Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on automated mechanical motion and does not mention any computational analysis, learning, or adaptive capabilities. The performance studies evaluate the clinical efficacy of the stimulation procedure itself, not the performance of any AI/ML algorithm.

Therapeutic

Yes
The device is intended for "symptomatic relief of tension-type headache of myofascial origin" and is used as "part of a treatment regimen" for "Intramuscular stimulation," indicating its therapeutic purpose.

Diagnostic

No

The device is described as an "Automatic Intramuscular Stimulator Device" and its intended use is for "Intramuscular stimulation" and "Symptomatic relief of tension-type headache of myofascial origin," which are therapeutic applications, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a main control unit, a hand-held motor unit, and an AC power supply adapter, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are 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).
Device Function: The AIS100 Automatic Intramuscular Stimulator Device is used to administer intramuscular stimulation (dry needling) directly into the body. It is a therapeutic device, not a diagnostic one.
Intended Use: The intended use is for intramuscular stimulation and symptomatic relief of tension-type headache, which are therapeutic applications.
Device Description: The description details a device that automates the physical act of inserting and moving a needle within the muscle, which is a direct treatment method.

Therefore, the AIS100 is a therapeutic device used for treatment, not a diagnostic device used for testing specimens outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DY Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for

1. Intramuscular stimulation
1. Symptomatic relief of tension-type headache of myofascial origin

Product codes (comma separated list FDA assigned to the subject device)

NRW

Device Description

The AIS 100 is an intramuscular stimulator device that aids administering of intramuscular stimulation (or dry needling) for treatment. The device produces an automated forward and backward motion of a needle at a constant speed, which replaces the manual stroking of a needle when rendering the intramuscular stimulation (or dry needling) treatment. This enables the practitioner to administer the intramuscular stimulation treatment effectively with less physical effort when compared to the manual method. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Human clinical studies were conducted using the AIS100 Automatic Intramuscular Stimulator device to demonstrate the safety of the subject device and the intramuscular stimulation procedure in treating chronic or recurrent pain by measuring any and all adverse effects of the procedure administered using the subject device.

To demonstrate the efficacy of the intramuscular stimulation (IMS) procedure using the AIS100 in the treatment of chronic or recurrent pain, particularly the tension-headache, efficacy was measured in terms of pain recurrence and pain relief using a pain scale and range of motion of the cervical spine. The impact upon quality of life was also evaluated using the pain disability index.

A prospective study of 28 individuals with tension-type headaches of at least 2 months' duration was conducted. Patients had received various other forms of treatment or no treatment at all before entering the study. The patients received a total of five treatments over a 10 week period, with each treatment consisting of myofascial release therapy (15 mins), IMS treatment using the AIS100 (30-45 mins), hot packs (10 mins), and AquaMED (15 mins). After the first treatment, 71.4% of the patients experienced relief for 72 hrs or more, and after two treatments, 64.3% of patients experienced a 50% decrease in their level of pain. Flexion, extension, and lateral flexion range of motion improvements were also statistically significant after five treatments. Finally, patients experienced a statistically significant improvement in all seven categories of the pain disability/lifestyle index. No adverse effects have been observed.

The IMS technique using the Automatic Intramuscular Stimulator device AIS100 appears to be an effective treatment for relieving the pain associated with tension-type headaches.

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.

K024207

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.

K973442

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

Regulation Number and Section

§ 880.5580 Acupuncture needle.

(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.

Summary

0

K040580 '93

AUG 2 6 2004 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K040580

1. Submitter's Identification:

D.Y. Instrument, Inc. 30 Manning Lane Cherry Hill, NJ 08003

Contact: Dr. Young H. Lee, President

Date Summary Prepared: May 30, 2004

2. Name of the Device:

AIS100 Automatic Intramuscular Stimulator

3. Predicate Device Information:

K024207, Vinco Brand Acupuncture Needle

4. Device Description:

The AIS 100 is an intramuscular stimulator device that aids administering of intramuscular stimulation (or dry needling) for treatment. The device produces an automated forward and backward motion of a needle at a constant speed, which replaces the manual stroking of a needle when rendering the intramuscular stimulation (or dry needling) treatment. This enables the practitioner to administer the intramuscular stimulation treatment effectively with less physical effort when compared to the manual method. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.

