GRI-FILL PERISTALTIC SET

• K Number: K162216
• Device Name: GRI-FILL PERISTALTIC SET
• Manufacturer: LABORATORIOS GRIFOLS, S.A.
• Date Cleared: 2017-10-19 ( 437 days)
• Product Code: LHI REG
• Regulation Number: 880.5440

Intended 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.

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.

Predicate Devices

KIRO Set

Reference Devices

KIRO Set, K152441

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and functional performance of a fluid transfer set used with a peristaltic pump, with no mention of AI or ML capabilities.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to be directly connected to the patient." A therapeutic device would typically have direct patient contact or perform a therapeutic function on a patient.

Diagnostic

No

This device is described as 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." Its purpose is to transfer fluids, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (silicone tube, luer-lock connectors, spike, air filter) and mentions sterilization and physical performance testing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Gri-Fill Peristaltic Set is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states that it 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." It is explicitly stated that "This device is not intended to be directly connected to the patient."
• Device Description: The description reinforces its function as a fluid transfer set for compounding in a pharmacy setting.
• Lack of Diagnostic Purpose: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Gri-Fill Peristaltic Set does not perform any such analysis or provide diagnostic information. Its purpose is purely for the preparation of intravenous solutions.

Therefore, the Gri-Fill Peristaltic Set falls under the category of a medical device used for compounding and fluid transfer, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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. The device is not intended to be directly connected to the patient.

Product codes

LHI

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. It 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained health-care personnel in the hospital pharmacy environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Biocompatibility testing was conducted according to ISO 10993-1 for External Communicating Devices, Indirect Contact with the blood path, Limited Duration, and included Hemocompatibility (Hemolysis), Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute systemic toxicity, and Material-mediated pyrogenicity.

Sterility testing included individual packaging validation (ISO 11607-1), ethylene oxide sterilization process validation (ISO 11135:2014), residuals of the ethylene oxide sterilization process (ISO 10993-7:2008), and bacterial endotoxin testing (ANSI/AAMI ST72:2002).

Performance Testing included chemical, physical, and functional performance testing as per ISO 8536-4 and ISO 22413, and physical testing of luer-locks as per ISO 594-1 and ISO 594-2. Functionality was tested under worst-case conditions (8 hours continuous, nonstop device and compounding system use), including dose accuracy determination and tightness test, and stress stability study.

All tests yielded correct results. No clinical data was presented.

Key Metrics

Not Found

Predicate Device(s)

KIRO Set, K152441

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] e-mail: [e-mail]

