PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.

AI/ML Overview

This is a 510(k) premarket notification for the PORTA 100HF, a portable general-purpose diagnostic X-ray unit. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Mikasa X-Ray Co., LTD.'s MinXray HF100H+ (K052721).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical and technical characteristics, and compliance with applicable safety and performance standards, rather than defining specific acceptance criteria for a novel performance claim.

The "Acceptance Criteria" here are implicitly successful demonstration of:

Identical Intended Use: The new device shares the same intended use as the predicate.
Similar Technical Characteristics: Key technical specifications fall within acceptable ranges compared to the predicate.
Compliance with Safety Standards: The device meets relevant electrical, electromagnetic, and X-ray performance standards.
Software Validation: The software functions as intended and meets its specifications.

The "Reported Device Performance" is the outcome of the nonclinical tests and characteristic comparisons.

Acceptance Criteria (Implicit)	Reported Device Performance (PORTA 100HF)
Intended Use (Same as predicate)	Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. (Same as predicate)
Physical Characteristics (Compared to predicate)	Size/weight: 160mmx161mmx291mm / 9.2Kgs (Smaller and lighter than predicate's 406mmx222mmx241mm / 18.6Kgs) Energy Source: AC100-120V/15A or AC200-240V/10A (Slightly narrower voltage range than predicate's AC100-140V or AC200-260V, but within typical operating ranges) Mounting Method: Mounted to a commercially available portable stand (Similar to predicate)
Technical Characteristics (Compared to predicate)	User Interface: Up and down Rotary switch for kV and mAs value with 7 segment LED (Different from predicate's pushbuttons/LED indicators) Exposure times: 0.01-2.50 second, 32 steps (Predicate: 0.03-2.00 sec, 0.01 increments. Range overlaps) Exposure switch: Dual stage, deadman type with curled cable (Same as predicate) Controls: Software based (Same as predicate) Construction: Monobloc HF generator, Medical full bridge inverter system (Same as predicate) High Voltage Adjustment: High frequency inverter (Same as predicate) Line Voltage Adjustment: Automatic, dynamic (Same as predicate) Tube Potential (kV): 40-100kV (2kV step) (Same as predicate) kV step: 31 (Same as predicate) Tube current: 30mA (40-66kV), 20mA (68kV-100kV) (Predicate: 30mA (40-60kV), 25mA (62-80kV), 20mA (82-100kV). Some differences but generally comparable) X-ray tube: Toshiba D-124 (Predicate: Toshiba D-124S. Very similar, likely minor variant) Anode heat Storage: 20,000HU (Same as predicate) Focal Spot Size: 1.2mm (Same as predicate) mAs: 0.3mAs-50mAs (Predicate: 0.6-120mAs. Lower maximum mAs than predicate) Total Filtration: 2.5mm Al. eq. at 100kV (Predicate: 3.2mm Al equivalent. Lower filtration, which can affect dose/image quality, but likely acceptable for equivalence) Collimator: Complete with 30 sec. timer and cross indication line (Similar to predicate) Source to Skin Distance (SSD): 216mm (Predicate: 300mm. Shorter SSD, which affects beam divergence and dose distribution, but again, likely within acceptable safety limits for portable units) KvP: 100KvP (Same as predicate)
Compliance with Safety Standards (as applicable)	Performance Standard: 21CFR 1020.30 & UL 2601-1 (Same as predicate for 21CFR 1020.30, and comparable UL standard) Electrical Safety: IEC 60601-1:2005, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54 (Demonstrates compliance with multiple relevant and updated safety standards, including some not explicitly listed for predicate but likely covered by its general IEC 60601-1 and IEC 60601-1-2)
Software Validation	Software validation and verification testing was performed. (Result concluded positively for substantial equivalence)
Device Output (Compatibility with imaging media)	Conventional X-ray film or digital imaging media (Same as predicate)

2. Sample size used for the test set and the data provenance:

The document describes nonclinical tests primarily focused on electrical safety, electromagnetic compatibility, and software validation. It does not refer to a clinical "test set" in terms of patient data or images. The "data provenance" would be from laboratory testing of the device itself, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is an X-ray unit, not an AI or diagnostic imaging interpretation device. The "ground truth" for the nonclinical tests would be the established international and national standards (e.g., IEC, UL, CFR) for device safety and performance. Compliance is demonstrated through measurements and verification against these standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no clinical "test set" requiring expert adjudication.

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:

No. This is an X-ray imaging device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is hardware.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the nonclinical tests described are the various safety, electromagnetic compatibility, and X-ray performance standards (e.g., IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-1:2005, and UL2601-1, 21CFR 1020.30). The device's measured performance is compared against the specifications defined by these standards.

8. The sample size for the training set:

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable for the same reason as above.

