(62 days)
Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.
The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion handle opens or closes each port.
The provided text describes a 510(k) summary for the Churchill Medical Systems 4 Way Stopcock. This document is a premarket notification for a medical device and does not detail a study proving specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and biological specifications and internal performance testing, rather than an AI model's performance.
Therefore, many of the requested sections about AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.
However, I can extract the relevant information from the provided text regarding the closest equivalents to "acceptance criteria" and "device performance" as presented in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device was tested against) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Conformance to applicable requirements set forth in ISO 10993 (Biological Evaluation of Medical Devices) | Device is manufactured and tested in accordance with biological specification conforming to ISO 10993. |
| Conformance to applicable requirements set forth in USP XXII (United States Pharmacopeia) | Device is manufactured and tested in accordance with chemical specification conforming to USP XXII. |
| Conformance to applicable requirements set forth in ISO 11607-1 (Packaging for terminally sterilized medical devices) | Device is manufactured and tested in accordance with physical specification conforming to ISO 11607-1. |
| Conformance to applicable requirements set forth in ISO 11135 (Sterilization of health care products - Ethylene oxide) | Device is manufactured and tested in accordance with physical specification conforming to ISO 11135. |
| Conformance to USP Pyrogenicity test requirements | Device is manufactured and tested in accordance with USP Pyrogenicity test requirements. |
| Conformance to documented internal requirements for physical testing | Device is manufactured and tested in accordance with documented internal requirements for physical testing. |
| Performance similar to predicate device (Ohmeda Connecta Plus 1 and Plus 3, 2 and 3 way stopcocks - K974083) | "Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device." |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the sum of various tests conducted by Churchill Medical Systems, Inc. in accordance with established international and national standards and internal protocols.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text. The submission mentions "testing summary results" and conformance to various standards, implying that samples were tested to demonstrate compliance, but specific quantities are not provided.
- Data Provenance: Not specified. The testing was conducted internally by Churchill Medical Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device (stopcock), not an AI/ML algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is the adherence to the specified physical, chemical, and biological performance parameters as defined by the standards (ISO, USP) and internal requirements.
4. Adjudication method for the test set:
- Not Applicable. As above, this is for a physical device, not an AI/ML algorithm interpretation. Performance is assessed against quantitative and qualitative standards.
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 is a physical medical device (stopcock), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. It does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established international standards (ISO), national pharmacopeia (USP), and internal validated specifications for physical properties, chemical compatibility, biological safety (e.g., cytotoxicity, sensitization, pyrogenicity), and sterility. The device is also compared to the performance characteristics of a predicate device to demonstrate substantial equivalence.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, a training set is not applicable for this type of device.
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Ko12/57
SEP 1 1 2001
510(K) Summary
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 DriveDover, NH 03820 | |
| Phone: | 603-743-5988 | |
| Fax: | 603-743-6328 | |
| Contact: | Keith Paluch (Consultant) | |
| 2. | Device Name: | 4 way Stopcock |
| Trade Name:Classification | 4 Way "Hi-Flow" Stopcock Latex Free, Lipid Resistant | |
| Name: | IV Set Stopcock, IV Administration Set | |
| 3. | Classification: | Class II, General Hospital 80 FPA |
| 4. | Predicate Device: | Ohmeda Connecta Plus 1 and Plus 3, 2 and 3 way stopcocks (K974083) |
| 5. | Device Description: | The Churchill Medical Systems 4 way stopcock consist of a housingwith two one male luer with rotating lock ring. The diversion handleopens or closes each port. |
| 6. | Intended Use: | This device is used to direct and control the flow of fluids. They areadded to IV cannula or extension sets for simultaneous or alternateadministration of fluids. |
| 7. | Performance Summary: | This device is manufactured and tested in accordance with physical,chemical and biological specification conforming to the applicablerequirements set forth in ISO 10993, USPXX111, ISO 11607-1, ISO11135, USP Pyrogenicity test requirements as well as documentedinternal requirements for physical testing. |
| 8. | Conclusion: | This device shares similar technical characteristics to 4 way stopcockscurrently available in the marketplace. Specifically, this deviceperforms similarly to the predicate device, referred to as Connecta Plus1 and 3 Stopcocks (K974083). Testing summary results confirm thisdevice to be safe and effective and substantially equivalent to thepredicate device. |
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
SEP 1 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith Paluch Manager Churchill Medical Systems, Incorporated 87 Venture Drive Dover, New Hampshire 03820
K012157 Re : Churchill Medical Systems Stopcock Trade/Device Name: Requlation Number: 880.5440 Regulatory Class: II Product Code: FMG Dated: July 2, 2001 Received: July 11, 2001
Dear Mr. Paluch:
We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the device fally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major be burfeer to bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug edrough perion (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Paluch
this response to your premarket notification submission does Unis response to your promason wight have under sections 531 not arrect any obirgation for devices under the Electronic Chrough 542 Of the not 10- 10- 10regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sist. I quivalence of your device to a legally Finding of Bubbeandaries results in a classification for your marketed predicate device robated in the to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulation (2) (2) devices) , please contact the Office of Compliance at (301) 594-4518. Additionally, for questions on ebmprianoc as (advertising of your device, please contact che Dromocron and adversee at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, Obtained From the Drisumer 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,
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): K012157
Device Name: Churchill Medical Systems Stopcock
Indications For Use:
Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.
Patrua Cissente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use_
Or
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.