GRI-FILL PERISTALTIC SET

K162216 · Laboratorios Grifols, S.A. · LHI · Oct 19, 2017 · General Hospital

Device Facts

• Record ID: K162216
• Device Name: GRI-FILL PERISTALTIC SET
• Applicant: Laboratorios Grifols, S.A.
• Product Code: LHI · General Hospital
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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

Device Story

Disposable fluid transfer set; connects source container to Gri-Fill Pharmacy Compounder. Components: silicone tubing, male luer-lock, vented spike with 1.2 um hydrophobic air filter, female luer-lock. Used in hospital pharmacies by trained personnel. Operates via peristaltic pump to transfer fluids from source to final IV container. Closed system; no direct patient contact. Provides fluid pathway for pharmacy compounding. Benefits: enables automated, sterile fluid transfer for drug reconstitution and medication preparation.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), sterility (ISO 11135, ISO 11607-1), and physical/mechanical performance (leakage, tensile strength, luer-lock testing per ISO 594, and dosage accuracy verification).

Technological Characteristics

Single-use, sterile (EtO, SAL 10^-6), non-pyrogenic fluid transfer set. Materials: medical-grade platinum-cured silicone tubing, ABS vented spike, acrylic copolymer spike filter, polypropylene connectors. Peristaltic pump-driven. Dimensions/form factor: single-channel tubing. Connectivity: standalone component for pharmacy compounding system. Complies with ISO 10993-1, ISO 8536-4, ISO 22413, ISO 594-1/2.

Indications for Use

Indicated for use by trained healthcare personnel in hospital pharmacies as an ancillary fluid transfer set for the Gri-Fill Pharmacy Compounder to deliver solutions into final IV containers. Not for direct patient connection.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KIRO Set (K152441)

Reference Devices

• Set Gri-fill 2 Way (K050339)

Submission Summary (Full Text)

