(29 days)
The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
This device is for prescription use only.
The Healthstar Elite is a multifunction elevation table designed to apply distraction forces to a patient's spine. The powered elevation adjustments of the table's surface height are designed to provide easier loading and unloading of the patient on and off the table.
The patient lies in a supine position on the table with either the knees bent or legs supported on an adjustable height stool creating a 90-degree bend between the calves and hamstrings. This position helps to provide comfort during distraction and to provide relaxation to the Para spine tissue during distraction.
The upper body is restrained through a chest harness, which is attached underneath the rib cage. The harness is attached to a metal spreader bar and web strap, then attached through a cam-type buckle assembly. The lower body is restrained to the moveable lower section of the table through a flexible pelvic restraint is fixed to the table's lower moveable section. Each side of the restraint can be moved in and out width wise by pushing a lever and having a stud engage into one of three numbered holes, depending on the size of the patient. The flexible restraint is designed to capture and secure the patients iliac crest.
The Healthstar Elite consists of two components:
-
- The elevation table with traction capabilities.
-
- An attachable control panel, which can be inserted into either side of the table.
The elevation table is controlled by a 24-volt actuator and is elevated by pushing a hand control with built in arrows indications (no label required).
The control panel allows the operator to select one of eight predetermined programs of distraction, time of treatment, pounds of distraction, and pelvic tilt angle.
The provided text is a 510(k) premarket notification for the Healthstar Elite, a powered traction equipment device. The document primarily describes the device's function, its similarities to predicate devices, and the FDA's determination of substantial equivalence.
However, the document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in a way that would allow for the completion of the requested table and accompanying details.
Here's a breakdown of what is not present in the provided text:
- Acceptance Criteria Table: There is no table outlining specific performance targets (e.g., accuracy, precision, safety thresholds) for the device. The document focuses on regulatory equivalence rather than quantitative performance.
- Reported Device Performance: No specific quantitative performance data (e.g., measurement accuracy of distraction force, reliability over time, patient outcome statistics) is reported.
- Study Details:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
- Number of Experts/Qualifications (Ground Truth): Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned. The document primarily compares the device's "principles and working characteristics" to predicate devices, not a rigorous comparative effectiveness study with human readers/operators.
- Standalone Performance: Not explicitly stated as a separate study. The document implies the device works as intended but doesn't detail a standalone performance evaluation with specific metrics.
- Type of Ground Truth: Not applicable, as no specific performance study is detailed with ground truth.
- Sample Size (Training Set): Not mentioned.
- Ground Truth Establishment (Training Set): Not applicable.
Summary of available information related to effectiveness and safety:
The "Summary of Safety and Effectiveness" section states:
"The operating principles of the Healthstar Elite permit the safe application of effective distraction tensions of the lumbar spine."
It further describes safety features like a patient handheld cut-off switch and a quick release for power failure.
Conclusion:
The provided 510(k) notification for the Healthstar Elite focuses on demonstrating substantial equivalence to predicate devices (SpineMED, DRS System, SPINA System) for regulatory approval, rather than providing a detailed performance study with quantifiable acceptance criteria and results. Therefore, it is impossible to complete the requested table and answer the study-specific questions based on the given text.
The FDA's letter states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the evaluation was against existing known devices in terms of intended use, technological characteristics, and safety/effectiveness principles, rather than requiring a new, comprehensive clinical performance study with specific metrics as would be expected for a novel device or a device requiring a PMA.
{0}------------------------------------------------
DEC 22 2004
| Trade Name: | Healthstar Elite |
|---|---|
| Common Name: | Powered Traction Equipment |
| Classification Name & Code: | Powered Traction EquipmentClass II (21 CFR Section 890.5900) ITH |
| Classification Advisory Committee | Physical Medicine |
| Reason: | It is a new device |
| Predicate Device: | DRS SystemProfessional Distribution Systems, Inc.510(k): K981822SpineMEDCert Health Sciences, LLC510(k): K030060 |
Description:
The Healthstar Elite is a multifunction elevation table designed to apply distraction forces to a patient's spine. The powered elevation adjustments of the table's surface height are designed to provide easier loading and unloading of the patient on and off the table.
The patient lies in a supine position on the table with either the knees bent or legs supported on an adjustable height stool creating a 90-degree bend between the calves and hamstrings. This position helps to provide comfort during distraction and to provide relaxation to the Para spine tissue during distraction.
The upper body is restrained through a chest harness, which is attached underneath the rib cage. The harness is attached to a metal spreader bar and web strap, then attached through a cam-type buckle assembly. The lower body is restrained to the moveable lower section of the table through a flexible pelvic restraint is fixed to the table's lower moveable section. Each side of the restraint can be moved in and out width wise by pushing a lever and having a stud engage into one of three numbered holes,
{1}------------------------------------------------
depending on the size of the patient. The flexible restraint is designed to capture and secure the patients iliac crest.
The Healthstar Elite consists of two components:
-
- The elevation table with traction capabilities.
-
- An attachable control panel, which can be inserted into either side of the table.
The elevation table is controlled by a 24-volt actuator and is elevated by pushing a hand control with built in arrows indications (no label required).
The control panel allows the operator to select one of eight predetermined programs of distraction, time of treatment, pounds of distraction, and pelvic tilt angle.
Technological Characteristics
Healthstar Elite incorporates various principles and working characteristics of the predicate devices, SpineMED (K030060), DRS System (K981822) and SPINA System (K002260). The Healthstar Elite employs a unique method of restraining the patient's body to the table surface, which has not impacted on, or changed the safety or effectiveness of the device.
Summary of Safety and Effectiveness
The operating principles of the Healthstar Elite permit the safe application of effective distraction tensions of the lumbar spine. The patient is provided with a handheld cut off switch, which, when depressed, will interrupt the treatment and will gradually eliminate the application of force to zero. If a power failure occurs operator or patient can simply push a button on a seat buckle assembly, which will immediately eliminate all distraction forces to the patient.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
DEC 22 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Marc M. Mouser Senior Project Engineer/Program Reviewer Conformity Assessment Services Underwriters Laboratories, Inc. 2600 NW Lake Road, Camas, Wyoming 98607
Re: K043239
Trade/Device Name: Healthstar Elite Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: November 17, 2004 Received: November 23, 2004
Dear Mr. Mouser:
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.
{3}------------------------------------------------
Page 2 - Mr. Marc M. Mouser
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): K043239
Device Name: Healthstar Elite
Indications for Use:
The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
This device is for prescription use only.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-CounterUse (21 CFR 801 Subpart C)
AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices
510(k) Number K643239
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).