UMBILICAL CORD CLAMP by MEDICAL SALES CO.

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.

Device Description

Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).

AI/ML Overview

This document describes a 510(k) premarket notification for an Umbilical Cord Clamp. It does not contain information about acceptance criteria or a study proving device performance in the way a medical AI/ML device submission would. The document focuses on establishing substantial equivalence to predicate devices based on material, configuration, function, manufacturing, packaging, and sterilization.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

Information not available in the provided document for this device:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Extracted Information (where applicable):

1. A table of acceptance criteria and the reported device performance:
Not applicable. This device is a physical umbilical cord clamp, not a diagnostic AI/ML device. The submission establishes substantial equivalence rather than meeting specific performance metrics against acceptance criteria typical for AI/ML.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No "test set" in the context of an AI/ML device study is mentioned. The device was subjected to non-clinical biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance would relate to its structural integrity, sterility, and biocompatibility, which were assessed through non-clinical tests.

8. The sample size for the training set:
Not applicable.

9. How the ground truth for the training set was established:
Not applicable.

Summary of Nonclinical Tests and Results (as provided in the document):

Tests: Biocompatibility (cytotoxicity, hemolysis)
Result: "no problems noted"
Testing body: An independent lab.

Conclusion: The provided document is for a traditional physical medical device (umbilical cord clamp) and not for an AI/ML device. Therefore, the questions related to AI/ML device evaluation (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission. The device demonstrates safety and effectiveness through substantial equivalence to predicate devices and results from non-clinical biocompatibility testing.

Summary

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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 CompanyP O Box 540314101 N. 700 WestNorth Salt Lake UT 84054
02. Packager:	Medical Techniques LC125 N. 400 West, Suite CNorth 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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Description: Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).
1. Intended 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.
1. Summary of the Technological Characteristics of This Device Compared to the Predicate(s):

There are no substantive changes in materials, basic configuration and function, method of manufacture or packaging, or sterilization between this device and its predicates.

1. Summary of Nonclinical Tests and 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.
1. Conclusion:
  The function and use of this device is no different than that of the predicates, as well as similare devices, marketed since pre-amendment.

Signed: Thomas Pilla Dated: 12-16-99

Thomas J. Haslam, Owner MEDICAL SALES COMPANY

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2000

Medical Sales Co. c/o Mr. John E. Lincoln J.E. Lincoln and Associates P. O. Box 154 Tooele, UT 84074

Re: K994367 Umbilical Cord Clamp Dated: February 17, 2000 Received: February 22, 2000 Regulatory Class: Il

21 CFR §884.4530/Procode: 85 HFW

Dear Mr. Lincoln:

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 26, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 Requlation (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 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 predication 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) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitiled, "Misbranding by reference to premarket notification" (21CFR 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) 443-5597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Kag436 510(k) Number (if known):

Umbilical Cord Clamp Device Name:

Indications For Use:

(PLRASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGES IF NEWDEND)

Concurrenos of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ XX (Per 21 CFR 801.109)

OR
Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

(Optional Formul 1-2-96)

Regulation Number and Section

§ 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.