(73 days)
The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi dose vials to inject or withdraw fluids without the use of a needle. The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.
The Gettig Universal Vial Access Pin is a plastic "needle" used to pierce the diaphragm of single and multi dose vials for the injection or withdrawal of fluids. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and plastic "needle" for piercing the diaphragm. There is also a polypropylene cover for the "needle" portion.
The provided document is a 510(k) summary for the Gettig Universal Vial Access Pin, a medical device. It does not describe a study involving an AI or algorithm or human readers for diagnostic purposes. Instead, it describes a non-clinical study to demonstrate substantial equivalence to predicate devices based on engineering standards.
Therefore, many of the requested categories (e.g., AI performance, reader studies, training sets, ground truth for AI) are not applicable to this document.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by compliance with specific ISO standards demonstrating the safety and functionality of the physical device. The reported performance is that the device met these standards and was found substantially equivalent to predicate devices.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 7886-1:1993 (Sterile Hypodermic Syringes for Single Use) | Achieved - testing results revealed substantial equivalence to predicate devices (which presumably comply with this standard). |
| Compliance with ISO 594-1:1986 (Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 1 General Requirements) | Achieved - testing results revealed substantial equivalence to predicate devices. |
| Compliance with ISO 594-2:1991 (Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment. Part 2 Lock Fittings) | Achieved - testing results revealed substantial equivalence to predicate devices. |
| Compliance with ISO 8536-4:1998 (Part 4 Infusion Equipment for Medical Use Infusion Sets for Single Use, Gravity Feed) | Achieved - testing results revealed substantial equivalence to predicate devices. |
Study Details (Non-Clinical / Substantial Equivalence)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was conducted on the Gettig Universal Vial Access Pin and the predicate devices according to the listed ISO standards. The standards themselves define the number of units or tests required for compliance.
- Data Provenance: Not applicable in the sense of country of origin for patient data. This was a non-clinical engineering/physical testing study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here. This study assessed the physical characteristics and performance of a medical instrument against engineering standards. The "ground truth" is adherence to the technical specifications defined by the ISO standards. The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against the standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used in clinical studies with human readers or AI outputs. This was a non-clinical, standards-based engineering test.
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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:
- Not Applicable. This is a physical medical device (vial access pin), not a diagnostic AI. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device; there is no algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical Compliance to ISO Standards: The "ground truth" for this substantial equivalence determination was the compliance of the device's physical properties and functionality with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2, ISO 8536-4). The predicate devices also serve as a benchmark for comparison within these standards.
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The sample size for the training set:
- Not Applicable. This is a hardware device. There is no AI or algorithm with a training set.
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How the ground truth for the training set was established:
- Not Applicable. There is no training set mentioned in this documentation.
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JUL 2 2 2004
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is Ko 412 32
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- Submitter's Identification:
Gettig Pharmaceutical Instrument Company 1 Streamside Place West P. O. Box 85 Spring Mills, PA 16875
- Submitter's Identification:
Date Summary Prepared: November 18, 2003
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- Name of the Device:
Trade Name: Gettig Universal Vial Access Pin
- Name of the Device:
Common Name: Vial Access Pin
Classification Name: Set, I.V. Fluid Transfer
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- Predicate Device Information:
- A. Alaris Single Dose Dispensing Pin (K#013087)
- B. MPS Acacia Flow Ease Plastic Vented Needle (K#853212)
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- Device Description:
The Gettig Universal Vial Access Pin is a plastic "needle" used to pierce the diaphragm of single and multi dose vials for the injection or withdrawal of fluids. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and plastic "needle" for piercing the diaphragm. There is also a polypropylene cover for the "needle" portion.
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- Intended Use:
- b. The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi dose vials to inject or withdraw fluids without the use of a needle.
The Gettig Universal Vial Access Pins is indicated for use with standard medication vials.
Image /page/0/Picture/20 description: The image shows a logo with the word "GETTIG" written in uppercase letters above a black and white graphic. The graphic appears to be a stylized letter "G" formed by a black square and a white semi-circle. To the right of the graphic, the letter "G" is repeated.
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- Summary of Technological Characteristics:
The Gettig Disposable Syringe has the same intended use as the predicate devices. All are operated manually. The materials used for the Gettig Universal Vial Access Pin (polysulfone and polypropylene) are the same class of materials as the materials used in the Alaris Single Dose Dispensing Pin and the MPS Acacia Flow Ease Plastic Vented Needle predicate devices.
- Summary of Technological Characteristics:
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- Non-Clinical Tests Performed for Determination of Substantial Equivalence:
Testing from the following standards was conducted on the Gettig Disposable Syringe and the predicate devices:
- Non-Clinical Tests Performed for Determination of Substantial Equivalence:
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A. ISO 7886-1:1993 Sterile Hypodermic Svringes for Single Use
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B. ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes. Needles and Certain Other Medical Equipment, Part 1 General Requirements
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C. ISO 594-2:1991 Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment. Part 2 Lock Fittings
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D. ISO 8536-4:1998 Part 4 Infusion Equipment for Medical Use Infusion Sets for Single Use, Gravity Feed.
The testing results revealed the Gettig Universal Vial Access Pin to be substantially equivalent to the predicate devices.
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- Conclusion:
The Gettig Universal Vial Access Pin has the same intended use and similar technological characteristics as the Alaris Single Dose Dispensing Pin and MPS Acacia Flow Ease Plastic Vented Needle. There are no new technological characteristics that raise any new questions of safety and effectiveness. Thus, the Gettig Universal Vial Access Pin is substantially equivalent to the predicate devices.
- Conclusion:
Image /page/1/Picture/12 description: The image shows a logo with the word "GETTIG" on top of a graphic. The graphic is a circle divided into quadrants, with the upper right quadrant being black and the rest of the circle being white. A thick black line runs vertically through the center of the circle, creating a visual separation.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Mr. James A. Benz Quality Assurance Manager Gettig Pharmaceutical Instrument Company One Streamside Place West Spring Mills, Pennsylvania 16875-0085
Re: K041232
Trade/Device Name: Gettig Universal Vial Access PIN Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: May 7, 2004 Received: May 10, 2004
Dear Mr. Benz:
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. Benz
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 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: K041232
Device Name: Gettig Universal Vial Access PIN
Indications For Use:
The intended use of the Gettig Universal Vial Access Pin is to pierce the The intended use of the occitir only to inject or withdraw fluids without the use of a needle.
The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Divisio Jugar-Off) Division a nesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number KU44232
§ 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.