(183 days)
Not Found
No
The device description and performance studies focus on mechanical compression and pressure control, with no mention of AI or ML algorithms.
Yes
The device is intended for the treatment of conditions such as chronic edema, lymphedema, venous insufficiency, and wound healing, which directly relates to therapy.
No
The device description and intended use indicate that the entré System is a therapeutic device designed for treatment (e.g., providing compression for chronic edema, lymphedema, venous insufficiency, and wound healing), not for diagnosing conditions.
No
The device description explicitly states that the system consists of a controller and a garment, which are hardware components. The controller fills the garment chambers with air for compression.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of conditions like chronic edema, lymphedema, venous insufficiency, and wound healing. This involves applying physical compression to the body.
- Device Description: The device is a compression system consisting of a controller and a garment that applies air pressure to an extremity. This is a physical therapy/treatment device.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body) to provide therapeutic treatment.
N/A
Intended Use / Indications for Use
The entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- · Chronic edema
- · Lymphedema
- · Venous insufficiency
- · Wound healing
Product codes
JOW
Device Description
The entré model PD08-U system consists of two main components: A controller and a garment. The garment is to be wrapped around the affected extremity providing a snug yet comfortable fit. The garment will have eight (8) chambers that are filled with air by the controller to provide compression on the extremity. A harness assembly consisting of eight (8) individual tubes will connect individual chambers with the controller. The controller has an internal valve manifold with a directly connected single eight (8) port connector extension that is accessible to the user on the front panel allowing easy garment connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
affected extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing and analysis was completed to verify the substantial equivalence between the entré model PD08-U, the subject of this submission, and the predicate devices.
Garment Chamber Pressure Testing: Both the entré model PD08-U and the predicate devices operate within similar pressure ranges. Pressure testing was performed to verify that the target pressures were met as stated in the device labeling.
Cycle Time Testing: Predicated devices and the entré model PD08-U are pressure based. Comparative cycle time data was recorded and evaluated. Both devices performed similarly and as stated in the device labeling.
Additional Testing: Additional non-clinical testing performed for the entré model PD08-U included:
- Electromagnetic Safety (IEC 60601-1-2:2007)
- Electrical Safety (IEC 60601-1:2005)
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.
Petite Basic System 701 ELT (K131420), CircuFlow 5150 (K123959), CircuFlow 5208 (K123647)
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.
Not Found
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2015
Tactile Systems Technology Inc Daniel Chase V.P. Engineering & Operations 1331 Tyler St NE Minneapolis, Minnesota 55413
Re: K143185
Trade/Device Name: entré Model PD08-U Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 27, 2015 Received: March 30, 2015
Dear Daniel Chase.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143185
Device Name entré Model PD08-U
Indications for Use (Describe)
The entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- · Chronic edema
- · Lymphedema
- · Venous insufficiency
- · Wound healing
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Tactile Medical. The logo features a stylized letter "T" in blue and gray, with the top of the "T" forming a triangle. To the right of the "T" is the word "Tactile" in blue, with the word "MEDICAL" in gray underneath. The logo is clean and modern, with a focus on the company's name.
510(k) Summary: K143185
| Submission Date: | April 30, 2015 |
|---|---|
| Submitter: | Daniel G. Chase |
| VP, Engineering and Operations | |
| Tactile Medical | |
| 1331 Tyler Street NE, Suite 200 | |
| Minneapolis, MN 55413 USA | |
| Telephone: (612) 355-5133 | |
| Contact Person: | Daniel G. Chase |
| Name of Device: | entré Model PD08-U |
| Classification: | Compressible Limb Sleeve (21 CFR 870.5800) |
| Predicate Devices: | Petite Basic System 701 ELT (K131420) |
| CircuFlow 5150 (K123959) | |
| CircuFlow 5208 (K123647) |
Device Description
The entré model PD08-U system consists of two main components: A controller and a garment. The garment is to be wrapped around the affected extremity providing a snug yet comfortable fit. The garment will have eight (8) chambers that are filled with air by the controller to provide compression on the extremity. A harness assembly consisting of eight (8) individual tubes will connect individual chambers with the controller. The controller has an internal valve manifold with a directly connected single eight (8) port connector extension that is accessible to the user on the front panel allowing easy garment connection.
Intended Use
The entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- . Chronic edema
- Lymphedema ●
- Venous insufficiency
- Wound healing ●
4
Image /page/4/Picture/0 description: The image shows the logo for Tactile Medical. The logo consists of a blue stylized letter "T" that also resembles a house, with the word "Tactile" in blue next to it. Below "Tactile" is the word "MEDICAL" in gray, with a blue line underneath.
Comparison of Technical Characteristics
The entré model PD08-U system has the same technological characteristics to the predicate devices with respect to intended use, design, materials used, and construction. The device has been certified to be compliant with ANSI/AAMI ES60601-1, IEC 60601-1 Ed. 3, CAN/CSA C22.2 No. 60601-1 (Medical Electrical Equipment- General require for Safety), EN 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-6 (Usability), and IEC 60601-1-11 (In-Home Medical Equipment).
Test Summary
The following performance testing and analysis was completed to verify the substantial equivalence between the entré model PD08-U, the subject of this submission, and the predicate devices.
Garment Chamber Pressure Testing .
Both the entré model PD08-U and the predicate devices operate within similar pressure ranges. Pressure testing was performed to verify that the target pressures were met as stated in the device labeling.
. Cycle Time Testing
Predicated devices and the entré model PD08-U are pressure based. Comparative cycle time data was recorded and evaluated. Both devices performed similarly and as stated in the device labeling.
. Additional Testing
Additional non-clinical testing performed for the entré model PD08-U included:
- Electromagnetic Safety (IEC 60601-1-2:2007) o
- o Electrical Safety (IEC 60601-1:2005)
Substantial Equivalence Conclusion
The results from nonclinical device testing demonstrates that the entré model PD08-U system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate devices for its intended use.