(222 days)
Not Found
No
The device description and performance studies focus on mechanical properties and clinical feedback, with no mention of AI or ML.
Yes
The device is intended to treat postpartum hemorrhage by providing mechanical compression inside the uterus to control or reduce bleeding, which is a therapeutic action.
No
The device is intended to treat uterine bleeding by providing physical compression, not to diagnose a condition.
No
The device description clearly outlines a physical medical device consisting of a catheter, balloon, stopcock, and check valve, which are hardware components.
Based on the provided information, the BT-Cath (BTC-100) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical catheter with an inflatable balloon designed to apply pressure within the uterus. It is a mechanical device used for treatment.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The BT-Cath does not perform any such testing.
- Anatomical Site: The device is used within the uterus, which is an internal anatomical site for treatment.
- Performance Studies: The performance studies described focus on mechanical integrity and clinical feedback on its effectiveness in controlling bleeding, not on the accuracy of diagnostic measurements from biological samples.
Therefore, the BT-Cath is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BT-Cath is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard conservative therapy including uterine massage and oxytocin administration.
BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.
Product codes
OQY
Device Description
The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine
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)
Substantial equivalence is also based on an assessment of mechanical tests where the structural integrity of the balloon, including the relationship of volume of saline infused into the balloon and resulting balloon diameter, the burst volume of the balloon, and the ability of the balloon to hold its shape and not leak during repeated and prolonged inflations; the structural integrity of the catheter using leak tests; and the tensile strength in each joint in the devices were evaluated. Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor. Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury.
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.
0
K101535...
Page 1/2
Image /page/0/Picture/1 description: The image shows the logo for Utah Medical Products Inc. The logo consists of the text "UTAH MEDICAL PRODUCTS INC." in a sans-serif font, with a line underneath the text. Below the text is a stylized symbol that resembles the letter "U" or a horseshoe shape, with a vertical line extending upwards from the center of the "U" shape.
JAN 1 1 2011
SECTION 9: 510(k) SUMMARY
and the state of the states and
| 510(k) Owner:
Address: | Utah Medical Products, Inc.
7043 South 300 West
Midvale, UT 84047 USA |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone No .:
Fax No .: | (801) 566-1200
(801) 566-2062 |
| Contact: | Kevin L. Cornwell, CEO |
| Date: | 3 January 2011 |
| Trade Name: | BT-Cath |
| Common Name: | Intrauterine Balloon Tamponade Catheter |
| Classification: | Obstetric-gynecologic specialized manual instrument,
21 CFR 884.4530; Product Code OQY |
| Predicate Devices: | Bakri Uterine Balloon Tamponade, (K013597, K062438)
Cook Ob/Gyn |
| Indications for Use: | BT-Cath is intended to provide temporary control or reduction of
uterine bleeding during postpartum hemorrhage that is unresponsive
to standard conservative therapy including uterine massage and
oxytocin administration. |
1
7080 2
Device Description:
Comparison to predicate devices:
Performance Data:
The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.
There are insignificant differences in the physical dimensions and physical configuration of the balloon tamponade catheters. The technological characteristics, methods of use, materials, intended use, indications for use and contraindications are the same as the predicate devices. Biocompatibility and shelf-life testing were also assessed to demonstrate substantial equivalence.
Substantial equivalence is also based on an assessment of mechanical tests where the structural integrity of the balloon, including the relationship of volume of saline infused into the balloon and resulting balloon diameter, the burst volume of the balloon, and the ability of the balloon to hold its shape and not leak during repeated and prolonged inflations; the structural integrity of the catheter using leak tests; and the tensile strength in each joint in the devices were evaluated. Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor. Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury.
K. Howell
Kevin L. Cornwell
Kevin L. Cornwell Chairman & CEO Utah Medical Products, Inc.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN USA" around the edge. Inside the circle is a stylized eagle symbol. The eagle is depicted with three thick, curved lines representing its body and wings. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Kevin L. Cornwell Chairman & CEO Utah Medical Products, Inc. 7043 South 300 West MIDVALE UT 84047
JAN 1 1 201
Re: K101535 Trade Name: BT-Cath® Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: OQY Dated: January 3, 2011 Received: January 3, 2011
Dear Mr. Cornwell:
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 of medical device-related
3
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert Semler MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3: INTENDED USE / INDICATIONS for USE
| 510(k) Number: | K101535 | JAN 1 1 2011 |
|---|---|---|
| ---------------- | --------- | -------------- |
Device Name: UTMD BT-Cath - Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage (BTC-100)
Indications for Use:
BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X (Per 21 CFR 801.109) OR
Lori K. Wertz
Visible Sign Off
10
Over-the-Counter Use