(365 days)
The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.
The Therapik is a small, portable, hand-held, battery-powered device equipped with a carrying wrist strap. It measures approximately 3cm x 10cm and weighs less than 4 ounces, including the 9 volt battery. The heat is initiated by use of a simple, non-locking, finger-or thumb-activated on/off switch. Heat is produced by pressing the switch. The Therapik device delivers 50 - 60°C heat directly on the user's skin. The user is instructed to apply the device for as long as the heat is comfortable on the skin (approximately 20 - 30 seconds).
Here's a breakdown of the acceptance criteria and study information for the Therapik® device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated: The documentation does not provide a formal table of pre-defined acceptance criteria with specific thresholds (e.g., "must achieve X% efficacy"). Instead, the performance is reported descriptively based on clinical findings.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Effectiveness (Pain Relief) | Demonstrate effective relief of pain from insect stings/bites. | Venezuela and France/Italy/Reunion Studies (N=69): - Total/complete disappearance of pain: 61/69 users - Distinct alleviation of pain: 7/69 users - Slight alleviation of pain: 1/69 users - Not effective: none Canadian Body-Pic Study (N=50, referenced): - Reported effective by all 50 users for a variety of stings and bites. |
| Effectiveness (Itching Relief) | Demonstrate effective relief of itching from insect stings/bites. | Venezuela and France/Italy/Reunion Studies (N=69): (Implied by overall effectiveness rating for "pain and inflammation" as "pain and itching" are grouped in the Indications for Use. Specific itching relief percentages are not broken out separately from pain.) Canadian Body-Pic Study (N=50, referenced): (Implied by overall effectiveness for stings and bites, which typically involve itching.) |
| Safety | No serious adverse effects related to device use. | No serious side effects related to the use of the Therapik were reported in the Venezuela and France/Italy/Reunion studies. |
| Operating Characteristics Comparability | Comparable Time/Temperature Profile and Maximum Operating Temperature to predicate devices. | Comparative performance testing was performed on the proposed Therapik device and the predicate National Health Care NH-202 device, establishing comparability of operating Time/Temperature Profile and Maximum Operating Temperature. Operating characteristics, recommended use time, operating temperature, and labeling were also compared to Li's Itch Stopper. (Specific data not provided, but comparability was established). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Therapik® Clinical Trials: 69 subjects (35 from Venezuela, 34 from France, Italy, and Reunion).
- Referenced Body-Pic Study: 50 subjects from Canada.
- Data Provenance: Prospective clinical trials. The Therapik trials were conducted in Venezuela, France, Italy, and Reunion. The referenced Body-Pic study was conducted in Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for the clinical effectiveness studies was based on the subjective self-reporting of the users themselves ("Each user was asked to rate the effectiveness of the device"). There were no external experts establishing ground truth in terms of diagnosis or outcome.
4. Adjudication Method for the Test Set
- None. Since the "ground truth" was subjective self-reporting by the individual users, there was no independent adjudication of their responses.
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
- Not Applicable. This device is a therapeutic heating device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes (effectively). The clinical studies describe the performance of the device used directly by individuals without the need for interpretation or intervention by a human expert in terms of its therapeutic effect. The "performance" is the device alone, applied by the user.
7. The Type of Ground Truth Used
- Subjective User-Reported Outcomes. The "ground truth" in the clinical studies was the users' subjective ratings of pain alleviation. This is a common method for assessing the effectiveness of devices for symptomatic relief where objective measures are difficult or less relevant than the patient's experience.
8. The Sample Size for the Training Set
- Not Applicable. This device relies on physical principles (heat application) and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training" of the device is its design and manufacturing to produce the specific thermal output.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As explained above, there is no "training set" in the context of AI/ML for this device. The design and validation of the thermal output would be based on engineering specifications and physical measurements, rather than a "ground truth" derived from clinical data in the same way an AI model's training set would be.
