SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE

K020718 · Precision Dynamics Corp. · HFW · Jun 3, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020718
• Device Name: SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
• Applicant: Precision Dynamics Corp.
• Product Code: HFW · Obstetrics/Gynecology
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Securline® Umbilical Cord Clamp is a single-use, disposable, molded plastic device; available in sterile (#3505) or non-sterile (#3515) configurations. Used by clinicians during delivery to clamp the newborn's umbilical cord. Device holds the cord securely to prevent blood loss and seepage during the drying and shrinking process post-birth. Mechanical design provides closing and gripping forces equivalent to predicate devices.

Clinical Evidence

Bench testing only. No clinical data provided. Device evaluated for biocompatibility (cytotoxicity and skin irritation) and mechanical performance (closing and gripping forces) in comparison to predicate devices.

Technological Characteristics

Molded plastic umbilical cord clamp; single-use; disposable. Available in sterile or non-sterile packaging. Mechanical clamping mechanism. No electronic components or software.

Indications for Use

Indicated for clamping the umbilical cord of a newborn infant at delivery to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IM Inc. Umbilical Cord Clamp (880753)
• Hollister® Double Grip® Umbilical Cord Clamp (781548)
• Alpha Unlimited, Inc. Disposable Umbilical Cord Clamp

Submission Summary (Full Text)

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Precision Dynamics Corporat .. products you can identify with

13880 Del Sur Street
San Fernando
California 91340-3490, USA

ornia 91409-9043, USA

Phone: [phone] Fax: [phone]

# 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<br>devices as a predicate: |
| | | IM Inc. Umbilical Cord Clamp 510(k) 880753 Hollister® Double Grip® Umbilical Cord Clamp 510(k)<br>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: [phone]

pg. 3.1

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# 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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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#### 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.

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# 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