Summary

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510(k) Summary

OCT 5 2012

510(k) Submitter:

JOB Corporation 1-19-8 Shinyokohama, Kohoku-ku, Yokohama, Kanagawa, Postal code 222-0033, Japan Tel: 81-45-473-0113 Fax: 81-45-473-0108 Date Prepared: August 16, 2012 Contact: Hiroya Obana, Senior Manager

Trade/Proprietary name: PORTA 100HF

Common/usual name: Portable general purpose diaqnostic X-ray unit Classification name: Mobile X-ray system, Product Code IZL

Equivalent Legally Marketed Device:

This product is similar in function to the Mikasa X-Ray Co., LTD.'s MinXray HF100H+ (K052721.)

Intended Use:

PORTA 100HF is 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:

Nonclinical Tests for a Determination of Substantial Equivalence:

PORTA 100HF has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with Underwriters Laboratories Standards for Safety (UL2601-1.) The software validation and verification testing was also performed. The results of nonclinical testing indicate that the PORTA 100HF is as safe and effective as the predicate device.

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Substantial Equivalence Chart:

Characteristics	(Mikasa X-Ray Co., LTD.)MinXray HF 100H+(K052721)	(JOB Corporation)PORTA 100HF
Intended Use	Intended use by aqualified/technician on bothadult and pediatric subjectsfor taking diagnostic X-rays	Same
Physical Characteristics
Size/weight	406mmx222mmx241mm18.6Kgs	160mmx161mmx291mm9.2Kgs
Energy Source(Input Voltage)	AC100-140V orAC200-260V	AC100-120V/15A orAC200-240V/10A
MountingMethod	Unit is usually mounted toMinXray XGS MKIII portablestand	Unit is mounted to acommercially availableportable stand
Technical Characteristics
User Interface	Up-down pushbottons forkVp selections andexposure time selectionswith LED indicators andmAs indicators	Up and down Rotary switchfor kV and mAs value with 7segment LED
Exposure times	0.03-2.00 sec.0.01 increments	0.01-2.50 second32 steps
Exposure switch	Dual-stage deadman type	Dual stage, deadman typewith curled cable.
Controls	Software based	Software based
Construction	Monobloc HF generator,Medical full bridge invertersystem	Monobloc HF generator,Medical full bridge invertersystem
High VoltageAdjustment	High frequency (60kHz)inverter	High frequency inverter
Line VoltageAdjustment	Automatic, dynamic	Automatic, dynamic
Tube Potential(kV)	40-100kV (2kVstep)	40-100kV (2kV step).
kV step	31(2kV-step)	31(2kV-step)
Tube current	30mA (40-60kV)25mA (62-80kV)20mA (82-100kV)	30mA (40-66kV)20mA (68kV-100kV)
X-ray tube	Toshiba D-124S	Toshiba D-124
Anode heatStorage	20,000HU	20,000HU
Focal Spot Size	1.2mm	1.2mm
mAs	0.6-120mAs	0.3mAs-50mAs
Total Filtration	3.2mm Al equivalent	2.5mm Al. eq. at 100kV
Collimator	Continuously adjustable (30 sec.) light beam type withcentral X-ray indicator	Complete with 30 sec. timerand cross indication line.
Source to SkinDistance (SSD)	300mm	216mm
KvP	100KvP	100KvP
PerformanceStandard	21CFR 1020.30UL 2601	21CFR 1020.30UL 2601-1
Electrical Safety	IEC 60601-1IEC 60601-1-2	IEC 60601-1:2005IEC 60601-1-3IEC 60601-2-28IEC 60601-1-2CISPR11IEC 60601-2-7IEC 60601-2-54
X-rayRadiography	Conventional X-ray film ordigital imaging media	Conventional X-ray film ordigital imaging media

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Conclusion:

The PORTA 100HF is intended for the same indications for use as the predicate device and the results of the nonclinical testing demonstrate that the PORTA 100HF is as safe and effective as the predicate device. It is the conclusion of JOB Corporation that the PORTA 100HF is as safe and effective as the predicate device and has few technological differences, thus rendering it substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around a stylized eagle symbol. The eagle is depicted with its wings spread, and its body is formed by three curved lines. The text is in a bold, sans-serif font, and the eagle is in black. The logo is likely used to represent the U.S. Department of Health and Human Services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JOB Corporation
% Mr. Takahiro Haruyama
President
Globizz Corporation
1411 West 190th Street, Suite 120
GARDENA CA 90248

Re: K122697

Trade/Device Name: PORTA 100HF Regulation Number: 21 CFR 892.1750 . Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: IZL Dated: August 27, 2012 Received: September 4, 2012

Dear Mr. Haruyama:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

OCT 5 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Michael D'Hara for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): __

Device Name: PORTA 100HF

Indications for Use:

PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ahn AD Oh

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

Page 1 of

Regulation Number and Section

§ 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.