(174 days)
No
The device description focuses on mechanical and pneumatic activation for chiropractic adjustments, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for chiropractic adjustment of the spine and extremities to facilitate spinal manipulative therapy, which is a therapeutic intervention.
No
The device is described as an "adjusting instrument" for "chiropractic adjustment of the spine and extremities" and "spinal manipulative therapy." Its purpose is to deliver a physical manipulation, not to diagnose a condition.
No
The device description clearly describes a physical instrument ("shaped in a 'gun-like' configuration," "activated pneumatically by a simple push-button") used for chiropractic adjustment, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Frye Adjusting Instrument Function: The Frye Adjusting Instrument is used for chiropractic adjustments, which are physical manipulations of the spine and extremities performed on the patient's body. It does not involve testing any specimens taken from the body.
The description clearly indicates it's a tool for physical therapy/manipulation, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Frye Adjusting Instrument is intended for chiropractic adjustment of the spine and extremities.
Product codes
LXM
Device Description
The Frye Adjusting Instrument is a chiropractic, adjusting instrument for use in spinal manipulative therapy. The Frye Adjusting Instrument is a modification of the Full Spectrum Activator® III Adjusting Instrument developed to offer easier use to those chiropractors that have limited strength or dexterity in their hands. Typically, these are chiropractors that have arthritis, age-related problems, or have a physical disability of their upper extremity. Thus, these chiropractors have difficulties using currently available adjusting instruments. The main differences between currently available adjusting instruments, such as the FS Activator® III, and the Frye adjusting instrument are that the Frye adjusting instrument is activated pneumatically by a simple push-button and it is shaped in a 'gun-like' configuration rather than a 'plunger-like' configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
chiropractors
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
Bench data performed by an independent laboratory compared the Frye Adjusting Instrument to the FS Activator® III. Results indicated that both devices produce similar peak dynamic loads at minimum, mid, and maximum settings.
Key Metrics
Not Found
Predicate Device(s)
FS Activator® III, K003185
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
02/1238
| OCT 09 2002
510(k) Summary
| Frye Adjusting Instrument page 1 of 2 | ||
|---|---|---|
| Manufacturer: | Frye Health Systems Inc | |
| 3126 S. Garnett Road, Suite H | ||
| Tulsa, OK 74146 | ||
| Contact: | Bruce Frye, D.C. | |
| 918-665-0036 | ||
| Trade name: | Frye Adjusting Instrument | |
| Common name: | chiropractic adjusting device | |
| Classification name: | Plunger-like joint manipulator | |
| Substantial equivalence: | FS Activator® III, K003185 | |
| Activator Methods, Phoenix, Arizona |
Intended Use:
The Frye Adjusting Instrument is intended for chiropractic adjustment of the spine and extremities.
Device Description:
The Frye Adjusting Instrument is a chiropractic, adjusting instrument for use in spinal manipulative therapy. The Frye Adjusting Instrument is a modification of the Full Spectrum Activator® III Adjusting Instrument developed to offer easier use to those chiropractors that have limited strength or dexterity in their hands. Typically, these are chiropractors that have arthritis, age-related problems, or have a physical disability of their upper extremity. Thus, these chiropractors have difficulties using currently available adjusting instruments. The main differences between currently available adjusting instruments, such as the FS Activator® III, and the Frye adjusting instrument are that the Frye adjusting instrument is activated pneumatically by a simple push-button and it is shaped in a 'gun-like' configuration rather than a 'plunger-like' configuration.
1
page 2 of 62
Comparison to predicate device:
Like the FS Activator® III, the Frye Adjusting Instrument is a manual hand-held chiropractic adjusting device which provides a repeatable force and displacement to the spine and extremities when activated. Both devices have a precision force setting feature and a silicone rubber body contact member. See Table 1 below for a comparison of the Frye Adjusting Instrument and the FS Activator® III.
| | FS Activator® III | Frye Adjusting
Instrument |
|--------------------------------------------------------|-------------------|-----------------------------------|
| Indicated for chiropractic adjustment of the
spine? | Yes | Yes |
| Hand held adjusting device? | Yes | Yes |
| Impact force delivered by spring energy? | Yes | Yes |
| Adjustable impact force? | Yes | Yes |
| Silicone rubber body contact member? | Yes | Yes |
| Precision operating force setting? | Yes | Yes |
| Spring activated directly by chiropractor? | Yes | No, is activated
pneumatically |
Table 1. Substantial Equivalence Comparison
Summary of data upon which substantial equivalence was based:
Bench data performed by an independent laboratory compared the Frye Adjusting Instrument to the FS Activator® III. Results indicated that both devices produce similar peak dynamic loads at minimum, mid, and maximum settings.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 7002
Frye Health Systems c/o Ms. Deborah F. Koeneman Regulatory Consultant 2751 East Hale Street Mesa, Arizona 85213
Re: K021238
Trade/Device Name: Frye Adjusting Instrument Regulation Number: n/a Regulation Name: n/a Regulatory Class: unclassified Product Code: LXM Dated: August 14, 2002 Received: August 15, 2002
Dear Ms. Koeneman;
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 reguirements 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.
3
Page 2 - Ms. Deborah F. Koeneman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stypt Rurler
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Frye Adjusting Instrument Premarket Notification
Indications for Use Enclosure
510(k) Number: K011238
Device Name: _________________________________________________________________________________________________________________________________________________________________ Frye Adjusting Instrument
Indications for Use: The Frye Adjusting Instrument is indicated for chiropractic adjustment of the spine and extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
| (Per 21 CFR 801.109) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K021238 |
|---|---|
| Over-the Counter Use |