(238 days)
This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called "Dr. Jahanger's Cutter (Umbilical Cord Cutter/Clamp)", dated October 29, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Type of Document: This is an FDA clearance letter, which confirms that a device has been found substantially equivalent to a predicate device. It is not a study report or a summary of device performance testing.
- Purpose of 510(k): The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a device already on the market (the "predicate device"). While some performance data might be submitted, the full details of clinical studies, acceptance criteria, and ground truth establishment are typically not included or summarized in the clearance letter itself.
- Specific Device: The device is a mechanical "Umbilical Cord Cutter/Clamp." For such a device, performance criteria would likely revolve around mechanical integrity, cutting efficiency, clamping effectiveness to prevent blood loss, biocompatibility of materials, and sterilization validation. These are engineering and performance specifications, not often clinical efficacy metrics in the same way an AI diagnostic would have.
Therefore, I cannot provide the requested table and study details because the provided document does not contain that information.
To answer your request, I would need a different type of document, such as:
- A clinical study report for the device.
- A premarket approval (PMA) application summary (which requires more extensive clinical data than a 510(k)).
- A detailed technical file or design history file from the manufacturer.
The provided text only includes the device name, its intended use (to cut and clamp the umbilical cord), and the FDA's determination of substantial equivalence. It does not elaborate on the specific tests, acceptance criteria, or the methodology of any studies conducted to demonstrate its performance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Mohammed S. Jahanger, M.D. Gynecology & Surgery 440 Egg Harbor Road Turnersville, NJ 08012
Re: K990738
Dr. Jahanger's Cutter (Umbilical Cord Cutter/Clamp) Dated: September 9, 1999 Received: September 15, 1999 Requiatory Class: I 21 CFR 884.4530/Procode: 85 KNA
Dear Dr. Jahanger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal. Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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H.D.J. K990738 510(K)
Dr. Jahanger's Cutter Device Name:
Indications For Use:
This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.
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Prescription Use
(Per 21 CFR 801.109
OR
Over-the-Counter Use (Optional Formal 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 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.