(67 days)
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.
The provided text describes a 510(k) premarket notification for the Bakri Postpartum Balloon. The core of this submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections (2-9 relating to study details) are not explicitly present in the provided documentation, as a different regulatory pathway was taken.
Here's a breakdown of the information that can be extracted and an explanation for the missing elements based on the nature of a 510(k) submission based on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria/Performance Goal: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device, specifically the SOS Bakri Tamponade Balloon Set (K013597).
Reported Device Performance:
| Characteristic | Acceptance Criteria (Substantial Equivalence to SOS Bakri Tamponade Balloon Set K013597) | Reported Device Performance (Bakri Postpartum Balloon) |
|---|---|---|
| Indications for Use | "Temporary control or reduction of postpartum uterine bleeding when conservative management is warranted." (Predicate device's original indication) | "Temporary control or reduction of postpartum uterine bleeding when conservative management is warranted." (No change, but removal of uterine atony as a contraindication implies broader applicability within this indication) |
| Design/Function | "Identical" to predicate device | "Identical in design and function" to the SOS Bakri Tamponade Balloon Set (K013597). Described as an "inflatable tamponade balloon designed and proven to be effective in reducing and controlling postpartum bleeding." |
| Materials | Not explicitly stated for predicate, but "similar" or "identical" expected for equivalence. | Silicone rubber. Biocompatibility testing shown to meet test requirements. |
| Sterility | Predicate device is sterile. | Provided sterile in peel-open pouches. |
| Durability | Not explicitly stated for predicate in this document, but implied safe and effective. | Bench testing has proven the product's durability during simulated use. |
| Use | One time use. | Intended for one time use. |
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 provided as this submission relies on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a "test set" for performance evaluation in the way requested. The "testing, gathered data, and the history of the predicate device" refer to the existing data for the already cleared predicate.
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 provided for the same reasons as above. No specific "test set" with expert-established ground truth was part of this 510(k) for the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no specific clinical "test set" requiring adjudication for ground truth was used in this 510(k) submission.
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
Not applicable. This device is a manual obstetric-gynecologic instrument (balloon), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the current device's safety and effectiveness is primarily established through demonstration of substantial equivalence to an already legally marketed and cleared predicate device (SOS Bakri Tamponade Balloon Set K013597). This implies that the predicate device's safety and effectiveness (likely supported by historical data, clinical experience, and potentially older, pre-market clearance studies not detailed here) serves as the basis. The current submission highlights:
- "testing, gathered data, and the history of the predicate device... proves that the Bakri Postpartum Balloon is a safe and effective device."
- Biocompatibility testing results for the specific materials.
- Bench testing for durability.
8. The sample size for the training set
This information is not provided. As this is a 510(k) submission for a physical medical device based on substantial equivalence, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided. No "training set" in the context of machine learning or AI was used. The "ground truth" for the device's overall claims relies on its demonstrated equivalence to the predicate and the predicate's established track record.
{0}------------------------------------------------
510(k) Premarket Notification Bakri Postpartum Balloon Cook Ob/Gyn
K062438
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Cindy Rumple Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 August 18, 2004
OCT 2 7 2006
Device
| Trade Name: | Baker |
|---|---|
| Common Name: | Post |
| Proposed Classification Name: | Inst |
ri Postpartum Balloon tpartum Balloon rument, Manual, Specialized Obstetric-Gynecologic KNA
Predicate Devices:
The Bakri Postpartum Balloon is identical to the currently marketed SOS Bakri Tamponade Balloon Set (K013597). The purpose of this submission is to request clearance for the removal of uterine atony as a contraindication for use.
Indications for Use:
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Device Description:
The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use. The testing, gathered data, and the history of the predicate device, the SOS Bakri Tamponade Balloon Catheter Set (K013597), which is identical in design and function proves that the Bakri Postpartum Balloon is a safe and effective device.
{1}------------------------------------------------
510(k) Premarket Notification Bakri Postpartum Balloon Cook Ob/Gyn
K062438
Page 2 of 2
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 r ris dovice thir and go pack. 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its body, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Cindy Rumple Regulatory Affairs Cook OB/GYN 1100 West Morgan Street SPENCER IN 47460
OCT 2 7 2006
Re: K062438
Trade/Device Name: Bakri Postpartum Balloon Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: KNA Dated: August 18, 2006 Received: August 21, 2006
Dear Ms. Rumple:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white logo with the letters "PA" in a bold, stylized font. Above the letters, the numbers "1896-1996" are printed. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial". The logo is surrounded by a dotted circle.
Protecting and Promoting Public Health
{3}------------------------------------------------
Page 2 -
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); 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,
This letter will allow you to begin marketing your device as described in your Section 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 proceed to the market.
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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Premarket Notification Bakri Postpartum Balloon Cook Ob/Gyn
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Bakri Postpartum Balloon
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Prescription Use? _ X (Part 21 CFR 801 Subpart D) Ard/Or
Over-The Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRTIE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Leggans
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
§ 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.