SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SETS GRI-FILL 3.0 device:

Acceptance Criteria and Device Performance Study for SETS GRI-FILL 3.0

The provided text focuses on establishing substantial equivalence for the SETS GRI-FILL 3.0 with predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel medical diagnostic algorithm. The information pertains to fluid transfer sets used in pharmacy compounding.

Based on the document, the "acceptance criteria" can be inferred from the comparison with predicate devices and the functional testing performed. The device's "performance" is reported qualitatively as demonstrating "correct operation" and meeting "applicable requirements."

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (fluid transfer sets) and the documentation provided (510(k) summary for substantial equivalence), the "acceptance criteria" are primarily related to functional and material specifications that ensure safe and effective fluid transfer, consistent with predicate devices.

Acceptance Criteria (Inferred from comparison & testing)	Reported Device Performance (SETS GRI-FILL 3.0)
Sterile / Non-pyrogenic	Sterile / Non-pyrogenic
Materials: PVC with DEHP plasticizer	PVC with DEHP plasticizer (matches predicate)
Number of Source Containers for 1WAY/2WAY	1 (1WAY Set), 2 (2WAY Set)
Number of Source Containers with MULTIPLE ancillary device	Up to 6
Functionality as a closed system (fluid not in contact with reusable parts)	YES (matches predicate)
Prevention of direct patient hook-up	NO (matches predicate)
Accurate delivery of specified source solutions	Correct operation demonstrated under normal and stress conditions
Fluid / air leakage checking	Correct operation demonstrated (implies passing leakage checks)
Chemical and biological compatibility of materials	Materials subjected to chemical and biological testing in accordance with applicable requirements
Ethylene Oxide Sterilization	Ethylene Oxide (matches predicate)

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

The document does not detail a specific "test set" in the context of a typical AI/algorithm study (e.g., patient data). The testing described is functional laboratory testing of the device itself.

Sample Size: Not specified in terms of number of devices or number of test runs, but it's implied that sufficient testing was done to ensure "correct operation."
Data Provenance: The "study" (functional laboratory testing) was conducted by Laboratorios Grifols, S.A. (Spain). The data is retrospective in the sense that the results are being presented after the tests were concluded.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. The ground truth for this type of device (fluid transfer set) is established through engineering and functional testing against predefined specifications and industry standards, not expert consensus on diagnostic images or clinical outcomes.
Qualifications of Experts: N/A. The "experts" would be the engineers and technicians involved in the design, manufacturing, and testing of the device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the traditional sense of clinical studies requiring expert review. The "adjudication" is inherent in the laboratory testing, where results are compared against pre-defined engineering and performance specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This device is not an AI diagnostic tool that would typically involve human readers.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Standalone Study Done: Yes, in the sense that the device's functional performance was evaluated independently without human intervention during the fluid transfer process itself (though humans operate the compounding system). The "algorithm" here is the physical design and manufacturing of the transfer set, and its performance was assessed directly.

7. Type of Ground Truth Used

Type of Ground Truth: Engineering specifications and performance standards. The device's functionality (accurate fluid delivery, no leakage, sterility, material compatibility) serves as its own "ground truth" when tested against these established criteria.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI or machine learning algorithm. There is no "training set" in the context of developing an intelligent system. The design and manufacturing process would involve iterative testing, but not a formal "training set" as understood in AI.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, and the intended function of a fluid transfer system in pharmacy compounding.

Summary

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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, 208150 PARETS DEL VALLESBARCELONASPAIN
TELEPHONE:	+ 34 93 571 01 00
FAX:	+ 34 93 573 09 12
e-mail:	sebastian.gascon@grifols.com
CONTACT:	Sebastian GascónTechnical 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)FLEBOSET MULTIPLE (K040456)

DEVICE DESCRIPTION:

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 /Feature	PROPOSED DEVICE	PREDICATE DEVICES
		SETS GRI-FILL 3.0	SETS GRI-FILL 2.0	FLEBOSETMULTIPLE
1	Intended useClaims	SETS GRI-FILL 3.0 1 WAYand 2 WAYS are disposablecomponents of the GRI-FILL3.0 pharmacy compoundingsystem used to provide a fluidpathway through which oneor two source substances arechanneled to an IV containeror syringe. SETS GRI-FILL3.0 MULTIPLE are ancillarydevices connected to SETSGRI-FILL 3.0 1 WAY or 2WAYS used to provide a fluidpathway through which thesame substance in up to 6source containers may bedelivered into a final IVcontainer. The device is NOTintended to be connecteddirectly to the patient.	SETS GRI-FILL 2.0 aredisposable components of theGRI-FILL 2.0 pharmacycompounding system used toprovide a fluid pathwaythrough which 1 or moresource solutions are deliveredinto a single final solution.The device is NOT intendedto be connected directly tothe patient.	FLEBOSET MULTIPLE isan ancillary device used asfluid pathway throughwhich substances from 6glass source flaskscontaining the samesolution may becontinuously delivered for:(a) Pharmacycompounding, when usedin conjunction with theGRI-FILL 2.0 pharmacycompounding device andassociated transfer sets,and(b) I.V. administration,when used in conjunctionwith a gravity or pumpinfusion set to channel thesolution from the sourcecontainers to the infusionset.The device should not beused with lipids.
2.	Technologicalfeatures:
	-Sterilization- Direct- patienthook-up	Ethylene OxideNO	Ethylene OxideNO	Ethylene OxideNO - Intended for usewith the pharmacycompounding device orINDIRECT - May be usedon-line with patient,upstream of the gravity orpump 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 /Feature	PROPOSED DEVICE	PREDICATE DEVICES
		SETS GRI-FILL 3.0	SETS GRI-FILL 2.0	FLEBOSETMULTIPLE
	containers	up to 6 with MULTIPLEancillary device.	Set)
3.	Main Transfer SetMaterial	PVC with DEHPplasticizer	PVC with DEHPplasticizer	PVC with DEHPplasticizer
4.	Physical, Mechanicaland BiologicalSpecifications	Sterile / Non pyrogenic	Sterile / Non pyrogenic	Sterile / Nonpyrogenic
5.	Closed system (fluidnot in contact withany resusable part ofthe compoundingdevice).	YES	YES	YES
6.	Integrated wastecontainer	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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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.

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 ._______________________________________________________________________________________________________________________________________________________________

Page 1 of 1 -

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.