(6 days)
No
The description details a computer-controlled mechanical traction table with safety features and data logging, but there is no mention of AI or ML for decision-making, treatment adjustments, or data analysis beyond simple monitoring and recording.
Yes.
The device's intended use is to provide relief from pain associated with various spinal conditions and achieve this through decompression of intervertebral discs, which is a therapeutic effect.
No
The device description clearly states its purpose is to provide "relief from pain" and "relieve pressures" through "distraction forces" and "decompression of intervertebral discs". This indicates a therapeutic or treatment function, not a diagnostic one. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly details a physical traction table with mechanical and electrical components (actuators, load cells, heating pad, safety switches, etc.), indicating it is a hardware device with integrated software for control and data capture.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpineMED® System is a physical therapy device that applies mechanical forces (distraction) to the spine. It directly interacts with the patient's body.
- Intended Use: The intended use is to provide pain relief through physical manipulation of the spine, not through the analysis of biological samples.
- Device Description: The description details a traction table with harnesses, restraints, and actuators, all designed for applying physical force to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the SpineMED® System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Product codes
ITH
Device Description
The SpineMED® is a multi-function Hi-Lo traction table designed to apply distraction forces to a patient's spine (Lumbar and Cervical). The powered Hi-Lo adjustments of the table surface height are designed to provide easier loading and unloading of the patient on and off the table. Maximum lift capacity and weight bearing capacity is 4001bs.
The patient lies in a supine position on the table with the legs supported with a removable knee bolster. For increased comfort during the distraction, and to provide relaxed distraction of paraspinal tissue, an infrared heating pad is incorporated into the table surface directly beneath the lumbar area. This 12 Vdc infrared element can be turned on or off during the treatment.
The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the table with a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the table though pelvic restraints that are designed to capture and secure the patient's iliac crest.
The removable pelvic restraints are supplied in two sizes, to accommodate different patient sizes, and are removed from the table for patient loading. The pelvic restraints are adjusted laterally to fit patient's widths through an acme screw assembly incorporated into the tilting lower section. Turn handles are attached to the acme screw on either side of the table, and allow for uniform movement of the pelvic restraints together and apart, for an operator controlled comfortable fitting to the patient.
The table is a split-table design, whereby distraction tensions are applied to the patient through the pelvic restraints during the separation of the table. The lower table section is powered by a computer-controlled 24 VDC actuator, which separates the two table sections to a maximum of eight inches. The distraction tensions and rates are continuously monitored and measured by load cells, which transfer this information to the integrated computer. A similar setting is present for the cervical setup. On top half of the split-table a cervical unit is attached, which applies tension to the high end of the spine. This unit is controlled by a 24 VDC actuator, which is controlled by the main computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.
An incorporated battery backup system provides adequate system power to continue full operation of the SpineMED® in event of power failure, allowing safe continuation of treatment session. For safety, the patient is provided with an electrical hand-held patient safety switch, which when depressed, immediately interrupts the treatment session and gradually eliminates the application of force to zero under a controlled rate. A secondary safety device incorporates a mechanicallyoperated buckle for the upper harness, which the patient can control its release by simply pulling a switch integrated in the side of the table. The switch releases all distraction forces to the patient.
All treatment parameters and data are captured on the LCD screen and can be printed out to a printer and are stored electronically in the database. There are no new potential flammable materials used in the S200B/C. All material remain the same as the original 510k submission of the S100A(K030060).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar and Cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician prescribed treatment, Prescription Use
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)
A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the SpineMED S200B/C product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices.
Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met. Testing is in accordance to the 'SpineMED Test Procedure Checklist' prior to any production units shipped to the end customer.
The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards. The SpineMED S200B/C system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for ERT Health Sciences, LLC, with the letters "ERT" inside of a circle with an arrow. The text "Health Sciences, LLC" is to the right of the logo. The date "APR 27 2005" is in the upper right corner of the image.
510(k) Summary of Safety and Effectiveness
| Company Name: | CERT HEALTH SCIENCES, LLC
10440 Little Patuxent Parkway, #300
Columbia, Maryland 21044
Telephone: (866) 990-4444
Fax: (866) 990-4445 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Tim Emsky
CERT HEALTH SCIENCES, LLC
Telephone: 1-866-990-4444
Fax: 1-866-990-4445
Email: [emsky@certhealthsciences.com] |
| Date of Summary: | January 28, 2005 |
| Trade Name: | SpineMED® S200B/S200C |
| Common Name: | Powered Traction Equipment |
| Classification Name: | Powered Traction Equipment |
| Class and Reference: | Class II (21 CFR Section 890.5900) |
| Product Code: | ITH |
| Panel Code: | 87ORS |
| Regulation Number: | 890.5900 |
Predicate Devices:
We are making the claim that the SpineMED® S200B/S200C is substantial equivalent to the predicated devices listed in the chart below.
| LEGALLY
MARKETED
PREDICATE DEVICE | MANUFACTURE
NAME | REGULATORY
CLASS AND
PRODUCT
CODE | 510(K)
REGISTRATION
NUMBER |
|-----------------------------------------|------------------------|--------------------------------------------|----------------------------------|
| 3D Activetrac | The Saunders
Group- | Class II/ITH | K001712 |
| DRX5000 | AXIOM USA Inc | Class II/ITH | K023160 |
The rationale of declaring the SpineMED S200B/C is substantial equivalent to the above 2 predicate devices are based on the following:
1
- Same Indications for use: All systems provide treatments for relief of pain associated with > low back pain, neck pain and sciatica. The treatment consists of a physician prescribed treatment period in which static, intermittent, and cycling distraction forces are applied to relieve pressures on structures that are causing low back pain, neck pain and sciatica.
