Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

Device Description

The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Access Device" (also referred to as "Mini Transfer Device"). The document outlines the device's description, intended use, and a performance summary. However, it does not detail specific acceptance criteria or a comprehensive study report with quantitative results in the way a modern clinical trial or AI/software validation study would.

Instead, the performance summary focuses on compliance with established standards and comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain market clearance.

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

Acceptance Criteria and Study for the Churchill Medical Systems Mini Transfer Device (K013950)

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a typical clinical trial format (e.g., specific sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The study described is a series of tests to ensure this compliance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Physical Performance	Conformance to applicable requirements set forth in documented internal requirements for physical testing. (Specific thresholds not detailed)	Device is "manufactured and tested in accordance with physical... specification." Implied successful performance as concluded to be safe and effective.
Chemical Performance	Conformance to applicable requirements set forth in documented internal requirements for chemical testing. (Specific thresholds not detailed)	Device is "manufactured and tested in accordance with... chemical... specification." Implied successful performance as concluded to be safe and effective.
Biological Performance	Conformance to ISO 10993-1 (Biological evaluation of medical devices).	Device is "manufactured and tested in accordance with... biological specification conforming to the applicable requirements set forth in ISO 10993-1..." Implied bio-compatibility and safety.
	Conformance to USP 24 (United States Pharmacopeia standards, likely for pyrogenicity and other sterility/endotoxin tests).	Device is "manufactured and tested in accordance with... biological specification conforming to the applicable requirements set forth in... USP 24..."
	Conformance to USP Pyrogenicity test requirements.	"USP Pyrogenicity test requirements" were met.
Sterilization/Packaging	Conformance to ISO 11607-1 (Packaging for terminally sterilized medical devices) and ISO 11135 (Sterilization of health care products — Ethylene oxide).	Device is "manufactured and tested in accordance with... specification conforming to the applicable requirements set forth in... ISO 11607-1, ISO 11135..." This indicates proper packaging integrity and effective sterilization.
Functional Equivalence	Performance similar to the predicate device: Baxter Healthcare Chemo-Aide Dispensing Pin (K003730).	"This device performs similarly to the predicate device... Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device." This is the core finding for 510(k) clearance, implying functional equivalence for transferring/dispensing medications from multi-dose vials. Specific quantitative functional metrics are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify the sample sizes used for the various tests (physical, chemical, biological, or functional comparison). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The implication is that standard manufacturing and testing batches were used as per the mentioned ISO and USP standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in the 510(k) summary. For a device like a vial access device, "ground truth" is typically established by objective measurement against engineering specifications and validated test methods, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be quality engineers, microbiologists, and other technical professionals conducting the tests, ensuring compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against established standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-driven systems where human interpretation is a key component and the goal is to show improvement with AI assistance. The Mini Transfer Device is a mechanical access device.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This concept is not applicable to this medical device. The device is a physical product, not a software algorithm that operates without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Compliance with international and national standards (e.g., ISO 10993-1, USP 24, ISO 11607-1, ISO 11135).
Adherence to internal company specifications for physical and chemical properties.
Performance comparison to a legally marketed predicate device (Baxter Healthcare Chemo-Aide Dispensing Pin), demonstrating "similar technical characteristics" and performance.

These are objective, measurable criteria related to the device's physical properties, biocompatibility, sterility, and functional operation (transferring/dispensing fluids) as designed.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary Takeaway:

The K013950 510(k) summary demonstrates compliance and substantial equivalence through a series of tests against established industry standards and comparison to a predicate device. It does not provide detailed quantitative performance metrics or studies akin to those for AI/software devices or complex diagnostic tools. The focus is on ensuring the device meets safety and effectiveness requirements through adherence to manufacturing and testing protocols relevant to its classification as an IV administration set accessory.

Summary

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K013950

510(K) Summary January 07, 2002

JAN 1 0 2002

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA and 21 CFR 807.92

Submitter: Churchill Medical Systems, Inc. Address: 87 Venture Drive Dover, NH 03820 Phone: 603-743-5988 Fax: 603-743-6328 Contact: Keith Paluch (Consultant)

1. Device Name: Mini Transfer Device Trade Name: Vented Vial Access Device Classification
- IV Administration Set, Accessory
Classification: Class II, General Hospital 80 FPA 3.
Predicate Device: 4. Baxter Healthcare Chemo-Aide Dispensing Pin (K003730)
న్. Device Description: The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.
Intended Use: Q. This device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.
1. Performance Summary: This device is manufactured and tested in accordance with physical, chemical and biological specification conforming to the applicable requirements set forth in ISO 10993-1, USP 24, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements as well as documented internal requirements for physical testing.
1. Conclusion:

Name:

This device shares similar technical characteristics to dispensing and transfer devices currently available in the marketplace. Specifically, this device performs similarly to the predicate device, referred to as Chemo-Aide Dispensing Pin Accessory (K003730). Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device.

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2002

Mr. Keith Paluch Consultant Churchill Medical Systems, Incorporated 87 Venture Drive Dover, New Hampshire 03820

Re: K013950

Trade/Device Name: Vented Vial Access Device Regulation Number: 880.5440 Regulation Name: IV Administration Set, Accessory Regulatory Class: II Product Code: LHI Dated: November 14, 2001 Received: November 30, 2001

Dear Mr. Paluch:

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.

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.

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Page 2 – Mr. Paluch

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Ruma

L. Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known): K013950

Device Name: Churchill Medical Systems Mini Transfer Device

Indications For Use:

Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Smant Rame

Pivision Sign-Off) Consion of Dental, Infection Control, - General Hospital Devices Number JARGSO ------------------

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.