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.

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.

AI/ML Overview

This document is a 510(k) summary for the biotouch™ Massage Therapy System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

A table of acceptance criteria and the reported device performance: This information is not present. The document states "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," but no specific criteria or results are detailed.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided. This type of device (a pneumatic compression system) typically doesn't involve "ground truth" derived from expert image interpretation in the same way an AI-driven diagnostic tool would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 is a physical therapy device, not an AI-driven diagnostic or image analysis tool. There are no "readers" in the context of an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, and likely not applicable in the way it would be for a diagnostic algorithm. Performance for such a device would typically relate to pressure accuracy, cycle timing, durability, and safety, not diagnostic ground truth.
The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document is a 510(k) submission summary for a physical medical device. It indicates that performance testing was completed and supports the safety and performance, but it does not provide any specific acceptance criteria, performance metrics, or details about the studies conducted. The submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, materials, and construction, rather than presenting detailed performance study results against specific criteria.

Summary

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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 PhysicalMedicine into Class II (21 CFR 890.5650) as a Massager,Powered Inflatable Tube

3. Device Description

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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).