PCH-2500 is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.

Device Description

PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws. PCH-2500 can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), two cephalometric scan type (Xmaru2301CF and Xmaru3001CF) and three flat panel one shot ceph sensors (1210SGA, 910SGA and 1417PGA). The proposed device is available with two X-ray generator options. PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging options based on the patient diagnostic needs.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for the PCH-2500 dental digital radiographic imaging system. However, it does not explicitly list specific acceptance criteria with numerical targets that the device had to meet. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (also named PCH-2500, K122155). The core argument is that the new device is an "upgraded version of the predicate device with the same model name, the same indications for use and technical characteristics" (Section 2).

The closest equivalent to "acceptance criteria" can be inferred from the technological characteristics comparison with the predicate device and the performance tests conducted to ensure safety and effectiveness.

Table 1. Inferred Acceptance Criteria and Reported Device Performance

Characteristic	Inferred Acceptance Criteria (from predicate device characteristics or regulatory standards)	Reported Device Performance (for new PCH-2500)	Notes
Indications for Use	Same as predicate (take panoramic and cephalometric images of oral/maxillofacial anatomy for adult and pediatric diagnostic information).	Identical to predicate device indications (Section 2, 5)	This is a primary criterion for substantial equivalence.
Performance Spec.	Panoramic and cephalometric imaging capability.	Panoramic and cephalometric imaging capability (Section 2)
Input Voltage	AC 100-120 / 200-240 V (predicate range)	AC 100-240 V (includes predicate range) (Section 2)	The new device has a wider, "Free Input Voltage" capability, which is an improvement but still covers the predicate's range. This change was explicitly addressed (Section 5).
Tube Voltage	50-90 kV (predicate range)	50-99 kV (includes predicate range) (Section 2)	The new device has an extended tube voltage range, indicating a potential performance enhancement while still meeting or exceeding the predicate's capability. This change was explicitly addressed with safety and image evaluation (Section 5).
Tube Current	4-10 mA (predicate range)	4-16 mA (includes predicate range) (Section 2)	The new device has an extended tube current range, indicating a potential performance enhancement while still meeting or exceeding the predicate's capability. This change was explicitly addressed with safety and image evaluation (Section 5).
Exposure Time	Max. 20.2 s (predicate)	Max. 20.2 s (Section 2)	Identical.
Focal Spot Size	0.5 mm (predicate)	0.5 mm (Section 2)	Identical.
Total Filtration	Min. 2.8 mmAl (predicate)	Min. 2.8 mmAl (Section 2)	Identical.
Pixel Resolution	5 lp/mm (for Xmaru series), 3.9 lp/mm (for SGA series) - (predicate)	5 lp/mm (for Xmaru series), 3.9 lp/mm (for SGA series) (Section 2)	Maintained identical pixel resolutions, demonstrating that new detectors (Xmaru3001CF, 1417PGA) perform at comparable levels. Non-clinical performance (MTF, DQE, NPS) was specifically evaluated (Section 6).
Pixel Size	100 x 100 µm (Xmaru), 127 x 127 µm (SGA) - (predicate)	100 x 100 µm (Xmaru), 127 x 127 µm (SGA) (Section 2)	Maintained identical pixel sizes.
Software	DICOM 3.0 Format compatible, EasyDent for 2D Image Viewing (predicate)	DICOM 3.0 Format compatible, EasyDent (Section 2, 7)	Found to be the same as the predicate (Section 5, 7).
Safety Conformity	Conformity to relevant IEC/EMC (e.g., IEC 60601-1, IEC 60601-1-2) and EPRC standards.	Conformed to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2. Also met 21 CFR 1020.30, 31. (Section 6)	Electrical, mechanical, environmental safety, and EMC testing were explicitly performed and found satisfactory (Section 6, 7). Separate safety tests for each generator were conducted (Section 5, 6).
Imaging Performance	Non-clinical & clinical considerations per FDA Guidance & acceptance test per IEC 61223-3-4. Not explicitly quantified as a specific numerical benchmark but implies maintenance of image quality.	Satisfactory non-clinical performance (MTF, DQE, NPS) and clinical consideration reports for new image receptors. Separate clinical image evaluation performed for each X-ray generator. Acceptance test per IEC 61223-3-4 performed. (Section 6)	The non-clinical performance (MTF, DQE, NPS) and clinical consideration reports for the new image receptors (Xmaru3001CF and 1417PGA) were provided. The outcome of an expert review of image comparisons was also relied upon for substantial equivalence (Section 6). "All test results were satisfactory" (Section 7).

Study that Proves the Device Meets the Acceptance Criteria:

The submission describes a set of tests to demonstrate substantial equivalence to the predicate device, rather than a single, large clinical study with specific acceptance criteria. The primary "study" is a compilation of various engineering tests, performance validations, and comparisons.

