(10 days)
Not Found
No
The device description and intended use focus on a mechanical Luer-lock spike with a filter, and there is no mention of AI, ML, or any computational processing.
No
The device is a compounding tool for preparing and dispensing IV substances, not for treating a disease or condition in a patient.
No
The device is described as a Luer-lock spike for pharmacy compounding (addition/extraction of IV substances) and is equipped with an air-filter. Its function is to facilitate drug preparation and dispensing, not to diagnose a medical condition.
No
The device description clearly states it is a "Luer-lock spike" and includes a "0.2 micron hydrophobic air-filter," which are physical hardware components.
Based on the provided information, the QUICKPIN device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the addition and/or extraction of IV substances from containers. This is a process related to preparing and dispensing medications, not for performing diagnostic tests on biological samples.
- Device Description: The description reinforces its function as a spike with a filter for handling substances in vials. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The QUICKPIN is a medical device used in the preparation and handling of medications, specifically in a pharmacy compounding setting.
N/A
Intended Use / 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 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. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
LHI
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 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.
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 healthcare personnel; manual or automated pharmacy compounding.
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)
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. Technological differences including the use of different filter materials and different dimensions on the air-inlet channel on the spike have been addressed and verified by bench-testing to have no adverse influence on the safety and performance of the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
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 | |
|---|---|---|---|---|
| BAXTER | ||||
| Chemo Aide | ||||
| Dispensing Pin | ||||
| K003730 | LAB.GRIFOLS | |||
| Fleboset Multiple | ||||
| K040456 | ||||
| 1. | Intended use / Claims | 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. | The Baxter CHEMO-AIDE | |||
| Dispensing Pin is intended | ||||
| for use in the preparation | ||||
| and dispensing of | ||||
| 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. | ||||
| # | Characteristic / | |||
| Feature | QUICKPIN | PREDICATES | ||
| BAXTER | ||||
| Chemo Aide | ||||
| Dispensing Pin | ||||
| K003730 | LAB.GRIFOLS | |||
| Fleboset Multiple | ||||
| K040456 | ||||
| 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. | Technological | |||
| features: |
- Sterilization
- Contact with patient | Ethylene Oxide
NO - Intended for use in manual or automated pharmacy compounding of IV substances including | Radiation - Gamma
NO - Intended for use by the pharmacist in the preparation and dispensing of chemotherapeutic | Ethylene Oxide
YES - May be used on-line with patient upstream of the gravity administration set or |
| # | Characteristic /
Feature | QUICKPIN | PREDICATES
BAXTER
Chemo Aide
Dispensing Pin
K003730 | LAB.GRIFOLS
Fleboset Multiple
K040456 |
| | | antineoplastics and
substances for chemotherapy. | medications. | infusion pump. |
| | Filter | YES - 0.2 micron hydrophobic
air-filter to minimize the
formation of aerosols during
preparation and
administration of the
substances. | YES - 0.22 micron
hydrophopic / oleophobic
air-venting filter that
minimizes potential for
aerosolization of
chemotherapeutic
medications during
reconstitution and
dispensing process. | YES - 1.2 micron air-
venting filter. |
| 4. | Physical, Mechanical
and Biological
Specifications | Sterile / Non-pyrogenic /
Single-use only | Sterile / Non pyrogenic /
Single-use only | Sterile / Non pyrogenic
Single-use only |
| 5. | Materials | Spike body: ABS (Acrylonitrile
butadiene styrene)
Luer Protective cap: PP
(Polypropylene)
Filter housing: PVC
Filter: PTFE (Polytetrafluoro-
ethylene) | Spike body: ABS + PE
(Acrylonitrile butadiene
styrene and polyester)
Filter housing: ABS + PE
(Acrylonitrile butadiene
styrene and polyester)
Filter: PVDF (Polyvinyldene
fluoride) | Spike body: ABS
(Acrylonitrile butadiene
styrene)
Spikeable twist-off
connection: PVC
(Polyvinylchloride)
Filter housing: PP
Filter: Acrylic copolymer
- PA |
| 6. | Conformance
standards | The spike conforms to
applicable requirements of
ISO 8536-4 except regarding
spike dimensions which have
been adapted specifically for
small container access.
Materials used meet the
requirements of USP
physicochemical tests for
plastics and biological tests
outlined in standard ISO
10993-1. | Materials used meet the
requirements of USP
physicochemical tests for
plastics and biological tests
outlined in standard ISO
10993-1. | The spike conforms to
applicable requirements
of ISO 8536-4.
Materials used meet the
requirements of USP
physicochemical tests
for plastics and
biological tests outlined
in standard ISO 10993-
-
|
1
K482752 (P. 20P4)
GRIFOLS
Document:
DOCUMENTATION
TECHNICAL EVALÚATION
ted-quickpin-05
SECTION 5 - QUICKPIN: 510(k) SUMMARY
2
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
3
| 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.
4
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.
5
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
6
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:
Device Name:
QUICKPIN
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.
(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 |
|---|---|
| ---------------- | ---------------------------------------------------------- |
9