications: Adherence to established international standards (ISO 10993 for biocompatibility, ISO DIS 15747, USP <661>, ISO 8536-4, ASTM F838-83 for functional performance).
Predicate Device Performance: The characteristics and demonstrated safety/efficacy of the legally marketed predicate devices (VIAFLEX PLASTIC CONTAINER and PALL SUPOR AEF filter).
Material Science and Engineering Principles: Ensuring materials meet appropriate properties and the device design functions as intended.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this type of device submission.

Summary

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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
		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

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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	SALGamma	SAL 10⁻⁶ ETO
5.	Single-use	YES	YES	YES
6.	Intended use	Bag, with anincorporated 0.2 μmfilter for the removalof undesired drugparticulate ormicrobial matter,intended for use asa container in thepreparation of drugsolutions with theGRI-FILL system.	Bag intended tobe used in thepreparation ofdrug admixturesavailable in sizesfrom 50 ml - 400ml.	Removal by in-linefiltration ofinadvertentcontaminants(including bacteria,particulates, andentrained air) frominfused intravenousfluids.

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.

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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 (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

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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)

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

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).