Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. This device is not intended to be directly connected to the patient.

Device Description

Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder. lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump. The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel. The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process. Gri-fill Peristaltic Set is not intended to be used for direct patient contact.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the Gri-fill Peristaltic Set, a fluid transfer set used in hospital pharmacies. It claims substantial equivalence to a predicate device, the KIRO Set (K152441).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as typically seen in clinical performance studies of AI/diagnostic devices. Instead, the "acceptance criteria" are implied by the various performance tests conducted to demonstrate substantial equivalence to the predicate device and adherence to relevant standards. The "reported device performance" is described qualitatively as "All tests yielded correct results."

However, the closest equivalent to quantitative acceptance criteria and performance data are those related to Dose Range and Accuracy, which are compared between the subject device and the predicate.

Characteristic	Acceptance Criteria (Implied by Predicate Device)	Gri-fill Peristaltic Set Performance (Claimed)	Comparison
Dose Range	0.5 ml to 200 ml	2 ml to 3000 ml	Different dose range as programmed through the respective pharmacy compounding devices.
Accuracy (Predicate's)	Doses into vials:5.0 ml to 100 ml: ±5%1.0 ml to 4.99 ml: ±10%0.5 ml to 0.99 ml: ±0.1 mlDoses into reservoirs:50 ml to 200 ml: ±10%10 ml to 49.99 ml: ±2 ml	Doses from 2.0 ml to 10 ml: ±0.2 mlDoses from 10 ml to 25 ml: ±0.5 mlDoses from 25 ml to 3000 ml: ±2 %	Different accuracy claims as achieved with the respective pharmacy compounding devices.
Sterility Assurance Level (SAL)	10^-6	10^-6	Identical to predicate device
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Identical to predicate device. Same biological tests performed.
Closed system (fluid not in contact with any reusable part of the compounding device)	YES	YES	Identical to predicate device
Shelf life	5 years	5 years	Identical to predicate device

Note: For most other performance tests (e.g., leakage, tensile strength, functionality, residuals, endotoxins), the document states "All tests yielded correct results," implying they met their respective standard-defined acceptance criteria, but these criteria are not numerically specified in the provided text.

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

The document does not provide specific sample sizes (e.g., number of devices tested) for the performance tests conducted. It only mentions that "Performance testing was conducted in accordance with 'FDA Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]' dated July 11, 2008."

The data provenance is implied to be from laboratory bench testing performed by the manufacturer, Laboratorios Grifols, S.A. (SPAIN). All studies were prospective bench tests rather than retrospective or prospective human data clinical studies.

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

This information is not applicable as the device is a physical medical device (fluid transfer set) and not an AI or diagnostic tool requiring ground truth established by human experts for interpretation of images or patient data. The "ground truth" for its performance is derived from physical and chemical measurements against established standards.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human interpretations or classifications of data that would require an adjudication method. Performance is assessed through objective physical and chemical testing.

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

This information is not applicable. The device is a physical medical device (fluid transfer set), not an AI or diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical medical device. It does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards, such as:

ISO 11607-1 for individual packaging validation.
ISO 11135:2014 for ethylene oxide sterilization process validation.
ISO 10993-7:2008 for residuals of ethylene oxide sterilization.
ANSI/AAMI ST72:2002 and FDA Guidance for Industry for bacterial endotoxin testing.
ISO 8536-4 for chemical, physical, and functional performance (leakage, tensile strength).
ISO 22413 for chemical, physical, and functional performance.
ISO 594-1 and ISO 594-2 for physical testing of luer-locks.
ISO 10993-1 for biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device. It does not involve AI or machine learning models that require a "training set."

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

This information is not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 19, 2017

Laboratorios Grifols, S.A. Marta Daniela Serra De Fortuny Technical Director C/can Guasch, 2 08150 Parets Del Valles, Barcelona SPAIN

Re: K162216 Trade/Device Name: Gri-fill Peristaltic Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: September 8, 2017 Received: September 13, 2017

Dear Marta Daniela Serra De Fortuny:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K162216

Device Name GRI-FILL PERISTALTIC SET

Indications for Use (Describe)

Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. The device is not intended to be directly connected to the patient.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary (K162216)

1. SUBMITTER

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

Contact person: Marta Daniela Serra de Fortuny Phone: +34 93 571 03 04 Fax: +34 93 573 09 12 e-mail: marta.serra@grifols.com

Date Prepared:

October 2nd, 2017

DEVICE II.

Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number:

GRI-FILL PERISTALTIC SET I.V. FLUID TRANSFER SET INTRAVASCULAR ADMINISTRATION SET Class II LHI 880.5440

III. PREDICATE DEVICE

Predicate Device

KIRO Set, K152441

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IV. DEVICE DESCRIPTION

Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder.

lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump.

The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel.

The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process.

Gri-fill Peristaltic Set is not intended to be used for direct patient contact.

V. INDICATIONS FOR USE

Gri-fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-fill Pharmacy Compounder and ancillary Gri-fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container.

This device is not intended to be directly connected to the patient.

Gri-fill Peristaltic Set and its predicate device are intended to be used for fluid transfer in conjunction with their respective Pharmacy compounding systems by trained health-care personnel in the hospital pharmacy environment. Both devices are not intended to be connected directly to patients.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Both Gri-fill Peristaltic Set and the predicate device are tubing sets with similar inlets for connection to source containers. Both the subject and predicate devices are based upon the same technological elements:

Both devices are single use, presented sterile (SAL = 1 x 10-6) and nonpyrogenic.
Tubing - Both are silicone tubing based upon medical grade tubing.
Input line connectors Both have vented spike connected by luer-lock to the . silicone tubing. In both devices, the female luer-lock end of the vented spike is connected to a barbed male luer-lock attached to the tubing.
Materials - The materials used for the vented spike, the spike filter and the spike cap in both devices are identical.

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Fluid transfer mechanism Both use a peristaltic pump for fluid transfer. .
The following technological differences exist between Gri-fill Peristaltic Set and predicate device:
Output line connectors Gri-fill Peristaltic Set uses a luer-lock female barb . connector while KIRO Set uses a luer- lock male barb connector.
Gri-fill Peristaltic Set has a single channel silicone tubing whilst KIRO Set has . a double channel silicone tubing.
Dose range/ Accuracy The dose range and accuracy of fluid transfer ● claimed for Gri-fill Peristaltic Set are different to those claimed for the KIRO Set.
Materials The material used for the luer-lock male barb connector in both ● devices is different. The luer-lock male barb connector of the Gri-fill Peristaltic Set is made of Polypropylene while in KIRO Set is made of Polycarbonate.
Components Gri-fill Peristaltic Set does not include any Y-connector, ● because is a single-channel tubing, whereas KIRO Set includes two Yconnector to connect the double-channel segments of tubing.
Packaging Gri-fill Peristaltic Set is packaged individually in a heat-sealed ● pouch made up of medical paper web sealed to a multilayer film laminate (PET/PP) whilst KIRO Set is packaged individually in a heat-sealed Tyvek/ PET pouch.
Sterilization Gri-fill Peristaltic Set is sterilized using ethylene oxide gas ● whereas KIRO Set is sterilized by gamma radiation.

In the establishment of substantial equivalence, Gri-fill Peristaltic Set is compared to the predicate device KIRO Set (K152441) as detailed in the comparison provided in the table below.

Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441	Comparison
		Predicate Device
Indications for Use	Gri-Fill Peristaltic Setfluid transfer set is anancillary device used inconjunction with the Gri-Fill PharmacyCompounder andancillary Gri-Fill sets inhospital pharmacy toprovide a fluid pathwaythrough which onesolution source isdelivered into a final IVcontainer.This device is notintended to be directlyconnected to thepatient.	The KIRO Set is asterile, single-use,disposable ancillarydevice used with theperistaltic pumps inthe KIRO Oncologypharmacycompounding devicefor the transfer offluids into sterilepowder drug vials forreconstitution ofintravenous drugs orinto sterilemedicationcontainers forintravenous drugadministration	The Indications forUse statement forthe Gri-fill PeristalticSet is not identical tothat of the predicatedevice. However, thedifferences do notalter the intendeduse of the device nordo they affect thesafety andeffectiveness of thedevice relative to thepredicate.
Intended Use	Gri-Fill Peristaltic Set isa disposable component	This product wouldbe used for fluid	Subject andpredicate have
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441Predicate Device	Comparison
	of the Gri-Fill PharmacyCompounder used toprovide a fluid pathwaythrough which onesource substance ischanneled repeatedly toan IV container. Thedevice is NOT intendedto be connected directlyto the patient.	transfer in thepreparation finalmedicationcontainers and thereconstitution of drugvials in hospitalpharmacies whenused with the KIROOncology pharmacycompounding device.	similar intended usefor fluid transfer inconjunction with theirrespective pharmacycompoundingsystems to provide afluid pathway throughwhich a sourcesubstance isdelivered into a finalIV container.
Product Code	LHI	LHI	Identical to predicatedevice
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Identical to predicatedevice
Classification	Class II	Class II	Identical to predicatedevice
SUBSTANTIAL EQUIVALENCE BASED UPON INTENDED USE
Use	Single Use	Single Use	Identical to predicatedevice
Prescription /OTCuse	Prescription Use	Prescription Use	Identical to predicatedevice
PharmacyCompoundingDevice Specified	Gri-Fill PharmacyCompounder	KIRO Oncologypharmacycompounding device	Subject andpredicate work withtheir respectivepharmacycompoundingsystems
Intended for DirectConnection toPatient	NO	NO	Identical to predicatedevice
Use environment	Hospital pharmacy	Hospital pharmacy	Identical to predicatedevice
Target users	Trained health-carepersonnel	Trained health-carepersonnel	Identical to predicatedevice
Sterility	Sterile; Non-pyrogenicfluid pathway	Sterile; Non-pyrogenic fluidpathway	Identical to predicatedevice
Sterilization	Ethylene Oxide	Gamma Radiation	Different to predicatedevice
Sterility AssuranceLevel	10-6	10-6	Identical to predicatedevice
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Identical to predicatedevice. Samebiological testsperformed.
SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Identical to predicatedevice. Samebiological testsperformed.
Tubing to channelfluids	Medical Grade Silicone	Medical GradeSilicone	Identical to predicatedevice
DosificationMechanism	Peristaltic Pump	Peristaltic Pump	Identical to predicatedevice
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441Predicate Device	Comparison
Closed system (fluidnot in contact withany reusable part ofthe compoundingdevice)	YES	YES	Identical to predicatedevice
Dose Range	2 ml to 3000 ml	0.5 ml to 200 ml	Different dose rangeas programmedthrough therespective pharmacycompoundingdevices
Accuracy	Doses from 2.0 ml to 10ml: ±0.2 mlDoses from 10 ml to 25ml: ±0.5 mlDoses from 25 ml to3000 ml: ±2 %	Doses into vials:5.0 ml to 100 ml:±5%1.0 ml to 4.99 ml:±10%0.5 ml to 0.99 ml:±0.1 mlDoses intoreservoirs:50 ml to 200 ml:±10%10 ml to 49.99 ml: ±2ml	Differentaccuracyclaims as achievedwith the respectivepharmacycompoundingdevices.
Number ofsource containers	One	One	Identical to predicatedevice
Input lineconnectors	Vented spike or maleluer	Vented spike or maleluer	Identical to predicatedevice
Output lineconnectors	Female luer lock	Male Luer Connector	Subject deviceoutput connector isto be connected toSet Gri-fill 2 Way(K050339) which isthen connected tothe final IV container.Predicate device is tobe connected directlyto the final IVcontainer.
Final container	Vials, Infusion Bags(Gribag,Gri-flex), Syringes,Elastomeric pumps	Vials, Infusion Bags,Cassettes,Elastomericpumps	Equivalent topredicate device
Shelf life	5 years	5 years	Identical to predicatedevice
Packaging	Individual packaging:Pouch Paper/Film PET-PP	Individual packaging:Pouch Tyvek / PETfilm	Differentpackagingmaterials
Materials	Medical grade silicone.Platinum cured	Medical gradesilicone. Platinumcured	Identical to predicatedevice
Vented Spike	ABS	ABS	Identical to predicatedevice
Spike filter	Filter: Acrylic copolymer	Filter: Acrylic	Identical to predicate
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441Predicate Device	Comparison
	Housing: Polypropylene	copolymerHousing:Polypropylene	device
Spike cap	Polyethylene	Polyethylene	Identical to predicatedevice
Luer-lock malebarb connector	Polypropylene	Polycarbonate	Different to predicatedevice
Luer-lock femalebarb connector	Polypropylene	Component notincluded in KIRO Set	Component notincluded in predicatedevice
Luer-lock maleconnector cap	Polypropylene	Component notincluded in KIRO Set	Component notincluded in predicatedevice
Luer-lock femaleconnector cap	Component not includedin Gri-fill Peristaltic Set	Polyethylene	Component notincluded in subjectdevice
Y- connector	Component not includedin Gri-fill Peristaltic Set	Polycarbonate	Component notincluded in subjectdevice

