QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.

Device Description

QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multi-dose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (QUICKPIN), focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the format requested. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, is not present.

However, I can extract information related to the device's functional validation, which serves as a form of acceptance in the context of a 510(k) submission.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criteria (Implied from Functional Testing)	Reported Device Performance
Materials meet USP physicochemical and ISO 10993-1 biological tests.	All materials comply.
Correct operation of the device in foreseeable operating conditions.	Correct operation demonstrated.
No adverse influence on safety and performance due to technological differences (filter materials, air-inlet dimensions).	Verified by bench-testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided document. The text mentions "bench tests performed on the proposed QUICKPIN device" and "Functional laboratory testing."
Data Provenance: The document implies in-house laboratory testing conducted by Grifols or a contracted lab. The exact country of origin and whether it was retrospective or prospective is not specified, but typically bench testing for device validation is prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This type of information is typically related to clinical studies or performance evaluations where human judgment forms the ground truth, which is not the primary focus of this 510(k) summary (which relies on bench testing for substantial equivalence).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done/reported. The device is a Luer-lock spike, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical medical device, not an algorithm. However, its "standalone" performance in terms of functionality was evaluated via bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For materials: Conformance to established standards (USP physicochemical tests, ISO 10993-1 biological tests) serves as the "ground truth."
For functional performance: The "ground truth" is the device operating correctly according to its intended use in simulated or laboratory conditions. This would be based on predefined engineering specifications and functional requirements.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/machine learning model.

Summary

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SEP 2 9 2008

K082752 (P. 1 of 4)

GRIFOLS	TECHNICAL EVALUATION DOCUMENTATION
# Document:	TED-QUICKPIN-05

SECTION 5 -- QUICKPIN: 510(k) SUMMARY#### INTENDED USE:

QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compoundinq for addition and/or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multi-dose vials.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, QUICKPIN is compared with another vial access device (Chemo-Aide Dispensing Pin – Baxter Healthcare Corporation) and with an IV fluid transfer set previously marketed by Laboratorios Grifols (Fleboset Multiple). The following fable summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.

#	Characteristic / Feature	QUICKPIN	PREDICATES
			BAXTERChemo AideDispensing PinK003730	LAB.GRIFOLSFleboset MultipleK040456
1.	Intended use / Claims	QUICKPIN is a Luer-lockspike used in manual orautomated pharmacycompounding for additionand/or extraction of IVsubstances, includingantineoplastics andsubstances for chemotherapy,from rubber-stopperedcontainers including multi-dose vials.	The Baxter CHEMO-AIDEDispensing Pin is intendedfor use in the preparationand dispensing ofchemotherapeuticmedications from rubber-stoppered vials.	FLEBOSET MULTIPLEis an ancillary deviceused as fluid pathwaythrough whichsubstances from 6glass source flaskscontaining the samesolution may becontinuously deliveredfor: (a) Pharmacycompounding, whenused in conjunction withthe GRI-FILL 2.0pharmacy compoundingdevice and associatedtransfer sets, and (b)I.V. administration,when used inconjunction with agravity or pump infusionset to channel thesolution from the sourcecontainers to theinfusion set.The device should notbe used with lipids.
#	Characteristic /Feature	QUICKPIN	PREDICATESBAXTERChemo AideDispensing PinK003730	LAB.GRIFOLSFleboset MultipleK040456
2.	Indications for use	QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician	The proposed Baxter CHEMO-AIDE Dispensing Pin is intended for use in the preparation and dispensing chemotherapeutic medications from rubber stoppered vials.	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.This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
3.	Technologicalfeatures:- Sterilization- Contact with patient	Ethylene OxideNO - Intended for use in manual or automated pharmacy compounding of IV substances including	Radiation - GammaNO - Intended for use by the pharmacist in the preparation and dispensing of chemotherapeutic	Ethylene OxideYES - May be used on-line with patient upstream of the gravity administration set or
#	Characteristic /Feature	QUICKPIN	PREDICATESBAXTERChemo AideDispensing PinK003730	LAB.GRIFOLSFleboset MultipleK040456
		antineoplastics andsubstances for chemotherapy.	medications.	infusion pump.
	Filter	YES - 0.2 micron hydrophobicair-filter to minimize theformation of aerosols duringpreparation andadministration of thesubstances.	YES - 0.22 micronhydrophopic / oleophobicair-venting filter thatminimizes potential foraerosolization ofchemotherapeuticmedications duringreconstitution anddispensing process.	YES - 1.2 micron air-venting filter.
4.	Physical, Mechanicaland BiologicalSpecifications	Sterile / Non-pyrogenic /Single-use only	Sterile / Non pyrogenic /Single-use only	Sterile / Non pyrogenicSingle-use only
5.	Materials	Spike body: ABS (Acrylonitrilebutadiene styrene)Luer Protective cap: PP(Polypropylene)Filter housing: PVCFilter: PTFE (Polytetrafluoro-ethylene)	Spike body: ABS + PE(Acrylonitrile butadienestyrene and polyester)Filter housing: ABS + PE(Acrylonitrile butadienestyrene and polyester)Filter: PVDF (Polyvinyldenefluoride)	Spike body: ABS(Acrylonitrile butadienestyrene)Spikeable twist-offconnection: PVC(Polyvinylchloride)Filter housing: PPFilter: Acrylic copolymer+ PA
6.	Conformancestandards	The spike conforms toapplicable requirements ofISO 8536-4 except regardingspike dimensions which havebeen adapted specifically forsmall container access.Materials used meet therequirements of USPphysicochemical tests forplastics and biological testsoutlined in standard ISO10993-1.	Materials used meet therequirements of USPphysicochemical tests forplastics and biological testsoutlined in standard ISO10993-1.	The spike conforms toapplicable requirementsof ISO 8536-4.Materials used meet therequirements of USPphysicochemical testsfor plastics andbiological tests outlinedin standard ISO 10993-1.

