ACCUDEXA BONE DENSITOMETER

K971735 · Schick Technologies, Inc. · KGI · Dec 2, 1997 · Radiology

Device Facts

• Record ID: K971735
• Device Name: ACCUDEXA BONE DENSITOMETER
• Applicant: Schick Technologies, Inc.
• Product Code: KGI · Radiology
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The accuDEXA is a dual-energy x-ray device indicated for use in measuring an index of the bone density of the middle finger of the nondominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. The measurement is compared to similar measurements from patients of the same gender and ethnicity to provide t-scores (number of standard deviations above or below the mean for a reference group of young healthy individuals) and z-scores (number of standard deviations above or below the mean for a cohort of the same age). A t-score or a z-score may be used by a physician as one factor, in conjunction with other clinical indicators, to diagnose osteoporosis and other bone disorders. When a normative database of the same ethnicity and gender is not available, the BMD value may still be used to compare to the patient's own baseline value, for example in following the patient's response to treatment for osteoporosis. Below normal bone density can be associated with a variety of conditions or disorders of bone. For example, the Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications for measurement of a patient's bone mass: for patients with premenopausal oophorectomy, spontaneous menopause, or estrogen deficiency conditions; for treatment-related osteopenia; when the diagnosis of osteopenia is suggested or established by other means, such as x-ray; during long-term immobilization; for endocrinopathies known to be associated with osteopenia; for post-gastrectomy and other malabsorption states leading to osteopenia: during long-term corticosteroid therapy; for chronic renal disease, particularly in childhood or adolescence; and to monitor treatment programs for osteoporosis.

Device Story

AccuDEXA is a Dual Energy X-Ray Absorptiometer (DEXA) for bone mineral density (BMD) measurement. Device captures images of the middle finger of the non-dominant hand using two distinct X-ray energy levels generated by varying X-ray tube high voltage. Algorithms analyze these images to calculate BMD and bone mineral content (BMC). Results are compared against a normative database to generate t-scores and z-scores. Used by clinicians to assist in diagnosing osteoporosis and monitoring treatment response. Provides a relative indicator of systemic bone density. Benefits include non-invasive assessment of bone mass in patients with risk factors for osteopenia.

Clinical Evidence

Bench testing only. Study on cadavers evaluated precision, accuracy, and repeatability of measurements. Results showed high repeatability with repositioning and high correlation with ashed bone weights. Performance compared favorably to predicate devices. A clinical study was conducted to develop a normative reference database for t-score and z-score calculations.

Technological Characteristics

Dual Energy X-Ray Absorptiometer (DEXA). Uses digital imaging array. Operates by modulating X-ray tube high voltage to produce two energy levels. Computes BMD and BMC via algorithmic analysis of finger images. Includes normative database for score calculation.

Indications for Use

Indicated for patients requiring bone mineral density (BMD) assessment of the middle finger of the non-dominant hand to diagnose osteoporosis or monitor bone disorders. Applicable to patients with conditions associated with osteopenia, including premenopausal oophorectomy, menopause, estrogen deficiency, treatment-related osteopenia, long-term immobilization, endocrinopathies, malabsorption states, long-term corticosteroid therapy, and chronic renal disease.

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

• The Osteogram Radiographic Absorptiometry (RA) device
• Hologic QDR 2000+ DXA bone densitometer (K913321)

Reference Devices

• Schick CDR Digital Dental X-ray Receptor Array (K933455)

Submission Summary (Full Text)

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KIMDS

DEC - 2 1997

## 510(k) Summary

# Schick accuDEXA Bone Densitometer

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: May 8, 1997

#### LEGALLY MARKETED PREDICATE DEVICES A.

The accuDEXA is substantially equivalent to bone densitometers The Osteogram Radiographic currently marketed in the U.S. Absorptiometry (RA) device, a pre-Amendment device originally from Compumed (now distributed by Merck), is similar in that it uses the three middle fingers of the hand to compute the bone density, though it uses X-ray film for recording. The Hologic QDR 2000+ DXA bone densitometer (K913321) is similar in that it uses the same dual-energy x-ray absorptiometry (DXA) technology, though it uses the forearm as the measurement site. The Schick CDR Digital Dental X-ray Receptor Array (K933455) currently marketed by Schick Technologies uses a similar digital imaging array.

### DEVICE DESCRIPTION B.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to calculate an index of 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 zscore 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.

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### INDICATIONS FOR USE C.

The accuDEXA is a dual-energy x-ray device indicated for use in measuring an index of the bone density of the middle finger of the nondominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. The measurement is compared to similar measurements from patients of the same gender and ethnicity to provide t-scores (number of standard deviations above or below the mean for a reference group of young healthy individuals) and z-scores (number of standard deviations above or below the mean for a cohort of the same age). A t-score or a z-score may be used by a physician as one factor, in conjunction with other clinical indicators, to diagnose osteoporosis and other bone disorders. When a normative database of the same ethnicity and gender is not available, the BMD value may still be used to compare to the patient's own baseline value, for example in following the patient's response to treatment for osteoporosis.