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August 19, 1997
Therapik®
NOV - 4 1997
K964397
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Thermolabile Technologies Corp. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." TTC chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Therapik® | ||
|---|---|---|---|
| Owner/Operator: | Thermolabile Technologies Corp.5407 Eglinton Avenue West, Suite 200Etobicoke, Ontario, Canada M9C 5K6 | ||
| Manufacturing Site: | Not yet determined | ||
| Device Generic Name: | Therapeutic heating device | ||
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II,Performance Standards (CFR 890.5500). | ||
| Predicate Devices: | Health Team Model 501500 Infrared Heater(Manufacturer unknown) | ||
| Model HT510-500 Infrared HeaterDistributed by:Graham Field, Inc.400 Rabro Drive, EastHauppauge, NY 11788 | |||
| Model NH-202 Infrared Heat LampDistributed by:National Health Care Equipment Inc.144 East Kingsbridge RoadMount Vernon, NY 10550 | |||
| Body Relaxer Infrared Heater and Massager(Manufacturer unknown)Distributed through the adaptAbility catalog (800-266-8856) | |||
| Li's Itch StopperHontech Foundation for Medical Technology402 Rindge Avenue, 17HCambridge, MA 02140K963824 |
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Product Description:
The Therapik is a small, portable, hand-held, battery-powered device equipped with a carrying wrist strap. It measures approximately 3cm x 10cm and weighs less than 4 ounces, including the 9 volt battery. The heat is initiated by use of a simple, non-locking, finger-or thumb-activated on/off switch. Heat is produced by pressing the switch. The Therapik device delivers 50 - 60°C heat directly on the user's skin. The user is instructed to apply the device for as long as the heat is comfortable on the skin (approximately 20 - 30 seconds).
Indications for Use:
The proposed Therapik device will be indicated for the temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.
Safety and Performance:
Comparative performance testing was performed on the proposed Therapik device and the predicate National Health Care NH-202 device to establish the comparability of the operating Time/Temperature Profile and the Maximum Operating Temperature of the two devices. The operating characteristics, recommended use time, operating temperature and labeling of the proposed Therapik were also compared to corresponding characteristics of the currently marketed Li's Itch Stopper.
Clinical safety and effectiveness data from clinical trials on the Therapik device conducted in Venezuela (35 subjects) and France, Italy and Reunion (34 subjects) was presented. The 69 total users applied the Therapik to a variety of stings and bites from venomous insects and sea creatures such as bees, wasps, hornets, ants, fleas, ticks, nettles, weaver fish and jellyfish. Each user was asked to rate the effectiveness of the device in relieving pain and inflammation from the injuries using a subjective rating of 1 (total/complete disappearance of the pain), 2 (distinct alleviation of pain), 3 (slight alleviation of pain) or 4 (not effective). Device ratings were as follows:
Total/complete disappearance of pain = 61/69 users Distinct alleviation of pain = 7/69 users Slight alleviation of pain = 1/69 users Not effective = none
No serious side effects related to the use of the Therapik were reported.
A fifty-subject study on a similar device (Body-Pic) marketed in Canada was also referenced, here, fifty users reported the device to be effective when used to treat the stings and bites of bees, wasps, ticks, hornets, sand fleas, ants, and Brulots (mosquitoes).
(Note: Although the clinical data included a variety of insect and sea creature injuries, Therapik is not indicated at this time for the treatment of stings/bites of animals and insects other than bees and wasps).
Conclusion:
Based on the indications for use, technological characteristics, and clinical testing, the Therapik device has been shown to be safe and effective for its intended use.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela Papineau ·Delphi Medical Device Consulting Representing Thermolabile Technologies Corporation 50 Brewster Street Pawtucket, Rhode Island 02860
. . . . . .
NOV - 4 1997
Re: K964397 Trade Name: Therapik® Requlatory Class: II Product Code: ILY Dated: August 19, 1997 Received: August 21, 1997
Dear Ms. Papineau:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Pamela Papineau
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page __ 1 _ of __ 1
510(k) Number (if known): __ K964397/A2_______________________________________________________________________________________________________________________________________
Device Name: Therapik®
Indications for Use:
The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K964397 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the -Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------------------------------- |
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.