(21 days)
The MinXray IIF120/60H PowerPlus™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator.
This appears to be a 510(k) summary for a medical device, the MinXray HF120/60H PowerPlus™ High Frequency Diagnostic X-Ray Unit. The purpose of this document is to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive acceptance criteria and a deep study proving its performance against those criteria in the way one might expect for a novel AI algorithm.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable in this context, as they pertain to the evaluation of algorithms or AI systems, not a new iteration of a diagnostic X-ray unit being compared to a pre-amendments device based on its physical and performance characteristics.
Here's the information that can be extracted relevant to your request, with the understanding that the "acceptance criteria" here are largely about demonstrating equivalence to an existing device rather than novel performance benchmarks:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating that the new device's performance characteristics are equivalent to or better than those of the predicate device, especially regarding safety and effectiveness for the stated intended use. The table below summarizes the comparison provided:
| Characteristic | Acceptance Criteria (based on Predicate Device: MinXray HF100H) | Reported Device Performance (MinXray HF120/60H PowerPlus™) |
|---|---|---|
| Intended Use | For diagnostic x-rays by qualified physician/technician on adult & pediatric subjects. | SAME |
| Physical Characteristics | ||
| Size/Weight | 406 x 222 x 241 mm, 18.6 kg | 406 x 221 x 240 mm, 20 kg. (Slight increase in weight) |
| Energy Source | 120 V 50-60~ AC | SAME |
| User Interface | Up-Down pushbuttons for three kVp selections and exposure time selections with LED indicators. | Up-Down pushbuttons for kVp selections and exposure time selections with LED indicators, mAs indicator. (Added mAs indicator) |
| Exposure times | 199 (in 0.01 sec. Steps) 0.08 - 4.00 sec. | (0.01 - 0.2 sec in 0.01 sec. Step), (0.2 - 0.4 sec in 0.02 sec. Step), (0.4 - 1.0 sec in 0.05 sec. Step), (1.0 - 5.0 sec in 0.1 sec. Step). (More granular and extended range) |
| mA | 20 mA constant | 30 mA (40-60kV), 25mA (62-80kV), 20mA (82-100kV). (Variable mA based on kV, higher peak mA) |
| kVp | 40-100 kVp | Max. 120 kVp. (Higher maximum kVp) |
| Standards & Safety | ||
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical Safety | UL 2601, IEC 60601-1 | SAME, plus UL listed. (Additional certification) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and user testing" but does not specify sample sizes for any test set or the provenance of any data. The evaluation is primarily a comparison of technical specifications against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This submission does not describe a study involving expert-established ground truth for a test set in the context of diagnostic accuracy, as it is for an X-ray unit itself, not an interpretive algorithm. The "user testing" mentioned would likely involve engineers or technicians verifying functionality, not radiologists establishing ground truth.
4. Adjudication Method for the Test Set
Not Applicable. No ground truth establishment or adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not mentioned or implied. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the scope of this device's submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No. This device is an X-ray unit, which is a hardware device for image acquisition, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance and safety profile of the predicate device (MinXray HF100H) and adherence to relevant performance and electrical safety standards (21 CFR 1020.30, UL 2601, IEC 60601-1). The new device is deemed "substantially equivalent" if it meets or exceeds these characteristics and standards.
8. The Sample Size for the Training Set
Not Applicable. This is an X-ray unit, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. This is an X-ray unit, not an AI algorithm.
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EXHIBIT 2
Mikasa X-Ray Co., LTD. (Manufacturer) 13-2, Hongo 3-chome Bunkvo-Ku. Tokyo 113-0033 Japan Tel 81-3-3813-3911 Fax 81-3-3813-4420
MinXray, Inc (Initial Distributor) 3611 Commercial Ave. Northbrook, IL 60062 Tel 847-564-0323 Fax 847-564-9040 Contact: Keith Kretchmer
January 6, 2004
510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: MinXray HF120/60H PowerPlus™ High Frequency Diagnostic X-Ray Unit" Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
- Equivalent legally marketed devices This product is similar in function to the 2. MinXray HF100H (a pre-amendments device)
- Indications for Use (intended use) The MinXray HF120/60H PowerPlus™ is 3. intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
- Description of the Device: MinXray HF120/60H PowerPlus™ is a portable unit 4. which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator.
- Safety and Effectiveness, comparison to predicate device. The results of న్న bench and user testing indicates that the new device is as safe and effective as the predicate device.
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| Characteristic | MinXray HF100H(Pre-amendments device) | MinXray HF120/60HPowerPlus™ |
|---|---|---|
| Intended Use: | Intended for use by a qualified/trainedphysician or technician on both adult andpediatric subjects for taking diagnostic x-rays. | SAME |
| Physical characteristics: | ||
| Size/weight | 406 x 222 x 241 mm 18.6 kg | 406 x 221 x 240 mm, 20 kg. |
| Energy Source: | 120 v 50-60~ AC | SAME |
| User Interface | Up-Down pushbuttons for three kVpselections and exposure time selections withLED indicators | Up-Down pushbuttons for kVpselections and exposure timeselections with LED indicatorsmAs indicator |
| Exposure times | 199 (in 0.01 sec. Steps)0.08 - 4.00 sec. | (0.01 - 0.2 sec ) (in 0.01 sec. Step) ,(0.2 - 0.4 sec ) (in 0.02 sec.Step)(0.4 - 1.0 sec ) (in 0.05 sec. Step),(1.0 - 5.0 sec ) (in 0.1 sec. Step) |
| Ma. | 20 mA constant | 30 mA( 40-60kV)25mA(62-80kV)20mA(82-100kV) |
| KvP | 40-100 KvP | Max. 120 KvP |
| Standards and Safetycharacteristics: | ||
| PerformanceStandard | 21 CFR 1020.30 | SAME |
| Electricalsafety | UL 2601, IEC 60601-1 | SAME, plus UL listed |
6. Substantial Equivalence Chart, MinXray HF120/60H PowerPlus™
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HF120/60H PowerPlus™ is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. Safety is further assured by Underwriters Laboratories testing and listing.
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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 features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
MinXray, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K040046
Trade/Device Name: MinXray HF120/60H PowerPlus™ Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: January 6, 2004 Received: January 13, 2004
Dear Mr. Kamm:
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 such 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 | (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. Brydon
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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j) Indications for Use
510(k) Number K040046
Device Name: MinXray HF120/60H PowerPlus™
Indications for Use: The MinXray IIF120/60H PowerPlus™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use X ાર
Over the Counter Use (Per 21 CFR 801.109)
David A. Syner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.