DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

The DF-211H Radiographic X-Ray system is complete, consisting of a 50kW X-Ray generator, control console, X-Ray tube assembly, collimator, and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It has functions such as general radiography, anatomic program radiography (APR), etc. It has option of ionization chamber automatic exposure control (AEC). It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50Hz; single phase: 120V, 60 Hz; fluctuation range for voltage: 10%; the power source capacity: 50kW.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DF-211H Radiographic X-Ray system:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the DF-211H Radiographic X-Ray system is cleared as "substantially equivalent" to a predicate device (HF-50R Computer Controlled X-Ray System, K052541) primarily through demonstrating adherence to safety and performance standards. There are no specific quantitative clinical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) provided in the summary.

The "acceptance criteria" are effectively the requirements outlined in the safety and performance standards listed, and the "reported device performance" is that the device met these standards.

Acceptance Criteria (Standards Met)	Reported Device Performance
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (1988, Amd. 1&2)	Device complies with this standard.
EN 60601-1-2:2007: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic	Device complies with this standard.
IEC 60601-2-7:1998 (GB 9706.3-2000 idt): Medical electrical equipment -Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators	Device complies with this standard.
IEC 60601-2-28:1993 (GB 9706.11-1997 idt): Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis	Device complies with this standard.
IEC 60601-1-3:1994 (GB 9706.12-1997 idt): Medical electrical equipment Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment	Device complies with this standard.
IEC 60601-2-32:1994 (GB 9706.14-1997 idt): Medical electrical equipment Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment	Device complies with this standard.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a clinical test set involving patients or images for evaluating diagnostic performance. The "testing data" mentioned are "bench and external laboratory testing data." Therefore, there is no sample size for a "test set" in the context of diagnostic performance (e.g., number of images, patients).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As noted above, there is no described clinical test set requiring ground truth established by experts for diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. There is no described clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The provided text indicates that "bench and external laboratory testing data" were used to establish substantial equivalence based on safety and performance standards, not a comparative effectiveness study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This device is an X-ray system, not an AI algorithm. Its performance is evaluated based on its ability to generate X-ray images safely and effectively according to established standards, not on an algorithm's diagnostic interpretation.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is its conformance to established international and national standards for medical electrical equipment, including general safety, electromagnetic compatibility, and specific requirements for X-ray generators and tube assemblies. This is determined through objective measurements and tests performed in bench and external laboratories against the specifications of these standards, rather than a clinical "ground truth" like pathology or expert consensus on images.

8. The Sample Size for the Training Set

Not applicable. An X-ray system is not an AI algorithm that requires a "training set" of data for machine learning. Its design and manufacturing adhere to engineering principles and standards.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is involved.

Summary

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KV20034

ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.

510(k) Summary

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:

The Assigned 510(k) Number is:
1. Submitter Information:

. Sponsor/510(k) Owner: ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. No. 16 Cuiming Road YAT-SEN Scientific Industrial Park, Tianjin Economic Technological Development Area, Tianjin 301726, China Phone: +86 22 8216 1240 Fax: +86 22 8216 0813

Dated: December 28, 2011

· 510(k) Contact Name:
Mr. Jun Peng

P&L SCIENTIFIC, INC. 6840 SW 45TH LN #5 MIAMI, FL 33155 Phone: (305) 609 4701 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com

2. Device Name

Trade Name:	DF-211H Radiographic X-Ray system
Common Name:	System, X-Ray, Stationary
Classification Name:	Stationary X-Ray System

3. Classification:

Classification:	21 CFR 892.1680; Class II
Product Code:	KPR

4. Predicate Devices:

Model
HF-50R ComputerControlled X-Ray System	K052541	AVANT Medical Systems

5. Description of Device

APR 1 7 2012

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6. Intended Use

7. Comparison of Technological Characteristics

The DF-211H radiographic X-ray system is similar to the predicate devices:

. Has the same intended use and indications for use
Utilizes the same operating principle .
. Incorporates the same basic design
. Incorporates the same technological characteristics
Tested to the same electrical and electromagnetic safety standards for medical � electrical equipment
. Manufactured under a quality system

8. Summary Performance Data

. IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
EN 60601-1-2:2007 (Third Edition, 2007), Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic
IEC 60601-2-7:1998 (GB 9706.3-2000 idt) Medical electrical equipment -Part 2-7: . Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
IEC 60601-2-28:1993 (GB 9706.11-1997 idt) Medical electrical equipment Part 2-. 28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
· IEC 60601-1-3:1994 (GB 9706.12-1997 idt) Medical electrical equipment Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-2-32:1994 (GB 9706.14-1997 idt) Medical electrical equipment Part 2-. 32: Particular requirements for the safety of associated equipment of X-ray equipment

9. Conclusion

After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white.

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

Orich Medical Equipment (Tianjin) Co., Ltd. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane #5 MIAMI FL 33155

Re: K120034

Trade/Device Name: DF-211H Radiographic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: March 2, 2012 Received: March 7, 2012

Dear Mr. Peng:

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

APR 1 7 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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120034

Device Name: DF-211H Radiographic X-Ray System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter 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)

Division Sign Off

of Radiological Ca Office of in vi lagnostic Device Evaiuation and Safety

510K K120034

Page 1 of 1

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.