Sample size used for the test set and the data provenance:
- Test Set: Not explicitly stated as a "test set" in the traditional sense of a clinical trial. The evaluation primarily involved device characteristics and performance metrics.
- Data Provenance: The studies are laboratory and engineering tests conducted by the sponsor's qualified individuals, likely at the manufacturing facility in Gyeonggi-Do, Republic of Korea, as indicated by the submitter's address. The data is retrospective in the sense that it relies on comparisons to an already cleared predicate device and established standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "an expert review of image comparisons for both devices" (Section 6).
- The number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text. It only states "qualified individuals employed by the sponsor" conducted laboratory and clinical performance testing (Section 5).
Adjudication method for the test set:
- The document mentions "outcome of an expert review of image comparisons" (Section 6), but the specific adjudication method (e.g., 2+1, 3+1, none) is not described.
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 MRMC comparative effectiveness study was done or reported. This device is a digital X-ray imaging system, not an AI-powered diagnostic tool. The focus is on the image acquisition system itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is an image acquisition system, not an algorithm. Its performance is evaluated based on image quality metrics and compliance with technical specifications and safety standards.
The type of ground truth used:
- For technical performance: The "ground truth" was based on established industry standards (e.g., IEC standards for safety, ISO/NEMA standards for image quality metrics like MTF, DQE, NPS), and comparison to the performance characteristics of the legally marketed predicate device.
- For clinical image evaluation: The "ground truth" was based on expert review of images produced by the device, likely assessing diagnostic utility and quality against established clinical imaging benchmarks, but the exact nature of this "ground truth" is not detailed (e.g., if it involved pathology confirmation or outcomes data).
The sample size for the training set:
- Not applicable. This device is an X-ray imaging system, not a machine learning algorithm that requires a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As the device is not an AI algorithm, no training set or its associated ground truth establishment mechanism is relevant to this submission.

In essence, the "study" demonstrating the device meets acceptance criteria is a comprehensive set of engineering, electrical, mechanical, and image quality tests, along with a direct comparison of all technical specifications to a pre-existing cleared predicate device (K122155). The conclusion of substantial equivalence is drawn from the satisfactory results of these tests and the identified similarities and acceptable changes from the predicate.

Summary

{0}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.

Date 510K summary prepared : February 28, 2013

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Vatech Co., Ltd.
Submitter's Address:	23-4, Seogu-Dong, Hwaseong-Si,Gyeonggi-Do, 445-170,Republic of Korea
Submitter's Telephone:	+82-31-379-9585
Contact person:	Mr. Sung-Hee Park
Official Correspondent:(U.S. Designated agent)	Dave Kim (davekim@mtech-inc.net)
Address:	12946 Kimberley Ln, Houston, TX 77079
Telephone:	+713-467-2607
Fax:	+713-464-8880

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/Proprietary Name:	PCH-2500
Common Name:	Digital X-ray Imaging System
Classification Name:	System, X-Ray, Extra oral Source, Digital (21CFR872.1800, class II)
Product Code:	MUH

{1}------------------------------------------------

Predicate Device:

Manufacturer:	Vatech Co., Ltd
Device Name:	PCH-2500
510(k) Number:	K130585

Description:

PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging options based on the patient diagnostic needs.

Indication for use:

Summary of the technological characteristics of the device compared to the predicate device:

The new device described in this Traditional 510(k) submission is an upgraded version of the predicate device with the same model name, the same indications for use and technical characteristics. Table I summarizes the technological characteristics of the new vs. the predicate device.

