HCMI X-RAY by HEALTH CARE MFG., INC.

"HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations 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 "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.

AI/ML Overview

The provided document is a 510(k) summary for the "HCMI X-Ray" High Frequency Radiographic System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies. As such, many of the requested details about acceptance criteria, test set, ground truth, and human reader studies are not present in this regulatory document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	"HCMI X-Ray" has the SAME intended use as the predicate device (Bennett X-Ray Radiographic System K952672). This implies the acceptance criterion for intended use was to match the predicate.
Performance Standard	Compliance with 21 CFR 1020.30. The "HCMI X-Ray" is stated to be SAME in performance standard, indicating it meets this regulation.
Electrical Safety	Compliance with Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment. The "HCMI X-Ray" is stated to be SAME in electrical safety, indicating it meets these standards.
Overall Safety and Effectiveness	The device is "as safe and effective as the predicate devices." This is a qualitative statement based on "bench and user testing."

2. Sample Size for the Test Set and Data Provenance

The document mentions "bench and user testing" but does not specify the sample size for these tests.
The data provenance (e.g., country of origin, retrospective/prospective) is not provided. Given the nature of a 510(k) for an X-ray system, "user testing" likely refers to operational evaluations rather than clinical trials with patient data.

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

The document does not mention the involvement of experts to establish ground truth for a test set in the context of diagnostic accuracy.
The evaluation revolved around demonstrating equivalence in function, safety standards, and electrical safety, not diagnostic performance.

4. Adjudication Method for the Test Set

Since there's no mention of a formal test set with ground truth established by experts for diagnostic performance, an adjudication method is not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted as part of this 510(k) submission. The submission is for a basic X-ray system, where the focus is on comparing its technical specifications and safety with existing devices, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was mentioned or conducted. This device is an X-ray imaging system, not an AI-powered diagnostic algorithm.

7. Type of Ground Truth Used

For the "HCMI X-Ray" system, the "ground truth" during testing was likely defined by engineering specifications, compliance with performance standards (21 CFR 1020.30), and adherence to electrical safety standards (UL-2601, IEC 60601, UL187).
The concept of "expert consensus," "pathology," or "outcomes data" as ground truth for diagnostic accuracy is not relevant to this type of device and submission.

8. Sample Size for the Training Set

Not applicable and not mentioned. There is no "training set" in the context of an X-ray imaging system being evaluated for substantial equivalence. This type of device does not involve machine learning or AI algorithms requiring training data.

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

Not applicable and not mentioned. As there is no training set for this device, a method for establishing its ground truth is not relevant.

Summary

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OCT 2 2 2002

Image /page/0/Picture/1 description: The image shows a document with the title "510(k) Summary of Safety and Effectiveness". The document includes the logo and contact information for Health Care MFG., INC. The address is listed as 2146 East Pythian St., Springfield, MO 65802. The phone number is 417-864-6511, and the fax number is 417-864-7394. The document also includes the number K022667.

EXHIBIT 2

August 9, 2002 Contact: Katrina Moulder, Official Correspondent

1. Identification of the Device:
  Proprietary-Trade Name: "HCMI X-Ray" High Frequency Radiographic System

Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System

1. Equivalent legally marketed devices This product is similar in function to the Bennett X-Ray Radiographic System K952672
1. Indications for Use (intended use) : "HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations 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
1. Description of the Device: The "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.

HCMI 100 kHz Generators with Anatomical Programming
Model	mA Range	kVp Range	Max KW
HF-300	25-300	40-125	30
HF-600	25-600	40-125	37.5
HF-3SE	25-300	40-125	30
HF-3SEE	25-300	40-125	30

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1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

Characteristic	Bennett X-RayRadiographic SystemK952672	"HCMI X-Ray"High FrequencyRadiographicSystem
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Electrical safety	Electrical Safety perUnderwriters LaboratoriesStandard UL-2601(IEC-60601) and IEC 60601,Underwriters LaboratoriesStandard UL187: ULStandard for Safety for X-Ray Equipment.	SAME,

1. Substantial Equivalence Chart, "HCMI X-Ray" High Frequency Radiographic System

7. Conclusion

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Health Care Manufacturing, Inc. that the "HCMI X-Ray" High Frequency Radiographic System 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.

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Image /page/2/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services. The seal features a stylized eagle with three lines emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2002

Health Care MFG., Inc. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015 USA Re: K022667

Trade/Device Name: "HCMI X-Ray" High Frequency Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 9, 2002 Received: August 12, 2002

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 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 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:

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" (21 CFR Part 807.97). 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. Snigdon

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

KU22667 510(k) Number

Device Name: "HCMI X-Ray" High Frequency Radiographic System

Indications for Use: "HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number -

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.