KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA

K140761 · Carefusion 2200, Inc. · HES · Apr 21, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K140761
• Device Name: KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
• Applicant: Carefusion 2200, Inc.
• Product Code: HES · Obstetrics/Gynecology
• Decision Date: Apr 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1300
• Device Class: Class 2

Indications for Use

The proposed devices are intended for use in obstetrical/gynecologic procedures wherein the device is connected to an insufflator on the proximal end. The distal end is inserted through the vagina into the cervix and the uterus and fallopian tubes are insufflated with Carbon Dioxide gas to check for patency.

Device Story

V. Mueller Uterine Cannulas (Kahn, Jarcho, and Neal models) are reusable instruments used in obstetrical/gynecologic procedures. The device consists of an elongate shaft, a stopcock, a finger ring control, and a distal rubber acorn tip. The proximal end connects to a CO2 insufflator; the distal end is inserted through the vagina into the cervix. The device delivers CO2 gas to the uterus and fallopian tubes to assess patency. Operated by clinicians in a clinical setting, the device provides a mechanical conduit for gas delivery. The procedure allows the physician to determine if fallopian tubes are obstructed, aiding in the diagnosis of infertility or tubal health. The device is non-sterile upon receipt and requires end-user steam sterilization.

Clinical Evidence

No clinical tests were conducted for this submission; substantial equivalence was determined based on non-clinical performance testing.

Technological Characteristics

Reusable uterine cannula; materials include stainless steel, black silicone, rubber, FEP (GL2360 only), brass, nickel, and chrome. Features a stopcock, finger ring control, and distal rubber acorn. Steam sterilization (gravity displacement or prevuvuum). Biocompatibility per ISO 10993-1:2009/AC 2010.

Indications for Use

Indicated for testing fallopian tube patency (lack of obstruction) by pressurizing the uterus and filling the fallopian tubes with carbon dioxide gas.

Regulatory Classification

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.

Predicate Devices

• V. Mueller Preamendment Uterine Cannulas

Submission Summary (Full Text)

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Special 510(k) Premarket Notification: Uterine Cannulas

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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.<br>Vernon Hills, IL 60061 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration Number | 1423507 | |
| Name of contact person | Jane Weber | |
| Date prepared | 18-APR-2014 | |
| DEVICE INFORMATION | | |
| Trade or proprietary<br>name | 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 marketed<br>device(s) to which<br>equivalence is claimed | V. Mueller Preamendment Uterine Cannulas | |
| Reason for 510(k)<br>submission | Material modification | |
| Device description | The V. Mueller® Uterine Cannula devices are constructed with a stopcock,<br>finger ring control, an elongate shaft and a distal end with a rubber acorn. | |
| Intended use of the<br>device | The proposed devices are intended for use in obstetrical/gynecologic<br>procedures wherein the device is connected to an insufflator on the proximal<br>end. The distal end is inserted through the vagina into the cervix and the<br>uterus and fallopian tubes are insufflated with Carbon Dioxide gas to check for<br>patency. | |
| Indications for use | The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula,<br>and Neal Fallopian Cannula are indicated to test the patency (lack of<br>obstruction) of the fallopian tubes by pressurizing the uterus and fallopian<br>tubes and filling them with carbon dioxide gas. | |
| Characteristic | Predicate Device<br>Preamendment Uterine Cannulas | New Device |
| Type of Device | Reusable | Reusable |
| Intended for direct patient<br>contact? | Yes | Yes |
| Intended for extended<br>use? (more than 24 hrs) | No | No |
| Cleaning Method | Manual and Ultrasonic | Manual and Ultrasonic |
| Sterilization Method | Product is sold non-sterile and<br>sterilized by the end user via the<br>following steam sterilization options:<br>• Gravity Displacement<br>• Prevacuum | Product is sold non-sterile and<br>sterilized by the end user via the<br>following steam sterilization options:<br>• Gravity Displacement<br>• Prevacuum |
| Materials | Stainless Steel<br>Black Silicone<br>Rubber<br>Flexible Tip Cannula: FEP (GL2360<br>only)<br>Stop cock component<br>• Brass<br>• Nickel | Stainless Steel<br>Black Silicone<br>Rubber<br>Flexible Tip Cannula: FEP(GL2360<br>only)<br>Stop cock component<br>• Brass<br>• Nickel<br>• Chrome |
| PERFORMANCE DATA | | |

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Special 510(k) Premarket Notification: Uterine Cannulas

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## 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 [phone] or [phone] 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)