(336 days)
Not Found
No
The device description and intended use describe a mechanical device for manipulating fetal membranes, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Not Found" entries for AI/ML mentions, training/test sets, and key metrics further support this.
Yes
The device is used to prolong pregnancy to a successful delivery, which is a therapeutic outcome. Additionally, its components and function (positioning fetal membranes, temporary occlusion of the internal cervical os) are directly involved in a medical procedure (cervical cerclage) aimed at treating a condition (emerging fetal membranes) to achieve a therapeutic effect.
No
This device is designed for a therapeutic purpose (manipulating fetal membranes during cerclage) rather than for diagnosing a condition or disease.
No
The device description explicitly states it is comprised of a polycarbonate dual lumen catheter with a silicone balloon, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically manipulate fetal membranes during a surgical procedure (cervical cerclage). This is a direct intervention on the patient's body.
- Device Description: The device is a physical tool (catheter with a balloon) used for mechanical manipulation.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions.
The Cook® Fetal Membrane Manipulator is a medical device used in a surgical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The device is used as an adjunct to a surgical needle such as the Deklene® Needle/Suture combination manufactured by Teleflex medical (needle is exempt, cervical needles are listed with FDA). Combination is also equivalent to the ZUMI™ Zinnanti Uterine manufactured by CooperSurgical (K941458):
The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
Product codes (comma separated list FDA assigned to the subject device)
KNA
Device Description
The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage membrancs back. In order to prolong programsy to a successful delivery. The Cook® Fetal Membrane Manipulator procedure in order in order as an adjunct to a cervical cerclage needle for replacement of fetal membranes and is mornound be do use a cervical cervical os during cervical cerclage. The Cook® Fetal Membrane temporary obolds or or the november polycarbonate dual lumen catheter with a silicone balloon. The balloon cathere assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal, uterus, internal cervical os
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)
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Diocompaibility, Stoniny and recognized international standards. Testing results were well within the acceptance criteria. Testing data and information is included in this submission.
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
K082939
SEP - 3 2009
510(k) SUMMARY
Submitted by:
Device:
Trade Name:
Cindy Foote Regulatory Affairs Specialist Cook Urological, Incorporated Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460 August 26, 2009
Cook® Fetal Membrane Manipulator
Proposed Classification Name:
Instrument, Manual, Specialized, Obstetric-Gynecologic 21 CFR Part 884 4530 Class II, KNA
Predicate Devices:
The Cook® Fetal Membrane manipulator is intended to be used as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical reprelage. The device is used as an adjunct to a surgical needle such as the Deklene® Needle/Suture combination manufactured by Teleflex medical (needle is exempt, cervical needles are listed with FDA). Combination is also equivalent to the ZUMI™ Zinnanti Uterine manufactured by CooperSurgical (K941458):
Device Description:
The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage membrancs back. In order to prolong programsy to a successful delivery. The Cook® Fetal Membrane Manipulator procedure in order in order as an adjunct to a cervical cerclage needle for replacement of fetal membranes and is mornound be do use a cervical cervical os during cervical cerclage. The Cook® Fetal Membrane temporary obolds or or the november polycarbonate dual lumen catheter with a silicone balloon. The balloon cathere assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
Substantial Equivalence:
The Cook® Cervical Ripening Balloon is comparable as an adjunct, with respect to intended use, to the The Ober of noar Ripon description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Diocompaibility, Stoniny and recognized international standards. Testing results were well within the acceptance criteria. Testing data and information is included in this submission.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Cindy Foote Regulatory Affairs Specialist Cook Urological, Inc. Cook Womens Health 750 Daniels Way BLOOMINGTON IN 47404
SEP - 3 2009
Re: K082939
Trade/Device Name: Cook™ Fetal Membrane Manipulator Regulation Number: 21 CFR §884.4530 Regulation Name: Instrument, Manual, Specialized Ob-Gyn Regulatory Class: II Product Code: KNA Dated: August 24, 2009 Received: August 26, 2009
Dear Ms. Foote:
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 (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 medical
2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KO82939
Indications for Use
K082939 510(k) Number (if known):
Device Name:
Indications for Use:
Cook® Fetal Membrane Manipulator
The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
Prescription Use? × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin Pollard
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.