(42 days)
The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on Tactographic incored. applications, and ing diagnostic radiographic exposures of body parts.
-The AJEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures.
-The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that are not mobile .
The AJEX 9015H and AJEX 135H are portable x-ray units which operate at 110V 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
-
Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the AJEX 9015H and AJEX 135H Portable X-Ray units in the traditional sense of performance metrics with specific thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly evaluated through a comparison of technical characteristics and intended use.
Characteristic Predicate Devices (PXP-HF15, PXP-HF20, PXP-HF40) Range AJEX 9015H Performance AJEX 135H Performance Acceptance (Substantially Equivalent) Intended Use Portable general radiographic applications SAME SAME Met MA (mA) 15 - 35 15 35 Met kVp (kV peak) 80 - 100 90 100 Met Max. Output (kW) 1.2 - 2.4 1.35 2.25 Met Focal Spot (mm) 1.2 1.2 1.2 Met Power Requirement 120/220 Vol., 50/60 Hz 110 Vol., 50/60 Hz 110 Vol., 50/60 Hz Minor difference, but considered equivalent for function User Interface LED display, Up-Down push buttons for kVp selection, With memory key storage SAME SAME Met Collimator Manual Halogen 4 Blade (50W - 150W) Manual 50W Halogen 4 Blade Manual 100W Halogen 4 Blade Met Size (cm) approx. 17.78x20.32x22.86 to 25x20x35 23.8x34x19.4 16.5x29x21.5 Within comparable range Weight (lb) 21 - 28 17 32 Within comparable range (AJEX 135H slightly heavier than PXP range, but the comparison emphasizes overall equivalence, not strict numerical matching of min/max across all predicates.) -
Sample Size Used for the Test Set and Data Provenance:
The document describes a comparison to predicate devices rather than a formal clinical study with a "test set" of patient data. The evaluation is based on technical specifications and intended use of the device itself, not on imaging performance on a set of clinical cases. Therefore, there is no specified sample size, data provenance, or retrospective/prospective nature for a "test set" in the context of clinical images. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical "test set" requiring expert ground truth establishment is described. The evaluation is based on technical specifications and substantial equivalence to existing devices. -
Adjudication Method for the Test Set:
Not applicable, as no clinical "test set" requiring adjudication is described. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This submission is for an X-ray unit, not an AI or image analysis software, so such a study would not be relevant. -
Standalone Performance Study (Algorithm only without human-in-the-loop):
Not applicable. This device is a portable X-ray unit, a hardware device that produces images. It is not an algorithm for image processing or interpretation. The performance evaluation is based on the device's technical specifications and functionality, not an algorithm's standalone capability. -
Type of Ground Truth Used:
The "ground truth" in this context is the established technical specifications and performance characteristics of the legally marketed predicate devices (PXP-HF15, PXP-HF20, PXP-HF40). The new devices (AJEX 9015H and AJEX 135H) are compared against these known, accepted standards to demonstrate "substantial equivalence." -
Sample Size for the Training Set:
Not applicable. This device is a hardware X-ray unit and does not involve machine learning algorithms that require a "training set." -
How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is used.
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K 05234//
OCT 7 - 2005 EXHIBIT 4 (Page 1 of 2) 510 (k) Summary
August 23, 2005
- Submitter:
| Company: | JPI America, Inc |
|---|---|
| 141-A Central Avenue | |
| Farmingdale, NY 11735 | |
| Telephone: | 631-454-0090 |
| Contact: | Abe Elgohary |
- Identification of Device:
Proprietary-Trade Name: Classification Name: Product Code: Common/Usual Name:
AJEX 9015H and AJEX 135H Portable X-ray Units Mobile X-ray System 90 IZL Portable general Purpose X-ray Unit.
3. Equivalent Marketed Devise:
This product is substantially equivalent to the PXP 15/20/40 Portable X-ray units (Predicate Device), which have been found to be substantially equivalent through the 510 (k) premarket notification process.
4. Description of Device:
The AJEX 9015H and AJEX 135H are portable x-ray units which operate at 110V 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
5. Intended Use of AJEX 9015H AND AJEX 135H:
The AJEX 9015/135H Portable X-rays are intended for use in mobile/portable applications, by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. -The AJEX 9015H is intended for use by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas.
-The AJEX 135H is intended for use in mobile applications for off-site patients that are not mobile.
.
.
.
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EXHIBIT 4 (Page 2 of 2) 510 (k) Summary
-
- Substantial Equivalence Chart
Model AJEX-9015H AND AJEX-135H
| Characteristics | PXP-HF15 | PXP-HF20 | PXP-HF40 | AJEX- 9015H | AJEX-135H |
|---|---|---|---|---|---|
| Intended use. | Portablegeneralradiographicapplications | SAME | SAME | SAME | SAME |
| MA | 15 | 20 | 35 | 15 | 35 |
| kVp | 80 | 90 | 100 | 90 | 100 |
| Max. output | 1.2kW | 1.35kW | 2.4kW | 1.35kW | 2.25kW |
| Focal Spot | 1.2 mm | 1.2 mm | 1.2 mm | 1.2 mm | 1.2 mm |
| Powerrequirement | 120/220Vol.,50/60 Hz | 120/220Vol.,50/60 Hz | 120/220 Vol.,50/60 Hz | 110 Vol.,50/60 Hz | 110 Vol.,50/60 Hz |
| User Interface | LEDdisplay.Up-Downpushbuttons forkVpselection.Withmemorykey storage. | LED display.Up-Downpush buttonsfor kVpselection.Withmemory keystorage. | LED display.Up-Downpush buttonsfor kVpselection.With memorykey storage. | LEDdisplay. Up-Down pushbuttons forkVpselection.Withmemory keystorage. | LEDdisplay. Up-Down pushbuttons forkVpselection.Withmemory keystorage. |
| Collimator | Manual50WHalogen4 Blade | Manual50WHalogen4 Blade | Manual150WHalogen4 Blade | Manual50WHalogen4 Blade | Manual100WHalogen4 Blade |
| Size | 20.32x22.86x17.78 cm | 20x32x30cm | 25x20x35cm | 23.8x34x19.4cm | 16.5x29x21.5cm |
| Weight | 22 Ib | 21 Ib | 28 Ib | 17 Ib | 32 Ib |
7. Conclusion:
After analyzing all the data it is the conclusion of JPI that the AJEX-9015H and 135H are as safe and effective as the predicate devise. The systems have few technological differences, and have no new indication for use, thus rendering them substantially equivalent to the predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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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 consists of a stylized eagle with three wings, representing health, human services, and well-being. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Abe Elgohary Vice President JPI America, Inc. 141-A Central Avenue FARMINGDALE NY 11735 Re: K052341 Trade/Device Name: AJEX 9015.135H Portable X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 23, 2005 Received: August 26, 2005
Dear Mr. Elgohary:
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 (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 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.
OCT 7 - 2005
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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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Indications for Use
510(k) Number (if known): K052341
Device Name: AJEX 9015/135H PORTABLE X-RAY
Indications for Use:
The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on Tactographic incored. applications, and ing diagnostic radiographic exposures of body parts.
-The AJEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures.
-The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that are not mobile .
Prescription Use __ X ============================================================================================================================================================================ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use N/A____________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Swanson
Page 1 of 1
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§ 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.