(26 days)
The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and filling them with carbon dioxide gas.
The V. Mueller® Uterine Cannula devices are constructed with a stopcock, finger ring control, an elongate shaft and a distal end with a rubber acorn.
The provided text describes the 510(k) summary for Uterine Cannulas, focusing on demonstrating substantial equivalence to a predicate device due to a "material modification". This submission is for a medical device, not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable.
However, I can extract the relevant acceptance criteria and study information provided for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 / AC 2010 | PASS |
| Functionality | Plating Thickness Analysis | PASS |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission concerns a physical medical device (Uterine Cannula) and its material modification, not an AI/ML algorithm requiring a test set of data. The performance evaluations are based on non-clinical tests (biocompatibility and functionality).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for AI/ML device evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by adherence to recognized standards for biocompatibility and engineering analysis for functionality.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not an AI/ML device requiring adjudication of results from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on established international standards for biocompatibility (ISO 10993-1:2009 / AC 2010) and engineering analysis (Plating Thickness Analysis) for functionality.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this physical medical device.
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Special 510(k) Premarket Notification: Uterine Cannulas
Image /page/0/Picture/2 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to be an abstract design, while the text is in a bold, sans-serif font.
APR 2 1 2014
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | ||
|---|---|---|
| Name | CareFusion 2200 Inc | |
| Address | 75 N. Fairway Dr.Vernon Hills, IL 60061 | |
| Phone number | (847) 362-8094 | |
| Fax number | (312) 949-0272 | |
| EstablishmentRegistration Number | 1423507 | |
| Name of contact person | Jane Weber | |
| Date prepared | 18-APR-2014 | |
| DEVICE INFORMATION | ||
| Trade or proprietaryname | V. Mueller Uterine Cannula | |
| Common or usual name | Uterine Cannula | |
| Classification name | Uterotubal carbon dioxide insufflator and accessories | |
| Classification panel | 85 Obstetrics/Gynecology | |
| Regulation | Class II per 21CFR 884.1300, Product code HES | |
| Product Code(s) | GL2360, GL2375, GL2400 | |
| Legally marketeddevice(s) to whichequivalence is claimed | V. Mueller Preamendment Uterine Cannulas | |
| Reason for 510(k)submission | Material modification | |
| Device description | The V. Mueller® Uterine Cannula devices are constructed with a stopcock,finger ring control, an elongate shaft and a distal end with a rubber acorn. | |
| Intended use of thedevice | The proposed devices are intended for use in obstetrical/gynecologicprocedures wherein the device is connected to an insufflator on the proximalend. The distal end is inserted through the vagina into the cervix and theuterus and fallopian tubes are insufflated with Carbon Dioxide gas to check forpatency. | |
| Indications for use | The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula,and Neal Fallopian Cannula are indicated to test the patency (lack ofobstruction) of the fallopian tubes by pressurizing the uterus and fallopiantubes and filling them with carbon dioxide gas. | |
| Characteristic | Predicate DevicePreamendment Uterine Cannulas | New Device |
| Type of Device | Reusable | Reusable |
| Intended for direct patientcontact? | Yes | Yes |
| Intended for extendeduse? (more than 24 hrs) | No | No |
| Cleaning Method | Manual and Ultrasonic | Manual and Ultrasonic |
| Sterilization Method | Product is sold non-sterile andsterilized by the end user via thefollowing steam sterilization options:• Gravity Displacement• Prevacuum | Product is sold non-sterile andsterilized by the end user via thefollowing steam sterilization options:• Gravity Displacement• Prevacuum |
| Materials | Stainless SteelBlack SiliconeRubberFlexible Tip Cannula: FEP (GL2360only)Stop cock component• Brass• Nickel | Stainless SteelBlack SiliconeRubberFlexible Tip Cannula: FEP(GL2360only)Stop cock component• Brass• Nickel• Chrome |
| PERFORMANCE DATA |
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Special 510(k) Premarket Notification: Uterine Cannulas
Image /page/1/Picture/2 description: The image shows the word "CareFusion" in a sans-serif font. To the left of the word is a circular logo with a stylized design. The logo appears to have three concentric shapes within the circle.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 / AC 2010 | PASS |
| Functionality | Plating Thickness Analysis | PASS |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests demonstrate the Uterine Cannulas meet all performance requirements, and are substantially equivalent to the predicate devices.
...
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2014
CareFusion 2200, Inc. Jane Weber Regulatory Affairs Manager 75 N. Fairway Drive Vernon Hills, IL 60061
Re: K140761
Trade/Device Name: V. Mueller Uterine Cannula (Kalın Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula) Regulation Number: 21 CFR§ 884.1300 Regulation Name: Uterotubal carbon dioxide insufflator and accessories Regulatory Class: II Product Code: HES Dated: March 25, 2014 Received: March 26, 2014
Dear Jane Weber,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Jane Weber
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140761
Device Name
V. Mueller Uterine Cannula (Kahn Uterine Trigger Cannula, Jarcho Cannula, and Neal Fallopian Cannula)
Indications for Use (Describe)
The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and filling them with carbon dioxide gas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
:・・・・ FOR FDA USE ONLY - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 : ਿਸ਼ਵੀਅਨ ਅਤੇ ਸਾਰੇ ਦੇ ਸਿੰਘ ਕੀ ਤੇ : - - - - - - - - -
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner 2014.04.21 14:5
FORM FDA 3881 (1/14)
§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.
(a)
Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.(b)
Classification. Class II (performance standards).