(81 days)
Not Found
No
The summary describes a simple mechanical device (umbilical cord clamp) with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device's purpose is to clamp the umbilical cord to prevent blood loss and seepage, which is a supportive and preventative measure, not a direct therapeutic intervention to treat a disease or condition.
No
Explanation: The device description states its purpose is to clamp the umbilical cord to prevent blood loss and seepage, which is a therapeutic and supportive function, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly indicates it is an injection-molded plastic umbilical cord clamp, which is a physical hardware device.
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 clamp the umbilical cord of a newborn to prevent blood loss. This is a mechanical action performed on the body.
- Device Description: The device is a physical clamp made of plastic.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide any diagnostic information about the patient's health or condition. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The device described is a surgical/medical instrument used for a physical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is a sterile, single-use, disposable umbilical cord clamp, used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth, prior to and after cutting.
Product codes (comma separated list FDA assigned to the subject device)
85 HFW
Device Description
Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).
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
newborn
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)
The device has been tested by an independent lab for biocompatability (cyctotoxicity, hemolysis) with no problems noted. The clamps will be subjected to QC upon receipt, during/after manufacture, and prior to release.
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.
K990737, et al, submissions, information attached, which were determined to be SE
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.
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MEDICAL SALES COMPANY PRODUCT DEVELOPMENT DIVISION
MAR 1 7 2000
PREMARKET NOTIFICATION
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Date Prepared: December 15, 1999
| 01. Submitter (and specification developer): | Medical Sales Company
P O Box 540314
101 N. 700 West
North Salt Lake UT 84054 |
|----------------------------------------------|--------------------------------------------------------------------------------------------|
| 02. Packager: | Medical Techniques LC
125 N. 400 West, Suite C
North Salt Lake UT 84054 |
| 03. Sterilizer: | Griffith Micro Sciences -- SLC Div.
5725 W. Harold Gatty Rd.
Salt Lake City UT 84116 |
| 04. Contact Person: | Tom Haslam, Sr., Owner |
| Telephone: | 800-292-4056 |
| 05. Trade Name: | Umbilical Cord Clamp |
| 06. Common Name: | Umbilical Cord Clamp |
| 07. Classification Name: | Clamp, Umbilical |
| 08. Product Code: | 85 HFW |
| Device Class: | Class II |
| 09. Performance Standards: | No performance standards have been officially adopted by the FDA. |
| 09. Predicate Device(s): | K990737, et al, submissions, information attached, which were determined to be SE |
510(k): UMBILICAL CLAMP Section 4 - 13063 South Davis Blvd * Bountiful, Utah * Telephone 801-295-6023 * Fax 801-296-5963
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