(293 days)
Not Found
No
The description mentions a "microprocessor controlled pneumatic compression device" with "pre-programmed" treatment programs. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is intended for use in treating various medical conditions, such as lymphedema, edema, and venous insufficiencies, and is used by medical professionals and patients under medical supervision.
No
The device description states that the biotouch™ device is a "microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest" for treating conditions like lymphedema, not for diagnosing them.
No
The device description explicitly states it consists of a "microprocessor controlled pneumatic compression device" with a "lightweight, portable pneumatic controller" and "extremity garments composed of 4 to 16 chambers," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the biotouch™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for treating various conditions like lymphedema and edema by applying pneumatic compression. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a pneumatic compression device that applies pressure to the body. This aligns with a physical therapy or rehabilitation device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the biotouch™ device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sport injuries
- Post immobilization edema
- Venous insufficiencies
- Lymphedema.
Product codes
IRP
Device Description
The TSTI biotouch™ device is a microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest. The device consists of two major components:
- lightweight, portable pneumatic controller, and .
- extremity garments composed of 4 to 16 chambers. .
The controller is pre-programmed with thirteen separate treatment programs. which consists of pre-determined sequences and inflation times and should be used under medical supervision. The device is provided to the end-user in individual cartons to ensure safe shipping and arrival of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm, leg, trunk, and/or chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home, who are under medical supervision
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
Performance testing was completed to verify the design specifications necessary for the biotouch™ device. Test results support the safety and performance of the biotouch™ device for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
JUL 1 2002
Tactile Systems Technology, Inc.
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
Eric McKee
Tel: (763) 434-2888 Fax: (763) 434-4161
Tactile Systems Technology, Inc. 1074 Legion Street Shakopee, MN 55379 Tel: (952) 445-7578 Fax: (952) 445-1864
2. General Information
| Trade Name: | biotouch™ Massage Therapy System |
|---|---|
| Classification Name: | Massager, Powered Inflatable Tube |
| Classification: | This device has been classified by the Division of Physical |
| Medicine into Class II (21 CFR 890.5650) as a Massager, | |
| Powered Inflatable Tube |
3. Device Description
The TSTI biotouch™ device is a microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest. The device consists of two major components:
- lightweight, portable pneumatic controller, and .
- extremity garments composed of 4 to 16 chambers. .
The controller is pre-programmed with thirteen separate treatment programs. which consists of pre-determined sequences and inflation times and should be used under medical supervision. The device is provided to the end-user in individual cartons to ensure safe shipping and arrival of the device. (See Attachment B for device drawings.)
4. Intended Use
The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:
- Primary lymphedema ●
- Post mastectomy edema .
- Edema following trauma and sport injuries ●
- Post immobilization edema .
- Venous insufficiencies .
- Lymphedema. .
CONFIDENTIAL
1
5. Substantial Equivalence Comparison
The biotouch™ device is substantially equivalent to the following devices with respect to intended use, design, materials and construction:
- (Progressive Medical Technology, Inc., Multipulse Sequential Compression . Unit (K914774))
No new safety and/or effectiveness issues are raised.
6. Summary of Studies
Performance testing was completed to verify the design specifications necessary for the biotouch™ device. Test results support the safety and performance of the biotouch™ device for its intended use.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the biotouch™ device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 JUL
Mr. Eric McKee President Tactile Systems Technology, Inc. 1074 Legion Street Shakopee, MN 55379
Re: K013061
Trade/Device Name: biotouch™ Massage Therapy System Regulation Number: 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: April 12, 2002 Received: April 15, 2002
Dear Mr. McKee:
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.
3
Page 2 - Mr. Eric McKee
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 Plude
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
Enclosure
4
Indications for Use Statement
Page 1 of 1
The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sport injuries
- Post immobilization edema
- Venous insufficiencies
- · Lymphedema.
Stupt. Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013061