ACCUDEXA BONE DENSITOMETER

K981124 · Schick Technologies, Inc. · KGI · Jun 4, 1998 · Radiology

Device Facts

• Record ID: K981124
• Device Name: ACCUDEXA BONE DENSITOMETER
• Applicant: Schick Technologies, Inc.
• Product Code: KGI · Radiology
• Decision Date: Jun 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.

Device Story

The accuDEXA is a Dual Energy X-Ray Absorptiometer (DEXA) that estimates bone mineral density (BMD) and bone mineral content (BMC) in the middle finger of the non-dominant hand. The device uses an X-ray tube with two high-voltage settings to produce two energy levels, generating images of the finger. Algorithms analyze these images to calculate BMD and BMC values. These values are compared against a normative database to generate t-scores (comparison to young healthy individuals) and z-scores (comparison to age-matched individuals). The device is intended for use by clinicians as an aid in assessing fracture risk. Output is provided to the physician to assist in clinical decision-making regarding bone health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and comparison to predicate devices.

Technological Characteristics

Dual Energy X-Ray Absorptiometer (DEXA). Uses X-ray tube with variable high-voltage settings to produce two energy levels. Analyzes images of the middle finger to calculate BMD and BMC. Compares results to normative databases for t-score and z-score calculation.

Indications for Use

Indicated for use in estimating bone mineral density (BMD) of the middle finger of the non-dominant hand as an aid to physicians in determining fracture risk.

Regulatory Classification

Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Norland pDEXA (K931996)
• Norland Model 178

Submission Summary (Full Text)

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

981124

### 510(k) Summary

# Schick accuDEXA Bone Densitometer Fracture Risk Claim

Common/Classification Name. Bone Densitometer 21 CFR 892.1170

Schick Technologies, Inc. 31-00 47th Avenue Long Island City, NY 11101 718-937-5765. 718-937-5962 (FAX) Contact: Enrico Renzi, Prepared: March 6, 1998

#### LEGALLY MARKETED PREDICATE DEVICES A.

The accuDEXA Bone Densitometer is substantially equivalent to the Norland pDEXA and Model 178 bone densitometer devices with respect to the fracture risk claim. The Norland pDEXA device was found to be substantially equivalent (K973104) with regard to claims of fracture risk to the Norland Model 178, which has been determined by CDRH to have been in commercial distribution prior to May 28, 1976 for use as an aid to the physician in determining fracture risk. The Norland pDEXA device was originally cleared under K931996

#### DEVICE DESCRIPTION B.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to estimate bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.

000019

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

#### C. INDICATIONS FOR USE

The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.

#### SUBSTANTIAL EQUIVALENCE SUMMARY D.

The addition to the indications statement for the accuDEXA and the indications statement cleared by FDA for the predicate device are the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices. The descriptive characteristics with respect to the fracture risk claim are precise enough to assure substantial equivalence. Therefore, the accuDEXA Bone Densitometer is substantially equivalent to the predicate devices with respect to the fracture claim.

#### TECHNOLOGICAL CHARACTERISTICS E.

See Device Description, above.

#### F. FRACTURE RISK DETERIMINATION

The recommendations of the World Health Organization and the National Osteoporosis Foundation were used in developing a modification to the patient report printout, an addition to the User Manual, and a Patient Information Brochure.

#### G. CONCLUSIONS

Schick Technologies has demonstrated through its comparison of characteristics with the predicate devices that the accuDEXA Bone Densitomctor is substantially equivalent to the predicate devices.

000019

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

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered on the image.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

Public Health Service

21 CFR 892.1170/Procode: 90 KGI

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K981124 Re: accuDEXA Bone Densitometer Dated: March 25, 1998 Received: March 27, 1998 Regulatory class: II

Dear Mr. Athey:

IUN

Whit Athey

1 1998

c/o C.L. Mcintosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625

Schick Technologies, Inc.

Rockville, MD 20852

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Festeral Food, Drug, and Commenc Act (Act.). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleral Regulations, Title 21, Parts 800 to 895. A substantially oquivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

William Hio, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Far, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): _

Device Name: _Schick accuDEXA Bone Densitometer

Indications For Use:

The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Ramrological Devices
510(k) Number K981124

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

000023