(84 days)
Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.
The Churchill Medical Systems Pressure Activated Check Valve consists of acrylic-polycarbonate alloy valve body and a silicone valve with male and female luer lock connections. The device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents back flow.
The provided text describes a 510(k) summary for a medical device called a "Pressure Activated Check Valve," but it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically expected for an AI/ML device.
This document is a premarket notification for a Class II medical device (a check valve accessory) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies and acceptance criteria for a novel technology or AI algorithm.
Therefore, many of the requested categories for AI/ML device evaluations are not applicable or cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (from "Device Description") |
|---|---|
| Device opens at a specific cracking pressure | Device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI |
| Prevents backflow | Prevents backflow |
| Conforms to applicable requirements set forth in ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements, and documented internal requirements for physical testing. | (Performance specifically to these standards is not detailed in the summary, but the device is stated to be tested in accordance with them.) |
Explanation: The document does not explicitly list "acceptance criteria" for performance. Instead, it describes the functional specifications of the device (cracking pressure, preventing backflow) as part of its description and states that it was tested "in accordance with" various physical, chemical, and biological specifications and standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not applicable/specified. The testing mentioned refers to physical, chemical, and biological specification testing of the device itself, not data used for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The device is a mechanical check valve, not an AI/ML algorithm requiring expert-established ground truth from a test set (e.g., medical images).
4. Adjudication method for the test set:
- This is not applicable as there is no mention of a test set requiring adjudication by experts.
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:
- This is not applicable. The device is a mechanical check valve, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This is not applicable. The "ground truth" for a mechanical device would be its physical properties and functional performance against engineering specifications and relevant standards.
8. The sample size for the training set:
- This is not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
- This is not applicable. There is no AI/ML model or training set.
Summary of the Study (Based on the Provided Text):
The "study" or performance evaluation described in the K011888 summary is a demonstration of substantial equivalence to a predicate device (KVQ Check Valve Accessory, K98441). This involves:
- Performance Summary: Stating that the device is manufactured and tested in accordance with physical, chemical, and biological specifications conforming to ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements, as well as documented internal requirements for physical testing.
- Conclusion: The device shares similar technical characteristics with existing check valves and "performs similarly to the predicate device." The summary results "confirm this device to be safe and effective and substantially equivalent to the predicate device."
This type of submission for a physical, mechanical medical device focuses on meeting established standards and demonstrating similarity to already approved devices, rather than an AI/ML-specific validation process.
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SEP 1 0 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:Address: | Churchill Medical Systems, Inc.87 Venture DriveDover, NH 03820 |
|---|---|---|
| Phone: | 603-743-5988 | |
| Fax: | 603-743-6328 | |
| Contact: | Keith Paluch (Consultant) | |
| 2. | Device Name: | Check Valve Accessory |
| Trade Name:Classification | Pressure Activated Check Valve | |
| Name: | IV Administration Set | |
| 3. | Classification: | Class II, General Hospital 80 FPA |
| 4. | Predicate Device: | KVQ Check Valve Accessory (K98441) |
| 5. | Device Description: | The Churchill Medical Systems Pressure Activated Check Valveconsists of acrylic-polycarbonate alloy valve body and a silicone valvewith male and female luer lock connections. The device opens atcracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents backflow. |
| 6. | Intended Use: | This device is used to directionally control the flow of fluids. They areadded to IV cannula or extension sets for simultaneous or alternateadministration of fluids while preventing back flow of medication. |
| 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 check valvescurrently available in the marketplace. Specifically, this deviceperforms similarly to the predicate device, referred to as KVO CheckValve Accessory (K984441). 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 U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all caps and is arranged in a circular fashion to match the shape of the logo.
Public Health Service
SEP 1 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith Paluch Consultant Churchill Medical Systems, Incorporated 87 Venture Drive Dover, New Hampshire 03820
Re: K011888
Trade/Device Name: Pressure Activated Check Valve Regulation Number: 21 CFR 880.5440 Regulation Name: Check Valve Accessory Regulatory Class: Class II Product Code: FPA Dated: July 24, 2001 Received: August 2, 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. 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.
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Page 2 - Mr. Paluch
This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ocgin maileding of substantial equivalence of your device to J ro(k) promation notificate 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 IT you desire specific ad rice for your for in vitro diagnostic devices), please contact the allu additionally 21 CF F R ar 8094-4618. Additionally, for questions on the promotion and Office of Comphance at (301) as contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under notheadon' (21 CF I I ar over the Division of Small Manufacturers, International and the Act may be obtained 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,
Tim Ulatowski
Timothy 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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011888 510(k) number
Page 1 of 1
Device Name: Pressure Activated Check Valve
Indications for Use: Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K011888
§ 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.