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."

Device Description

The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Tamponade Uterine Balloon Catheter Set. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would describe a diagnostic AI device or a novel therapeutic.

Therefore, much of the requested information cannot be directly extracted from this document. This submission is for a physical medical device, not an AI software.

Here's the information that can be extracted or inferred, and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) document. A 510(k) for a device like this primarily demonstrates substantial equivalence to predicate devices, focusing on materials, design, indications for use, and manufacturing processes, rather than presenting specific quantitative performance criteria and results like sensitivity, specificity, or precision. The "acceptance criteria" for a 510(k) are typically regulatory in nature (e.g., meeting biocompatibility standards, sterilization validation, etc.), not performance metrics of the device against a defined clinical outcome.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present. The document does not describe a clinical test set in the traditional sense. Substantial equivalence for this type of device is usually established through comparison to legally marketed predicate devices and validation of manufacturing and material properties, not a clinical trial with a defined test set of patients.

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)

This information is not applicable/not present. As there is no described clinical test set with ground truth establishment, this detail is not relevant to this 510(k) submission.

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

This information is not applicable/not present.

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

This information is not applicable/not present. This is a physical uterine balloon catheter, not an AI-assisted diagnostic or therapeutic device.

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

This information is not applicable/not present.

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

This information is not applicable/not present.

8. The sample size for the training set

This information is not applicable/not present. This is a physical device, not an AI algorithm requiring a training set.

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

This information is not applicable/not present.

Summary of Extracted Information:

The 510(k) document primarily describes the device, its intended use, and its substantial equivalence to predicate devices. It states:

Device Name: Tamponade Uterine Balloon Catheter Set
Intended Use: To provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted.
Predicate Devices: Mentor U-Stasis balloons and the Balloon Uterine Stent manufactured by Cook OB/GYN®.
Basis for Substantial Equivalence: Indications for use, design, materials of construction, manufacturing process controls, Quality Assurance Program, packaging, and sterilization procedures similar to currently marketed devices. The materials are all silicone, and biocompatibility testing showed they meet requirements.

The document does not contain the specific performance "acceptance criteria" and detailed study results typical for an AI software or a novel clinical intervention requiring extensive performance validation. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

Summary

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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.

page 8

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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.

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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.

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Tamponade Uterine Balloon Catheter Set

K013597

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)

Over-The-Counter Use_

Nancy C. Brogdon

f Repr and Radiological Devices 510(k) Number

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.