MAS WITH OR WITHOUT SYRINGE

K021876 · Marina Medical Instruments, Inc. · HHK · Apr 8, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K021876
• Device Name: MAS WITH OR WITHOUT SYRINGE
• Applicant: Marina Medical Instruments, Inc.
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Intended Use

This device is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy or for menstrual extraction

Device Story

The Marina Ampler Sampler (MAS) is a manual endometrial suction curette used to obtain endometrial tissue samples. The device is available in two configurations: one with a twist-and-lock syringe (3mm O.D.) and one without a syringe (3.5mm O.D.). The version with a syringe utilizes the syringe to generate vacuum suction; the version without a syringe utilizes a tight-fitting internal piston pulled proximally to generate suction. Both devices feature a distal cutting edge or fenestration to scrape the uterine mucosal lining. The device is intended for single-patient use and is sterilized via ethylene oxide. It is operated by a clinician in a clinical setting to collect tissue for biopsy or menstrual extraction, aiding in the diagnosis of uterine conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

Manual endometrial suction curette. Materials: unspecified medical-grade plastics. Sensing/Actuation: mechanical scraping via distal cutting edge/fenestration and manual vacuum generation (syringe or piston). Dimensions: 3mm or 3.5mm O.D. Sterilization: Ethylene Oxide. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring uterine tissue sampling for histological biopsy or menstrual extraction. Prescription use only.

Regulatory Classification

Identification

An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

Predicate Devices

• Curelle from Bioteque Corporation (K915491)

Submission Summary (Full Text)

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K021876

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

APR 0 8 2003

1-Submitter Name: Mansour Consulting LLC

- 1308 Morningside Park Dr 2-Address:
Alpharetta, GA 30022 USA

- 3-Phone: [phone]
(425) 795- 9341 4-Fax:

5-Contact Person: Jay Mansour

6-Date summary prepared: May 28th, 2002

7-Device Trade or Proprietary Name: Marina Ampler Sampler (with and without syringe)

8-Device Common or usual name: Endometrial Suction Curette

- Curette, Suction, Endometrial 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device:

- Curelle from Bioteque Corporation, 510k #K915491 .
## 11-Description of the Device:

The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.

The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.

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

This device is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy or for menstrual extraction

## 13-Safety and Effectiveness of the device:

This device 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:

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

7

| FDA file reference number | 510k 915491 | |
|-----------------------------------------------------|----------------------------|-----------------|
| Attachments inside notification<br>submission file | Appendix 1 and 2 | |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result | |
| | With Syringe | Without Syringe |
| Indications for use | Identical | |
| Target population | Identical | |
| Design | Identical | Similar |
| Materials | Identical | |
| Performance | Identical | |
| Sterility | Identical (Ethylene Oxide) | |
| Biocompatibility | Identical | |
| Mechanical safety | Identical | |
| Chemical safety | Identical | |
| Anatomical sites | Identical | |
| Human factors | Identical | |
| Energy used and/or delivered | Identical | |
| Compatibility with environment<br>and other devices | Identical | Similar |
| 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Marina Medical Instruments, Inc. % Mr. Jay Mansour Regulatory Consultant Mansour Consulting, LLC 1308 Morningside Park Dr. ALPHARETTA GA 30022

Re: K021876

APR 0 8 2003

Trade/Device Name: MAS With or Without Syringe Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories Regulatory Class: II Product Code: 85 HHK

Dated: January 28, 2003 Received: January 30, 2003

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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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

KOZI876 510(k) Number (if known): CUTH SYRINGE & all THOUT Device Name: Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn
(Division Sign-Off)

Division of Reproductive, Abdomina d Radiological Devices

Prescription Use
(Per 21 CFR 801.109) √

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Over-The-Counter Use

(Optional Format 1-2-96