(28 days)
Not Found
No
The device description and performance studies focus on the physical components, packaging, and mechanical testing of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is intended to provide temporary control or reduction of postpartum uterine bleeding, which is a therapeutic action.
No
The device is intended to treat postpartum uterine bleeding, not to diagnose it. Its function is to provide temporary control or reduction of bleeding, which is a therapeutic action.
No
The device description clearly states it is composed of a double lumen silicone balloon catheter and a stopcock, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bakri Essential Postpartum Balloon is a physical device inserted into the uterus to control bleeding. It does not analyze biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use is to "provide temporary control or reduction of postpartum uterine bleeding," which is a therapeutic intervention, not a diagnostic one.
- Device Description: The description details a physical balloon catheter and its components, not a test kit or analytical system.
Therefore, the Bakri Essential Postpartum Balloon falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Product codes (comma separated list FDA assigned to the subject device)
OQY
Device Description
The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.
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)
The support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) according to ISO 14971:2019 was performed. The Bakri Essential Postpartum Balloon was subjected to applicable testing to assure reliable design and performance under the testing parameters. As the differences in the subject device compared to the predicate device include packaging differences and the removal of the syringe from the set, the following tests were conducted to ensure the reliability of the packaging at time zero and end of the three year shelf-life:
- Pouch Seal Strength Testing: verification that the minimum seal strength shall meet ● or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15
- Bubble Leak Testing: verification that packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11
- Dye Penetration Testing: verification that no packaging seal may be breached by dye ● per F1929-15
- Additional distribution testing followed by functional verification: verification that ● device shows no signs of damage after sterilization and simulation distribution.
The results of these testing described above demonstrate that the Bakri Essential Postpartum Balloon is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2022
Cook Incorporated Ian Herrman Senior Regulatory Affairs Specialist 750 Daniels Wav. P.O. Box 489 Bloomington, IN 47402
Re: K223098
Trade/Device Name: Bakri Essential Postpartum Balloon Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: OQY Dated: September 29, 2022 Received: September 30, 2022
Dear Ian Herrman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223098
Device Name Bakri Essential Postpartum Balloon
Indications for Use (Describe)
The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ | ☐ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K223098 Page 1 of 3
510(k) SUMMARY
Bakri Essential Postpartum Balloon
Submitted By
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Ian Herman |
| Address: | 750 Daniels Way |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | (812) 335-3575 x104034 |
| Contact Fax Number: | (812) 332-0281 |
| Date Prepared: | October 26, 2022 |
| Device Information | |
| Proprietary Name: | Bakri Essential Postpartum Balloon |
| Common Name: | Intrauterine tamponade balloon |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Regulation Number: | 21 CFR 884.4530 |
Predicate Device
Regulation Class:
Product Code:
Bakri Postpartum Balloon, manufactured by Cook Incorporated (K170622).
II
The predicate device has not been subject to a design-related recall.
Device Description
The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
OQY, Intrauterine Tamponade Balloon
The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.
4
The Bakri Essential Postpartum Balloon is a modified version of the predicate device cleared under K170622.
Indications for Use
The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Comparison to Predicate Device
A comparison of the intended use and technological characteristics of the subject and predicate device are outlined in the table below.
| General Device | Subject device | Predicate device | Comments |
|---|---|---|---|
| Characteristics | K223098 | K170622 | |
| Product code | OQY | OQY | Same |
| Intended | |||
| use/Indications | |||
| for Use | Bakri Essential | ||
| Postpartum Balloon is | |||
| intended to provide | |||
| temporary control or | |||
| reduction of postpartum | |||
| uterine bleeding when | |||
| conservative | |||
| management is | |||
| warranted | Bakri Postpartum Balloon is | ||
| intended to provide | |||
| temporary control or | |||
| reduction of postpartum | |||
| uterine bleeding when | |||
| conservative management is | |||
| warranted. | |||
| & | |||
| Bakri Postpartum Balloon | |||
| with Rapid Instillation | |||
| Component is intended to | |||
| provide temporary control | |||
| or reduction of postpartum | |||
| uterine bleeding when | |||
| conservative management is | |||
| warranted. | Same. | ||
| Dimensions | Length: 58 cm (working | ||
| length of 54 cm) | |||
| Outer Diameter: 24 Fr | |||
| Balloon Volume: 500 | |||
| mL | Length: 58 cm (working | ||
| length of 54 cm) | |||
| Outer Diameter: 24 Fr | |||
| Balloon Volume: 500 mL | Same | ||
| Materials | Balloon Catheter and | ||
| Shaft: Silicone | |||
| Female Luer-Lock | |||
| Adapter: Polyamide | Balloon Catheter and Shaft: | ||
| Silicone | |||
| Female Luer-Lock Adapter: | |||
| Polyamide | Same | ||
| Syringe | Syringe not included | 60 mL syringe | Different |
| Stopcock | Included | Included | Same |
5
| Packaging | Sterile Barrier: Tyvek
(1073B)/Polyethylene
Peel Open Pouch
Package.
5 individually packaged
units per Box (8" & 1/8"
X 2 & 3/8" X 17") | Sterile barrier: Tyvek
(1059B)/Polyethylene Peel
Open Pouch Package.
1 packaged unit per box
(8" X 1 & 7/16" X 16")
Inner packaging: Fitted in
a PETG (Polyethylene
Terephthalate Glycol-
Modified tray with PETG
retainer and seal | Different. |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Sterilization | EO, 10-6, single use | EO, 10-6, single use | Same |
The subject and predicate device have the same intended use, principles of operation, and technological characteristics. The only differences between the Bakri Essential and the predicate device are the packaging configuration and the removal of the syringe from the set. These differences do not raise different questions of safety and effectiveness and can be assessed by verification and validation testing.
Summary of Non-clinical Performance Testing
The support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) according to ISO 14971:2019 was performed. The Bakri Essential Postpartum Balloon was subjected to applicable testing to assure reliable design and performance under the testing parameters. As the differences in the subject device compared to the predicate device include packaging differences and the removal of the syringe from the set, the following tests were conducted to ensure the reliability of the packaging at time zero and end of the three year shelf-life:
- Pouch Seal Strength Testing: verification that the minimum seal strength shall meet ● or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15
- Bubble Leak Testing: verification that packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11
- Dye Penetration Testing: verification that no packaging seal may be breached by dye ● per F1929-15
- Additional distribution testing followed by functional verification: verification that ● device shows no signs of damage after sterilization and simulation distribution.
Conclusion
The results of these testing described above demonstrate that the Bakri Essential Postpartum Balloon is as safe and effective as the predicate device and supports a determination of substantial equivalence.