All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospites in hospites for a macy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician.

Device Description

SETS GRI-FILL 2.0 are fluid transfer sets for use with the GRI-FILL 2.0 pharmacy compounding device in order tc compound or mix different multi-ingredient solutions and to channel them into a final suitable container. The set is a disposable component of the compounding device made up of a syringe, a distributor and tubing to channel the fluid. Sets are available for 1 or 2 source solutions. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The model Luer Connection Tube can be joined to the 1 way or 2 ways sets as prolongation for connection to source solution containers with luer terminals.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SETS GRI-FILL 2.0 based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Intended Use	Disposable component of the GRI-FILL 2.0 pharmacy compounding system to provide a fluid pathway for 1+ source solutions into a single final solution. Not for direct patient connection.
Technological Features:
- Sterilization Method	Ethylene Oxide
- Direct Patient Hook-up	NO
- Number of Source Solutions	2 (Sets available for 1 or 2 source solutions)
Main Transfer Materials	PVC with DEHP plasticizer
Physical, Mechanical, Biological Specs	Sterile / Non-pyrogenic
Closed System	YES (fluid not in contact with any reusable part of the compounding device)
Chemical and Biological Testing	All materials used were subject to chemical and biological testing in accordance with applicable requirements for a parenteral drug solution transfer set.
Functional Laboratory Testing	Showed correct operation of the device as per its intended use:
- Accurate Delivery	Accurate delivery of specified source solutions under normal and stress conditions.
- Fluid / Air Leakage	Fluid / air leakage checking performed.

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

The document does not explicitly state a specific "sample size" for the test set in terms of number of devices or number of tests conducted for each functional parameter. It broadly mentions "Functional laboratory testing performed in foreseeable operating conditions." The data provenance is not explicitly mentioned as country of origin, but the submission is from Laboratorios Grifols, S.A. in Spain. The study appears to be prospective as it's a submission for premarket notification, indicating the tests were conducted for the purpose of demonstrating substantial equivalence.

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

The document does not mention the use of experts to establish ground truth for a "test set" in the context of clinical or diagnostic performance. The evaluation is focused on the device's functional integrity and material compatibility, which would typically be assessed through engineering and laboratory testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an I.V. fluid transfer set, and its evaluation focuses on functional and material equivalence, not diagnostic or clinical accuracy requiring human interpretation of cases.

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

Yes, the evaluation described is essentially a standalone (algorithm only, if "algorithm" refers to the device's inherent design and function) performance assessment. The device itself performs the function of fluid transfer, and its performance was evaluated in this standalone capacity through laboratory functional testing. There is no human-in-the-loop component in the performance of the device itself (though human operators operate the compounding device with which it is used).

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on engineering specifications, material compatibility standards (chemical and biological testing), and functional performance criteria (e.g., accurate fluid delivery, no leakage). It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as the device's function is mechanical fluid transfer.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device with a "training set." The evaluation is based on the physical and functional properties of the manufactured device.

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

Not applicable, as there is no training set for this device.

Summary

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K033682

DEC 1 7 2003

Attachment la Page 2 of 6 Revised: 7/1/96

12 2017 10:30 10 10 10 10 1 REELL 2.0: 510(K)

DATE OF SUBMISSION:

SUBMITTER NAME: SUBMITTER ADDRESS: 2003-07-30

Laboratorios Grifols, S.A. C/ Can Guasch, 2 08150 PARETS DEL VALLES BARCELONA SPAIN

TELEPHONE: FAX: e-mail:

sebastian.gascon@grifols.com Sebastian Gascón

34 93 571 01 00
34 93 573 09 12

Technical Director

SETS GRI-FILL 2.0

I.V. FLUID TRANSFER SETS

CONTACT:

DEVICE TRADE NAME: COMMON NAME: CLASSIFICATION NAME:

PREDICATE DEVICE:

DEVICE DESCRIPTION:

I.V. FLUID TRANSFER SETS (21 CFR 880.5440)

Exacta-Mix 2400 Compounding System Administration Set (BAXA) Automix 3+3 Compounder Transfer Set (BAXTER HEALTHCARE)

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Image /page/1/Picture/1 description: The image shows a document with the title "TECHNICAL EVALUATION DOCUMENTATION" and the logo "GRIFOLS" on the left side. On the right side, it says "Document: TED-SETS GRI-FILL 2.0-01". The bottom of the document says "SECTION 1 - SETS GRI-FILL 2.0: 510(k) SUMMARY".

