SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE

{0}------------------------------------------------ K033682 # DEC 1 7 2003 Attachment la Page 2 of 6 Revised: 7/1/96 # 12 2017 10:30 10 10 10 10 1 REELL 2.0: 510(K) #### DATE OF SUBMISSION: SUBMITTER NAME: SUBMITTER ADDRESS: 2003-07-30 Laboratorios Grifols, S.A. C/ Can Guasch, 2 08150 PARETS DEL VALLES BARCELONA SPAIN TELEPHONE: FAX: e-mail: sebastian.gascon@grifols.com Sebastian Gascón + 34 93 571 01 00 + 34 93 573 09 12 Technical Director SETS GRI-FILL 2.0 I.V. FLUID TRANSFER SETS CONTACT: DEVICE TRADE NAME: COMMON NAME: CLASSIFICATION NAME: PREDICATE DEVICE: DEVICE DESCRIPTION: SETS GRI-FILL 2.0 are fluid transfer sets for use with the GRI-FILL 2.0 pharmacy compounding device in order tc compound or mix different multi-ingredient solutions and to channel them into a final suitable container. The set is a disposable component of the compounding device made up of a syringe, a distributor and tubing to channel the fluid. Sets are available for 1 or 2 source solutions. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The model Luer Connection Tube can be joined to the 1 way or 2 ways sets as prolongation for connection to source solution containers with luer terminals. I.V. FLUID TRANSFER SETS (21 CFR 880.5440) Exacta-Mix 2400 Compounding System Administration Set (BAXA) Automix 3+3 Compounder Transfer Set (BAXTER HEALTHCARE) {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a document with the title "TECHNICAL EVALUATION DOCUMENTATION" and the logo "GRIFOLS" on the left side. On the right side, it says "Document: TED-SETS GRI-FILL 2.0-01". The bottom of the document says "SECTION 1 - SETS GRI-FILL 2.0: 510(k) SUMMARY". #### INTENDED USE: 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. ## SUMMARY OF COMPARISON WITH PREDICATE DEVICE: In the establishment of substantial equivalence, SETS GRI-FILL 2.0 are compared with other transfer sets used in pharmacy compounding. The following table summarizes the similanties of the principal technological characteristics and features of both predicate and new devices. | # | Characteristic /<br>Feature | SETS GRI-FILL | PREDICATES | | |----|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | BAXA<br>Exacta-Mix Set | BAXTER<br>Automix 3+3<br>(set presented<br>together with<br>compounder) | | 1. | Intended use / Claims | SETS GR-FILL 2.0 are<br>disposable components of<br>the GRI-FILL 2.0 pharmacy<br>compounding system used<br>to provice a fluid pathway<br>through which 1 or more<br>source solutions are<br>delivered into a single final<br>solution. The device is NOT<br>Intended to be connected<br>directly to the patient | Exacta-Mix 2400<br>Compounding System<br>Administration set is a<br>disposable component of a<br>compounding device used in<br>the pharmacy to compound<br>multiple source ingrediens<br>into one final solution. This<br>device is not intended for<br>direct patient hook-up. | Positive displacement<br>fluid compounding<br>system employing the<br>3+3 compounder,<br>TRANSFER SETS,<br>empty Viafex or<br>Travamulsion<br>containers and multitask<br>computer software to<br>provide compounding of<br>a wide var ety of fuids | | 2. | Technological features:<br>- Sterilization<br>- Direct patient<br>hook-up<br>- Source<br>solutions | Ethylene Oxide<br>NO<br>2 | Ethylene Oxide<br>NO<br>Multiple | Radiation<br>NO<br>6 | | 3. | Main Transfer<br>Materials | Set PVC with DEHP<br>plasticizer | PVC | PVC with DEHP<br>plasticizer | | 4. | Physical, Mechanical<br>and Biological<br>Specifications | Sterile / Non pyrogenic | Sterile / Non pyrogenic | Sterile / Non<br>pyrogenic | | 5. | Closed system (fluid not<br>in contact with any<br>resusable part of the<br>compounding device). | YES | YES | YES | {2}------------------------------------------------ Image /page/2/Figure/1 description: The image shows a document with the title "TECHNICAL EVALUATION DOCUMENTATION" and the logo "GRIFOLS" on the left side. On the right side, it says "# Document: TED-SETS GRI-FILL 2.0-01". The bottom of the image says "SECTION 1 - SETS GRI-FILL 2.0: 510(k) SUMMARY". From the above table, it can be established that the new device and the predicate devices are very similar ### SUMMARY DISCUSSION OF NON-CLINICAL DATA: All materials used in the construction of SETS GRI-FILL 2.0 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 transfer set. 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 2.0 and the predicate devices for fluid transfer in pharmacy compounding are essentially the same. Hence, substantial equivalence of SETS GRI-FILL 2.0 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 features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, body, and legs. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle, with the department's name at the top and "USA" at the bottom. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 17 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: K033682 Trade/Device Name: Set GRI-FILL 2.0-1 way 2.0-2 ways . Luer Connection Tube Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI, NEP Dated: December 11, 2003 Received: December 12, 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 Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 -Ms. Gill 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) 594-14618. 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, Cloris 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}------------------------------------------------ GRIFOLS TECHNICAL EVALUATION DOCUMENTATION # Document: TED-SETS GRI-FILL 2.0-09 SECTION 09 – SETS GRI-FILL 2.0: INDICATIONS FOR USE STATEMENT # PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (as required by ODE for all 510(k) received after Jan. 1, 1996) 510(k) Number: Device Name: SETS GRI-FILL 2.0 Indications for Use: All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospites in hospites for a macy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician. (Do not write below this line. Continue on another page in needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Patrizia Cucorete (Division Sign-Off) Division of Anesthesiology, General nospilal Infection Control, Dental Devices 510(k) Number: N033682 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use