(81 days)
THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SysTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.
The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
The provided text describes a 510(k) submission for a mammography system, not an AI/algorithm-based device. Therefore, the questions related to AI/algorithm performance (such as sample sizes for test and training sets, ground truth establishment for AI, MRMC studies, or standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence of the Bennett Profile 2000 Mammography System to predicate mammography systems. The acceptance criteria for this type of device are primarily related to safety, operational performance, and functional equivalence compared to existing devices.
Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of basic features, operation, and functionality, and meeting safety functions. The document does not provide specific quantitative acceptance criteria or detailed performance metrics in a tabular format as one might find for an AI algorithm's sensitivity/specificity.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Bennett Profile 2000 Mammography System is substantially equivalent to currently marketed devices in terms of basic features, operation, and functionality." |
| Conformance to Safety Requirements | "The safety functions of the Profile 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions." |
| Fulfillment of Design Requirements | "The Profile 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations." |
| Intended Use | "dedicated mammographic imaging system used for mammographic examinations." (Same as predicate devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical imaging hardware device (X-ray system), not an algorithm or AI. There is no "test set" of clinical images as there would be for an AI diagnostic device. The "testing" referred to is related to the hardware's safety and functional performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as there is no "test set" or "ground truth" to establish in the context of an AI/algorithm for this device. The evaluation would involve engineering tests and potentially clinical performance assessments by users, but not ground truth establishment for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a standalone imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mammography system. "Standalone performance" in the AI context would refer to an algorithm making a diagnosis without human intervention. This device is the imaging equipment, which serves as a component in a diagnostic process that involves a human reader (radiologist).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the submission of an X-ray hardware device.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device, not an AI algorithm.
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FEB 5 1999
SECTION 2
SUMMARY AND CERTIFICATION
510(k) SUMMARY
| Submitted by: | Trex Medical Corporation, Bennett Division |
|---|---|
| Address: | 445 Oak Street, Copiague, NY 11726 |
| Phone: | (516) 691-6100, (516) 691-6103 (fax) |
| Contact: | Lim Cheung |
| Device Name: | Bennett Profile 2000 Mammography System, Model PRO-2000 |
| Equivalent Device: | Bennett Profile Mammography System, Model M-PRO (#K964576),LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, andPlanmed Sophie Classic |
| Date: | November 13, 1998 |
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 as promulgated in 59 FR 64287-01 for §807.92.
- Description of the Device: The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
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- Same Intended Use: The Bennett Profile 2000 Mammography System (Model PRO-2000), 2. like the Bennett Profile M-PRO, LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, and Planmed Sophie Classic mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
The Bennett Profile 2000 Mammography System is substantially equivalent to currently marketed devices in terms of basic features, operation, and functionality. The safety functions of the Profile 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Profile 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 5 1999
Walter F. Schneider President Trex Medical Corporation Bennett Division 445 Oak Street Copiague, NY 11726
Re:
K984092 Bennett Profile 2000 Mammography System Model PRO-2000 Dated: November 13, 1998 Received: November 16, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Schneider:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):
Device Name: PROFILE 2000 MAMMOGRAPHY SYSTEM,
MODEL PRO-2000
Indications for Use:
THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SYSTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use_
(Optional Format 1-2-95)
David A. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.