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

Device Description

The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.

AI/ML Overview

This document is a 510(k) premarket notification for the Bakri Essential Postpartum Balloon, a medical device. It does not describe a study involving an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects cannot be extracted.

The document discusses the substantial equivalence of the Bakri Essential Postpartum Balloon to a predicate device (Bakri Postpartum Balloon, K170622). It focuses on non-clinical performance testing related to packaging modifications and the removal of a syringe from the product set, not on a study proving a device's performance against specific clinical acceptance criteria in the context of an AI/ML system.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance (in the context of an AI/ML device).
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
Whether standalone performance was done for an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How the ground truth for the training set was established.

The "Summary of Non-clinical Performance Testing" section details tests performed for the physical device's packaging and sterilization integrity, with specific acceptance criteria for those tests:

Pouch Seal Strength Testing: Minimum seal strength shall meet or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15.
Bubble Leak Testing: Packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11.
Dye Penetration Testing: No packaging seal may be breached by dye per F1929-15.
Additional distribution testing followed by functional verification: Device shows no signs of damage after sterilization and simulation distribution.

These criteria and tests relate to the physical integrity and sterility of the packaged device, not a performance study of a diagnostic or therapeutic AI/ML algorithm.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 28, 2022

Cook Incorporated Ian Herrman Senior Regulatory Affairs Specialist 750 Daniels Wav. P.O. Box 489 Bloomington, IN 47402

Re: K223098

Trade/Device Name: Bakri Essential Postpartum Balloon Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: OQY Dated: September 29, 2022 Received: September 30, 2022

Dear Ian Herrman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K223098

Device Name Bakri Essential Postpartum Balloon

Indications for Use (Describe)

The Bakri Essential Postpartum Balloon 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)
☑	☐

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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}------------------------------------------------

K223098 Page 1 of 3

510(k) SUMMARY

Bakri Essential Postpartum Balloon

Submitted By

Applicant:	Cook Incorporated
Contact:	Ian Herman
Address:	750 Daniels WayP.O. Box 489Bloomington, IN 47402
Contact Phone Number:	(812) 335-3575 x104034
Contact Fax Number:	(812) 332-0281
Date Prepared:	October 26, 2022
Device Information
Proprietary Name:	Bakri Essential Postpartum Balloon
Common Name:	Intrauterine tamponade balloon
Regulation Name:	Obstetric-Gynecologic Specialized Manual Instrument
Regulation Number:	21 CFR 884.4530

Predicate Device

Regulation Class:

Product Code:

Bakri Postpartum Balloon, manufactured by Cook Incorporated (K170622).

The predicate device has not been subject to a design-related recall.

Device Description

OQY, Intrauterine Tamponade Balloon

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

The Bakri Essential Postpartum Balloon is a modified version of the predicate device cleared under K170622.

Indications for Use

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

Comparison to Predicate Device

A comparison of the intended use and technological characteristics of the subject and predicate device are outlined in the table below.

General Device	Subject device	Predicate device	Comments
Characteristics	K223098	K170622
Product code	OQY	OQY	Same
Intendeduse/Indicationsfor Use	Bakri EssentialPostpartum Balloon isintended to providetemporary control orreduction of postpartumuterine bleeding whenconservativemanagement iswarranted	Bakri Postpartum Balloon isintended to providetemporary control orreduction of postpartumuterine bleeding whenconservative management iswarranted.&Bakri Postpartum Balloonwith Rapid InstillationComponent is intended toprovide temporary controlor reduction of postpartumuterine bleeding whenconservative management iswarranted.	Same.
Dimensions	Length: 58 cm (workinglength of 54 cm)Outer Diameter: 24 FrBalloon Volume: 500mL	Length: 58 cm (workinglength of 54 cm)Outer Diameter: 24 FrBalloon Volume: 500 mL	Same
Materials	Balloon Catheter andShaft: SiliconeFemale Luer-LockAdapter: Polyamide	Balloon Catheter and Shaft:SiliconeFemale Luer-Lock Adapter:Polyamide	Same
Syringe	Syringe not included	60 mL syringe	Different
Stopcock	Included	Included	Same

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

Packaging	Sterile Barrier: Tyvek(1073B)/PolyethylenePeel Open PouchPackage.5 individually packagedunits per Box (8" & 1/8"X 2 & 3/8" X 17")	Sterile barrier: Tyvek(1059B)/Polyethylene PeelOpen Pouch Package.1 packaged unit per box(8" X 1 & 7/16" X 16")Inner packaging: Fitted ina PETG (PolyethyleneTerephthalate Glycol-Modified tray with PETGretainer and seal	Different.
Sterilization	EO, 10-6, single use	EO, 10-6, single use	Same

The subject and predicate device have the same intended use, principles of operation, and technological characteristics. The only differences between the Bakri Essential and the predicate device are the packaging configuration and the removal of the syringe from the set. These differences do not raise different questions of safety and effectiveness and can be assessed by verification and validation testing.

Summary of Non-clinical Performance Testing

The support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) according to ISO 14971:2019 was performed. The Bakri Essential Postpartum Balloon was subjected to applicable testing to assure reliable design and performance under the testing parameters. As the differences in the subject device compared to the predicate device include packaging differences and the removal of the syringe from the set, the following tests were conducted to ensure the reliability of the packaging at time zero and end of the three year shelf-life:

Pouch Seal Strength Testing: verification that the minimum seal strength shall meet ● or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15
Bubble Leak Testing: verification that packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11
Dye Penetration Testing: verification that no packaging seal may be breached by dye ● per F1929-15
Additional distribution testing followed by functional verification: verification that ● device shows no signs of damage after sterilization and simulation distribution.

Conclusion

The results of these testing described above demonstrate that the Bakri Essential Postpartum Balloon is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
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.
(b)
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.