(14 days)
Not Found
No
The document describes a fluid transfer set, which is a disposable component of a pharmacy compounding device. The description focuses on the physical components and function of channeling fluids. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is an "ancillary device" that provides a "fluid pathway" for compounding solutions, not for directly treating a patient.
No
The device is described as an "ancillary device" and "fluid transfer sets" used in pharmacy compounding to mix and channel substances into IV containers. Its function relates to preparing medications, not diagnosing medical conditions.
No
The device description explicitly states it is a "fluid transfer set" made up of physical components like a syringe, distributor, tubing, and a waste/residue bag. It is described as a "disposable component of the compounding device," indicating it is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a fluid pathway for compounding or mixing different multi-ingredient solutions for IV containers or syringes. This is a process of preparing medications, not diagnosing a condition or analyzing a sample from the human body.
- Device Description: The device is described as fluid transfer sets, tubing, connectors, a syringe, a distributor, and a waste bag. These are components for fluid handling and mixing, not for performing diagnostic tests.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, treatment, or prevention of disease.
- Performance Studies: The performance studies focus on the functional aspects of fluid delivery and leakage, which are relevant to compounding accuracy and safety, not diagnostic performance.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is entirely related to the preparation and delivery of medications for administration in vivo (within the body).
N/A
Intended Use / Indications for Use
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in SETS OFF I the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to confulletion will the Orthway through which one or two source substances are delivered into a final IV container or syringe.
SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated 1 WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.
This device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.
Product codes
LHI
Device Description
SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1WAY / 2WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1WAY / 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- accurate delivery of specified source solutions under normal conditions and stress conditions
- fluid / air leakage checking -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K454339 (P. 10f 3)
TECHNICAL EVALUATION # Document CRIFOLS TED-SETS GRI-FIL DOCUMENTATION SECTION 1 - SETS GRI-FILL 3.0: 510(k) SUM
| DATE OF SUBMISSION: | 2004-11-30 |
|---|---|
| SUBMITTER NAME: | Laboratorios Grifols, S.A. |
| SUBMITTER ADDRESS: | C/ Can Guasch, 2 |
| 08150 PARETS DEL VALLES | |
| BARCELONA | |
| SPAIN | |
| TELEPHONE: | + 34 93 571 01 00 |
| FAX: | + 34 93 573 09 12 |
| e-mail: | sebastian.gascon@grifols.com |
| CONTACT: | Sebastian Gascón |
| Technical Director | |
| DEVICE TRADE NAME: | SETS GRI-FILL 3.0 |
| COMMON NAME: | I.V. FLUID TRANSFER SETS |
| CLASSIFICATION NAME: | I.V. FLUID TRANSFER SETS (21 CFR 880.5440) |
| PREDICATE DEVICE: | SETS GRI-FILL 2.0 1WAY / 2WAY / LUER (K033682) |
| FLEBOSET MULTIPLE (K040456) |
DEVICE DESCRIPTION:
SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1WAY / 2WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1WAY / 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.
INTENDED USE:
SETS GRI-FILL 3.0 1 WAY and 2 WAYS are disposable components of the GRI-FILL 3.0 pharmacy compounding system used to provide a fluid pathway through which one or two source substances are channeled to an IV container or syringe. SETS GRI-FILL 3.0 MULTIPLE are ancillary devices connected to SETS GRI-FILL 3.0 1 WAY or 2 WAYS used to provide a fluid pathway through which the same substance in up to 6 source containers may be delivered into a final IV container. The device is NOT intended to be connected directly to the patient.
1
KAS4339 (P.2 aP3)
TECHNICAL EVALUATION # Document; GRIFOLS TED-SETS GRI-FILL 3.0-01 DOCUMENTATION SECTION 1 -- SETS GRI-FILL 3.0: 510(k) SUMMARY
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, SETS GRI-FILL 3.0 are compared with other transfer sets used in pharmacy compounding.
The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.
| # | Characteristic /
Feature | PROPOSED DEVICE | PREDICATE DEVICES | |
|----|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | SETS GRI-FILL 3.0 | SETS GRI-FILL 2.0 | FLEBOSET
MULTIPLE |
| 1 | Intended use
Claims | SETS GRI-FILL 3.0 1 WAY
and 2 WAYS are disposable
components of the GRI-FILL
3.0 pharmacy compounding
system used to provide a fluid
pathway through which one
or two source substances are
channeled to an IV container
or syringe. SETS GRI-FILL
3.0 MULTIPLE are ancillary
devices connected to SETS
GRI-FILL 3.0 1 WAY or 2
WAYS used to provide a fluid
pathway through which the
same substance in up to 6
source containers may be
delivered into a final IV
container. The device is NOT
intended to be connected
directly to the patient. | SETS GRI-FILL 2.0 are
disposable components of the
GRI-FILL 2.0 pharmacy
compounding system used to
provide a fluid pathway
through which 1 or more
source solutions are delivered
into a single final solution.
