LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

K021012 · Quality Medical Solusions, LLC · HDY · Jun 25, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021012
• Device Name: LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
• Applicant: Quality Medical Solusions, LLC
• Product Code: HDY · Obstetrics/Gynecology
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4260
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

Device Story

Single-use hygroscopic cervical dilator; composed of dried root of seaweed (Laminaria digitata). Device inserted into cervical canal; absorbs moisture to expand slowly over 6 to 24 hours; provides mechanical dilation of cervical os. Available in diameters 2-9 mm; length 50-65 mm; includes attached string for removal. Used by clinicians in clinical settings. Benefits include gradual, physiological dilation of body orifice. Improper use may cause patient discomfort or uterine complications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics, materials, and design to the predicate device.

Technological Characteristics

Hygroscopic cervical dilator made from Laminaria digitata root. Cylindrical form factor; 2-9 mm diameter; 50-65 mm length. Includes removal string. Passive mechanical expansion via moisture absorption. Sterilized via ethylene oxide.

Indications for Use

Indicated for patients requiring cervical canal dilation for procedures including uterine curettage, labor induction, IUD placement/removal, and radium placement.

Regulatory Classification

Identification

A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.

Predicate Devices

• Staol Laminaria Tents (K951330)

Submission Summary (Full Text)

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K021012

## JUN 2 5 2002

# 510(k) Summary As Required by 21 section 807.92 ( c )

| 1-Submitter Name: | Quality Medical Solutions LLC |
|---------------------------------------------------------------------|------------------------------------------------------|
| 2-Address: | 1308 Morningside Park Dr<br>Alpharetta, GA 30022 USA |
| 3-Phone: | [phone] |
| 4-Fax: | [phone] |
| 5-Contact Person: | Jay Mansour |
| 6-Date summary prepared: | March 25th, 2002 |
| 7-Device Trade or Proprietary Name: | Laminaria |
| 8-Device Common or usual name: | Laminaria digitata |
| 9-Device Classification Name: | Hygroscopic laminaria cervical dilator |
| 10-Substantial Equivalency is claimed against the following device: | |

- Staol Laminaria Tents from Norscan Trading Group ●
### 11-Description of the Device:

This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.

The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications

Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement

#### 12-Intended use of the device:

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

#### 13-Safety and Effectiveness of the device:

This device (Laminaria) is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

#### 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that Laminaria is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

\$\rho\$ 6

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| FDA file reference number | 510k 951330 |
|--------------------------------------------------|-------------------------------------------------------------------|
| Attachments inside notification submission file | VERY IMPORTANT: REFER TO TABLE WITHIN MAIN SUBMISSION FOR DETAILS |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide but different parameters) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be interconnected.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 5 2002

Mr. Jay Mansour Director, Quality & Regulatory Quality Medical Solutions, LLC 1308 Morningside Park Road ALPHARETTA GA 30022

Re: K021012

Trade/Device Name: Laminaria 2mm, 3mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm Regulation Number: 21 CFR 884.4260 Regulation Name: Hygroscopic-Laminaria Cervical Dilator Regulatory Class: II Product Code: 85 HDY Dated: March 26, 2002 Received: March 29, 2002

Dear Mr. Mansour:

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): //1

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

DESIRABLE LAMINARIA IS INDICATED FOR USE WHENEVER IT IS CERVICAL CANAL, SUCH AS UTERINE CURETTAGE , TO DILATE THE REHOVAL, AND LABOR INDULTION PLACEHENT TUD AND PLACE MENT KADIUM

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrenee of CDRH, Office of Device Evaluation (ODE)

David h. Bergman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01012

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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