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K482752 (P. 20P4)

GRIFOLS

Document:

DOCUMENTATION

TECHNICAL EVALÚATION

ted-quickpin-05

SECTION 5 - QUICKPIN: 510(k) SUMMARY

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K482052 (P.3084)

GRIFOLS

Document:

DOCUMENTATION

TECHNICAL EVALUATION

TED-QUICKPIN-05

SECTION 5- QUICKPIN: 510(k) SUMMARY

From the above table, it can be established that the new device and the predicate device Baxter Chemo-Aide Dispensing Pin have very similar intended uses and indications. Also, the materials used in the construction of the proposed spike and those used in spike component of the predicate device Fleboset Multiple are identical. Some differences may be noted in the

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	K482752 (P.4 of 4)
GRIFOLS	TECHNICAL EVALUATION	# Document:
	DOCUMENTATION	TED-QUICKPIN-05
SECTION 5 - QUICKPIN: 510(k) SUMMARY

dimensions and type of materials used in the filter component and air-inlet on the spike. These differences have been addressed in the different bench tests performed on the proposed QUICKPIN device.

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

All materials used in the construction of QUICKPIN have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use,

CONCLUSIONS:

We believe the intended use, the indications for use, the functionality and the operation of QUICKPIN and the CHEMO-AIDE predicate device as access devices for rubber stoppered containers are essentially the same. Also, the materials used in the construction the proposed device and those used in the spike component of the FLEBOSET MULTIPLE predicate device are identical. Technological differences including the use of different filter materials and different dimensions on the air-inlet channel on the spike have been addrt fined and verified by bench-testing to have no adverse influence on the safety and performance of the proposed device. Hence, substantial equivalence of QUICKPIN with the legally marketed devices may be established.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2008

Laboratorios Grifols, S.A. C/O Mr. Norbert Stuiber Responsible Third Party Officer TUV SUD America, Incorporated 1775 Old Highway 8 N.W. New Brighton, Minnesota 55112-1891

Re: K082752

Trade/Device Name: QUICKPIN Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 17, 2008 Received: September 19, 2008

Dear Mr. Stuiber:

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.

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Page 2 - Mr. Stuiber

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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GRIFOLS

TECHNICAL EVALUATION DOCUMENTATION

Document: TED-QUICKPIN-04

SECTION 04 - QUICKPIN:

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:

K082752

Device Name:

QUICKPIN

Indications for Use:

This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.

(Do not write below this line. Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓(21 CFR 801 Subpart D)	OR	Over-The-Counter Use ____(21 CFR 801 Subpart C)
-----------------------------------------------------------------------------------------------	----	------------------------------------------------------------------------------------------------------

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K982752
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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.