- Similar key design technical characteristics- Multi-function table designed to applied > distraction forces and controlled by a computer console.
-
Same/similar components for treatment and measurement.
- Similar size, power source, and performance
Device Description:
The SpineMED® is a multi-function Hi-Lo traction table designed to apply distraction forces to a patient's spine (Lumbar and Cervical). The powered Hi-Lo adjustments of the table surface height are designed to provide easier loading and unloading of the patient on and off the table. Maximum lift capacity and weight bearing capacity is 4001bs.
The patient lies in a supine position on the table with the legs supported with a removable knee bolster. For increased comfort during the distraction, and to provide relaxed distraction of paraspinal tissue, an infrared heating pad is incorporated into the table surface directly beneath the lumbar area. This 12 Vdc infrared element can be turned on or off during the treatment.
The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the table with a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the table though pelvic restraints that are designed to capture and secure the patient's iliac crest.
The removable pelvic restraints are supplied in two sizes, to accommodate different patient sizes, and are removed from the table for patient loading. The pelvic restraints are adjusted laterally to fit patient's widths through an acme screw assembly incorporated into the tilting lower section. Turn handles are attached to the acme screw on either side of the table, and allow for uniform movement of the pelvic restraints together and apart, for an operator controlled comfortable fitting to the patient.
The table is a split-table design, whereby distraction tensions are applied to the patient through the pelvic restraints during the separation of the table. The lower table section is powered by a computer-controlled 24 VDC actuator, which separates the two table sections to a maximum of eight inches. The distraction tensions and rates are continuously monitored and measured by load cells, which transfer this information to the integrated computer. A similar setting is present for the cervical setup. On top half of the split-table a cervical unit is attached, which applies tension to the high end of the spine. This unit is controlled by a 24 VDC actuator, which is controlled by the main
2
Image /page/2/Picture/1 description: The image shows the logo for "Health Sciences, LLC". The logo consists of a stylized letter "C" that wraps around the letters "ERT". To the right of the logo is the text "Health Sciences, LLC" in a simple, sans-serif font. The logo is clean and professional, suggesting a company in the healthcare or scientific field.
computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.
An incorporated battery backup system provides adequate system power to continue full operation of the SpineMED® in event of power failure, allowing safe continuation of treatment session. For safety, the patient is provided with an electrical hand-held patient safety switch, which when depressed, immediately interrupts the treatment session and gradually eliminates the application of force to zero under a controlled rate. A secondary safety device incorporates a mechanicallyoperated buckle for the upper harness, which the patient can control its release by simply pulling a switch integrated in the side of the table. The switch releases all distraction forces to the patient.
All treatment parameters and data are captured on the LCD screen and can be printed out to a printer and are stored electronically in the database. There are no new potential flammable materials used in the S200B/C. All material remain the same as the original 510k submission of the S100A(K030060).
Indications for Use:
The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Summary of Performance Testing:
A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the SpineMED S200B/C product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices.
Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met. Testing is in accordance to the 'SpineMED Test Procedure Checklist' prior to any production units shipped to the end customer.
The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards. The SpineMED S200B/C system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified
Conclusion:
As stated above, CERT Health Sciences's conclusion is that the SpineMED S200B/C is safe and effective and complies with the appropriate medical standards and is substantially equivalent to the above identified predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2005
ﯿﻢ
CERT HEALTH SCIENCES, LLC c/o Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newton, Connecticut 06470
Re: K051013
Trade/Device Name: SpineMED® S200B/S200C Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: April 14, 2005 Received: April 21, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section > Fo(x) prematice is substantially equivalent (for the indications felerenced above and nave decemined we are and a marketed predicate devices marketed in interstate for use stated in the encrosure) to regars names date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enated with the provisions of the Federal Food, Drug, devices mall have been reclassified in acceracy of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, mercrore, market the devices, equirements for annual registration, listing of general controls provisions of the Free Hebeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of D may be subject to sach additional controller Lineang of Shipany of Sheen of Sheep. In addition, FDA may be found in the Cour of Peach Boncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dris issuated on a device complies with other requirements of the Act that TDA has made a dolormination as administered by other Federal agencies. You must of any Federal statutes and regalations and limited to: registration and listing (21 comply with an the Act 31equirements, n.c., and manufacturing practice requirements as set CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -- Mr. Thomas Borsai
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin mancing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dev premarket nothication. The PDA midning of backlands of 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 Patt 801), please If you desire specific advice for your ac not on one one note the regulation entitled, contact the Office of Compliance at (210) 276 - 16 - 16 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 " Misbranding by reference to premance notifications in the Act from the Division of Small
on of Small other general information on your responsion in total free number (800) 638-2041 or 1941)
Manufacturers, International and Consumer Assistance at its to blind as thind Manufacturers, International and Consumer Assistance article of the new carbindex.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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Indications for Use
510(k) Number (if known):
Device Name:
SpineMED® S200B/S200C
Indications For Use:
The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or row unling discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Office Dental, Restorative |
| Dental, Herrological Devices |
| K051013 |
Proprietary to Cert Health Sciences LLC