(168 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to provide temporary control or reduction of post-partum uterine bleeding, which is a therapeutic purpose.
No
The device is described as providing temporary control or reduction of post-partum uterine bleeding, which is a therapeutic function, not a diagnostic one. It is a treatment device, not for identifying a condition.
No
The device description explicitly states it is a "Tamponade Uterine Balloon Catheter Set" made of silicone, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tamponade Uterine Balloon Catheter Set is a physical device inserted into the uterus to apply pressure and control bleeding. It does not analyze any biological specimens.
- Intended Use: The intended use is to physically manage bleeding, not to diagnose or monitor a condition through laboratory analysis.
Therefore, based on the provided information, this device falls under the category of a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile.
Product codes (comma separated list FDA assigned to the subject device)
85 KNA
Device Description
The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum I he ramponate overille Development of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
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)
Not Found
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.
Not Found
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.
Mentor U-Stasis manons, the Balloon Uterine Stent manufactured by Cook OB/GYN
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
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "KD13597". The characters are written in a dark color, possibly black ink, against a white background. The handwriting is somewhat rough, giving the impression that it was written quickly or with a thick marker.
510 (K) Premarket Notification Tamponade Uterine Balloon Catheter Set Cook OB/GYN®
510(k) SUMMARY I.
Submitted By:
Cindy Rumple Cook OB/GYN® 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 October 30, 2001
Device
Trade Name: Proposed Classification Name: Tamponade Uterine Balloon Catheter Set Instrument, Manual, Specialized, Obstetric-Gynecologic
Predicate Devices:
The Tamponade Uterine Balloon Catheter Set is substantially equivalent to predicate devices in terms of Indications for use, design, and materials of construction. Predicate devices include Mentor U-Stasis manons for use, actively and the Balloon Uterine Stent manufactured by Cook OB/GYN®.
Device Description:
The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum I he ramponate overille Development of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and The device will and go process . Being similar with respect to indications for use, materials, and physical construction to predicate devices, this device meets the requirements for section 510 (K) substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Ms. Cindy Rumple Regulatory Affairs Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460
Re: K013597 Trade/Device Name: Tamponade Uterine Balloon Catheter Set
Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument
Regulatory Class: II Product Code: 85 KNA Dated: March 6, 2002 Received: March 6, 2002
Dear Ms. Rumple:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty of the enactment date of the Medical Device Amendments, or to conime.cc pror to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, de vices that nave over that do not require approval of a premarket approval application (PMA). and Costiculo Trol (110.) that the device, subject to the general controls provisions of the Act. The I ou may, alerchere, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
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 n may be subject to additions, 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 I lease oc actived that I Dr bristian that your device complies with other requirements of the Act that I Dr has made a avoid regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 OF ICF art 807), accems (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.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
proceed to the market.
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Tamponade Uterine Balloon Catheter Set
Device Name:
The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when
conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or
reduction of post-partum uterine bleeding when conservative management is warranted."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Nancy C. Brogdon
f Repr and Radiological Devices 510(k) Number