Churchill Medical Systems Vial Access Spike with Needleless Connector is used in I.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device climinates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.

Device Description

The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "Universal Vial Access Spike with Needleless Connector" by Churchill Medical Systems, Inc. However, the document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and performance studies.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device is manufactured and tested in accordance with certain physical, chemical, and biological specifications. It references standards but does not provide specific quantitative acceptance criteria or detailed results.

Acceptance Criteria Category	Reported Device Performance
Physical Specifications	Conforms to internal requirements
Chemical Specifications	Conforms to applicable requirements set forth in USPXX111
Biological Specifications	Conforms to applicable requirements set forth in ISO 10993, USP Pyrogenicity test requirements
Sterilization	Conforms to applicable requirements set forth in ISO 11135
Packaging	Conforms to applicable requirements set forth in ISO 11607-1
Prevention of Accidental Needle Sticks	Confirmed to be safe and effective (by sharing similar technical characteristics to predicate device)

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

Sample size: Not specified.
Data provenance: Not specified, but generally, such studies for 510(k) submissions are conducted internally by the manufacturer or their contracted labs. Given the device type, it's likely physical and chemical lab testing, not patient data. Retrospective or Prospective: N/A (not applicable as it's not a clinical study with patient data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The nature of the device (a vial access spike) suggests that "ground truth" would be established through laboratory testing against predefined specifications rather than expert consensus on medical images or clinical outcomes.

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

This information is not provided. Given it's a device for fluid transfer and needle stick prevention, not diagnostic imaging, adjudication methods like 2+1 or 3+1 are not typically relevant.

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. This type of study (MRMC for AI assistance) is not applicable to this device. The device is a physical medical instrument, not an AI-powered diagnostic tool.

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

No. This is not an AI algorithm. Its performance is evaluated based on its physical and material properties and its ability to prevent needle sticks, which is a standalone function of the device itself.

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

The "ground truth" for this device would be the specific, quantifiable parameters defined by the referenced industry standards (ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements) and internal physical testing requirements. For example, burst pressure for the spike, material compatibility, sterility assurance level, and ability to prevent needle sticks in simulated use.

8. The sample size for the training set:

N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

N/A. This device does not involve a "training set" or "ground truth" for training in the machine learning sense. The "ground truth" for its physical performance characteristics is established by adherence to recognized standards and validated internal test methods.

Summary

{0}------------------------------------------------

K013949

510(K) Summary

MAR 2 7 2002

and the comments of

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

1.	Submitter:	Churchill Medical Systems, Inc.
	Address:	87 Venture Drive
		Dover, NH 03820
	Phone:	603-743-5988
	Fax:	603-743-6328
	Contact:	Keith Paluch (Consultant)
2.	Device Name:	Vial Access Device
	Trade Name:	Universal Vial Access Spike with Needleless Connector
	Classification Name:	IV Set Stopcock, IV Administration Set Accessories
3.	Classification:	Class II, General Hospital 80 FPA
4.	Predicate Device:	B-D Blunt Plastic Cannula 510(k) 974363
5.	Device Description:	The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.
6.	Intended Use:	This device is used to replace hypodermic needles used to pierce and withdraw medical fluids from plastic and glass vials. Use of this device prevents accidental needle sticks in this application.
7.	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, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements as well as documented internal requirements for physical testing.
8.	Conclusion:	This device shares similar technical characteristics to the B-D Blunt Plastic Cannula in that both devices guard against accidental needle sticks caused by human contact with sharp surfaces. Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device.

{1}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling an abstract representation of a bird or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

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

Re: K013949

Trade/Device Name: Churchill Medical Systems Vial Access Spike with Needleless Connector Regulation Number: Intravascular Administration Set and Hypodermic Single Lumen Needle Regulation Name: 880.5440 and 880.5570 Regulatory Class: II Product Code: LHI and FMI Dated: January 19, 2002 Received: January 28, 2002

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.

{2}------------------------------------------------

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 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 Ruisner

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

Enclosure

{3}------------------------------------------------

Indications For Use

510(k) Number (if known): Kol 3949

Device Name: Churchill Medical Systems Vial Access Spike with Needleless Connector

Indications For Use:

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

Prescription Use

Over-The-Counter Use

Patricia Cuscente

(Division Sign-Off) ിന്നാരം മുഴിക്കുന്ന and General Hospital D 510(k) Number -

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.