The ebb Complete Tamponade System 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 ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Device Description

The ebb Complete Tamponade System 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 ebb Complete Tamponade System is supplied sterile in peel open pouches for one time use to a single patient.

AI/ML Overview

This document describes a Special 510(k) notice for a modified medical device, the ebb Complete Tamponade System. It's a re-submission for a device that already has a predicate (K150573). The modification is specifically the addition of a UV Band around the proximal and distal ends of the vaginal and uterine balloons.

The information provided focuses on demonstrating that the modified device is substantially equivalent to its predicate, meaning the changes do not introduce new questions of safety or effectiveness. As such, the study described is a performance test to validate the modification, not a clinical trial to establish initial efficacy or performance against a broader set of acceptance criteria in a clinical setting.

Therefore, many of your requested points regarding clinical study design, ground truth, expert opinions, and comparative effectiveness are not applicable to this type of submission. The document primarily reports on bench testing to ensure the modified component maintains or improves strength.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Maintain or improve strength compared to previous version.	"Testing performed on the modified devices demonstrated significant improvement in strength over the previous version."
Withstand cyclic physiologic pressures without failure.	"The testing consisted of subjecting the device to cyclic physiologic pressures under more challenging conditions than indicated in published literature. None of the modified devices failed under those conditions."
Continued safety and effectiveness (demonstrating substantial equivalence).	Performance data presented (related to strength testing) supports the conclusion that the modified device "is as safe and effective as the ebb Complete Tamponade System [predicate]."

2. Sample size used for the test set and data provenance

Sample size: Not explicitly stated. The document mentions "the modified devices" and "none of the modified devices failed," implying multiple units were tested.
Data provenance: Bench testing (laboratory environment), not country of origin of clinical data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This was a bench test focused on the mechanical strength of the device, not a diagnostic or treatment device requiring expert clinical ground truth. The "ground truth" was the physical performance of the device under stress.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As this was a bench test, there was no clinical adjudication process involving human reviewers. Performance was measured by defined physical parameters (e.g., failure under stress).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic or therapeutic device requiring human reader improvement studies. It is a physical medical device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this performance study was determined by physical stress testing where the operational limits and failure points of the device were observed and measured under controlled laboratory conditions, particularly focusing on cyclic physiologic pressures.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

Summary

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Public Health Service

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

January 14, 2016

Clinical Innovations, LLC Tom Haueter Director, QA/RA 747 West 4170 South Murray, UT 84123

Re: K153591

Trade/Device Name: ebb Complete Tamponade System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: Class II Product Code: OQY Dated: December 14, 2015 Received: December 16, 2015

Dear Tom Haueter,

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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153591

Device Name ebb Complete Tamponade System

Indications for Use (Describe)

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)

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510(k) SUMMARY

Clinical Innovations' ebb Complete Tamponade System

Clinical Innovations, LLC

747 W. 4170 S.

Murray, UT 84123

Phone: 801-260-6100

Fax: 801-266-7373

Contact Person: Tom Haueter

Date Prepared: December 14, 2015

Name of Device and Name/Address of Sponsor

ebb Complete Tamponade System Clinical Innovations, LLC 747 W. 4170 S. Murray, UT 84123

Common or Usual Name: Intrauterine tamponade balloon

Classification Name: Class II per 21 CFR 884.4530

Product Code: OQY

Predicate Device:

K150573 ebb Complete Tamponade System

Purpose of the Special 510(k) notice:

The subject ebb Complete Tamponade System is a modification to the previous ebb Complete Tamponade System (K150573). This modification is the addition of a UV Band around the proximal and distal ends of the vaginal and uterine balloons.

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Device Description:

Indications for Use:

	Ebb Complete Tamponade SystemDevice	Ebb Complete Tamponade System(K150573)	Comparison
Intended Use/Indications For Use	The ebb Complete TamponadeSystem is indicated for use inproviding temporary control orreduction of postpartum uterinebleeding. Inflation of the VaginalBalloon anchors the Uterine Balloonand provides vaginal tamponade ifvaginal bleeding is present. The ebbComplete Tamponade Systemshould only be used in the setting ofpost-partum uterine bleeding whenconservative management iswarranted.	The ebb Complete TamponadeSystem is indicated for use inproviding temporary control orreduction of postpartum uterinebleeding. Inflation of the VaginalBalloon anchors the Uterine Balloonand provides vaginal tamponade ifvaginal bleeding is present. The ebbComplete Tamponade Systemshould only be used in the setting ofpost-partum uterine bleeding whenconservative management iswarranted.	Same
Technology	Tamponade achieved by inflation ofballoon with saline solution	Tamponade achieved by inflation ofballoon with saline solution	Same
Operating Principle	Manual Operation	Manual Operation	Same

Technological Characteristics:

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Components	- Uterine balloon to create tamponade, recommended fill volume of 750 ml- Vaginal balloon to assist in positioning, recommended fill volume of 350 ml- Spike assembly to allow for rapid fluid fill from IV bag- Leuer assembly for a measured fill- Drainage lumen- Separate irrigation lumen	- Uterine balloon to create tamponade, recommended fill volume of 750 ml- Vaginal balloon to assist in positioning, recommended fill volume of 350 ml- Spike assembly to allow for rapid fluid fill from IV bag- Leuer assembly for a measured fill- Drainage lumen- Separate irrigation lumen	Same
Safety Features	Labels on Lumens for immediate identification	Labels on Lumens for immediate identification	Same
Sterility	Ethylene Oxide, SAL of 10-6	Ethylene Oxide, SAL of 10-6	Same
Reuse	Single Use	Single Use	Same
Shelf Life	3 Years	3 Years	Same
Dimensions	- Recommended uterine balloon fill volume of 750 ml- Recommended vaginal balloon fill volume of 350 ml	- Recommended uterine balloon fill volume of 750 ml- Recommended vaginal balloon fill volume of 350 ml	Same

Performance Data

Testing performed on the modified devices demonstrated significant improvement in strength over the previous version. The testing consisted of subjecting the device to cyclic physiologic pressures under more challenging conditions than indicated in published literature. None of the modified devices failed under those conditions.

Substantial Equivalence

The ebb Complete Tamponade System has the same intended use and similar indications, principles of operation, and technological characteristics as the previous ebb Complete Tamponade System. The minor differences is the addition of a UV Rings at the distal end and proximal ends of the uterine and vaginal balloons, does not raise any new questions of safety or effectiveness. Performance data demonstrates that the ebb Complete Tamponade System is as safe and effective as the ebb Complete Tamponade System. Thus, the ebb Complete Tamponade System is substantially equivalent to its predicate device.

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.