Below normal bone density can be associated with a variety of conditions or disorders of bone. For example, the Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications for measurement of a patient's bone mass: for patients with premenopausal oophorectomy, spontaneous menopause, or estrogen deficiency conditions; for treatment-related osteopenia; when the diagnosis of osteopenia is suggested or established by other means, such as x-ray; during long-term immobilization; for endocrinopathies known to be associated with osteopenia; for post-gastrectomy and other malabsorption states leading to osteopenia: during long-term corticosteroid therapy; for chronic renal disease, particularly in childhood or adolescence; and to monitor treatment programs for osteoporosis.

### D. SUBSTANTIAL EQUIVALENCE SUMMARY

The intended use for the accuDEXA and the predicate devices is the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices. However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, Schick Technologies sponsored performance tests on the device and the predicate devices (see Section F, below), and a comparison of these data demonstrate that the accuDEXA Bone Densitometer is substantially equivalent to the predicate devices.

### E. TECHNOLOGICAL CHARACTERISTICS

See Device Description, above.

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### TESTING F.

Schick Technologies has sponsored a study on cadavers that examines the precision and accuracy of the accuDEXA device. The study also directly compared the bone density values obtained with the predicate devices. This study showed that the accuDEXA measurements are very repeatable, even with repositioning. The very high correlation of the accuDEXA measurements with the ashed bone weights shows that the accuDEXA measurements are very accurate. The good correlation of the accuDEXA measurement with measurements with the two predicate devices demonstrates that the accuDEXA results for the middle finger are at least as good an indicator of BMD as the currently marketed predicate devices.

A reference data base has been developed in a clinical study which allows the calculation of t-scores and z-scores for each patient.

### G. CONCLUSIONS

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 2 1997

Schick Technologies, Inc. c/o T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re:

K971735 AccuDEXA Bone Densitometer Dated: September 11, 1997 Received: September 11, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Dr. Athey:

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 542 of the Act for devices under 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/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

KIMDS

DEC - 2 1997

## 510(k) Summary

# Schick accuDEXA Bone Densitometer

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: May 8, 1997

#### LEGALLY MARKETED PREDICATE DEVICES A.

The accuDEXA is substantially equivalent to bone densitometers The Osteogram Radiographic currently marketed in the U.S. Absorptiometry (RA) device, a pre-Amendment device originally from Compumed (now distributed by Merck), is similar in that it uses the three middle fingers of the hand to compute the bone density, though it uses X-ray film for recording. The Hologic QDR 2000+ DXA bone densitometer (K913321) is similar in that it uses the same dual-energy x-ray absorptiometry (DXA) technology, though it uses the forearm as the measurement site. The Schick CDR Digital Dental X-ray Receptor Array (K933455) currently marketed by Schick Technologies uses a similar digital imaging array.

### DEVICE DESCRIPTION B.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to calculate an index of 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 zscore 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.

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

### INDICATIONS FOR USE C.

The accuDEXA is a dual-energy x-ray device indicated for use in measuring an index of the bone density of the middle finger of the nondominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. The measurement is compared to similar measurements from patients of the same gender and ethnicity to provide t-scores (number of standard deviations above or below the mean for a reference group of young healthy individuals) and z-scores (number of standard deviations above or below the mean for a cohort of the same age). A t-score or a z-score may be used by a physician as one factor, in conjunction with other clinical indicators, to diagnose osteoporosis and other bone disorders. When a normative database of the same ethnicity and gender is not available, the BMD value may still be used to compare to the patient's own baseline value, for example in following the patient's response to treatment for osteoporosis.

Below normal bone density can be associated with a variety of conditions or disorders of bone. For example, the Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications for measurement of a patient's bone mass: for patients with premenopausal oophorectomy, spontaneous menopause, or estrogen deficiency conditions; for treatment-related osteopenia; when the diagnosis of osteopenia is suggested or established by other means, such as x-ray; during long-term immobilization; for endocrinopathies known to be associated with osteopenia; for post-gastrectomy and other malabsorption states leading to osteopenia: during long-term corticosteroid therapy; for chronic renal disease, particularly in childhood or adolescence; and to monitor treatment programs for osteoporosis.

### D. SUBSTANTIAL EQUIVALENCE SUMMARY

The intended use for the accuDEXA and the predicate devices is the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices. However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, Schick Technologies sponsored performance tests on the device and the predicate devices (see Section F, below), and a comparison of these data demonstrate that the accuDEXA Bone Densitometer is substantially equivalent to the predicate devices.

### E. TECHNOLOGICAL CHARACTERISTICS

See Device Description, above.

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

### TESTING F.

Schick Technologies has sponsored a study on cadavers that examines the precision and accuracy of the accuDEXA device. The study also directly compared the bone density values obtained with the predicate devices. This study showed that the accuDEXA measurements are very repeatable, even with repositioning. The very high correlation of the accuDEXA measurements with the ashed bone weights shows that the accuDEXA measurements are very accurate. The good correlation of the accuDEXA measurement with measurements with the two predicate devices demonstrates that the accuDEXA results for the middle finger are at least as good an indicator of BMD as the currently marketed predicate devices.

A reference data base has been developed in a clinical study which allows the calculation of t-scores and z-scores for each patient.

### G. CONCLUSIONS

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

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

Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 2 1997

Schick Technologies, Inc. c/o T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re:

K971735 AccuDEXA Bone Densitometer Dated: September 11, 1997 Received: September 11, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Dr. Athey:

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 542 of the Act for devices under 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/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Siegman

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use