INTENDED USE:

SETS GRI-FILL 2.0 are disposable components of the GRI-FILL 2.0 pharmacy compounding system used to provide a fluid pathway through which 1 or more source solutions are delivered into a single final solution. The device is NOT intended to be connected directly to the patient.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, SETS GRI-FILL 2.0 are compared with other transfer sets used in pharmacy compounding.

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

#	Characteristic /Feature	SETS GRI-FILL	PREDICATES
			BAXAExacta-Mix Set	BAXTERAutomix 3+3(set presentedtogether withcompounder)
1.	Intended use / Claims	SETS GR-FILL 2.0 aredisposable components ofthe GRI-FILL 2.0 pharmacycompounding system usedto provice a fluid pathwaythrough which 1 or moresource solutions aredelivered into a single finalsolution. The device is NOTIntended to be connecteddirectly to the patient	Exacta-Mix 2400Compounding SystemAdministration set is adisposable component of acompounding device used inthe pharmacy to compoundmultiple source ingrediensinto one final solution. Thisdevice is not intended fordirect patient hook-up.	Positive displacementfluid compoundingsystem employing the3+3 compounder,TRANSFER SETS,empty Viafex orTravamulsioncontainers and multitaskcomputer software toprovide compounding ofa wide var ety of fuids
2.	Technological features:- Sterilization- Direct patienthook-up- Sourcesolutions	Ethylene OxideNO2	Ethylene OxideNOMultiple	RadiationNO6
3.	Main TransferMaterials	Set PVC with DEHPplasticizer	PVC	PVC with DEHPplasticizer
4.	Physical, Mechanicaland BiologicalSpecifications	Sterile / Non pyrogenic	Sterile / Non pyrogenic	Sterile / Nonpyrogenic
5.	Closed system (fluid notin contact with anyresusable part of thecompounding device).	YES	YES	YES

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Image /page/2/Figure/1 description: The image shows a document with the title "TECHNICAL EVALUATION DOCUMENTATION" and the logo "GRIFOLS" on the left side. On the right side, it says "# Document: TED-SETS GRI-FILL 2.0-01". The bottom of the image says "SECTION 1 - SETS GRI-FILL 2.0: 510(k) SUMMARY".

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 SETS GRI-FILL 2.0 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 transfer set.

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 2.0 and the predicate devices for fluid transfer in pharmacy compounding are essentially the same. Hence, substantial equivalence of SETS GRI-FILL 2.0 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 in profile, composed of three curved lines that suggest a head, body, and legs. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle, with the department's name at the top and "USA" at the bottom.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2003

Laboratories Grifols, S.A. Ms. Susan Gill Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709-3995

Re: K033682

Trade/Device Name: Set GRI-FILL 2.0-1 way 2.0-2 ways . Luer Connection Tube Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI, NEP Dated: December 11, 2003 Received: December 12, 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) 594-14618. 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,

Cloris

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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GRIFOLS
TECHNICAL EVALUATION
DOCUMENTATION

Document:

TED-SETS GRI-FILL 2.0-09
SECTION 09 – SETS GRI-FILL 2.0: 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:

SETS GRI-FILL 2.0

Indications for Use:

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)

Patrizia Cucorete

(Division Sign-Off) Division of Anesthesiology, General nospilal Infection Control, Dental Devices

510(k) Number: N033682

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.