DYNAWELL OR DYNAWELL

K992120 · Ekeroth Quality AB · LNH · Aug 13, 1999 · Radiology

Device Facts

• Record ID: K992120
• Device Name: DYNAWELL OR DYNAWELL
• Applicant: Ekeroth Quality AB
• Product Code: LNH · Radiology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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.

Device Story

DynaWell is a medical compression device used to improve CT and MR diagnostic imaging of the spinal canal. The device applies axial compression to the lumbar spine using a harness, two cords, and a foot part. It is intended for use in clinical or research settings under the direction of a radiologist or treating physician. By compressing the spine during imaging, the device aims to reveal dural sac deformation or stenosis that might not be apparent in an unloaded state, potentially aiding in the diagnosis of conditions like disc herniation or spinal stenosis.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Mechanical compression device consisting of a harness, two cords, and a foot part. Designed as an accessory for CT and MR imaging equipment to provide axial loading of the lumbar spine.

Indications for Use

Indicated for patients 15-65 years old with neurogenic claudication, sciatica (D-CSA < 130 mm2), suspected dural sac deformation, disc herniation, recess stenosis, foraminal stenosis, or intraspinal synovial cyst. Contraindicated for myofascia syndrome, vertebral trauma, tumor/malignancy, known/suspected osteoporosis, cardiopulmonary disease, trauma/abuse, psychiatric history, or language illiteracy.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

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# 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 [phone] Fax [phone] E-mail: [e-mail]

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.

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#### 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.

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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 [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/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

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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 | <div style="font-size: 2em;">✓</div> | OR | Over-the-Counter |
|----------------------|--------------------------------------|----|------------------|
| (Per 21 CFR 801.109) | | | (Optional for |

(Optional format 1-2-96)

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