The device is NOT intended
to be connected directly to
the patient. | 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. |
| 2. | Technological
features: | | | |
| | -
Sterilization
- Direct
- patient
hook-up | Ethylene Oxide
NO | Ethylene Oxide
NO | Ethylene Oxide
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 | 1(1WAY Set) 2(2WAY Set) | 1 (1WAYSet) or 2 (2WAY | 6 |
2
TECHNICAL EVALUATION GRIFOLS DOCUMENTATION . ECTION 1 - SETS GRI-FILL 3.0: 510(k) SU
| # | Characteristic /
Feature | PROPOSED DEVICE | PREDICATE DEVICES | |
|----|-----------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------|------------------------------|
| | | SETS GRI-FILL 3.0 | SETS GRI-FILL 2.0 | FLEBOSET
MULTIPLE |
| | containers | up to 6 with MULTIPLE
ancillary device. | Set) | |
| 3. | Main Transfer Set
Material | PVC with DEHP
plasticizer | PVC with DEHP
plasticizer | PVC with DEHP
plasticizer |
| 4. | Physical, Mechanical
and Biological
Specifications | Sterile / Non pyrogenic | Sterile / Non pyrogenic | Sterile / Non
pyrogenic |
| 5. | Closed system (fluid
not in contact with
any resusable part of
the compounding
device). | YES | YES | YES |
| 6. | Integrated waste
container | YES | NO | NO |
From the above table, it can be established that the new device and the predicate devices are very similar. In fact, the proposed device is a newer version of the SETS GRI-FILL 2.0. As a new feature, the proposed SETS GRI-FILL 3.0 incorporate a waste bag as a permanently attached COMPONENT. The 3.0 version has been designed specifically to be used in conjunction with the GRI-FILL 3.0 pharmacy compounder which also allows the addition of a determined amount of solution to a pre-filled container as well as the reconstitution of powder drugs previous to their being used in subsequent pharmacy compounding
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
All materials used in the construction of SETS GRI-FILL 3.0 have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use as a parenteral drug solution fluid pathway.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- accurate delivery of specified source solutions under normal conditions and stress conditions
- fluid / air leakage checking -
CONCLUSIONS:
We believe the intended use, the indications for use, the functionality and the operation of both SETS GRI-FILL 3.0 and the predicate devices for fluid transfer in pharmacy compounding are essentially the same. Hence, substantial equivalence in pharmacy contpolining allering allering marketed device may be established.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
FEB 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laboratorios Grifols, S.A. C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 1655 Scott Boulevard Santa Clara, California 95050-4169
Re: K050339
Trade/Device Name: Sets Gri-Fill 3.0 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: February 10, 2005 Received: February 11, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becales as a section is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use batter to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to de views martic Act (Act) that do not require approval of a premarket the Federal I ood, Drug, and Ocomette , therefore, market the device, subject to the general approvincianon (Included to the general controls provisions of the Act include condivis provisions of the rion i listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device to subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the evas nouncements concerning your device in the Federal Register.
4
Page 2 - Mr. Christensen
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticase be auvrisod that 1 DTF o lection of that your device complies with other requirements mean that I Drima mass statutes and regulations administered by other Federal agencies. or the Act of ally I oderal blance and by sequirements, including, but not limited to: registration 1 ou intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 CF rear 807), aquality systems (QS) regulation (21 CFR Part 820); and if requirements us sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This retter wifi and in your finding of substantial equivalence of your device to a premarket notification. - The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific at no Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ LOSU33 S
Device Name: SETS GRI-FILL 3.0
Indications for Use:
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in SETS OFF I the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to confulletion will the Orthway through which one or two source substances are delivered into a final IV container or syringe.
SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated 1 WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.
This device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C. Kunn
Frion Sign-Off) Invision of Anesthesiology, General Hospital, Infection Control, Dental Devices
长45.033 110(k) Number ._______________________________________________________________________________________________________________________________________________________________
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