Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

K170622 · Cook Incorporated · OQY · Mar 31, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K170622
• Device Name: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
• Applicant: Cook Incorporated
• Product Code: OQY · Obstetrics/Gynecology
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Device Story

Intrauterine tamponade device; consists of dual-lumen silicone balloon catheter, stopcock, and 60 mL syringe; Rapid Instillation (RI) configuration adds dual check valve and polymer tubing for saline bag connection. Used in clinical settings by physicians to manage postpartum hemorrhage. Balloon inserted into uterus; inflated with saline to apply pressure to uterine wall; provides tamponade effect to control bleeding. RI components allow continuous saline instillation without disconnecting syringe. Output is mechanical pressure on uterine tissue; aids in hemorrhage control; potentially avoids more invasive surgical interventions.

Clinical Evidence

Bench testing only. Testing included inflated balloon reliability, dimensional evaluation, integrity, distal tip tensile testing, sideport drainage/deflation reliability, radial pressure testing (100 mm Hg for 3 hours), balloon inflation capacity (500 mL), simulated use, and component tensile testing. Biocompatibility testing was not required as materials are identical to the predicate or do not contact the patient.

Technological Characteristics

Dual-lumen silicone balloon catheter; 500 mL maximum balloon volume. RI configuration includes polymer tubing and dual check valve. Sterile, single-use. Mechanical tamponade principle. No electronic components or software.

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

• Bakri® Postpartum Balloon (K062438)

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

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

March 31, 2017

Cook Incorporated Naomi Funkhouser, MBA Regulatory Product Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K170622

> Trade/Device Name: Bakri® Postpartum Balloon, Bakri® Postpartum Balloon with Rapid Instillation Components Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: OOY Dated: February 28, 2017 Received: March 1, 2017

Dear Naomi Funkhouser:

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.

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

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 (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Charles Viviano -S

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

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

## Indications for Use

510(k) Number (if known) K170622

Device Name Bakri® Postpartum Balloon Bakri® Postpartum Balloon with Rapid Instillation Components

Indications for Use (Describe)

Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif; font-size: 10pt;"></span> <span style="font-family: Symbol;">☑</span> <span style="font-family: Arial, sans-serif; font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial, sans-serif; font-size: 10pt;"></span> <span style="font-family: Symbol;">☐</span> <span style="font-family: Arial, sans-serif; font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### 510(k) SUMMARY

## Bakri® Postpartum Balloon with Rapid Instillation Components 21 CFR §884.4530 Date Prepared: March 29, 2017

| Submitted By: | |
|-----------------------|------------------------|
| Applicant: | Cook Incorporated |
| Contact: | Naomi Funkhouser |
| Applicant Address: | 750 Daniels Way |
| | P.O. Box 489 |
| | Bloomington, IN 47402 |
| Contact Phone Number: | [phone] x104371 |
| Contact Fax Number: | [phone] |

### Device Information:

| Trade Names: | Bakri ^® Postpartum Balloon<br>Bakri ^® Postpartum Balloon with Rapid Instillation Components |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | Obstetrics-gynecology Specialized Manual Instrument |
| Classification Name: | Obstetrics/Gynecology |
| Regulation: | 21 CFR §884.4530 |
| Regulation Class: | II |
| Product Code: | OQY, Intrauterine Tamponade Balloon |

### Device Description:

The proposed devices are offered in two configurations, the Bakri Postpartum Balloon (henceforth referred to as Bakri) consisting of a double lumen silicone balloon catheter, a stopcock, and a 60 mL Luer-tip syringe and the Bakri Postpartum Balloon with Rapid Instillation Components (henceforth referred to as Bakri RI) configuration which additionally includes a dual check valve and polymer tubing. The tubing is fitted with a Luer lock-type connector to the dual check valve and a non-vented bag spike with a vented cap that connects to a saline bag (not included in the device).

The balloon catheter common to both configurations is designed as a dual lumen silicone shaft with 500 mL balloon. The proximal end of the catheter has a lighthouse adaptor designed to accept a drainage bag connector and a side arm which is fitted with a Luer Lock-type adaptor to

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

which a stopcock is attached and subsequently a Luer tip syringe or a dual check valve can be connected. The distal end of the catheter has two sideports spaced 180° opposite of each other, and the tip is rounded to a smooth finish. The polymer tubing of the Bakri RI rapid instillation components is 180 cm in length. Both the Bakri and the Bakri RI is supplied sterile and intended for one time use.

## Indications for Use:

Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

## Predicate Device:

The predicate device, the Bakri® Postpartum Balloon manufactured by Cook Incorporated (K062438), is a medical device intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. It is a tamponade balloon catheter constructed with silicone material and a 500 mL (max) balloon adhered to a dual lumen catheter used for drainage and balloon inflation. The device is sold with a stopcock and 60 mL syringe. The predicate device has not been subject to a design-related recall.

## Comparison to Predicate Device:

The proposed Bakri and the balloon catheter of the Bakri RI as compared to the predicate device. Bakri Postpartum Balloon (K062438), are identical in terms of intended use, principles of operation, basic technological characteristics, materials of construction, and nearly identical in dimension and design. The Bakri RI includes Rapid Instillation Components which consist of a dual check valve and tubing. The Rapid Instillation components allow the physician fill the balloon without disconnecting and reconnecting the syringe at each reiteration of saline instillation into the balloon. The technological differences as a result of the changes to the balloon catheter and the addition of the rapid instillation components do not raise any different questions of safety and effectiveness.

{5}------------------------------------------------

# Test Data:

The following tests were performed to demonstrate that the modifications to the balloon catheter of both the Bakri and Bakri RI and the addition of the rapid instillation component have met applicable design and performance requirements to support a determination of substantial equivalence. Biocompatibility testing was deemed unnecessary, since the materials used in the device are identical to the predicate, and all new materials do not directly or indirectly contact the patient.

- . Inflated Balloon Reliability, Dimensional Evaluation, and Integrity -Verification that when subjected to maximum labeled volume, the inflated balloon and components of the proposed device do not show signs of leakage and/or rupture, and balloon dimensions meet the clinical and anatomical requirements.
- Tensile Test of the Distal Tip Verification that when subjected to maximum load . requirements, the distal tip satisfies the minimum load requirements.
- Sideport Drainage and Deflation Reliability- Verification that the proposed device . will drain approximately 200 mL from the sideport in less than or equal to 1 minute and will have less than or equal to 30 mL of water left inside the balloon catheter after 15 minutes of drainage.
- Radial Pressure Verification that the balloon can withstand a radial pressure of . 100 mm Hg for up to 3 hours without leakage or rupture.
- Balloon Inflation Testing Verification that the balloon can be inflated to the . minimal volume of 500 mL with the Rapid Instillation Components.
- Simulated Use and Leak Test Verification that the device performs as intended and . does not leak during normal use.
- Tensile Testing Verification that the Spike/Tubing, MLLA/Tubing, and Tubing . withstands normal use forces.

In conclusion, the results of these tests support a determination of substantial equivalence of the balloon catheter common to the two configurations of the subject device to the predicate device.