KOALA CLAMP, KOALA CLAMP AND CUTTER

K011621 · Maternus, Inc. · HFW · Aug 10, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011621
• Device Name: KOALA CLAMP, KOALA CLAMP AND CUTTER
• Applicant: Maternus, Inc.
• Product Code: HFW · Obstetrics/Gynecology
• Decision Date: Aug 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.

Device Story

The Koala Clamp & Cutter is a manual surgical instrument used during childbirth to simultaneously clamp and cut the umbilical cord. The device consists of a plastic clamp and a stainless steel surgical blade. It is operated by a healthcare practitioner in a clinical setting. The device functions by applying a clamp to the umbilical cord while a built-in blade performs the cutting action. A protective shield is integrated into the design to cover the blade. The device is provided sterile and is intended for single use. By combining the clamping and cutting steps, the device facilitates the procedure for the clinician.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Lexan 144R or 124R plastic, stainless steel surgical blade. Dimensions: 74mm x 50.6mm x 32.9mm (open). Sterilization: Gamma-sterilized or Ethylene Oxide gas. Biocompatible. Manual mechanical operation.

Indications for Use

Indicated for use in all births to simultaneously clamp and cut the umbilical cord.

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

• ClampCut (K982464)

Submission Summary (Full Text)

{0}------------------------------------------------

## KOII621

AUG 1 0 2001

### 510(k) Summary

## Substantial Equivalence & Safety & Effectiveness Information

[May 18, 2001]

- Koala Clamp & Cutter I. Proprietary Name:
- Umbilical Cord Clamp & Cutter Device Common Name: II.
- Umbilical Clamp (HFW), Umbilical Scissors (HDJ) Classification Name: III.
- Cutter is substantially Clamp & Substantial Equivalence: The Koala IV. equivalent to the ClampCut by PriceInvena APS, a legally marketed device in the US. [510(k) No. 982464]
- Statement of Intended Use: The indications for use of the Koala Clamp & are to V. simultaneously clamp and cut the umbilical cord.

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# KO 11621

#### Comparison of Present Device & Predicate Device: VI.

| Comparison Chart of Koala Clamp & Cutter and<br>Predicate Device | | |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Koala Clamp | ClampCut (SCC-23) |
| Indications for Use | The indications for use are to<br>simultaneously clamp and cut the umbilical<br>cord. | The indications for use are to<br>simultaneously clamp and cut the umbilical<br>cord. The device reduces the risk to<br>healthcare practitioners of unnecessary<br>exposure to infection by bloodborne<br>diseases. |
| Target Population | All births | All births |
| Materials: Plastic | Lexan 144R (alternate: Lexan<br>124R) | Polyamid 6.6. |
| Biocompatible | Yes | Yes |
| Materials: Blade | Stainless Steel Surgical Blade | Stainless Steel Knife |
| Shield (for Blade) | Yes | No |
| Dimensions: Open Unit | 74mm x 50.6mm x 32.9mm | 120mm x 70mm x 20mm |
| Dimensions: Closed Unit | 46.8mm x 50.6mm x 32.9mm | 85mm x 60mm x 20mm |
| Dimensions: Infant<br>Clamp | 43.5mm x 23.9mm x 6.5mm | 50mm x 9mm x 7mm |
| Weight of Total Unit | 1.316 oz | 0.811 oz (23 grammes) |
| Weight of Cutter Unit<br>alone | 0.53 oz | 0.713 oz (20.2 grammes) |
| Weight of Infant Clamp<br>alone | 0.086 oz | 0.099 oz (2.8 grammes) |
| Sterility | Gamma-Sterilized (alternate:<br>Ethylene Oxide Gas) | Ethylene Oxide Gas |
| Anatomical Sites | Umbilical Cord | Umbilical Cord |

31

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

AUG 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald B. Hicks Vice President and COO Maternus, Inc. P.O. Box 782089 SAN ANTONIO TX 78278-2089 Re: K011621 Koala Clamp & Cutter, Umbilical Cord Clamp and Cutter Dated: May 22, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR \$884.4530/Procode: 85 HFW

Dear Mr. Hicks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have been include devices We have reviewed your Section 310(x) noutications of mise enclosed to legally marketd predicate devices and device is substantially equivalent (10) the materials to tass and added Device Americal Device Amendmants, or to devices of to devices of to devices of to devices of tot Act marketed in intersate commerce provisions of the Federal Food, Drug, and Comments Act (Act.). You may, accorple provisions of the Ar that have been reclassified in accordance with the provisions of the every means a controls provisions of the Act. therefore, market the device, subject to the general controls of the Programment of the contributions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premater Approval), it may be subjections If your device is classinod (See above) nito elifecting your device can be in the Code of Federal Regulations, to such additional controls. Existing major regulation and the Current Good Manufacturing (11 CFR Parts Title 21, Parts 800 to 893. A substant decimination assame and called Devices: Central regulation (21 CFR Partice, coursely, could Practice requirements, as set form in the Food and Drug Administration (PDA) will be rify such assumptions. Failure 820) and that, through periodic QS inspections, the Pod and Drag From and the may publish further announcements.
The comply with the GMP regulation may result in regulatory a to comply with the GMP regulation in regulations and this resolution of theming world. Includion submission does not
concerning your device in the Federal Register. Please n concerning your device in the rederal Register. Trease noter and response of the Electronic Product 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) premarks incification for your province and This letter will allow you to begally marketed predicated anyone of your of your 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 and additionally on the scameration on the scameration on the scameration on the sca If you desire specific advice tor your device of Compliance at [phone]. Additionally, for questions on the promotion diagnosite devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information of your of the fire entitled, "Misbanding by relectice to picharker nothe Division of Small Manufactures Assistance at its toll-free number (800)
responsibilities under the Act may be obtained f responsibilities under the Act may be obtained internet address "http://www.fda.gov/cdrh/dsmala.html".

Sincerely yours.

Nancy C Brogdon

Nancy C. rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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## Statement of Indications for Use

| 510(k) Number: | K011621 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Device Name: | Koala Clamp & Cutter |
| Indications for Use: | The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

9

David C. Simpson

.............................................................................................................................................................................

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ 0/162

**Prescription Use**
(Per 21 CFR 801.109)

510(k) Premarket Notification Koala Clamp & Cutter