(90 days)
Not Found
Not Found
No
The description focuses on a simple mechanical device (umbilical cord clamp) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for data sets and performance studies typically associated with AI/ML devices.
No
The device, an umbilical cord clamp, compresses the umbilical cord. This action is not considered a therapeutic function; instead, it is a clamping mechanism for a physiological process.
No
The device is used to compress the umbilical cord, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is an "instrument" and a "device used to compress the umbilical cord," which are physical actions performed by a hardware device, not software.
Based on the provided text, the Dynarex Umbilical Cord Clamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "compress the umbilical cord." This is a physical action performed on a part of the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical function and design of the clamp, comparing it to similar devices on the market. It doesn't mention any reagents, assays, or analysis of biological samples, which are characteristic of IVD devices.
- Lack of IVD Indicators: The text does not mention any of the typical elements associated with IVD devices, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or assays
- Analysis of results to provide diagnostic information
Therefore, the Dynarex Umbilical Cord Clamp is a medical device used for a physical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
90 HFW
Device Description
The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
umbilical cord
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
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.
Not Found
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
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Dynarex Corporation (Pre-market Notification)
Page 14
NOV 2 8 2001
Appendix A (Summary of Safety And Effectiveness)
Submitter:
John Gagliardi, President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net
Umbilical Cord Clamp Trade Name:
Common Name: Umbilical Cord Clamp
Classification Name: Umbilical Clamp (21 CFR, Part 884.4530)
Summary of Safety and Effectiveness:
The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.
The Dynarex Umbilical Cord Clamp is indicated for use to compress the umbilical cord and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services-USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Dynacare, Inc. c/o Mr. John Gagliardi MidWest Process Innovation, LLC 7736 Woodside Court MAINEVILLE OH 45039
Re: K012917
Trade/Device Name: Dynarex Umbilical Cord Clamp Models-6833 and 6833-B Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 90 HFW
Dated: August 28, 2001 Received: August 30, 2001
Dear Mr. Gagliardi:
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); 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.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarketed This letter will allow you to begil marksting your device of your device to a legally marketed
notification. The FDA finding of substantial equivale society, and device to notification. The FDA inding of substantal equivaliation of 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), please If you desire specific advice for your device on our has and one of the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. company of any and information on Office of Compliance at (301) 274-1057. They Part 807.97). Other general information on by reference to premarket notification (21 CF CF it is on the Division of Small Maunfacturers, your responsibilities under the Accentry of South or (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free number (800) 443-6597
Internation merilanonal and Consumer Fristiww.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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Dynarex Corporation Pre-market Notification
Page 5
Device Name: Dynarex Umbilical Cord Clamp
Indications for Use: The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012917
on Use Pres