(90 days)
Output:
For rapid transcervical aspiration of the uterine cavity.
The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested.
The Berkeley® VC-10 Vacuum Curettage System is a medical device for rapid transcervical aspiration of the uterine cavity. The 510(k) summary provides limited information about the performance testing. However, based on the provided document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Vacuum Performance: The Berkeley® VC-10 Vacuum Unit was tested to determine vacuum performance. | "Performance of the system shows substantial equivalence to the predicates." The specific vacuum levels or parameters required for acceptance are not detailed, but the device met these unstated criteria. |
| Sterilization Validation: Sterilization validation was performed for the disposables used with the vacuum unit. | "Performance of the system shows substantial equivalence to the predicates." The specific sterilization efficacy criteria are not detailed, but the device met these unstated criteria. |
| Substantial Equivalence: The device should be substantially equivalent to its predicate devices: Berkeley® VC-2 Vacuum Curettage System (Preamendment) and Synevac® Vacuum Curettage System 10 (K813282) in terms of technological characteristics and performance. | "The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested." Also, "Performance of the system shows substantial equivalence to the predicates." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. This type of device (vacuum curettage system) typically does not rely on expert-established ground truth in the same way an AI or diagnostic imaging device would. Performance is measured against engineering specifications and functional testing.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Performance testing for this device would involve objective measurements (e.g., vacuum pressure, flow rate, sterilization effectiveness) rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, this type of study was not performed or mentioned. MRMC studies are typically relevant for diagnostic devices where human interpretation is involved. This device is a surgical tool.
- Effect Size: Not applicable.
6. Standalone Performance Study:
- Standalone Study: Yes, performance testing of the Berkeley® VC-10 Vacuum Unit was conducted to determine its vacuum performance, and sterilization validation was performed for the disposables. This represents a standalone assessment of the device's functional capabilities. The results concluded substantial equivalence to predicate devices.
7. Type of Ground Truth Used:
- Ground Truth: For this device, "ground truth" would refer to objective engineering and functional specifications, as well as adherence to established sterilization standards. For example, vacuum performance would be measured against a predefined range of acceptable vacuum pressure and flow, and sterilization validation against established sterility assurance levels (SALs).
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This document describes a medical device clearance based on substantial equivalence, not an AI/ML algorithm that requires a training set. The performance testing conducted is for the device itself, not for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for ACMI, which is a medical technology company. The logo consists of three slanted lines followed by the letters "ACMI" in a bold, sans-serif font. The lines are parallel and angled upwards to the right, creating a sense of forward movement.
Berkeley® VC-10 Vacuum Curettage System 510(k) Premarket Notification
JUN 2 3 2003
IV. Summary of Safety and Effectiveness
.
510(k) Summary for Berkeley® VC-10 Vacuum Curettage System
| A. Sponsor | ACMI CORPORATION136 Turnpike RdSouthborough, 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 andAccessories has been tested and compared to similar devices,and is substantially equivalent to the predicates in characteristicsdescribed and the parameters tested. |
| 3. Performance Testing | The Berkeley® VC-10 Vacuum Unit was tested to determinevacuum performance. Sterilization validation was performed for |
the disposables used with the vacuum unit. Performance of the system shows substantial equivalence to the predicates.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
- 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
§ 884.5070 Vacuum abortion system.
(a)
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.(b)
Classification. Class II (performance standards).