DXL CALSCAN

K033550 · Demetech AB · KGI · May 5, 2004 · Radiology

Device Facts

• Record ID: K033550
• Device Name: DXL CALSCAN
• Applicant: Demetech AB
• Product Code: KGI · Radiology
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The DXL Calscan™ Bone Densitometer estimated bone mineral density (BMD) (g/cm²) for the region of the heel (os calcis). By comparing estimated BMD to a physician-selected reference region of the heel (os calcis), a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk. Use of the DXL Calscan is restricted to prescription use only. The Operator's Manual for the DXL Calscan contains the following statement: "United States Federal Law restricts this device to the sale, distribution and use by or on the order of a physician."

Device Story

DXL Calscan Bone Densitometer estimates bone mineral density (BMD) of os calcis. Device utilizes Dual Energy X-ray Absorptiometry (DEXA) principle to measure heel width and compensate for soft/adipose tissue effects. Input: X-ray scan of heel; Output: BMD (g/cm²) and T-score. Operated by clinical staff in a medical setting; output used by physicians to assess fracture risk. Scan duration is 55 seconds. Effective patient dose is 0.02 mrem. Includes laser ruler (max power 5 mW, wavelength 635 nm) for positioning/measurement. Benefits include non-invasive fracture risk assessment.

Clinical Evidence

Clinical evidence includes an in vivo short-term precision study showing a BMD precision error (CV%) of 1.2%. Non-clinical evidence includes an in vitro accuracy study (r=0.99 correlation with hydroxyapatite content), an in vitro short-term precision study (CV% 0.77%), and a laser ruler study (CV% 0.01%, accuracy error 1.5%).

Technological Characteristics

DEXA-based bone densitometer. Features a laser ruler (max power 5 mW, wavelength 635 nm). Scan time: 55 seconds. Effective patient dose: 0.02 mrem. Measures BMD in g/cm² at the os calcis.

Indications for Use

Indicated for the estimation of bone mineral density (BMD) in the heel (os calcis) to assist physicians in the assessment of fracture risk. Restricted to prescription use.

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

• PIXI Bone Densitometer, GE Lunar (K970224 & K983262)
• DTX-200 Bone Densitometer, Osteometer Meditech (K964562)

Submission Summary (Full Text)

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KO33550

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# 5.0 510 (k) SUMMARY

Information shown in this section is furnished in accordance with 21CFR807.92. The paragraph headings correspond directly with those in 21CFR807.92

807.92(a)(1) Name, address, telephone number, contact person and preparation date

- Submitters name and address: .
Demetech AB Dalvägen 24 169 56 Solna Sweden

#### Submitters telephone number .

| Phone: | [phone] |
|---------|-----------------------------|
| Cell: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### Contact person . Joakim Arwidson International Product Manager Demetech AB Dalvägen 24 169 56 Solna Sweden

- Preparation date . November 7, 2003
### 807.92(a)(2) Proprietary/Trade name, Common name, Classification name

- Proprietary/Trade name . DXL Calscan™
- Common name . Bone Densitometer
- Classification name . Bone Densitometer, 21CFR892.1170

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### 807.92(a)(3) Legally marketed device (predicate device)

- PIXI Bone Densitometer, GE Lunar, 510(k) K970224 & K983262 .
- DTX-200 Bone Densitometer, Osteometer Meditech, 510(k) K964562 .

## 807.92(a)(4) Description of the device that is subject of this premarket notification

The DXL Calscan™ Bone Densitometer estimates Bone Mineral Density (BMD) of the Os Calcis. THE DAL Calstan - Bone Densitometor Societator Sectionetry (DEXA). Heel width, measured by a The lectificiously is based on Dual Enorgy Artay Arage in the effects from soft and adipose tissues.

### 807.92(a)(5) Intended use

The DXL Calscan™ Bone Densitometer estimates bone mineral density (BMD) (g/cm3) for the The DXL Galscan - Bone Donomotor other the BMD to a physician-selected reference region of the nece (os oalor). By ochipatible of his or her discretion, may assess fracture risk.

### 807.92(a)(6) Technological characteristics

One patient scan with DXL Calscan takes 55 seconds to perform. The effective patient dose is 0.02 One patient scan with DXL Oalooan takes by loser ruler with a maximum power of 5 mW and wavelength 635 nm.

### 807.92(b)(1) Brief discussion of the nonclinical tests submitted, referenced or relied on in this premarket notification submission.

DXL Calscan in vitro Accuracy Study shows correlation (r=0.99) between estimated BMD and actual hydroxyapatite content.

DXL Calscan in vitro Short-Term Precision Study shows BMD precision error (CV%) of 0.77%.

DXL Calscan in vitro Laser Ruler Study shows short-term precision error (CV%) of 0.01% and an accuracy error of 1.5%.

### 807.92(b)(2) Brief discussion of the clinical tests submitted, referenced or relied on in this premarket notification submission.

DXL Calscan in vivo Short-Term Precision Study shows BMD precision error (CV%) of 1.2%.

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807.92(b){3} Conclusions drawn from the nonclinical and clinical tests that demonstrate that 807.92(0)(3) Conclusions drawn from the nonomical and should or better than the predicate device.

Based on the results from the tests, the DXL Calscan™ Bone Definetive se sustantially Based on the results from the tests, the DAL Ouround - Bone Bellenshill.
equivalent to previously registered devices. No new safety and effectiveness questions are raised with the DXL Calscan Bone Densitometer.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joakim Arwidson International Product Manager DEMETECH AB Box 3095 SE-16903 Solna SWEDEN

Rc: K033550

Trade/Device Name: DXL Calscan Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: March 14, 2004 Received: March 16, 2004

Dear Mr. Arwidson:

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 such 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.

MAY - 5 2004

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,

This letter will allow you to begin marketing your device as described in your Section 510(k) I this lotter will and TOA finding of substantial equivalence of your device to a legally premantee nodicated. " Tresults 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 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" (21CFR Part 807.97) you may obtain. 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. Broughton

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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#### INDICATION FOR USE FORM 8.0

- 510(k) Number (if known) __033550_ .
- Device Name: DXL Calscan .
- . Indications for use:

The DXL Calscan™ Bone Densitometer estimated bone mineral density (BMD) (g/cm²) for the region of the heel (os calcis). By comparing estimated BMD to a (grim ) for the region of the Rose (a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk.

One patient scan with DXL Calscan takes 55 seconds to perform. The effective One patient dose is 0.02 mrem. This performance is substantially equivalent to PIXI performance and poses no new safety or efficacy concerns.

Use of the DXL Calscan is restricted to prescription use only. The Operator's Manual for the DXL Calscan contains the following statement:

"United States Federal Law restricts this device to the sale, distribution and use by or on the order of a physician."

## PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

David Ro. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number