FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:

(a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
(b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.
The 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 order of a physician.

Device Description

FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for I.V. fluid transfer to minimize tubing manipulation when working with small volume source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an individual clamp. The set terminal, for connection to pharmacy compounding device sets or the administration sets (gravity or pump) consists of a spikeable twist-off valve connector.

AI/ML Overview

This firm did not perform a clinical study to prove substantial equivalence. Instead, they relied on non-clinical data. They compared the technological characteristics of their device (FLEBOSET MULTIPLE) to three predicate devices that are already legally marketed. All materials used in the construction of FLEBOSET MULTIPLE were subject to chemical and biological testing in accordance with applicable requirements, taking into account its intended use, and functional laboratory testing was performed in foreseeable operating conditions that showed correct operation of the device as per its intended use.

Here's the information requested based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative or measurable format typical for device performance metrics. Instead, the demonstration of equivalence is based on the device's characteristics being "very similar" to existing predicate devices and having passed chemical, biological, and functional laboratory testing. The "reported device performance" is described qualitatively.

Characteristic / Feature	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (FLEBOSET MULTIPLE)
Intended Use / Claims	Comparable to predicate devices for pharmacy compounding and I.V. administration (excluding lipids).	An ancillary device used as a fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for: (a) Pharmacy compounding (with GRI-FILL 2.0) and (b) I.V. administration (with gravity or pump infusion set). Not for use with lipids.
Sterilization	One of the methods used by predicate devices (Radiation, Ethylene Oxide).	Ethylene Oxide
Contact with Patient	Similar to predicate devices (No direct patient contact, or indirect online use).	NO - Intended for use with the pharmacy compounding device OR INDIRECT - May be used on-line with patient, upstream of the gravity or pump administration sets.
Source Solutions	Ability to handle a number of source solutions from predicate devices (1, 2, 3, or 6).	6
Principle Materials	Similar to materials used in predicate devices (e.g., PVC).	PVC with DEHP plasticizer
Sterility	Sterile	Sterile
Chemical & Biological Safety	Applicable requirements for intended use met.	All materials used in the construction of FLEBOSET MULTIPLE have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use.
Functional Operation	Correct operation in foreseeable operating conditions.	Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable. No clinical test set data is described. The evaluation was based on non-clinical (laboratory and materials) testing and comparison to predicate devices.
Data provenance: Not applicable for a test set. The non-clinical data would originate from the manufacturer's internal laboratory testing. The document does not specify a country of origin for this testing data, only the submitter's address is Spain.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth for a clinical test set was established as no clinical study was performed.

4. Adjudication method for the test set

Not applicable. No clinical test set and thus no adjudication method were used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for fluid transfer, not an AI-based diagnostic or imaging device. No MRMC study was conducted.

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

Not applicable. This is a medical device for fluid transfer, not an algorithm.

7. The type of ground truth used

Not applicable for a clinical ground truth. The "ground truth" equivalent in this submission is the established performance and safety profiles of the predicate devices and the results of laboratory-based chemical, biological, and functional testing.

8. The sample size for the training set

Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device.

Summary

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K040456

3/9/04

TECHNICAL EVALUATION DOCUMENTATION multiple-01 GRIFOLS SECTION 1 - FLEBOSET MULTIPLE: 510(k) SUMMARY

: 上一

DATE OF SUBMISSION:	2004-02-06
SUBMITTER NAME:SUBMITTER ADDRESS:	Laboratorios Grifols, S.A.C/ Can Guasch, 208150 PARETS DEL VALLESBARCELONASPAIN
TELEPHONE:FAX:e-mail:	+ 34 93 571 01 00+ 34 93 573 09 12sebastian.gascon@grifols.com
CONTACT:	Sebastián GascónTechnical Director
DEVICE TRADE NAME:COMMON NAME:	FLEBOSET MULTIPLEI.V. FLUID TRANSFER SETSFLUID DELIVERY TUBING
CLASSIFICATION NAME:	SET, I.V. FLUID TRANSFER (21 CFR 880.5440, LHI)TUBING. FLUID DELIVERY (21 CFR 880.5440, FPK)
PREDICATE DEVICE:	Automix 3+3 Compounder Transfer Set (BAXTERHEALTHCARE CORP.)Medrad Transfer Set (MEDRAD INC.)Merit Medical Contrast ManagementSystem(MERIT MEDICAL SYSTEMS, INC.)
DEVICE DESCRIPTION:	FLEBOSET MULTIPLE is a fluid transfer tubing setused to enable continuous (uninterrupted) deliveryof drug solutions from 6 glass source containers. Itis used in pharmacy compounding or for I.V. fluidtransfer to minimize tubing manipulation whenworking with small volume source containers. Thedevice is made up of 6 spikes connected in serieswith flexible tubing segments, each segment with anindividual clamp. The set terminal, for connection topharmacy compounding device sets ortheadministration sets (gravity or pump) consists of aspikeable twist-off valve connector.

