(70 days)
The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.
The provided text describes a 510(k) summary for the "Impulse iQ Adjusting Instrument" and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on providing a detailed clinical study demonstrating the device's efficacy against specific acceptance criteria.
Therefore, the information required to populate most of the requested sections (e.g., acceptance criteria, test set details, ground truth, MRMC study, training set) is not present in the provided text.
Here's what can be extracted based on the given document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. | Produces approximately 100 N, 200 N, and 400 N on its low, medium, and high force settings, respectively. |
| Pulse rate varies between 4-12 Hz. |
Note: The document states "Performance Standards: None known established." This indicates that the device was not evaluated against predefined formal performance standards or acceptance criteria. The performance data provided are descriptive measurements of the device's output.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document describes mechanical testing of the device's force and pulse rate, not a study involving a test set of data (e.g., patient data or images).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth establishment by experts for a test set is not relevant to the mechanical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are not relevant to the mechanical testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a chiropractic adjusting instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical chiropractic adjusting instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the mechanical performance data, the "ground truth" would be the direct measurement of force and pulse rate using calibrated equipment, not expert consensus or clinical outcomes.
8. The sample size for the training set
Not applicable/Not provided. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. This device does not involve machine learning or a training set.
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| 510(k) Summary | K080261 | APR 11 2008 | ||
|---|---|---|---|---|
| Device Name: | Impulse iQ Adjusting Instrument | |||
| Manufacturer: | Neuromechanical Innovations, LLC11011 S. 48th St., Suite 205Phoenix, AZ 85044 | |||
| Contact: | Christopher J. Colloca, D.C.Phone: 480-785-8442Fax: 480-785-3916Email: DrC100@aol.com | |||
| Trade Name(s): | Impulse iQ Adjusting Instrument or Impulse iQ | |||
| Common or Usual Name: | Chiropractic Adjusting Instrument | |||
| Product Code: | LXM | |||
| Classification Name: | Manipulator, Plunger-like Joint | |||
| Classification: | Unclassified | |||
| Predicate Devices forSubstantial Equivalence: | K023462 | Impulse Adjusting Instrument | ||
| K930431 | Arthrostim Manipulator | |||
| K973914 | FRAS, Sense Technology, Inc. | |||
| K003185 | Full Spectrum Activator III | |||
| K010851 | Harrison Hand Held Adjusting Instrument | |||
| Panel: | Physical Medicine |
Performance Standards: None known established
The Impulse iQ Adjusting Instrument has been mechanically tested Performance Data: and found to produce approximately 100 N, 200 N, and 400 N on its low, medium, and high force settings respectively. Total peak force output is also dependent upon operator preload. The pulse rate varies between 4-12 Hz.
Device Description & Specifications: The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.
Intended Use: The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
APR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuromechanical Innovations, LLC % Christopher J. Colloca, D.C. 11011 S. 48th Street, Suite 205 Phoenix, Arizona 85044
Re: K080261 Trade/Device Name: Impulse iQ Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: March 20, 2008 Received: March 25, 2008
Dear Dr. Colloca:
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 (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. 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
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Page 2 - Christopher J. Colloca, D.C.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240)- 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240)- 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K080261
Impulse iQ Adjusting Instrument Intended Use:
The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
Prescription Use
Over-The-Counter Use_
(Part 21 CFR801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Order for mxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K080261
N/A