(19 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fluid dynamics, with no mention of AI/ML algorithms or data processing.
Yes
The device is designed to provide temporary control or reduction of postpartum uterine bleeding, which is a therapeutic function.
No
The document describes a device used for temporary control or reduction of postpartum uterine bleeding by providing tamponade. This is a therapeutic function, not a diagnostic function which would involve identifying a condition or disease.
No
The device description clearly outlines physical components (catheters, balloons) and a mechanical function (inflation with fluid) for providing tamponade, 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ebb Complete Tamponade System is a physical device inserted into the uterus and vagina to provide mechanical tamponade (pressure) to control bleeding. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide temporary control or reduction of postpartum uterine bleeding through physical means.
The device description and intended use clearly indicate a physical, mechanical intervention within the body, not an in vitro diagnostic test.
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 (comma separated list FDA assigned to the subject device)
OQY
Device Description
The ebb Complete Tamponade System and the predicate have the same technological characteristics. Both devices are disposable, multiple lumen catheters attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The devices consist 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. The uterine and vaginal balloons are permanently assembled and are not to be separated. The devices may be retained in position for up to 24 hours in the post-operative mode of treatment, and are supplied sterile in peel open pouches for one time use to a single patient. There are no differences in the material, chemical composition or energy source of the subject and predicate devices. The change in design of the subject device is limited to the modification to the bond of the distal end of the uterine balloon from a heat bond to a UV bond, to increase the bond strength.
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 physiologic pressures under worst-case conditions. None of the modified devices failed under those conditions. Further, we subjected the modified devices to 7.5 times the pressure indicated in the published literature, and no failures were encountered.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure, with three faces in profile. The figure is stylized and appears to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Clinical Innovations, LLC Tom Haueter Director, Quality and Regulatory Affairs 747 West 4170 South Murray, UT 84123
Re: K150573
Trade/Device Name: ebb Complete Tamponade System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: OQY Dated: March 6, 2015 Received: March 6, 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 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
1
the quality systems (OS) 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,
Benjamin R. Fisher -S
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
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Indications for Use
510(k) Number (if known) K150573
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: | March 3, 2015 |
| Name of Device: | ebb Complete Tamponade System |
| Common or Usual Name: | Intrauterine tamponade balloon |
| Classification Name: | Class II per 21 CFR 884.4530 |
| Product Code: | OQY |
Predicate Device
K091958 Belfort-Dildv Obstetric Tamponade System
Purpose of the Special 510(k) notice.
The ebb Complete Tamponade System is a modification to the Belfort-Dildy Obstetric Tamponade System (K091958). Clinical Innovations has modified the subject device and have completed verification and validation testing to verify that the modified device is substantially equivalent to the predicate. Specifically, the company has minimized the potential for leaks at the distal end of the uterine balloon by modifying the bond at the distal end of the uterine balloon from a heat bond to a UV bond.
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 vaqinal 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.
Technological Characteristics
The ebb Complete Tamponade System and the predicate have the same technological characteristics. Both devices are disposable, multiple lumen catheters attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The devices consist 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
4
separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The devices may be retained in position for up to 24 hours in the post-operative mode of treatment, and are supplied sterile in peel open pouches for one time use to a single patient. There are no differences in the material, chemical composition or energy source of the subject and predicate devices. The change in design of the subject device is limited to the modification to the bond of the distal end of the uterine balloon from a heat bond to a UV bond, to increase the bond strength.
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 physiologic pressures under worst-case conditions. None of the modified devices failed under those conditions. Further, we subjected the modified devices to 7.5 times the pressure indicated in the published literature, and no failures were encountered.
Substantial Equivalence
The ebb Complete Tamponade System has the same intended use and similar indications, principles of operation, and technological characteristics as the Belfort-Dildy Obstetric Tamponade System. The minor differences between the subject and the predicate devices do 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 Belfort-Dilty Obstetric Tamponade System. Thus, the ebb Complete Tamponade System is substantially equivalent to its predicate device.
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