(12 days)
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No
The description focuses on the physical characteristics and intended use of an IV bag with a filter, with no mention of AI or ML capabilities.
No
Explanation: The device (GRI-BAG) is described as a container for preparing drug solutions that are later administered to a patient. It does not directly treat or diagnose a disease or condition; rather, it facilitates the preparation of therapeutic solutions.
No
This device is an I.V. bag used as a container for preparing drug solutions, which are later administered to the patient. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical, single-use, non-pyrogenic flexible empty container with an incorporated filter, available in different volume capacities. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the GRI-BAG is a container for the preparation of drug solutions and is later administered to the patient. This is a direct therapeutic application, not a diagnostic one.
- Device Description: The description details a flexible bag with a filter for removing particulates and microbes, designed to hold drug solutions. This aligns with a container for intravenous administration, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The GRI-BAG's function is to safely contain and filter drug solutions for direct administration to the patient.
N/A
Intended Use / Indications for Use
All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 urn filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL, pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health care personnel. It is restricted to sale by or on order of a physician. The device should not be used with lipids.
Product codes (comma separated list FDA assigned to the subject device)
KPE, FPB, NEP
Device Description
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 um filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml. 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRI-BAG AP models have a conus vial output connector.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
trained health care personnel
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).
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- 1 - 1 - 1 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 -GRIFOLS CA CALLA CA ION 1 - GRI-BAG: 510(k) SUN
DATE OF SUBMISSION:
2003-04-14 (re-submitted 2003-11-24)
SUBMITTER NAME: SUBMITTER ADDRESS: Laboratorios Grifols, S.A. C/ Can Guasch, 2 08150 PARETS DEL VALLES BARCELONA SPAIN
TELEPHONE: FAX: e-mail:
CONTACT:
Sebastian Gascón Technical Director
-
34 93 571 01 00
-
34 93 573 09 12
DEVICE TRADE NAME: COMMON NAME: CLASSIFICATION NAME: GRI-BAG I.V. BAG with in line 0.2 um filter I.V. CONTAINER (880.5025, KPE) WITH IN LINE FILTER (880.5440, FPB and NEP)
PREDICATE DEVICE:
DEVICE DESCRIPTION:
(BAG) VIAFLEX PLASTIC CONTAINER (BAXTER) (FILTER) PALL SUPOR AEF
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 um filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml. 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRI-BAG AP models have a conus vial output connector.
INTENDED USE:
GRI-BAG is a flexible bag with an incorporated 0.2 um filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. The device should not be used with lipids.
1
Image /page/1/Figure/0 description: The image shows a document with the word GRIFOLS on the left side. The document is titled "TECHNICAL EVALUATION DOCUMENTATION" and has a document number of TED-GRI-BAG-01. The document is labeled as SECTION 1-GRI-BAG: 510(k) SUMMARY.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the GRI-BAG device is compared with 2 predicate devices (bag + filter) due to the fact that it is essentially a combination of these 2 devices marketed as a single unit.
The following table summarizes the principal technological characteristics and features of both predicate and new devices.
| # | Characteristic /
Feature | GRI-BAG | PREDICATE | |
|----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | BAG | FILTER |
| 1. | Filter membrane | Cellulose acetate | N/A | Polyethersulphone |
| 2. | Filter pore | 0.2µm | N/A | 0.2µm |
| 3. | Filter housing | Cyrolite | N/A | Polypropylene |
| 4. | Bag material | PVC with DEHP plasticizer | PVC with DEHP plasticizer | N/A |
| 5. | Tubing material | Medical grade PVC | Medical grade PVC | N/A |
| 6. | Closure material | PVC membrane protected with a PVC Twist-off valve in GRI-BAG models and Chlorobutyl rubber stopper in a polycarbonate housing protected with a polypropylene cover in GRI-BAG AP models. | PVC membrane with protective film sheath | N/A |
| 7. | Sterility | SAL 106 ETO | SAL 106 Gamma | SAL 106 ETO |
| 8. | Single-use | YES | YES | YES |
| 9. | Intended use | GRI-BAG is a flexible bag with an incorporated 0.2 µm filter for the drug removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. The device should not be used with lipids | Intended for use in the preparation of drug admixtures available in sizes from 50 - 400 ml. | Removal by in-line of filltration of inadvertent contaminants (including bacteria, particulates, and entrained air) from infused intravenous fluids. |
2
-BAG: 510(k) SUMM
The principal differences between the GRI-BAG device and the predicate devices lie The principal differences both on the filter are different and also, the predicate with the fact that the matehally whereas the GRI-BAG is presented as an integral unit combining the two.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
SUMMANT DIGOOOON Of the biocompatibility test data available for all materials and the biological According to the broompanality we have established that the GRI-BAG device fulfills the requirements set out in ISO 10993 and ISO DIS 15747.
Functional testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use.
With reference to the following guidelines:
- · "Guidance on Premarket Notifications for Intravascular Administration Sets"
- · Guidance of Promante Rouidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA";
functional testing has been performed in accordance with applicable clauses of $50. functional testing has boom portembag component) and ISO 8536-4 and ASTM F838-DIG 1014) and OOF - 0011 (for the Dag correct operation of the device as per its intended use.
CONCLUSIONS:
We believe the intended use, the indications for use and the design for both GRI-BAG vve believe the intendou acon ate devices are essentially the same. Moreover, the filter aria the combination of patthough different, are of comparable safety and, hence, construction materials, annough and with the legally marketed devices may be established.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Laboratories Grifols, S.A. Ms. Susan Gill Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709-3995
Re: K033916
Trade/Device Name: GRI-BAG, GRI-BAG AP Regulation Number: 880.5025, 880.5440 Regulation Name: I.V. Container Intravascular Administration Set Regulatory Class: II Product Code: KPE, FPB, NEP Dated: December 16, 2003 Received: December 18, 2003
Dear Ms. Gill:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucurite/for
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
5
CHNICAL EVALUATION BISCHIMEN LANE (8) GRI-BAG: INDICATIONS FOR USE
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (as required by ODE for all 510(k) received after Jan. 1, 1996)
510(k) Number:
Device Name:
GRI-BAG
Indications for Use:
All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 urn filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL, pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health care personnel. It is restricted to sale by or on order of a physician
The device should not be used with lipids.
(Do not write below this line. Continue on another page in needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucurella
(Division Sign-111 (Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K033916
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use