The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

Device Description

The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os.

In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.

AI/ML Overview

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. This device is regulated under 21 CFR § 884.4260 as a Class II device (Hygroscopic Laminaria cervical dilator).

Acceptance Criteria and Device Performance:

The provided document describes a series of verification tests to demonstrate the reliable design and performance of the Cook® Cervical Ripening Balloon. The acceptance criteria are implicitly defined by the successful completion of these tests.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Balloon Deflation Reliability	Balloons deflate properly after use.	Demonstrated (explicitly stated: "to demonstrate that the balloons deflate properly after use.")
Balloon Burst	Balloons do not burst at the maximum recommended inflation volume under simulated use conditions.	Demonstrated (explicitly stated: "to demonstrate that the balloons do not burst at the maximum recommended inflation volume under simulated use conditions.")
Balloon Volume Maintenance	Balloons do not leak.	Demonstrated (explicitly stated: "to demonstrate that the balloons do not leak.")
Balloon Integrity	Balloons do not rupture under simulated use conditions.	Demonstrated (explicitly stated: "to demonstrate that the balloons do not rupture under simulated use conditions.")
Balloon Response to Pullout	Distal balloon does not pull out from the patient under simulated use conditions.	Demonstrated (explicitly stated: "to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions.")
Catheter Tensile	Catheter shaft can sustain the maximum tensile forces anticipated in use.	Demonstrated (explicitly stated: "to demonstrate that the catheter shaft can sustain the maximum tensile forces anticipated in use.")
Biocompatibility	Acceptance criteria from ISO 10993-1 are met.	Acceptance criteria from ISO 10993-1 were met (explicitly stated: "The testing shows that the acceptance criteria from ISO 10993-1 were met.").
Simulated Use	Non-clinical users can properly follow the use instructions in a simulated environment.	Demonstrated (explicitly stated: "to demonstrate that the non-clinical users can properly follow the use instructions in a simulated environment.")

Study Details:

The provided text describes a premarket notification for a medical device (510(k)) and outlines the verification testing performed. It does not describe a clinical study in the traditional sense with patient data, statistical analyses, or comparative effectiveness. Instead, it focuses on engineering and biocompatibility testing. Therefore, many of the requested details are not applicable to the information provided.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes verification testing rather than testing on a clinical "test set" of patient data. The "samples" would refer to the number of devices tested for each engineering and biocompatibility test (e.g., how many balloons were burst tested, how many catheters were tensile tested). This information (specific sample sizes per test) is not provided in the summary.
- Data provenance for these engineering tests would typically be the manufacturing facility or a contract testing lab. This information is not explicitly stated, nor is it typically included in a high-level 510(k) summary for engineering tests. The tests are "simulated use conditions," implying laboratory or bench testing rather than human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For engineering and biocompatibility tests, "ground truth" is typically defined by scientific principles, standards (like ISO 10993-1), and pre-defined pass/fail criteria. These tests are conducted by engineers and scientists, not typically by medical experts establishing a "ground truth" for patient cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among reviewers. For physical product verification tests, the results are typically objective measurements against pre-defined specifications.
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 physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, especially of AI/CAD systems.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, for the same reason as above. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO 10993-1 for biocompatibility), and physical laws that govern the device's performance. The successful demonstration against these criteria means the device performs as intended and meets safety requirements.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of physical medical device verification testing as described. This term applies to machine learning or AI models.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

Summary

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Cook Incorporated Traditional 510(k) Premarket Notification Cook® Cervical Ripening Balloon

Cook Incorporated Cook® Cervical Ripening Balloon 510(k) Summary 21 CFR 807.92 Date Prepared: September 24, 2013

1. Submitter Information

Applicant:

Cook Incorporated

(800) 468-1379

(812) 332-0281

Address:

750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Phone Number:
Fax Number:

Contact: Contact Address: Chris Kilander Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Contact Phone Number:	(812) 339-2235 x2564
Contact Fax Number:	(812) 332-0281

2. Device Information

Trade Name:	Cook® Cervical Ripening Balloon
Common Name:	Catheter, Balloon, Dilation of the Cervical Canal
Classification:	Class II
Regulation:	21 CFR § 884.4260
Regulation Description:	Hygroscopic Laminaria cervical dilator
Product Code:	PFJ

3. Predicate Devices

The Cook® Cervical Ripening Balloon is substantially equivalent to the Atad Pre-Induction Cervical Dilator (Atad Developments and Medical Services Ltd.) cleared January 18, 2005 under 510(k) number K040625.

SEP 27 2013

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Cook Incorporated Traditional 510(k) Premarket Notification Cook® Cervical Ripening Balloon

4. Comparison to Predicates:

The intended use and technological characteristics of the Cook® Cervical Ripening Balloon are substantially equivalent to the intended use and technological characteristics of the Atad Pre-Induction Cervical Dilator.

Device Description ડ.

6. Intended Use

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

7. Technological Characteristics

The Cooke Cervical Ripening Balloon consists of an 18 Fr., 40 cm silicone catheter with a silicone tip and two silicone balloons, each inflatable up to 80 mL. Each balloon is inflated via a separate inflation lumen through a check valve at the proximal end of the

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device. The check valves are marked with a "U" for the distal, uterine balloon and a "V" for the proximal, vaginal balloon.

For the Cook® Ccrvical Ripening Balloon with Stylet, a 46 cm malleable stainless steel stylet with an adjustable handle is included. The stylet is placed through a separate third lumen that is closed at the distal tip and marked at the proximal end with an "S." The stylet handle allows the user to adjust the stylet so that the distal tip is advanced to the distal (closed) end of the lumen.

The Cook® Cervical Ripening Balloon may be left indwelling for up to 12 hours. The Cook Cervical Ripening Balloon is supplied sterile and is intended for one-time use.

To demonstrate reliable design and performance of the Cook® Cervical Ripening Balloon the following verification testing and information is presented:

Balloon Deflation Reliability Testing to demonstrate that the balloons . deflate properly after use.
. Balloon Burst - Testing to demonstrate that the balloons do not burst at the maximum recommended inflation volume under simulated use conditions.
Balloon Volume Maintenance Testing to demonstrate that the balloons do . not leak.
. Balloon Integrity - Testing to demonstrate that the balloons do not rupture under simulated use conditions.
. Balloon Response to Pullout - Testing to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions,
. Catheter Tensile - Testing to demonstrate that the catheter shaft can sustain the maximum tensile forces anticipated in use.
. Biocompatibility - Testing to demonstrate that the device is biocompatible. The testing shows that the acceptance criteria from ISO 10993-1 were met.
. Simulated Use - Testing to demonstrate that the non-clinical users can properly follow the use instructions in a simulated environment.

In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate and support a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2013

Cook, Inc. % Chris Kilander, MS, RAC, CQE Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47404

Re: K131206

Trade/Device Name: Cook® Cervical Ripening Balloon Regulation Number: 21 CFR§ 884.4260 Regulation Name: Hygroscopic Laminaria cervical dilator Regulatory Class: II Product Code: PFJ Dated: August 29, 2013 Received: August 30, 2013

Dear Chris Kilander,

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 (reporting of

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Page 2 - Chris Kilander, MS, RAC, CQE

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRHOffices/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 P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

510(k) Number (if known): K131206

Device Name: Cook® Cervical Ripening Balloon

Indications for Use:

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.09.27 11:53:55 -04'00'

Regulation Number and Section

§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).