(29 days)
Not Found
No
The description focuses on mechanical components and fluid inflation for tamponade, with no mention of AI/ML terms or functionalities.
Yes
The device is designed to provide temporary control or reduction of postpartum uterine bleeding, which is a therapeutic intervention.
No
This device is designed for therapeutic purposes (temporary control or reduction of postpartum uterine bleeding, providing tamponade for controlling hemorrhage) rather than diagnosing a condition.
No
The device description clearly details physical components like catheters, balloons, and lumens, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ebb Complete Tamponade System is a physical device used inside the body (uterus and vagina) to provide mechanical tamponade (pressure) to control bleeding. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide temporary control or reduction of postpartum uterine bleeding through physical means.
Therefore, the ebb Complete Tamponade System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known) K153591
Device Name ebb Complete Tamponade System
Indications for Use (Describe)
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.
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.
4
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.
Indications for Use:
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.
| | Ebb Complete Tamponade System
Device | Ebb Complete Tamponade System
(K150573) | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use
/Indications For Use | 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. | 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. | Same |
| Technology | Tamponade achieved by inflation of
balloon with saline solution | Tamponade achieved by inflation of
balloon with saline solution | Same |
| Operating Principle | Manual Operation | Manual Operation | Same |
Technological Characteristics:
5
| 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.