(51 days)
No equivalence claimed
Not Found
No
The device description and the lack of mentions of AI, ML, or related concepts indicate a purely mechanical device for spinal compression.
No
The device is described as an "Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use," specifically to "improve CT and MR diagnostic of the spinal canal." Its intended function is to enhance diagnostic imaging rather than to treat a condition or disease.
No
The device is described as an "accessory for axial compression of the Lumbar spine" used to "improve CT and MR diagnostic of the spinal canal." It aids in the imaging process by compressing the spine, which enhances the quality or clarity of the diagnostic images, but it does not independently perform diagnosis or analyze data to provide a medical conclusion. It facilitates diagnosis, but is not a diagnostic device itself.
No
The device description explicitly mentions physical components like a "Harness, two cords and a foot part" used for compression, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use." It physically compresses the spine to improve imaging.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It interacts directly with the patient's body to facilitate imaging.
Therefore, this device falls under the category of a medical device used for imaging purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use. "Accessory for was vempresses during research and clinical purposes.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH, 90 JAK
Device Description
Through compression of the spine with a Harness, two cords and a foot part improve CT and MR diagnostic of the spinal canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR
Anatomical Site
spinal canal, Lumbar spine
Indicated Patient Age Range
Patient from 15 to 65 years of age
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
No equivalence claimed
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
992120
10 510(k) Summary
Product Trade name: DynaWell Common name: Medical Compression Device, MCD Classification name: Assessory for CT and MR equipment Company & Specification developer. DynaMed AB , (Organizational Number 556 560-5515) President S Mikulowski Nybrokajen 7 102 41 Stockholm
Sweden
Prepared by, Official correspondent regulatory affairs ekeroth Quality AB Nils Ekeroth Sturevägen 4B S-181 33 Lidingö Sweden Tel +46 8 731 98 95 Fax +46 8 731 97 95 E-mail: nils.ekeroth@eqab.se
No equivalence claimed
10.1 Description of the device
Through compression of the spine with a Harness, two cords and a foot part improve CT and MR diagnostic of the spinal canal.
1
10.2 Statement of intended use
Criteria for when to use DynaWell:
Ideally, the examination is performed directly after the basic unloaded investigation and thus decided by the radiologist. The examination might be performed later and planned through the treating doctor or the radiologist.
DynaWell inclusion criteria
Patient from 15 to 65 years of age
Neurogenic claudition in all cases
- D-CSA (dural cross section area of the spinal canal in disc level) is Sciatica below 130 mm2
Suspected dural sac deformation
Disc herniation
Recess stenosis
Foraminal stenosis
- Intraspinal synovial cyst
Etc
DynaWell exclusion criteria
Myofascia syndrome
Vertebral trauma
Tumor -malignancy
Known or suspected osteoporosis
Cardiopulmonary disease
Trauma/Abuse
Psychiatric history
Language illiterate individual
The competence of the examination physician in judging what the proper inclusion or exclusion criteria's are is of outmost importance for the proper use of DynaWell
Image /page/1/Picture/25 description: The image contains a handwritten number "13". The number is written in a simple, slightly slanted style. The ink appears dark, providing a clear contrast against the background.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
Nils Ekeroth C/O DynaMed AB Nybrokajen 7 102 41 Stockholm SWEDEN
Re:
K992120 DynaWell Dated: June 18, 1999 Received: June 23, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Ekeroth:
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 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 redassified 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 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlatory 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 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 (301) 594-4613. 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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdch/dsma/dsmamain.html".
Sincerely yours,
Dan Setiz
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1 August 11:th, 1999
បាយ។ ។ ប្រជាជនជ្រ
ﺳﮯ ﻣﺴ
510(k) Number (if known): K992120
Device Name: DynaWell
Indication For Use: Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use. "Accessory for was vempresses during research and clinical purposes.
(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 Devices | |
| 510(k) Number | K992120 |
| Prescription Use | ✓ | OR | Over-the-Counter |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional for |
(Optional format 1-2-96)