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Image /page/1/Picture/0 description: The image is a document header with the word GRIFOLS on the left side. The header also contains the words TECHNICAL EVALUATION DOCUMENTATION. The document number is TED-FLEBOSET MULTIPLE-01. The section is titled SECTION 1 - FLEBOSET MULTIPLE: 510(k) SUMMARY.

INTENDED USE:

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for.

Pharmacy compounding, (a) when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and

I.V. administration, when used in conjunction with (b) a gravity or pump infusion set to channel the solution from the source containers to the infusion set. The device should not be used with lipids.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, FLEBOSET MULTIPLE is compared with other fluid delivery tubing used in pharmacy compounding and I.V. administration. The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.

			PREDICATES
#	Characteristic /Feature	FLEBOSETMULTIPLE	BAXTERAutomix 3+3(transfer setpresentedtogether withcompounder)K894827	MEDRADTransfer SetK022431	MERIT MEDICALTransfer SetsK961794
1.	Intended use / Claims	FLEBOSET MULTIPLE isan ancillary device usedas fluid pathway throughwhich substances from 6glasssourceflaskscontainingthesamesolutionmaybecontinuously delivered for.(a) Pharmacy compoun-ding, whenusedinconjunction with the GRI-FILL2.0 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 infusion	Positivedisplacementfluidcompoundingsystem employing the3+3compounder,TRANSFERSETS,emptyViaflexorTravamulsion containerswithconnectors andmultitaskcomputersoftware to providecompounding of a widevariety of fluids	The Medrad TransferSet is medicaldisposable device usedto transfer intravascularcontrast media andsaline from a spikeablecontainer to a powerinjector syringe. Thedevice componentsconsist of a ventedspike, connector tube, ameans of manuallystopping flow, femaleluer, and individuallypackaged sterile caps.	Contrast media deliverysystems used to transferI.V. contrast media froma spikeable container toa syringe.

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230SET MULTIPLE: 510(k) S

#	Characteristic /Feature	FLEBOSETMULTIPLE	PREDICATES
			BAXTERAutomix 3+3(transfer setpresentedtogether withcompounder)K894827	MEDRADTransfer SetK022431	MERIT MEDICALTransfer SetsK961794
		set. The device should notbe used with lipids.
2.	Technologicalfeatures:-Sterilization-Contact with patient	Ethylene OxideNO- Intended for usewith the pharmacycompounding device orINDIRECT - May be usedon-line with patient,upstream of the gravity orpump administration sets.	RadiationNO - Intended for usewith the pharmacycompounding device.	Ethylene OxideNO- Must be removedfrom the syringe beforethe syringe can beconnected to thepatient.	Ethylene OxideINDIRECT - May beused on-line with thepatient through asyringe with stopcock ora manifold port.
	-Source solutions	6	3 or 6.	2	1
3.	Principle Materials	PVC with DEHP plasticizer	PVC with DEHPplasticizer	PVC	Flexible plastic
4.	Sterility	Sterile	Sterile	Sterile	Sterile

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 FLEBOSET MULTIPLE have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use.

CONCLUSIONS:

We believe the intended use, the indications for use, the functionality and the operation of FLEBOSET MULTIPLE and the predicate devices for fluid transfer both in pharmacy compounding and for 1.V. administration are essentially the same. Hence, substantial equivalence of FLEBOSET MULTIPLE 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, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The profiles are arranged to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

MAR - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040456

Trade/Device Name: Fleboset Multiple Regulation Number: 880.5440 Regulation Name: Set, Intravenous Fluid Transfer Regulatory Class: II Product Code: LHI Dated: February 20, 2004 Received: February 23, 2004

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 offecting 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.

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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ECHNICAL EVALUATION DOCUMENTATION ON 09 FLEBOSET MULTIPLE: INDICATIONS FO A CHE CHENE

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(as required by ODE for all 510(k) received after Jan. 1, 1996)

510(k) Number:

K040456

Device Name:

FLEBOSET MULTIPLE

Indications for Use:

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:

(a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
(b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.

The 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 order of a physician.

(Do not write below this line. Continue on another page in needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arne Nannestad, Interim Branch Chief
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040456

Prescription Use X (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.