(90 days)
880753, 781548
880753, 781548
No
The summary describes a simple mechanical device for clamping an umbilical cord and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No.
The device's intended use is to clamp the umbilical cord to prevent blood loss and seepage, which is a supportive rather than a therapeutic function.
No
The device is purely mechanical, used for clamping the umbilical cord to prevent blood loss. It does not perform any measurements, analysis, or detection of medical conditions.
No
The device description explicitly states it is a "molded plastic device," indicating it is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Securline Umbilical Cord Clamp Function: The Securline Umbilical Cord Clamp is a physical device used externally on the umbilical cord after birth. Its purpose is to physically clamp and secure the cord to prevent blood loss and aid in the drying process. It does not involve testing any bodily fluids or tissues to diagnose or monitor a condition.
The provided information clearly describes a mechanical device used for a physical purpose, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Securline ® Umbilical Cord Clamp intended use is to clamp over the newborn infants umbilical cord at delivery and prevent blood loss as the cord dries and shrinks after the birth.
The Securiting Unbilical Cord Clamp is 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 ard seepage as the curd dries and shrinks after the birth.
Product codes
85 HFW
Device Description
The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
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 infants
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 tested by an independent laboratory for biocompatability (cytotoxicity and skin irritation) with favorable results. The device has been evaluated ın comparison to predicate devices as to closing and gripping forces,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IM Inc. Umbilical Cord Clamp 510(k) 880753, Hollister® Double Grip® Umbilical Cord Clamp 510(k) 781548, Alpha Unlimited, Inc. Disposable Umbilical Cord Clamp
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
Precision Dynamics Corporat .. products you can identify with
13880 Del Sur Street
San Fernando
California 91340-3490, USA
ornia 91409-9043, USA
Phone: (818) 897-1111 Fax: (818) 899-4045
510(k) Summary
JUN 0 3 2002
| Image: logo | Trade Name: | Securline® Umbilical Cord Clamp #3505 and #3515 |
|---|---|---|
| Common Name : | Umbilical Cord Clamp | |
| Classification: | Umbilical Clamp (per 21CFR §884.4530(3) | |
| Predicate device: | Precision Dynamics Corporation identifies the following | |
| devices as a predicate: | ||
| IM Inc. Umbilical Cord Clamp 510(k) 880753 Hollister® Double Grip® Umbilical Cord Clamp 510(k) | ||
| 781548 Alpha Unlimited, Inc. Disposable Umbilical Cord Clamp |
Description of the device: The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
Intended use: The Securline ® Umbilical Cord Clamp intended use is to clamp over the newborn infants umbilical cord at delivery and prevent blood loss as the cord dries and shrinks after the birth.
Performance standards:
No performance standards have been officially adopted by the FDA. The device tested by an independent laboratory for biocompatability (cytotoxicity and skin irritation) with favorable results. The device has been evaluated ın comparison to predicate devices as to closing and gripping forces,
Conclusion: Precision Dynamics Corporation concludes that the function and use of the device is no different than that of the predicate devices.
Submitter Information: Precision Dynamics Corporation Contact: Kalyna Snylyk Telephone: (818) 897-11111
pg. 3.1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows a partial logo of the Department of Health and Human Services (HHS). The logo features the stylized silhouette of an eagle's head and neck, rendered in black. The text "DEPARTMENT OF" is partially visible, curving around the left side of the logo. The overall impression is of a formal, official emblem.
JUN . 3 2002
Ms. Kalvna Snylyk Manager of Regulatory Affairs and Quality Assurance Precision Dynamics Corporation 13880 Del Sur St. SAN FERNANDO CA 91340
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K020718
Trade/Device Name: Securline® Umbilical Cord Clamp #3505 (sterile), #3515 (non-sterile) Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HFW
Dated: January 30, 2002 Received: March 5, 2002
Dear Ms. Snylyk:
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) 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), please contact the Office of Compliance at one of the following numbers, based on 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
8 a c
KO20718 510(k) Number (if known): _
Cord Clamp 43505 (sterile) and 43515 (non-sterile) Umbilical Device Name:
Indications For Usc:
The Securiting Unbilical Cord Clamp is 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 ard seepage as the curd dries and shrinks after the birth.
(FLEASE DO NOT WRITE BINLOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formel 1-2-96)
David le Seaman
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number