(302 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and electrical components and their physical effects, with no mention of AI/ML technologies or data processing for decision-making.
Yes
The device is intended to assist in making a chiropractic adjustment to the atlas vertebrae, with the objective of moving the Atlas toward its proper alignment. This function is a therapeutic intervention aimed at treating a physical condition.
No
The device is described as an instrument to deliver a chiropractic adjustment, with the objective of moving the Atlas toward proper alignment. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like a Chiropractic Adjusting Table, a support system, a percussion device, a solenoid, and a stylus. The performance studies also include testing related to physical aspects like electromagnetic immunity, acoustic pressure, and force imparted by the solenoid. This indicates it is a hardware device with mechanical and electrical components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Spinalight Atlas Percussion Instrument is a physical device used by a chiropractor to directly apply force to a patient's atlas vertebrae. It does not involve testing any samples from the body.
- Intended Use: The intended use is to assist in making a chiropractic adjustment, which is a physical manipulation.
The description clearly indicates a device for physical manipulation and adjustment, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
Product codes
LXM
Device Description
The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atlas vertebrae (C-1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed Chiropractor
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)
The Atlas Percussion Adjustment Instrument C-1000 was tested and compared to the predicate device in a number of areas. The changes made in the Atlas Percussion Adjustment Instrument C1000 do not affect the safety of the device. This conclusion is based on the following verification/performance tests having been completed:
- Electromagnetic Immunity Testing of the Atlas C-1000 to radiated Radio-Frequency (RF) Emissions from RF transmitters
- Testing to measure and calculate the acoustic pressure transmitted from the stylus of the Atlas C-1000
- Testing to measure the force imparted by the solenoid to the stylus of the Atlas C-1000
- Patient positioning and adjustment tests.
- EMC and Electrical Safety Testing
In addition, a Risk analysis was prepared to include consideration of the above changes.
Based on the results of the performance testing it has been determined that the Atlas Percussion Adjusting Instrument is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 26, 2018 Spinalight, Inc Stanford Pierce President 6721 23rd Street North St. Petersburg, Florida 33702
Re: K172536
Trade/Device Name: Atlas Percussion Adjusting Instrument, Model C-1000 Regulatory Class: Unclassified Product Code: LXM Dated: May 24, 2018 Received: May 29, 2018
Dear Stanford Pierce:
This letter corrects our substantially equivalent letter of June 20, 2018.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2018.06.26 12:41:48 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172536
Device Name
Atlas Percussion Adjusting Instrument Model C-1000
Indications for Use (Describe)
The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K172536 (as required by 807.92)
I. SUBMITTER
Spinalight, Inc 6721 23rd Street North St. Petersburg, FL 33702 Contact Person: Dr. G. Stanford Pierce Email: award@ajwtech.com Date Prepared: 25 June 2018
II. DEVICE
Name of Device: Atlas Percussion Adjusting Instrument, Model C-1000 Common or Usual Name: Manipulator, Plunger-Like Joint Classification Name: Manipulator, Plunger-Like Joint Device Panel: Physical Medicine Regulatory Class: Unclassified Unclassified Reason: Pre-Amendment Product Code: LXM Regulation Number: None
III. PREDICATE DEVICE
Device: The Atlas Adjusting Instrument, Model 8000 Manufacturer: Spinalight, Inc 510(k) Reg. No: K946258 This predicate device has not been subject to a design-related recall. Regulatory Class: Unclassified Product Code: LXM No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the
4
patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.
V. INDICATIONS FOR USE
The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
VI. CONTRA-INDICATIONS
Do not use on:
-
- Fractures
-
- Bones incapable of bearing body weight due to pathological processes
-
- Osteoporosis
-
- Soft tissue including:
- a. Eyeball
- b. Testicles
- Mammary glands ﻥ
- d. Ovaries
- e. Auditory Canal
Contra-indications for the self-adjustment itself are:
The adjustment should not be attempted with a patient who has had neck or cervical or spinal surgery, or has infected or inflamed areas or open wounds near the cervical spine. Adequate precautions should be taken in cases of persons suspected or diagnosed with epilepsy.
VII. DEVICE MODIFICATIONS
The Atlas Percussion Adjusting Instrument Model C-1000 is an update of the Atlas Adjusting Instrument Model 8000. The differences are the following:
1. Table Shoulder Section from Fixed to Movable
Proper placement of the patient in the side posture position on the adjusting table produce mild biomechanical influences on the upper cervical articulations to affect a better outcome in the re-alignment of the atlas vertebra. The predicate device required the doctor to manually lift and reposition the patient's shoulders to get them in the proper position. The moveable shoulder section on the New Device activated by a 4-way joy stick, enables the doctor to make precise positioning changes of the patient. An electric drive motor was added to enable the clinician to adjust the shoulder section by use of the added joy stick. This is for ease of patient positioning and has no impact on safety or effectiveness.
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- Percussion Adjusting Head from Variable Wave Setting to Single Wave Setting 2. The New Device eliminates the un-used, variable settings, and uses one percussion setting.
