(116 days)
Not Found
No
The description focuses on electromechanical components and operational modes without mentioning any AI/ML algorithms or data processing for decision-making.
Yes
The device is described as being for "adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine," which are therapeutic actions aimed at treating or alleviating a condition.
No
The device is described as an instrument for adjustment, mobilization, or manipulation of musculoskeletal joints, which are therapeutic actions, not diagnostic ones. Its function involves transmitting force to the spine, not gathering information about a patient's condition.
No
The device description explicitly details hardware components such as a handheld electromechanical device, handset, console, pistons, valves, PCB, and power supply.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ASMI Function: The Advanced Spinal Mobilization Instrument (ASMI) is a physical device used for the external manipulation of musculoskeletal joints. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine." This is a physical intervention, not a diagnostic test.
- Device Description: The description details a mechanical device with pistons, valves, and air pressure, all related to physical force application, not sample analysis.
Therefore, based on the provided information, the ASMI is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional.
Product codes (comma separated list FDA assigned to the subject device)
LXM
Device Description
The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical The Advanced Spinal Hoomobilize, or manipulate the musculoskeletal joints of the spine. The motions assure assure as a licensed health care professional. Because manual spinal device is intended for ass of the ASMI gives the licensed health care professional the moontanton is diffreent spinal mobilization with a handheld electromechanical device.
The device operates in three distinct modes. The introductory mode initiates a therapy session The device operated in the touch and feel of the instrument. The mobilization mode is and accrimatizes the patient to me actions of a physical therapist's hands performing spinal mobilization. The recovery mode is used between the mobilization treatments to lightly massage the paraspinal area and promote a soothing feeling of well-being.
The system incorporates a handset connected to a console. The handset consists of a metal body The system moorporates a ing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon and printThe system is designed for standard connection to a compressed air source.
The equipment is manufactured to the highest possible standards and is failsafe, i.e., if it r no oquipment is malling the seases to operate. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
musculoskeletal joints of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care professional.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023462, K003185, K021238, K962239
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Advanced Spinal Technologies, Inc.
. #
433 Plaza Real. Suite 255 Boca Raton, Florida 33432 Phone: (561) 886-3224 • Facsimile: (561) 886-3244
'JUN 1 4 2005
510(k) Summary Advanced Spinal Mobilization Instrument (ASMI)
| Date of Preparation: | February 14, 2005 |
|---|---|
| Submitter: | Advanced Spinal Technologies, Inc. |
| 433 Plaza Real, Suite 255 | |
| Boca Raton, Florida 33432 | |
| Contact: | Jeffrey R. Perelman, M.D. |
| Phone: (561) 338-9700 | |
| Fax: (561) 338-9780 | |
| E-Mail: jperelman@advancedspinaltech.com | |
| Specification developer: | Alteristic Instruments Limited |
| 66 Lemon Street | |
| Truro, Cornwall TR1 2PN | |
| United Kingdom | |
| Contract manufacturer: | SMC Pneumatics (UK) Ltd. |
| Vincent Avenue | |
| Crownhill, Milton Keynes MK8 OAN | |
| United Kingdom | |
| Trade Name: | Advanced Spinal Mobilization Instrument (ASMI) |
| Common Name: | Adjusting or Joint Mobilization Instrument |
| Classification Name: | Plunger-Like Joint Manipulator |
| Intended Use: | Adjustment, mobilization, or manipulation of the musculoskeletal |
| joints of the spine by a licensed health care professional. | |
| Predicate Devices: | K023462 – Impulse™ Adjusting Instrument |
| K003185 – Full Spectrum Activator® III | |
| K021238 - Frye Adjusting Instrument | |
| K962239 - Smart Adjuster Adjusting or Joint Mobilization |
2
page 1 f 3
1
| Establishment
| Registration Number: | 3005096823 |
|---|---|
| Regulatory Class: | Unclassified |
| Product Code: | LXM |
| Panel: | Physical Medicine |
| Performance Standards: | None known established |
Device Description & Specifications:
The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical The Advanced Spinal Hoomobilize, or manipulate the musculoskeletal joints of the spine. The motions assure assure as a licensed health care professional. Because manual spinal device is intended for ass of the ASMI gives the licensed health care professional the moontanton is diffreent spinal mobilization with a handheld electromechanical device.
The device operates in three distinct modes. The introductory mode initiates a therapy session The device operated in the touch and feel of the instrument. The mobilization mode is and accrimatizes the patient to me actions of a physical therapist's hands performing spinal mobilization. The recovery mode is used between the mobilization treatments to lightly massage the paraspinal area and promote a soothing feeling of well-being.
The system incorporates a handset connected to a console. The handset consists of a metal body The system moorporates a ing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon and printThe system is designed for standard connection to a compressed air source.
The equipment is manufactured to the highest possible standards and is failsafe, i.e., if it r no oquipment is malling the seases to operate. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.
Substantial Equivalence Comparison:
The Advanced Spinal Mobilization Instrument (ASMI) is substantially equivalent to other FDA listed and 510(k) cleared hand-held chiropractic adjusting/mobilization instruments. Specifically, the ASMI has the same intended use and similar technological characteristics as the above-listed devices. All of these devices are used by licensed professionals to impart or transmit controlled force to musculoskeletal joints as part of the practice of physical therapy, chiropractic medicine, and related professional fields. While substantially equivalent to the identified predicate devices in their totality, the ASMI is similar to, for example, the Impulse
3
Page 2 of 3
2
Image /page/2/Picture/0 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K050428'. The characters are written in a simple, slightly irregular style, typical of handwriting.
(K023462) fitted with the dual stylus attachments. The Smart Adjuster (K962239) is also available with a dual prong attachment. Additionally, while all means of activating the impact force are substantially equivalent, the Frye Adjusting Instrument (K021238) is, like the ASMI device, activated pneumatically.
A comparison of the technological characteristics of the current device and the predicate devices is set forth in the chart below.
Comparison Chart:
| Feature | ASMI | Impulse | Activator III | Smart
Adjuster | Frye |
|------------------------------------------------------------------|------|---------|---------------|-------------------|------|
| Indicated for
adjustment and
mobilization of
the spine? | Yes | Yes | Yes | Yes | Yes |
| Hand held
adjusting
device? | Yes | Yes | Yes | Yes | Yes |
| Adjustable
impact force? | Yes | Yes | Yes | Yes | Yes |
| Silicone rubber
body contact
member? | Yes | Yes | Yes | N/A | Yes |
| Activated
pneumatically? | Yes | No | No | N/A | Yes |
| More than one
body contact
member
available? | Yes | Yes | No | Yes | No |
N/A = information not available
page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2005
Jeffrey R. Perelman, M.D. President Advanced Spinal Technologies, Inc. 433 Plaza Real, Suite 255 Boca Raton, Florida 33432
Re: K050428
Trade/Device Name: Advanced Spinal Mobilization Instrument (ASMI) Regulatory Class: Unclassified Product Code: LXM Dated: June 9, 2005 Received: June 10, 2005
Dear Dr. Perelman:
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.
4
Page 2 -- Jeffrey R. Perelman, M.D.
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,
A. Hup E. Elurde
Miriam C. Provost, Ph.D.
Miriam C. Provost. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K050428
Device Name: Advanced Spinal Mobilization Instrument (ASMI)
The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, Indications for Use: mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. I
Concurrence of
Atut. Qurlis
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K050428
page 1 of 1