5. Intended Use:

The DY Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for

1. Intramuscular stimulation
1. Symptomatic relief of tension-type headache of myofascial origin

1

Ko 40580

27

6. Comparison to Predicate Devices:

The needle used with the AIS100, the TECA EMG needle (K973442), is equivalent to the predicate, Vinco Acupuncture Needle (K024707), in terms of physical dimension - diameter, length, and tip shape; and material of construction - stainless-steel. Both needles are FDA-cleared, supplied in sterile packages, and have handles for manual handling. The needling technique used with the AIS100 is equivalent to one of the needling techniques used with the predicate device in the practice of acupuncture in terms of initial insertion method, the use of short multiple strokes, the shortness of stroke length, and the needling termination method.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Non-clinical performance testing included:

· IEC 60601-1
· IEC 60601-1-2

8. Discussion of Clinical Tests Performed:

Human clinical studies were conducted using the AIS100 Automatic Intramuscular Stimulator device to demonstrate the safety of the subject device and the intramuscular stimulation procedure in treating chronic or recurrent pain by measuring any and all adverse effects of the procedure administered using the subject device.

To demonstrate the efficacy of the intramuscular stimulation (IMS) procedure using the AIS100 in the treatment of chronic or recurrent pain, particularly the tension-headache, efficacy was measured in terms of pain recurrence and pain relief using a pain scale and range of motion of the cervical spine. The impact upon quality of life was also evaluated using the pain disability index.

A prospective study of 28 individuals with tension-type headaches of at least 2 months' duration was conducted. Patients had received various other forms of treatment or no treatment at all before entering the study. The patients received a total of five treatments over a 10 week period, with each treatment consisting of myofascial release therapy (15 mins), IMS treatment using the AIS100 (30-45 mins), hot packs (10 mins), and AquaMED (15 mins). After the first treatment, 71.4% of the patients experienced relief for 72 hrs or more, and after two treatments, 64.3% of patients experienced a 50% decrease in their level of pain. Flexion, extension, and lateral flexion range of motion improvements were also statistically significant after five treatments. Finally, patients experienced a statistically significant improvement in all seven categories of the pain disability/lifestyle index. No adverse effects have been observed.

The IMS technique using the Automatic Intramuscular Stimulator device AIS100 appears to be an effective treatment for relieving the pain associated with

2

tension-type headaches.

K040580$^{373}$

9. Conclusions:

The AIS100 Automatic Intramuscular Stimulator has similar intended uses and similar characteristics as the predicate device. Moreover, bench testing contained in this submission and human clinical testing supplied demonstrate that any differences in their technological characteristics or modes of operations do not raise any new questions of safety or effectiveness. Thus, the AIS100 Automatic Intramuscular Stimulator is substantially equivalent to the predicate device.

3

Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Dr. Young H. Lee President D. Y. Instrument, Incorporated 30 Manning Lane, Cherry Hill, New Jersey 08003

Re: K040580

Trade/Device Name: AIS100 Automatic Intramuscular Stimulator Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: NRW Dated: August 23, 2004 Received: August 24, 2004

Dear Dr. Lee:

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.

4

Page 2 - Dr. Lee

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.

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 (301) 594-4618. 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,

Siva Ruone
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

K040580

Exhibit B

Page 1

510(k) Number (if known): K040580

Device Name: AIS100 Automatic Intramuscular Stimulator

Indications For Use:

The D.Y. Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for

1. Intramuscular stimulation
1. Symptomatic relief of tension-type headache of myofascial origin

Prescription Use _X

Over-The Counter Use

(Per 21 CFR 801 Subpart D)

OR (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

13v (Division Sign-Off) (Division of Anesthesiology, General Hospital, Division Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________