-
- Percussion Head Actuator from Foot Pedal Activation to Push Button Activation The percussion head actuator on the predicate device was initiated by a foot pedal on the floor. The New Device has replaced the foot pedal with a push button mounted on the percussion head. This assists the doctor in maintaining his focus on the patient/instrument relationship during the adjustment of the atlas vertebra. The push button control also may help to reduce the possibility of the clinician inadvertently stepping on the foot pedal.
-
- Head Piece Tilt Adjustment from Push Button Control to Toggle Switch Control This action of setting the head piece tilt angle is important in stabilizing the patients head before and during the percussion atlas adjustment. The predicate device utilized a manual, screw-type mechanism for this purpose. The New Device provides a motor driven tilt mechanism which is activated by a self-centering toggle switch. This may help the doctor to simultaneously observe the patient and the tilt positioning of the head piece while it is being adjusted. An electric drive motor was added to enable the clinician to adjust the head piece tilt section by use of the added self-centering toggle switch for patient positioning, which has no impact on safety or effectiveness.
-
- Table Top Pad from 1" Thick to 2.5" thick
Since the establishment of the original 510K for the predicate device, there has been substantial improvement in the quality and durability of foam rubber padding. The New Device will incorporate a 2.5-inch marine foam padding which affords greater comfort to the patient without compromising the efficiency of the device in its intended purpose. The pad change was only for patient comfort and is the most standard table top pad in use for chiropractic tables currently.
-
- Vertical Table Lift
The original 510K predicate device was built on a 4-legged, stationary table base. The New Device incorporates a lift mechanism which can vary the table top height from approximately 26 inches to 35 inches. This is most beneficial for wheelchair users as well as those with ambulatory difficulties. This modification is solely for patient accessibility and has no influence on the purpose nor the effectiveness of the percussion adjusting device. This is now a standard chiropractic table as the vertical lift has become a normal and not custom modification.
- Vertical Table Lift
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- VIII. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following table lists the technological characteristics for the new device vs the predicate device.
| Characteristic | Predicate Device K946258 | New Device (C-1000) | |
|---|---|---|---|
| Indications for Use | The Spinalight Atlas | ||
| Percussion Instrument is to be | |||
| used by a licensed | |||
| Chiropractor to assist in | |||
| making a Chiropractic | |||
| adjustment to the atlas | |||
| vertebrae. This adjustment is | |||
| indicated when the doctor | |||
| believes this bone to be out of | |||
| alignment. | The Spinalight Atlas | ||
| Percussion Instrument is to be | |||
| used by a licensed | |||
| Chiropractor to assist in | |||
| making a Chiropractic | |||
| adjustment to the atlas | |||
| vertebrae. This adjustment is | |||
| indicated when the doctor | |||
| believes this bone to be out of | |||
| alignment. | |||
| Table width | 24" | 24" | |
| System overall length | Approx. 100" | Approx. 100" | |
| System weight | Approx. 300 lbs. | Approx. 300 lbs. | |
| Table Shoulder Section | Fixed | Movable | |
| Floor and Head Protractor for | |||
| positioning | Yes | Yes | |
| Fixed Stylus | Yes | Yes | |
| Percussion Adjusting Head | Variable Percussion Wave | ||
| Settings | Fixed Percussion Wave Setting | ||
| Percussion Actuator | Activated by Foot Pedal | Activated by Push Button | |
| Percussion Head Position Lock | Yes | Yes | |
| Power | 115 VAC | 115 VAC | |
| Device Vertical Adjustment | Electric vertical lift column | Electric vertical lift column | |
| Head Piece Vertical | |||
| Adjustment | Toggle Switch Control | Toggle Switch Control | |
| Head Piece Tilt Adjustment | Manual operated screw | ||
| control | Motorized | ||
| Table Pad | Approx. 1" thick | Approx. 2.5" thick | |
| Table Top | Vinyl covered | Vinyl covered | |
| Foot Rest Extender | Yes | Yes | |
| Vertical table lift | None | Yes |
The differences in characteristics between the subject and predicate device were implemented for convenience and comfort purposes. The differences do not change how the device is used nor do they adversely impact the safety or effectiveness of the device.
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IX. PERFORMANCE DATA
Summary of Testing:
The Atlas Percussion Adjustment Instrument C-1000 was tested and compared to the predicate device in a number of areas. The changes made in the Atlas Percussion Adjustment Instrument C1000 do not affect the safety of the device. This conclusion is based on the following verification/performance tests having been completed:
- Electromagnetic Immunity Testing of the Atlas C-1000 to radiated Radio-Frequency (RF) Emissions from RF transmitters
- Testing to measure and calculate the acoustic pressure transmitted from the stylus of the Atlas C-1000
- . Testing to measure the force imparted by the solenoid to the stylus of the Atlas C-1000
- Patient positioning and adjustment tests.
- EMC and Electrical Safety Testing ●
In addition, a Risk analysis was prepared to include consideration of the above changes.
Based on the results of the performance testing it has been determined that the Atlas Percussion Adjusting Instrument is substantially equivalent to the predicate.
X. CONCLUSIONS
By virtue of its intended use and physical and technological characteristics, the Atlas Percussion Adjustment Instrument C-1000 is substantially equivalent to the Spinalight Predicate device that has been cleared for marketing in the United States. The performance data shows that the Atlas Percussion Adjustment Instrument C-1000 is as safe and effective as the predicate device.