BERKELEY V-10 VACUUM CURETTAGE SYSTEM

K030935 · Acmi Corporation · HHI · Jun 23, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030935
• Device Name: BERKELEY V-10 VACUUM CURETTAGE SYSTEM
• Applicant: Acmi Corporation
• Product Code: HHI · Obstetrics/Gynecology
• Decision Date: Jun 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For rapid transcervical aspiration of the uterine cavity.

Device Story

The Berkeley® VC-10 Vacuum Curettage System is a medical device designed for the rapid transcervical aspiration of the uterine cavity. It functions as a vacuum-based suction system to facilitate uterine procedures. The system consists of a vacuum unit and associated disposables. It is intended for use by healthcare professionals in a clinical setting. The device operates by generating controlled vacuum pressure to perform aspiration. By providing a reliable suction mechanism, the system assists clinicians in performing uterine cavity procedures efficiently, potentially improving procedural outcomes for patients requiring such interventions.

Clinical Evidence

Bench testing only. Performance testing was conducted to determine vacuum performance and to validate the sterilization of disposables used with the system.

Technological Characteristics

Vacuum-based suction system; includes vacuum unit and disposable accessories. Sterilization validation performed for disposables. No specific materials or software algorithms described.

Indications for Use

Indicated for rapid transcervical aspiration of the uterine cavity.

Regulatory Classification

Identification

A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

Predicate Devices

• Berkeley® VC-2 Vacuum Curettage System (Preamendment)
• Synevac ®Vacuum Curettage System 10 (K813282)

Submission Summary (Full Text)

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Berkeley® VC-10 Vacuum Curettage System 510(k) Premarket Notification

JUN 2 3 2003

K030935

## IV. Summary of Safety and Effectiveness

.

## 510(k) Summary for Berkeley® VC-10 Vacuum Curettage System

| A. Sponsor | ACMI CORPORATION<br>136 Turnpike Rd<br>Southborough, MA 01772 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Device Name | Berkeley® VC-10 Vacuum Curettage System |
| C. Predicate Device(s) | Berkeley® VC-2 Vacuum Curettage System (Preamendment) |
| | Synevac ®Vacuum Curettage System 10 (K813282) |
| D. Device Description | |
| 1. Intended Use | For rapid transcervical aspiration of the uterine cavity. |
| 2. Technological Characteristics and Substantial Equivalence | The Berkeley® VC-10 Vacuum Curettage System and<br>Accessories has been tested and compared to similar devices,<br>and is substantially equivalent to the predicates in characteristics<br>described and the parameters tested. |
| 3. Performance Testing | The Berkeley® VC-10 Vacuum Unit was tested to determine<br>vacuum performance. Sterilization validation was performed for |

the disposables used with the vacuum unit. Performance of the system shows substantial equivalence to the predicates.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged along the circumference of the circle.

Public Health Service

JUN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Frank Fucile, JD, RAC Director, Global Regulatory Affairs ACMI Corporation Global Headquarters 136 Turnpike Road SOUTHBOROUGH MA 01772-2104 Re: K030935

Trade/Device Name: Berkeley® VC-10 Vacurette Curettage System Regulation Number: 21 CFR 884.5070 Regulation Name: Vacuum abortion system Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories Regulatory Class: II Product Code: 85 HHI and HHK Dated: March 21, 2003 Received: March 25, 2003

Dear Mr. Fucile:

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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- V. Statement of Intended Use.
JUN 2 3 2003

510(k) Number (if Known): K030935

Device Name:

Berkeley® VC-10 Vacuum Curettage System

Indications For Use:

For rapid transcervical aspiration of the uterine cavity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use (Optional Format 1-2-96)

David A. Legarra

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