BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

K091958 · Glenveigh Surgical, LLC · OQY · Apr 30, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K091958
• Device Name: BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
• Applicant: Glenveigh Surgical, LLC
• Product Code: OQY · Obstetrics/Gynecology
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Device Story

Disposable, multiple-lumen catheter with dual inflatable balloons (uterine and vaginal). Used in clinical settings for postpartum hemorrhage. Physician inflates uterine balloon inside uterus and vaginal balloon inside vagina using isotonic intravenous fluid (saline or Ringers Lactate). Uterine catheter includes separate lumens for inflation/deflation, irrigation, and drainage; vaginal catheter includes inflation/deflation lumen. Device provides mechanical tamponade to control bleeding; retained for up to 24 hours. Benefits patient by providing temporary hemorrhage control.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Design verification testing demonstrated performance equivalent to the Bakri predicate device.

Technological Characteristics

Disposable, multiple-lumen catheter with dual inflatable balloons. Materials are biocompatible per ISO 10993-1. Inflation via isotonic IV fluid. Sterile, single-use. No electronic or software components.

Indications for Use

Indicated for temporary control or reduction of postpartum uterine bleeding in patients where conservative management is warranted.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• Cook Bakri Postpartum Tamponade Balloon (K062438)
• Cook Bakri Postpartum Tamponade Balloon (K013597)
• Frontline Vaginal Tamponade Balloon (K060289)
• Utah Medical BT Cath Uterine Tamponade Balloon (K862480)

Submission Summary (Full Text)

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

### SUMMARY OF SAFETY & EFFECTIVENESS

April 29, 2010

K091958
pg. 1 of 2

Glenveigh™

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Glenveigh Surgical, LLC<br>401 Chestnut Street, Suite 230 |
|-----------|-----------------------------------------------------------|
| | Chattanooga, TN 37402<br>Rick Proctor |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

APR 3 0 2010

SUBMISSION Penny Northcutt, RAC, CQA CORRESPONDENT REGSolutions, LLC 717 Lakeglen Drive Suwanee, GA 30024 Tel: [phone] Fax: [phone] Email: [e-mail]

GLENVEIGH, LLC We have submitted Form FDA 2891 through FDA FURLS and have received the owner/operator number 10029247 as ESTABLISHMENT REGISTRATION No.: a manufacturer.

#### 1.2 DEVICE NAME & CLASSIFICATION

| TRADE NAME: | Belfort-Dildy Obstetric Tamponade System (OTS) |
|------------------------|---------------------------------------------------------------------------------------|
| COMMON NAME: | Obstetric-gynecologic specialized manual instrument<br>Intrauterine tamponade balloon |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §884.4530 |
| PRODUCT CODE: | OQY |

#### 1.3 PREDICATE DEVICE INFORMATION

PREDICATE K062438 & K013597 Cook Bakri Postpartum Tamponade Balloon DEVICE: K060289 Frontline Vaginal Tamponade Balloon K862480 Utah Medical BT Cath Uterine Tamponade Balloon

### SUBSTANTIAL EQUIVALENCE:

The Belfort-Dildy Obstetric Tamponade System is substantially equivalent to other legally marketed post partum tamponade balloons with the same fundamental scientific technology, same intended use as the original, predicate devices, equivalent materials, same mechanisms and equivalent technological characteristics. Those device predicates are the Cook Bakri

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

Postpartum Tamponade Balloon K062438 and K013597 and Frontline Medical Tamponade Balloon K060289, and the Utah Medical BT-Cath Uterine Balloon Tamponade Catheter K862480.

All devices have the same method of operation to tamponade postpartum hemorrhage. Bench testing versus the predicate Bakri device has demonstrated that the Belfort-Dildy Obstetric Tamponade System is functionally equivalent to the Bakri predicate device and that any minor differences do not affect safety or effectiveness.

## DESCRIPTION OF THE DEVICE:

The Belfort-Dildy Obstetric Tamponade System (OTS) is a disposable, multiple lumen catheter attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The device consists of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation/deflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The device may be retained in position for up to 24 hours in the post-operative mode of treatment. The Belfort-Dildy Obstetric Tamponade System (OTS) is supplied sterile in peel open pouches for one time use to a single patient.

# INDICATIONS FOR USE:

The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

### PERFORMANCE DATA:

The Belfort-Dildy Obstetric Tamponade System materials that come in direct contact with the patient have a long history of use in catheter manufacture and are demonstrated to be biocompatible through testing according to ISO 10993-1. Design verification performance test results demonstrate that the Belfort-Dildy Obstetric Tamponade System performs its intended use and is equivalent to the Bakri predicate device.

## CONCLUSION:

Based on the performance testing and device attributes, it can be concluded that the Belfort-Dildy Obstetric Tamponade System is equivalent to the predicate devices with respect to intended use and technological characteristics.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

APR 30 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Glenveigh Surgical, LLC c/o Ms. Penny Northcutt, RAC, CQA Regulatory Consultant for Glenveigh Surgical REGSolutions, LLC 717 Lakeglen Drive SUWANEE GA 30024

Re: K091958

> Trade/Device Name: Belfort-Dildy Obstetric Tamponade System Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: OQY Dated: April 23, 2010 Received: April 26, 2010

Dear Ms. Northcutt:

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. 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 of medical device-related

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

#### Page 2 -

adverse events) (21 CFR 803); 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): KO9/958

Device Name: BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

Indications For Use:

The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qumul Xusain

wision of Reproductive, Abdominal, and Radiotogical Devices (Dalgag 510(k) Number