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 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.	The KIRO Set is a
sterile, single-use,
disposable ancillary
device used with the
peristaltic pumps in
the KIRO Oncology
pharmacy
compounding device
for the transfer of
fluids into sterile
powder drug vials for
reconstitution of
intravenous drugs or
into sterile
medication
containers for
intravenous drug
administration	The Indications for
Use statement for
the Gri-fill Peristaltic
Set is not identical to
that of the predicate
device. However, the
differences do not
alter the intended
use of the device nor
do they affect the
safety and
effectiveness of the
device relative to the
predicate.
Intended Use	Gri-Fill Peristaltic Set is
a disposable component	This product would
be used for fluid	Subject and
predicate have
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441
Predicate Device	Comparison
	of the Gri-Fill Pharmacy
Compounder used to
provide a fluid pathway
through which one
source substance is
channeled repeatedly to
an IV container. The
device is NOT intended
to be connected directly
to the patient.	transfer in the
preparation final
medication
containers and the
reconstitution of drug
vials in hospital
pharmacies when
used with the KIRO
Oncology pharmacy
compounding device.	similar intended use
for fluid transfer in
conjunction with their
respective pharmacy
compounding
systems to provide a
fluid pathway through
which a source
substance is
delivered into a final
IV container.
Product Code	LHI	LHI	Identical to predicate
device
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Identical to predicate
device
Classification	Class II	Class II	Identical to predicate
device
SUBSTANTIAL EQUIVALENCE BASED UPON INTENDED USE
Use	Single Use	Single Use	Identical to predicate
device
Prescription /OTC
use	Prescription Use	Prescription Use	Identical to predicate
device
Pharmacy
Compounding
Device Specified	Gri-Fill Pharmacy
Compounder	KIRO Oncology
pharmacy
compounding device	Subject and
predicate work with
their respective
pharmacy
compounding
systems
Intended for Direct
Connection to
Patient	NO	NO	Identical to predicate
device
Use environment	Hospital pharmacy	Hospital pharmacy	Identical to predicate
device
Target users	Trained health-care
personnel	Trained health-care
personnel	Identical to predicate
device
Sterility	Sterile; Non-pyrogenic
fluid pathway	Sterile; Non-
pyrogenic fluid
pathway	Identical to predicate
device
Sterilization	Ethylene Oxide	Gamma Radiation	Different to predicate
device
Sterility Assurance
Level	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.
SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Identical to predicate
device. Same
biological tests
performed.
Tubing to channel
fluids	Medical Grade Silicone	Medical Grade
Silicone	Identical to predicate
device
Dosification
Mechanism	Peristaltic Pump	Peristaltic Pump	Identical to predicate
device
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441
Predicate Device	Comparison
Closed system (fluid
not in contact with
any reusable part of
the compounding
device)	YES	YES	Identical to predicate
device
Dose Range	2 ml to 3000 ml	0.5 ml to 200 ml	Different dose range
as programmed
through the
respective pharmacy
compounding
devices
Accuracy	Doses from 2.0 ml to 10
ml: ±0.2 ml
Doses from 10 ml to 25
ml: ±0.5 ml
Doses from 25 ml to
3000 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 ml
Doses into
reservoirs:
50 ml to 200 ml:
±10%
10 ml to 49.99 ml: ±2
ml	Different
accuracy
claims as achieved
with the respective
pharmacy
compounding
devices.
Number of
source containers	One	One	Identical to predicate
device
Input line
connectors	Vented spike or male
luer	Vented spike or male
luer	Identical to predicate
device
Output line
connectors	Female luer lock	Male Luer Connector	Subject device
output connector is
to be connected to
Set Gri-fill 2 Way
(K050339) which is
then connected to
the final IV container.
Predicate device is to
be connected directly
to the final IV
container.
Final container	Vials, Infusion Bags
(Gribag,
Gri-flex), Syringes,
Elastomeric pumps	Vials, Infusion Bags,
Cassettes,
Elastomeric
pumps	Equivalent to
predicate device
Shelf life	5 years	5 years	Identical to predicate
device
Packaging	Individual packaging:
Pouch Paper/Film PET-
PP	Individual packaging:
Pouch Tyvek / PET
film	Different
packaging
materials
Materials	Medical grade silicone.
Platinum cured	Medical grade
silicone. Platinum
cured	Identical to predicate
device
Vented Spike	ABS	ABS	Identical to predicate
device
Spike filter	Filter: Acrylic copolymer	Filter: Acrylic	Identical to predicate
Characteristics	Gri-fill Peristaltic Set	Kiro Set - K152441
Predicate Device	Comparison
	Housing: Polypropylene	copolymer
Housing:
Polypropylene	device
Spike cap	Polyethylene	Polyethylene	Identical to predicate
device
Luer-lock male
barb connector	Polypropylene	Polycarbonate	Different to predicate
device
Luer-lock female
barb connector	Polypropylene	Component not
included in KIRO Set	Component not
included in predicate
device
Luer-lock male
connector cap	Polypropylene	Component not
included in KIRO Set	Component not
included in predicate
device
Luer-lock female
connector cap	Component not included
in Gri-fill Peristaltic Set	Polyethylene	Component not
included in subject
device
Y- connector	Component not included
in Gri-fill Peristaltic Set	Polycarbonate	Component not
included in subject
device

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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 .