(30 days)
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Not Found
No
The device is a simple mechanical clamp with no mention of software, data processing, or any terms related to AI/ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device, an umbilical cord clamp, is used to close the umbilical cord after birth and prevent bleeding, which is a supportive rather than therapeutic function in the context of a medical device definition.
No
The device is described as an umbilical cord clamp, which is used for physical closure of the umbilical cord, not for diagnosing any medical condition.
No
The device description and intended use clearly describe a physical, disposable, sterile umbilical cord clamp, which is a hardware device. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The description clearly states the device is a "DISPOSABLE, STERILE UMBILICAL CORD CLAMP" used for "OBSTETRICS USE ONLY" to "PREVENT THE UMBILICAL CORD FROM GOING OUT OF THE BLOCKING COMBS" and for "IRREVERSIBLE CLOSURE". This is a physical device used on the body to perform a mechanical function (clamping the umbilical cord).
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, based on the provided information, this device is a surgical/obstetric instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
DISPOSABLE, STERILE UMBILICAL CORD CLAMP
TO BE USED FOR OBSTETRICS USE ONLY.
UMBILICAL CORD CLAMP WITH SIDE FASTENERS
TO PREVENT THE UMBILICAL CORD FROM GOING
OUT OF THE BLOCKING COMBS
IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL
OPENING.
Product codes
85 HFW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
UMBILICAL CORD
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The text "HEALTH & HUMAN SERVICES - USA" is arranged in an arc above the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
GPS, S.R.L. c/o Louis M. Pagliara Vice President, Marketing DirectMed, Incorporated 11 Lowell Road Port Washington, New York 11050 Re: K974227
Umbilical Cord Clamp Dated: November 7,1997 Received: November 12, 1997 Regulatory Class: I 21 CFR §884.4530/Product Code: 85 HFW
Dear Mr. Pagliara:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 800) and that, through periodic OS 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 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 question 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/dsmamain.html".
Sincerely yours,
W. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
| 12/08/1997 17:28 | ||||
|---|---|---|---|---|
| 12.01/97 12:58 | FDA QDE ORARD | |||
| 510(k) Number (if known): | K974227 | |||
| Device Name: | HOSPITAL'S CLAMP | |||
| Indications For Use: | DISPOSABLE, STERILE UMBILICAL CORD CLAMP | |||
| TO BE USED FOR OBSTETRICS USE ONLY. | ||||
| UMBILICAL CORD CLAMP WITH SIDE FASTENERS | ||||
| TO PREVENT THE UMBILICAL CORD FROM GOING | ||||
| OUT OF THE BLOCKING COMBS | ||||
| IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL | ||||
| OPENING. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | Robert R. Ratting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices |
|---------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K974227 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
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