(190 days)
Not Found
No
The description mentions a "programmable microprocessor" and "software controls the sequential opening and closing of the solenoid valves," which indicates standard programmed logic, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond a "preset therapy program."
Yes.
The device is intended for the treatment of various medical conditions such as lymphedema and venous insufficiencies, indicating its therapeutic purpose.
No
The device description and intended use clearly state that it is for "treatment of lymphedema, venous insufficiencies, and other edematous conditions" and "intended to improve lymphatic and venous return circulation," which are therapeutic purposes, not diagnostic ones.
No
The device description clearly outlines hardware components including a pneumatic compression pump, hose assembly, inflatable appliances, air compressor, solenoid valves, printed circuit board, graphic display, and associated electronic and pneumatic connections. While software controls the operation, it is integral to a physical system.
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 lymphedema, venous insufficiencies, and other edematous conditions. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples from the human body.
- Device Description: The device is a pneumatic compression system that applies external pressure to the body. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device operates externally on the patient's body.
Therefore, the Wright Gradient 52 - Torso and Wright 51 - Torso are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Wright Gradient 52 - Torso and Wright 51 - Torso is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Product codes
JOW
Device Description
The Wright Gradient 52 - Torso and Wright 51 - Torso consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances. It is typically used to compress upper and lower body extremities and portions of the torso.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential. opening and closing of the solenoid valves, which are connected to five (5) external pressure ports.
The appliance assembly is made of fabric and consists of one or two limb appliances (for an arm or a leg) and a torso appliance (for abdomen or chest area). Each limb appliance comprises four cells, with the dimensions of the appliance dependent upon the physician's order and the patient's limb measurements. There are two basic variations of the torso appliance: (1) a vest-like appliance for compression of the upper torso; and (2) a girdle-like appliance for compression of the lower torso. In each case the dimensions of the appliance dependent upon the physician's order and the patient's anatomical measurements.
In operation, the pump fills the inflatable appliance(s) with air to compress the prescribed limb(s) and torso area with the prescribed pressures in a preset therapy program. The therapy program is based on manual fymph drainage massage principles and intended to improve ymphatic and venous return circulation for the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower body extremities and portions of the torso
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
The evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices and bench tests to verify conformity to performance specifications. Bench performance testing consisted of measurements of the sequences, timing, and pressure of therapy delivery along with verification of the functionality of the operator interface. Bench performance testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K131387
510(k) Summary per 21 CFR 807.92 13.
Date Prepared
Submitter Information
May 10, 2013
Wright Therapy Products 103-B International Drive Oakdale, PA 15071-3907
NOV 20 2013
Telephone: 800-631-9535 Fax: 724-695-0406
Contact Person
Proprietery name of Device
Common Name:
Device Classification:
Predicate Device
Carol Wright, Chief Technology Officer
Wright Gradient 52 - Torso and Wright 51 -Torso
Pneumatic compression pump
21 CFR 870.5800, Class II, Sleeve, Limb, Compressible Product Code JOW
Wright 51 and 52 Sequential Compression System (K071040)
Device Description:
The Wright Gradient 52 - Torso and Wright 51 - Torso consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances. It is typically used to compress upper and lower body extremities and portions of the torso.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential. opening and closing of the solenoid valves, which are connected to five (5) external pressure ports.
The appliance assembly is made of fabric and consists of one or two limb appliances (for an arm or a leg) and a torso appliance (for abdomen or chest area). Each limb appliance comprises four cells, with the dimensions of the appliance dependent upon the physician's order and the patient's limb measurements. There are two basic variations of the torso appliance: (1) a vest-like appliance for compression of the upper torso; and (2) a girdle-like appliance for compression of the lower torso. In each case the dimensions of the appliance dependent upon the physician's order and the patient's anatomical measurements.
In operation, the pump fills the inflatable appliance(s) with air to compress the prescribed limb(s) and torso area with the prescribed pressures in a preset therapy program. The therapy program is based on manual fymph drainage massage principles and intended to improve ymphatic and venous return circulation for the patient.
1
Intended Use
Wright Gradient 52 - Torso and Wright 51 -- Torso is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Summary of technological characteristics compared to the predicate devices.
The Wright Gradient 52 -- Torso and Wright. 51 -- Torso has the following similarities to the technological characteristics of the previously cleared predicate device: Wright 51 and 52 Sequential Compression System, K071040):
- . Same intended use
- Same operating principle .
- Same fundamental scientific technology ●
- . Same pump design
- Same materials used .
- Similar appliance design .
- Similar compression sequence .
The Wright Gradient 52 - Torso and Wright 51 - Torso has the following differences in technological characteristics of the previously cleared predicate device (Wright 51 and 52 Sequential Compression System, K071040):
- The maximum pressure on the torso cell has been reduced to 30 mmHg. ●
- The appliances have been changed to include torso appliances and 4-cell limb appliances. .
- The inflation sequence has been revised. .
- The software algorithm for inflation and deflation is revised to accurately control pressure . � during the variable therapy program and the unique geometry of the torso cells.
Summary of non-clinical testing submitted, referenced, or relied on in the 510(k)
The evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices and bench tests to verify conformity to performance specifications. Bench performance testing consisted of measurements of the sequences, timing, and pressure of therapy delivery along with verification of the functionality of the operator interface. Bench performance testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.
Conclusion
Based on the above, we concluded that the Wright Gradient 52 -- Torso is substantially equivalent to the identified legally marketed predicate device, is safe and effective for its intended use, and performs as well as the predicate device.
End of section.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, featuring a staff with three wavy lines representing snakes.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2013
Wright Therapy Products Ms. Carol Wright Chief Technology Officer 103-B International Drive Oakdale, PA 15071-3907
Re: K131387
Trade/Device Name: Wright 51 - Torso Wright Gradient 52 - Torso Regulation Number: 21 CFR 870.5800 Regulation Name: Cardiovascular Regulatory Class: Class II Product Code: JOW Dated: August 21, 2013 Received: August 23, 2013
Dear Ms. Wright:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Carol Wright
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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. EDWARDS
for Bram Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
ર્. Indications for Use
5 l 0(k) Number (if known):
Device Name: Wright Gradient 52 - Torso and Wright 51 - Torso
Indications For Use:
Wright Gradient 52 - Torso and Wright 51 - Torso are for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ﻌﺒﮧ ﻋ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MEDA
Page 1 of _1
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