SPINEMED S200B/S200C

{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<br>10440 Little Patuxent Parkway, #300<br>Columbia, Maryland 21044<br>Telephone: (866) 990-4444<br>Fax: (866) 990-4445 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mr. Tim Emsky<br>CERT HEALTH SCIENCES, LLC<br>Telephone: 1-866-990-4444<br>Fax: 1-866-990-4445<br>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<br>MARKETED<br>PREDICATE DEVICE | MANUFACTURE<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT<br>CODE | 510(K)<br>REGISTRATION<br>NUMBER | |-----------------------------------------|------------------------|--------------------------------------------|----------------------------------| | 3D Activetrac | The Saunders<br>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 Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white. 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}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for ERT Health Sciences, LLC. The logo consists of the letters "ERT" inside of a circle. To the right of the logo is the text "Health Sciences, LLC". # 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