(175 days)
No
The summary does not mention AI, ML, or related terms, and the description of the technology (DEXA) and performance studies do not suggest the use of these technologies.
No
The device estimates bone mineral density and calculates a T-score to assess fracture risk, which is a diagnostic function, not a therapeutic one. It provides information for a physician to make a decision, but does not directly treat or alleviate a condition.
Yes
The device is described as estimating bone mineral density (BMD) and calculating a T-score to help a physician assess fracture risk. This function of providing information for assessment of a medical condition (fracture risk) makes it a diagnostic device.
No
The device description explicitly states it is based on Dual Energy X-ray Absorptiometry (DEXA) and uses a laser ruler, indicating it includes hardware components for measurement.
Based on the provided information, the DXL Calscan™ Bone Densitometer is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device measures bone mineral density in vivo (within a living person) by scanning the heel. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The description clearly states it uses Dual Energy X-ray Absorptiometry (DEXA) to scan the heel. This is a direct measurement on the patient.
- Anatomical Site: The device operates on the Os Calcis (heel), which is part of the human body.
- Performance Studies: The performance studies describe in vitro accuracy and precision studies using hydroxyapatite content (likely a phantom or standard), but the primary function and intended use are in vivo measurements.
Therefore, the DXL Calscan™ Bone Densitometer is a medical device used for in vivo bone density measurement, not an IVD.
N/A
Intended Use / Indications for Use
The DXL Calscan™ Bone Densitometer estimates bone mineral density (BMD) (g/cm3) 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.
Product codes
90 KGI
Device Description
The DXL Calscan™ Bone Densitometer estimates Bone Mineral Density (BMD) of the Os Calcis. THE DXL 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual Energy X-ray Absorptiometry (DEXA)
Anatomical Site
Os Calcis (heel)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%.
DXL Calscan in vivo Short-Term Precision Study shows BMD precision error (CV%) of 1.2%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
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.(b)
Classification. Class II.
0
KO33550
Image /page/0/Picture/2 description: The image shows the word "demetech" in bold, black letters. Above the word are three small, faint circles arranged horizontally. To the left of the word is a partial circular design, also faint, that appears to be made up of small lines or strokes.
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: | +46 8 555 79 204 |
|---|---|
| Cell: | +46 733 10 50 91 |
| Fax: | +46 8 555 79 249 |
| E-mail: | joakim.arwidson@demetech.se |
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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1
Image /page/1/Picture/0 description: The image shows the word "demetech" in a bold, sans-serif font. There is a partial parenthesis to the left of the word and three circles above the "tech" portion of the word. The text and symbols are all in black and white. The image appears to be a logo or brand name.
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%.
2
Image /page/2/Picture/0 description: The image shows the word "demetech" in a bold, sans-serif font. There are three small circles above the "tech" portion of the word. A curved line is present on the left side of the word, resembling a parenthesis. The text is black and the background is white.
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.
DEMETECH AB Postal address ROK 30345 SE 1300 C North NG ないのではな
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1990 PM = 044-05 300 2001 144 8 555 79 249 !バメ
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3
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
4
,
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
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