The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

Device Description

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.

AI/ML Overview

The provided text is a 510(k) summary for the Cook® Sonohysterography Biopsy Catheter, submitted in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this information.

The document details:

Device Description: The Cook® Sonohysterography Biopsy Catheter is designed for saline infusion sonohysterography and, if indicated, endometrial biopsy using the same device. It is supplied sterile for one-time use.
Substantial Equivalence: The submission asserts that the device is substantially equivalent to existing predicate devices based on its indications for use, materials, physical construction, manufacturing process controls, quality assurance, packaging, and sterilization procedures.
Predicate Devices: Several predicate devices are listed for both the sonohysterography function (e.g., Tampa Catheter, EZ-HSG Catheter, Cook Hysterocath™, Goldstein Sonohysterography Catheter) and the biopsy function (e.g., Probet, Uterine Explora Model I, Wallace Suresample, Pipelle de Cornier®, Aspiracath™).
Testing Mentioned: The document briefly states, "Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective." However, it does not elaborate on these "test requirements," specific acceptance criteria, or the results of these tests in detail. It also mentions "Literary articles prove the usefulness of this type of device," implying reliance on existing scientific literature rather than a new, specific performance study for this device.

None of the requested specific information about acceptance criteria, a formal study demonstrating performance against these criteria, sample sizes, ground truth establishment, or expert involvement is present in the provided text. The 510(k) process for this type of device often relies on demonstrating similarity to already marketed devices, and detailed performance studies with explicit acceptance criteria might not be fully presented in the public summary.

Summary

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KD6 0908 page 1/2

K. 510(k) Summary

JUN 2 9 2006

Submitted by:

Cindy Rumple Cook Urological, Incorporated and Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460 March 31, 2006

Device:

Trade Name:	Cook® Sonohysterography Biopsy Device
Proposed Classification Name:	Endometrial Aspirator, Unclassified
Product Code:	HHF, LKF
Regulation Number:	884.1060, Unclassified
Class:	Class II

Predicate Devices:

The Cook® Sonohysterography Biopsy Catheter is comparable to existing predicate devices in distribution including the Tampa Catheter distributed by CooperSurgical, theEZ-HSG Catheter distributed by OBG Products, the Cook Hysterocath™ distributed by Cook Incorporated and Cook Ob/Gyn, the Goldstein Sonohysterography Catheter distributed by Cook Ob/Gyn. The biopsy function of the Cook® Sonohysterography Biopsy Catheter is similar to the Probet distributed by Gynetic Medical Products N.V., the Uterine Explora Model I distributed by Milex Products, the Wallace Suresample Endometrial Sampler distributed by Smiths Medical, the Pipelle de Cornier® Endometrial Suction Curette distributed by CooperSurgical, and the Aspiracath™ distributed by Cook Ob/Gyn.

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KD60908 00

Device Description:

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 distributed by Cook Urological, Incorporated and Cook Ob/Gyn. 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling a human figure embracing another, with three flowing lines representing the arms and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

February 18, 2014

Cook Urological, Inc. Cindy Rumple Regulatory Affairs Technical Writer 1100 West Morgan Street Spencer, IN 47460

K060908 Trade/Device Name: Cook® Sonohysterography Biopsy Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PGK, HFF Dated (Date on orig SE Itr): March 31, 2006 Received (Date on orig SE Itr): April 3, 2006

Dear Cindy Rumple,

Re:

This letter corrects our substantially equivalent letter of June 29, 2006.

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. Ilsting 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.

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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 medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/7 description: The image shows the name "Benjamin Fisher-S" in a bold, sans-serif font. The letters "F", "D", and "A" are stylized with a decorative, outlined pattern. The name is written in black ink on a white background.

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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5 10(k) Preamendment Notification Cook® Sonotysterography Biopsy Catheter

Indications for Use

510(k) Number (if known):

K060908 Not Yet Assigned

Device Name:

Indications for Use:

Cook® Sonohysterography Biopsy Catheler

Prescription Use X (Part 21 CFR 801 Subpart D)

Over the Counter Use (Part 21 CFR 807 Subpart C)

(Please do not write below this line-FDA use only-continue on another page it needed)

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· Division · · · · · !し ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and Radiological Decress 510(k) Number

of____________________________________________________________________________________________________________________________________________________________________________

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.