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Table 1. Substantial Equivalence Comparison – Gri-Fill Peristaltic Set and Predicate
Device (K152441)

Based on the results of comparison of intended use and technological characteristics, Gri-fill Peristaltic Set is substantially equivalent to the predicate device, Kiro Set. Any technological differences between Gri-fill Peristaltic Set and the predicate device have been demonstrated to raise no different questions of safety or effectiveness.

VII. PERFORMANCE DATA

Performance testing was conducted in accordance with "FDA Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]" dated July 11, 2008 including the following specific testing:

Biocompatibility Testing

The biocompatibility evaluation for Gri-fill Peristaltic Set device was conducted in accordance with the FDA Guidance for Industry and FDA Staff - "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", June 16, 2016; ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", as recognized by FDA; and FDA Guidance for Industry and FDA Staff - "Intravascular Administration Sets Premarket Notification Submissions [510(k)],"July 11, 2008. Biocompatibility testing as required for External Communicating Devices, Indirect Contact with the blood path, Limited Duration was conducted in accordance with cited guidances and standards.

The battery of testing included the following tests:

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Hemocompatibility Hemolysis ●
Cytotoxicity ●
Sensitization
Irritation or Intracutaneous reactivity ●
Acute systemic toxicity ●
Material-mediated pyrogenicity ●

Sterility Testing

Individual packaging validation according to ISO 11607-1. ●
Ethylene oxide sterilization process validation according to ISO 11135:2014. ●
Residuals of the ethylene oxide sterilization process according to ISO 10993-● 7:2008.
Bacterial endotoxin testing based on ANSI/AAMI ST72:2002 and following ● FDA Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers.

Performance Testing

Chemical, physical and functional performance testing was conducted as set . out in the applicable parts of ISO 8536-4, including leakage and tensile strength testing. The applicable parts of ISO 22413 were also taken into account for chemical, physical and functional performance testing.
. Physical Testing of luer-locks was conducted as set out in the applicable parts of ISO 594-1 and ISO 594-2.
Functionality, simulating worst case conditions (device and compounding ● system during 8 hours in continuous, nonstop) including determination of the accuracy of the dosage achieved (dose verification at different intervals) and tightness test. Also conducted in the stress stability study.

Summary discussion of non-clinical data:

Chemical, physical, mechanical and biological test data relevant to the new device are used to support the device biocompatibility and stability as well the applicable physical and mechanical specifications. Non-clinical bench testing performed on Grifill Peristaltic Set included leakage testing, flow-rate testing and functional checking as per its intended use. Final evaluation included specific testing for ethylene oxide sterilization process residuals, manufacturing process residuals, sterility and endotoxins on final finished sterilized devices. All tests yielded correct results.

Summary discussion of clinical data:

No clinical data presented in this submission.

VIII. CONCLUSIONS

Minor technological differences have been analyzed and the results of the bench testing conducted demonstrate the subject device is substantially equivalent to the predicate device in the intended use, indication for use and functionality .

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.