APOLLO

K972882 · Norland Corp. · KGI · Oct 31, 1997 · Radiology

Device Facts

• Record ID: K972882
• Device Name: APOLLO
• Applicant: Norland Corp.
• Product Code: KGI · Radiology
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.

Device Story

Apollo is a portable DXA bone densitometer for heel (os calcis) assessment. Device uses low-dose X-ray pencil beam technology; two CdZnTe/CdTe detectors perform dual radiometric scans per mechanical scan to increase speed without mechanical complexity. Operates in High Speed (<1 min) or High Precision (<3 min) modes. Provides BMC, Area, BMD, and longitudinal/short-term percentage change metrics. Used by clinicians to monitor bone density; output assists in clinical decision-making for metabolic bone conditions. Eliminates need for water bath required by older SXA systems. Patient dose is ~1 mrem.

Clinical Evidence

Clinical study involving 33 subjects with 6 scans each to establish precision. High Speed mode precision: 1.8% CV; High Precision mode precision: 1.2% CV.

Technological Characteristics

Dual energy X-ray absorptiometry (DXA); pencil beam geometry; two CdZnTe or CdTe detectors; 60 kVdc constant tube voltage; 0.10-0.20 mA tube current; >1.5 mm Al equivalent filtration. Portable form factor. No water bath required.

Indications for Use

Indicated for bone assessment of the heel in patients across various medical disciplines including nephrology, endocrinology, rheumatology, and gynecology.

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

• OsteoAnalyzer bone densitometer (K891582)
• pDEXA bone densitometer (K931996)

Submission Summary (Full Text)

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Apollo TM 510(k) Summary - Appendix 5

August 1997

## 510k Summary as required by 807.92(c) for Norland ApolloTM Bone Densitometer Prepared 4 August 1997

OCT 31 1997

Submitted by: Norland Corporation W6340 Hackbarth Road Fort Atkinson, WI 53538 Reg. # 2124648 920-563-8456

Mr. Terry Schwalenberg Contact Person: Director Regulatory Affairs

Norland Apollo TM X-Ray Bone Densitometer Device Trade Name:

Common Name: Dual energy x-ray bone densitometer

Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II

Predicate Devices: OsteoAnalyzer bone densitometer (K891582) Dove Medical Systems, Newbury Park, CA

> pDEXA bone densitometer (K931996) Norland Corporation, Fort Atkinson, WI

Apollo™ is a low cost, portable, easy-to-use bone densitometer which Description of Device: uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.

The Apollo The can be used whenever it is desirable to do a bone Intended Use: assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo " assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.

Substantial Apollo is is similar to the pDEXA in that it uses the dual energy x-ray Equivalence to absorptiometry (DXA) technique and the proven pencil beam scan Predicate Devices: method. Apollo is similar to the OsteoAnalyzer in that it scans the same area of the heel as does the OsteoAnalyzer.

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The Apollo The is an improvement over the OsteoAnalyzer because its DXA technology inherently eliminates the water bath; and because it has reduccd scan times. Apollo 1M uses two detectors so that two radiometric scans are performed for each mechanical scan; thereby doubling the scan speed without complicating the mechanicals. The detectors are small enough and close enough to preserve the bone edge and area performance inherent in the pencil beam geometry; unlike the distortions seen with fan beam and cone beam geometries.

Apollo 101 provides two scan modes, High Speed, and High Precision. The High Speed mode completes a scan in < 1 minute with a precision of 1.8 % coeficient of variation (CV). The High Precision mode takes < 3 minutes for a scan and delivers a precision of 1.2 % CV. These precision values were established via a clinical study involving 33 subjects with 6 scans each. Patient dose is about 1 mrem and scatter radiation is less than 0.1 mrem/hr.

| ITEM | APOLLO™ | OSTEOANALYZER | pDEXA |
|---------------------------------|--------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------|
| Scan Site | Os calcis (heel) | same | Forearm |
| Scan Method | DXA<br>Pencil beam<br>Rectilinear scanning | SXA<br>same | DXA<br>same |
| Indications for Use | Heel bone assessment | same | Forearm assessment |
| Intended Uses | Provides BMC, Area,<br>BMD, % Long term change,<br>& % Short term change | same | same |
| Operating Modes | Hi Speed<br>Hi Precision | Standard<br>Hi Speed | Standard<br>High Speed<br>High Precision |
| Scan Time | < 1 minute (High Speed)<br>< 3 minutes (High Precision) | 3.5 min. (Standard)<br>2.0 min. (Hi Speed) | < 2 min. (High Speed)<br>5 min. (High Precision) |
| Precision | 1.8 % (High Speed)<br>1.2 % (High Precision) | < 1 % | 1.8 % (High Speed)<br>1.4 % (High Precision) |
| Accuracy | 2 % to hydroxapatite | dipotassium<br>hydrogen phosphate | hydroxapatite |
| Machine-to-<br>machine variance | 2 % for BMD | not specified | 2% for BMD |
| Dose | < 1 mrem | 1.3 mrem | < 4.5 mrem |
| Technology | DXA (no water) | SXA (water needed) | DXA (no water) |
| Detectors | two CdZnTe (or CdTe) | one CdTe | two CdZnTe (or CdTe) |
| Tube Voltage | 60 kVdc (constant) | 36 kVdc (constant) | 60 kVdc (constant) |
| Tube Current | 0.10 - 0.20 mA | 0.1 mA | 0.12 mA |
| Filtration | >1.5 mm Al equivalent | same | same |

## Comparison Table

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 1997

Terry Schwalenberg Director, Regulatory Affairs Norland Corporation W6340 Hackbarth Rd. Fort Atkinson, WI 53538-8999 Re:

K972882 Norland Apollo Bone Densitometer Dated: August 4, 1997 Received: August 5, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Schwalenberg:

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 Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 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 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.

h Lillian Yin, Ph.D.

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

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Apollo 510(k) - Appendix 1

510(k) Number (if known):

cvice Name:

Norland Apollo X-Ray Bone Densitometer

Indications For Use:

The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.

(printed on FDA Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Formal 1-2-46)

August 1997