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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)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> 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<br>fluid transfer set is an<br>ancillary device used in<br>conjunction with the Gri-<br>Fill Pharmacy<br>Compounder and<br>ancillary Gri-Fill sets in<br>hospital pharmacy to<br>provide a fluid pathway<br>through which one<br>solution source is<br>delivered into a final IV<br>container.<br>This device is not<br>intended to be directly<br>connected to the<br>patient. | The KIRO Set is a<br>sterile, single-use,<br>disposable ancillary<br>device used with the<br>peristaltic pumps in<br>the KIRO Oncology<br>pharmacy<br>compounding device<br>for the transfer of<br>fluids into sterile<br>powder drug vials for<br>reconstitution of<br>intravenous drugs or<br>into sterile<br>medication<br>containers for<br>intravenous drug<br>administration | The Indications for<br>Use statement for<br>the Gri-fill Peristaltic<br>Set is not identical to<br>that of the predicate<br>device. However, the<br>differences do not<br>alter the intended<br>use of the device nor<br>do they affect the<br>safety and<br>effectiveness of the<br>device relative to the<br>predicate. |
| Intended Use | Gri-Fill Peristaltic Set is<br>a disposable component | This product would<br>be used for fluid | Subject and<br>predicate have |
| Characteristics | Gri-fill Peristaltic Set | Kiro Set - K152441<br>Predicate Device | Comparison |
| | of the Gri-Fill Pharmacy<br>Compounder used to<br>provide a fluid pathway<br>through which one<br>source substance is<br>channeled repeatedly to<br>an IV container. The<br>device is NOT intended<br>to be connected directly<br>to the patient. | transfer in the<br>preparation final<br>medication<br>containers and the<br>reconstitution of drug<br>vials in hospital<br>pharmacies when<br>used with the KIRO<br>Oncology pharmacy<br>compounding device. | similar intended use<br>for fluid transfer in<br>conjunction with their<br>respective pharmacy<br>compounding<br>systems to provide a<br>fluid pathway through<br>which a source<br>substance is<br>delivered into a final<br>IV container. |
| Product Code | LHI | LHI | Identical to predicate<br>device |
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical to predicate<br>device |
| Classification | Class II | Class II | Identical to predicate<br>device |
| SUBSTANTIAL EQUIVALENCE BASED UPON INTENDED USE | | | |
| Use | Single Use | Single Use | Identical to predicate<br>device |
| Prescription /OTC<br>use | Prescription Use | Prescription Use | Identical to predicate<br>device |
| Pharmacy<br>Compounding<br>Device Specified | Gri-Fill Pharmacy<br>Compounder | KIRO Oncology<br>pharmacy<br>compounding device | Subject and<br>predicate work with<br>their respective<br>pharmacy<br>compounding<br>systems |
| Intended for Direct<br>Connection to<br>Patient | NO | NO | Identical to predicate<br>device |
| Use environment | Hospital pharmacy | Hospital pharmacy | Identical to predicate<br>device |
| Target users | Trained health-care<br>personnel | Trained health-care<br>personnel | Identical to predicate<br>device |
| Sterility | Sterile; Non-pyrogenic<br>fluid pathway | Sterile; Non-<br>pyrogenic fluid<br>pathway | Identical to predicate<br>device |
| Sterilization | Ethylene Oxide | Gamma Radiation | Different to predicate<br>device |
| Sterility Assurance<br>Level | 10-6 | 10-6 | Identical to predicate<br>device |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical to predicate<br>device. Same<br>biological tests<br>performed. |
| SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS | | | |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical to predicate<br>device. Same<br>biological tests<br>performed. |
| Tubing to channel<br>fluids | Medical Grade Silicone | Medical Grade<br>Silicone | Identical to predicate<br>device |
| Dosification<br>Mechanism | Peristaltic Pump | Peristaltic Pump | Identical to predicate<br>device |
| Characteristics | Gri-fill Peristaltic Set | Kiro Set - K152441<br>Predicate Device | Comparison |
| Closed system (fluid<br>not in contact with<br>any reusable part of<br>the compounding<br>device) | YES | YES | Identical to predicate<br>device |
| Dose Range | 2 ml to 3000 ml | 0.5 ml to 200 ml | Different dose range<br>as programmed<br>through the<br>respective pharmacy<br>compounding<br>devices |
| Accuracy | Doses from 2.0 ml to 10<br>ml: ±0.2 ml<br>Doses from 10 ml to 25<br>ml: ±0.5 ml<br>Doses from 25 ml to<br>3000 ml: ±2 % | Doses into vials:<br>5.0 ml to 100 ml:<br>±5%<br>1.0 ml to 4.99 ml:<br>±10%<br>0.5 ml to 0.99 ml:<br>±0.1 ml<br>Doses into<br>reservoirs:<br>50 ml to 200 ml:<br>±10%<br>10 ml to 49.99 ml: ±2<br>ml | Different<br>accuracy<br>claims as achieved<br>with the respective<br>pharmacy<br>compounding<br>devices. |
| Number of<br>source containers | One | One | Identical to predicate<br>device |
| Input line<br>connectors | Vented spike or male<br>luer | Vented spike or male<br>luer | Identical to predicate<br>device |
| Output line<br>connectors | Female luer lock | Male Luer Connector | Subject device<br>output connector is<br>to be connected to<br>Set Gri-fill 2 Way<br>(K050339) which is<br>then connected to<br>the final IV container.<br>Predicate device is to<br>be connected directly<br>to the final IV<br>container. |
| Final container | Vials, Infusion Bags<br>(Gribag,<br>Gri-flex), Syringes,<br>Elastomeric pumps | Vials, Infusion Bags,<br>Cassettes,<br>Elastomeric<br>pumps | Equivalent to<br>predicate device |
| Shelf life | 5 years | 5 years | Identical to predicate<br>device |
| Packaging | Individual packaging:<br>Pouch Paper/Film PET-<br>PP | Individual packaging:<br>Pouch Tyvek / PET<br>film | Different<br>packaging<br>materials |
| Materials | Medical grade silicone.<br>Platinum cured | Medical grade<br>silicone. Platinum<br>cured | Identical to predicate<br>device |
| Vented Spike | ABS | ABS | Identical to predicate<br>device |
| Spike filter | Filter: Acrylic copolymer | Filter: Acrylic | Identical to predicate |
| Characteristics | Gri-fill Peristaltic Set | Kiro Set - K152441<br>Predicate Device | Comparison |
| | Housing: Polypropylene | copolymer<br>Housing:<br>Polypropylene | device |
| Spike cap | Polyethylene | Polyethylene | Identical to predicate<br>device |
| Luer-lock male<br>barb connector | Polypropylene | Polycarbonate | Different to predicate<br>device |
| Luer-lock female<br>barb connector | Polypropylene | Component not<br>included in KIRO Set | Component not<br>included in predicate<br>device |
| Luer-lock male<br>connector cap | Polypropylene | Component not<br>included in KIRO Set | Component not<br>included in predicate<br>device |
| Luer-lock female<br>connector cap | Component not included<br>in Gri-fill Peristaltic Set | Polyethylene | Component not<br>included in subject<br>device |
| Y- connector | Component not included<br>in Gri-fill Peristaltic Set | Polycarbonate | Component not<br>included in subject<br>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 .