{2}------------------------------------------------

510(k) Submission – PCH-2500

Table 1. Comparison of new PCH-2500 and the predicate device
Characteristic	ProposedVatech Co., Ltd.PCH-2500	PredicateVatech Co., Ltd.PCH-2500
510(k) number	K130585	K122155, dated on10/4/2012
Indicationsfor use	PCH-2500 is a digitalextra oral source x-raysystem intended to takepanoramic andcephalometric images ofthe oral and maxillofacialanatomy to providediagnostic informationfor adult and pediatricpatients. The deviceshould be operated andused by dentists, x-raytechnicians and otherprofessionals licensed bythe law of the state inwhich the device is used.	PCH-2500 is a digitalextra oral source x-raysystem intended to takepanoramic andcephalometric images ofthe oral and maxillofacialanatomy to providediagnostic informationfor adult and pediatricpatients. The deviceshould be operated andused by dentists, x-raytechnicians and otherprofessionals licensed bythe law of the state inwhich the device is used.
PerformanceSpecification	Panoramic andcephalometric	Panoramic andcephalometric
Input Voltage	AC 100-240 V	AC 100-120 / 200-240 V
Tube Voltage	50-99 kV	50-90 kV
Tube Current	4-16 mA	4-10 mA
Exposure Time	Max. 20.2 s	Max. 20.2 s
X-ray Source	D-052SBOPX/105	D-052SB
X-ray Generator	DG-07D11T2 (for D-052SB)DG-07D11C1 (forOPX/105)	HDG-07B10T2
Focal Spot Size	0.5 mm	0.5 mm
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	Min. 2.8 mmAl	Min. 2.8 mmAl
Chin Rest	Equipped Headrest	Equipped Headrest
Mechanical	Compact design	Compact design
Electrical	LDCP logic circuit	LDCP logic circuit
Software	DICOM 3.0 Formatcompatible	DICOM 3.0 Formatcompatible
2D Image ViewingProgram	EasyDent	EasyDent
Anatomical Sites	Maxillofacial	Maxillofacial
ImageReceptor	panoramic(CMOSphotodiodearray)	Xmaru1501CF	Xmaru1501CF
	Cephalometric(CMOSphotodiodearray)	Xmaru2301CF	Xmaru2301CF
		Xmaru3001CF	-
	Cephalometric(Amorphoussilicon TFTwithscintillator)	1210SGA	1210SGA
		910SGA	910SGA
		1417PGA	-
PixelResolution	Xmaru1501CF	5 lp/mm	5 lp/mm
	Xmaru2301CF	5 lp/mm	5 lp/mm
	Xmaru3001CF	5 lp/mm	-
	1210SGA	3.9 lp/mm	3.9 lp/mm
	910SGA	3.9 lp/mm	3.9 lp/mm
	1417PGA	3.9 lp/mm	-
Pixel Size	Xmaru1501CF	100 x 100 um	100 x 100 um
	Xmaru2301CF	100 x 100 um	100 x 100 µm
	Xmaru3001CF	100 x 100 um	-
	1210SGA	127 x 127 μm	127 x 127 μm
	910SGA	127 x 127 um	127 x 127 μm
	1417PGA	127 x 127 um	-

Table 1. Comparison of new PCH-2500 and the predicate device

{3}------------------------------------------------

{4}------------------------------------------------

{5}------------------------------------------------

Summary of Performance Testing:

The PCH-2500 dental digital radiographic imaging system described in this 510(k) is identical to the predicate device in its indications for use, performance, materials, safety characteristics, image viewing program and accessory components

Furthermore, the following information further substantiates the substantial equivalence between two devices:

The fundamental technological characteristics of the subject and predicate . device were the same.
Laboratory and clinical performance testing using the same test protocols . as used for the cleared detectors was evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.
. The intended use of the modified device, as described in the labeling, has not changed as a result of the labeling modification(s).

For both devices, the differences are as follows.

New SSXI detectors, 1417PGA (One Shot Ceph mode) and Xmaru3001CF (Scan Ceph mode) for the newly upgraded PCH-2500 have different active areas compared with K122155, the predicate device.
Change to Free Input Voltage: For the predicate device, changing the input voltage from 110V to 200V would require separate tools and electrical works whereas the new device is equipped with a newly designed power board which is capable of handling the input power between 100 V and 240 V without a separate tool or electrical modification.
The proposed PCH-2500 is available with two different X-ray generator options. To evaluate the safety, safety test is conducted for each generator according to the IEC Standard. Moreover, separate image evaluation is performed for each Xray generator which is considered as one of critical components affecting the quality of radiographic images and imaging performance of the device.
For proposed PCH-2500, a new generator for X-ray tube has the capacity to generate more tube current and tube voltage than the predicate device. Moreover, the maximum irradiation condition for each capture mode is defined differently by diversifying the operating range of the generator specifications.

{6}------------------------------------------------

The non-clinical performance (including MTF, DQE, NPS test) and clinical consideration report for the new image receptor, Xmaru3001CF and 1417PGA, are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, we can claim the substantial equivalence of PCH-2500 in comparison with its predicate device, PCH-2500(K122155), in terms of safety and effectiveness.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (2000), IEC 60601-1-3 (1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993) and IEC 60601-2-32 (Ed. 1, 1994) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2 (2007).

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review.

PCH-2500 also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. For clinical consideration, separate clinical image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the quality of radiographic images of the device.

Acceptance test according to IEC 61223-3-4 was performed. The separate imaging evaluation is performed for each X-ray generator which is considered as one of critical components affecting the imaging performance of the device.

DICOM Conformance Statement, image viewing SW validation reports, biocompatibility evaluation report and nonclinical consideration for detectors same with predicate device are not provide in this submission, because DICOM standard

{7}------------------------------------------------

conformance, accessory components, image viewing program and the detectors between proposed and predicate device are same.

All test results were satisfactory.

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Vatech Co., Ltd. concludes that PCH-2500 is safe and effective and substantially equivalent to predicate device as described herein.

END

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 15, 2013

VaTech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K130585

Trade/Device Name: PCH-2500 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 7, 2013 Received: June 11, 2013

Dear Mr. Kim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

{9}------------------------------------------------

Page 2 - Mr. Kim

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

Enclosure

{10}------------------------------------------------

Indications for Use

510(k) Number (if known): K130585

Device Name: PCH-2500

Indications for Use:

PCH-2500 is a digital extra oral source X-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and X-ray technicians and other professionals licensed by the law of the states in which the device is used.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh.7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K130585 510(k)

Page 1 of 1

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.