HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC

K022737 · Health Care Mfg., Inc. · KPR · Oct 22, 2002 · Radiology

Device Facts

• Record ID: K022737
• Device Name: HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
• Applicant: Health Care Mfg., Inc.
• Product Code: KPR · Radiology
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

HCMI X-Ray" High Frequency Chiropractic 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 Story

Stationary high-frequency X-ray system for chiropractic use. System components: high-voltage generator, control panel, tube stand (Model S-82RM), Toshiba tube head, Eureka collimator, and wall-mount cassette holder. Optional: radiographic table and wall stand with bucky. Operates on 120/220V AC. Used by physicians or technicians in clinical settings to perform diagnostic radiographic exposures. Output is a radiographic image used by clinicians to assess anatomical structures and support diagnostic decision-making. Benefits include high-frequency imaging capabilities for general diagnostic purposes.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through electrical safety testing (UL-2601/IEC-60601), EMC compatibility testing, and performance verification against 21 CFR 1020.30 standards.

Technological Characteristics

Stationary high-frequency X-ray system; 100 kHz generators (HF-300, HF-600, HF-3SE); 120/220V AC power; Toshiba tube head; Eureka collimator; anatomical programming; stationary form factor; compliant with 21 CFR 1020.30 and UL-2601/IEC-60601 standards.

Indications for Use

Indicated for general purpose radiographic examinations of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Procedures performed with patient sitting, standing, or lying (prone/supine).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bennett X-Ray Radiographic System (K952672)

Submission Summary (Full Text)

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# OCT 2 2 2002

EXHIBIT 2 510(k) Summary of Safety and Effectiveness

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KC22737

August 9, 2002 Contact: Katrina Moulder, Official Correspondent

- 1. Identification of the Device: Proprietary-Trade Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System
- Equivalent legally marketed devices This product is similar in function and 2. design to the Bennett X-Ray Radiographic System K952672
- 3. Indications for Use (intended use) : "HCMI X-Ray" High Frequency Chiropractic 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
- Description of the Device: The "HCMI X-Ray" is a chiropractic radiographic 4. high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.

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 |

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- 5. 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-Ray<br>Radiographic System<br>K952672 | "HCMI X-Ray"<br>High Frequency<br>Chiropractic<br>Radiographic<br>System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest, abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position. | SAME |
| Performance<br>Standard | 21 CFR 1020.30 | SAME |
| Electrical safety | Electrical Safety per<br>Underwriters Laboratories<br>Standard UL-2601(IEC-<br>60601) and IEC 60601,<br>Underwriters Laboratories | SAME, plus tested for<br>EMC compatibility |

- 6. Substantial Equivalence Chart, "HCMI X-Ray" High Frequency Chiropractic 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 Chiropractic 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Health Care Mfg., Inc. % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K022737

Trade/Device Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 14, 2002 Received: August 19, 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) 594-459 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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## j) Indications for Use

510(k) Number K (222

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

Indications for Use: "HCMI X-Ray" High Frequency Chiropractic 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. Hodgdon

(Division Sign-Off) Dession of Reproductive, Abdominal, are Padiological Devices 5 : (k) Number _______________________________________________________________________________________________________________________________________________________________

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